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mostlysignssomeportents · 1 year ago

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At long last, a meaningful step to protect Americans' privacy

This Saturday (19 Aug), I'm appearing at the San Diego Union-Tribune Festival of Books. I'm on a 2:30PM panel called "Return From Retirement," followed by a signing:

https://www.sandiegouniontribune.com/festivalofbooks

Privacy raises some thorny, subtle and complex issues. It also raises some stupid-simple ones. The American surveillance industry's shell-game is founded on the deliberate confusion of the two, so that the most modest and sensible actions are posed as reductive, simplistic and unworkable.

Two pillars of the American surveillance industry are credit reporting bureaux and data brokers. Both are unbelievably sleazy, reckless and dangerous, and neither faces any real accountability, let alone regulation.

Remember Equifax, the company that doxed every adult in America and was given a mere wrist-slap, and now continues to assemble nonconsensual dossiers on every one of us, without any material oversight improvements?

https://memex.craphound.com/2019/07/20/equifax-settles-with-ftc-cfpb-states-and-consumer-class-actions-for-700m/

Equifax's competitors are no better. Experian doxed the nation again, in 2021:

https://pluralistic.net/2021/04/30/dox-the-world/#experian

It's hard to overstate how fucking scummy the credit reporting world is. Equifax invented the business in 1899, when, as the Retail Credit Company, it used private spies to track queers, political dissidents and "race mixers" so that banks and merchants could discriminate against them:

https://jacobin.com/2017/09/equifax-retail-credit-company-discrimination-loans

As awful as credit reporting is, the data broker industry makes it look like a paragon of virtue. If you want to target an ad to "Rural and Barely Making It" consumers, the brokers have you covered:

https://pluralistic.net/2021/04/13/public-interest-pharma/#axciom

More than 650,000 of these categories exist, allowing advertisers to target substance abusers, depressed teens, and people on the brink of bankruptcy:

https://themarkup.org/privacy/2023/06/08/from-heavy-purchasers-of-pregnancy-tests-to-the-depression-prone-we-found-650000-ways-advertisers-label-you

These companies follow you everywhere, including to abortion clinics, and sell the data to just about anyone:

https://pluralistic.net/2022/05/07/safegraph-spies-and-lies/#theres-no-i-in-uterus

There are zillions of these data brokers, operating in an unregulated wild west industry. Many of them have been rolled up into tech giants (Oracle owns more than 80 brokers), while others merely do business with ad-tech giants like Google and Meta, who are some of their best customers.

As bad as these two sectors are, they're even worse in combination – the harms data brokers (sloppy, invasive) inflict on us when they supply credit bureaux (consequential, secretive, intransigent) are far worse than the sum of the harms of each.

And now for some good news. The Consumer Finance Protection Bureau, under the leadership of Rohit Chopra, has declared war on this alliance:

https://www.techdirt.com/2023/08/16/cfpb-looks-to-restrict-the-sleazy-link-between-credit-reporting-agencies-and-data-brokers/

They've proposed new rules limiting the trade between brokers and bureaux, under the Fair Credit Reporting Act, putting strict restrictions on the transfer of information between the two:

https://www.cnn.com/2023/08/15/tech/privacy-rules-data-brokers/index.html

As Karl Bode writes for Techdirt, this is long overdue and meaningful. Remember all the handwringing and chest-thumping about Tiktok stealing Americans' data to the Chinese military? China doesn't need Tiktok to get that data – it can buy it from data-brokers. For peanuts.

The CFPB action is part of a muscular style of governance that is characteristic of the best Biden appointees, who are some of the most principled and competent in living memory. These regulators have scoured the legislation that gives them the power to act on behalf of the American people and discovered an arsenal of action they can take:

https://pluralistic.net/2022/10/18/administrative-competence/#i-know-stuff

Alas, not all the Biden appointees have the will or the skill to pull this trick off. The corporate Dems' darlings are mired in #LearnedHelplessness, convinced that they can't – or shouldn't – use their prodigious powers to step in to curb corporate power:

https://pluralistic.net/2023/01/10/the-courage-to-govern/#whos-in-charge

And it's true that privacy regulation faces stiff headwinds. Surveillance is a public-private partnership from hell. Cops and spies love to raid the surveillance industries' dossiers, treating them as an off-the-books, warrantless source of unconstitutional personal data on their targets:

https://pluralistic.net/2021/02/16/ring-ring-lapd-calling/#ring

These powerful state actors reliably intervene to hamstring attempts at privacy law, defending the massive profits raked in by data brokers and credit bureaux. These profits, meanwhile, can be mobilized as lobbying dollars that work lawmakers and regulators from the private sector side. Caught in the squeeze between powerful government actors (the true "Deep State") and a cartel of filthy rich private spies, lawmakers and regulators are frozen in place.

Or, at least, they were. The CFPB's discovery that it had the power all along to curb commercial surveillance follows on from the FTC's similar realization last summer:

https://pluralistic.net/2022/08/12/regulatory-uncapture/#conscious-uncoupling

I don't want to pretend that all privacy questions can be resolved with simple, bright-line rules. It's not clear who "owns" many classes of private data – does your mother own the fact that she gave birth to you, or do you? What if you disagree about such a disclosure – say, if you want to identify your mother as an abusive parent and she objects?

But there are so many stupid-simple privacy questions. Credit bureaux and data-brokers don't inhabit any kind of grey area. They simply should not exist. Getting rid of them is a project of years, but it starts with hacking away at their sources of profits, stripping them of defenses so we can finally annihilate them.

I'm kickstarting the audiobook for "The Internet Con: How To Seize the Means of Computation," a Big Tech disassembly manual to disenshittify the web and make a new, good internet to succeed the old, good internet. It's a DRM-free book, which means Audible won't carry it, so this crowdfunder is essential. Back now to get the audio, Verso hardcover and ebook:

http://seizethemeansofcomputation.org

If you'd like an essay-formatted version of this post to read or share, here's a link to it on pluralistic.net, my surveillance-free, ad-free, tracker-free blog:

https://pluralistic.net/2023/08/16/the-second-best-time-is-now/#the-point-of-a-system-is-what-it-does

Image: Cryteria (modified) https://commons.wikimedia.org/wiki/File:HAL9000.svg

CC BY 3.0 https://creativecommons.org/licenses/by-sa/3.0/deed.en

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mariacallous · 8 months ago

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In his spare time, Tony Eastin likes to dabble in the stock market. One day last year, he Googled a pharmaceutical company that seemed like a promising investment. One of the first search results Google served up on its news tab was listed as coming from the Clayton County Register, a newspaper in northeastern Iowa. He clicked, and read. The story was garbled and devoid of useful information—and so were all the other finance-themed posts filling the site, which had absolutely nothing to do with northeastern Iowa. “I knew right away there was something off,” he says. There’s plenty of junk on the internet, but this struck Eastin as strange: Why would a small Midwestern paper churn out crappy blog posts about retail investing?

Eastin was primed to find online mysteries irresistible. After years in the US Air Force working on psychological warfare campaigns he had joined Meta, where he investigated nastiness ranging from child abuse to political influence operations. Now he was between jobs, and welcomed a new mission. So Eastin reached out to Sandeep Abraham, a friend and former Meta colleague who previously worked in Army intelligence and for the National Security Agency, and suggested they start digging.

What the pair uncovered provides a snapshot of how generative AI is enabling deceptive new online business models. Networks of websites crammed with AI-generated clickbait are being built by preying on the reputations of established media outlets and brands. These outlets prosper by confusing and misleading audiences and advertisers alike, “domain squatting” on URLs that once belonged to more reputable organizations. The scuzzy site Eastin was referred to no longer belonged to the newspaper whose name it still traded in the name of.

Although Eastin and Abraham suspect that the network which the Register’s old site is now part of was created with straightforward moneymaking goals, they fear that more malicious actors could use the same sort of tactics to push misinformation and propaganda into search results. “This is massively threatening,” Abraham says. “We want to raise some alarm bells.” To that end, the pair have released a report on their findings and plan to release more as they dig deeper into the world of AI clickbait, hoping their spare-time efforts can help draw awareness to the issue from the public or from lawmakers.

Faked News

The Clayton County Register was founded in 1926 and covered the small town of Ekader, Iowa, and wider Clayton County, which nestle against the Mississippi River in the state’s northeast corner. “It was a popular paper,” says former coeditor Bryce Durbin, who describes himself as “disgusted” by what’s now published at its former web address, claytoncountyregister.com. (The real Clayton County Register merged in 2020 with The North Iowa Times to become the Times-Register, which publishes at a different website. It’s not clear how the paper lost control of its web domain; the Times-Register did not return requests for comment.)

As Eastin discovered when trying to research his pharma stock, the site still brands itself as the Clayton County Register but no longer offers local news and is instead a financial news content mill. It publishes what appear to be AI-generated articles about the stock prices of public utility companies and Web3 startups, illustrated by images that are also apparently AI-generated.

“Not only are the articles we looked at generated by AI, but the images included in each article were all created using diffusion models,” says Ben Colman, CEO of deepfake detection startup Reality Defender, which ran an analysis on several articles at WIRED’s request. In addition to that confirmation, Abraham and Eastin noticed that some of the articles included text admitting their artificial origins. “It’s important to note that this information was auto-generated by Automated Insights,” some of the articles stated, name-dropping a company that offers language-generation technology.

When Eastin and Abraham examined the bylines on the Register’s former site they found evidence that they were not actual journalists—and probably not even real people. The duo’s report notes that many writers listed on the site shared names with well-known people from other fields and had unrealistically high output.

One Emmanuel Ellerbee, credited on recent posts about bitcoin and banking stocks, shares a name with a former professional football player. When Eastin and Abraham started their investigation in November 2023, the journalist database Muck Rack showed that he had bylined an eye-popping 14,882 separate news articles in his “career,” including 50 published the day they checked. By last week, the Muck Rack profile for Ellerbee showed that output has continued apace—he’s credited with publishing 30,845 articles. Muck Rack’s CEO Gregory Galant says the company “is developing more ways to help our users discern between human-written and AI-generated content." He points out that Ellerbee’s profile is not included in Muck Rack’s human-curated database of verified profiles.

The Register’s domain appears to have changed hands in August 2023, data from analytics service Similar Web shows, around the time it began to host its current financial news churn. Eastin and Abraham used the same tool to confirm that the site was attracting most of its readership through SEO, targeting search keywords about stock purchasing to lure clicks. Its most notable referrals from social media came from crypto news forums on Reddit where people swap investment tips.

The whole scheme appears aimed at winning ad revenue from the page views of people who unwittingly land on the site’s garbled content. The algorithmic posts are garnished with ads served by Google’s ad platform. Sometimes those ads appear to be themed on financial trading, in line with the content, but others are unrelated—WIRED saw an ad for the AARP. Using Google's ad network on AI-generated posts with fake bylines could fall foul of the company's publisher policies, which forbid content that “misrepresents, misstates, or conceals” information about the creator of content. Occasionally, sites received direct traffic from the CCR domain, suggesting its operators may have struck up other types of advertising deals, including a financial brokerage service and an online ad network.

Unknown Operator

Eastin and Abraham’s attempts to discover who now owns the Clayton County Register’s former domain were inconclusive—as were WIRED’s—but they have their suspicions. The pair found that records of its old security certificates linked the domain to a Linux server in Germany. Using the internet device search engine Shodan.io, they found that a Polish website that formerly advertised IT services appeared associated with the Clayton County Register and several other domains. All were hosted on the same German server and published strikingly similar, apparently AI-generated content. An email previously listed on the Polish site was no longer functional and WIRED’s LinkedIn messages to a man claiming to be its CEO got no reply.

One of the other sites within this wider network was Aboutxinjiang.com. When Eastin and Abraham began their investigation at the end of 2023 it was filled with generic, seemingly-AI-generated financial news posts, including several about the use of AI in investing. The Internet Archive showed that it had previously served a very different purpose. Originally, the site had been operated by a Chinese outfit called “the Propaganda Department of the Party Committee of the Xinjiang Uyghur Autonomous Region,” and hosted information about universities in the country’s northwest. In 2014, though, it shuttered, and sat dormant until 2022, when its archives were replaced with Polish-language content, which was later replaced with apparently-automated clickbait in English. Since Eastin and Abraham first identified the site it has gone through another transformation. Early this month it began redirects to a page with information about Polish real estate.

Altogether, Eastin and Abraham pinpointed nine different websites linked to the Polish IT company that appeared to comprise an AI clickbait network. All the sites appeared to have been chosen because they had preestablished reputations with Google that could help win prominence in search rankings to draw clicks.

Google claims to have systems in place to address attempts to game search rankings by buying expired domains, and says that it considers using AI to create articles with the express purpose of ranking well to be spam. “The tactics described as used with these sites are largely in violation of Search’s spam policies,” says spokesperson Jennifer Kutz. Sites determined to have breached those policies can have their search ranking penalized, or be delisted by Google altogether.

Still, this type of network has become more prominent since the advent of generative AI tools. McKenzie Sadeghi, a researcher at online misinformation tracking company NewsGuard, says her team has seen an over 1,000 percent increase in AI-generated content farms within the past year.

WIRED recently reported on a separate network of AI-generated clickbait farms, run by Serbian DJ Nebojša Vujinović Vujo. While he was forthcoming about his motivations, Vujo did not provide granular details about how his network—which also includes former US-based local news outlets—operates. Eastin and Abraham’s work fills in some of the blanks about what this type of operation looks like, and how difficult it can be to identify who runs these moneymaking gambits. “For the most part, these are anonymously run,” Sadeghi says. “They use special services when they register domains to hide their identity.”

That’s something Abraham and Eastin want to change. They have hopes that their work might help regular people think critically about how the news they see is sourced, and that it may be instructive for lawmakers thinking about what kinds of guardrails might improve our information ecosystem. In addition to looking into the origins of the Clayton County Register’s strange transformation, the pair have been investigating additional instances of AI-generated content mills, and are already working on their next report. “I think it’s very important that we have a reality we all agree on, that we know who is behind what we’re reading,” Abraham says. “And we want to bring attention to the amount of work we��ve done just to get this much information.”

Other researchers agree. “This sort of work is of great interest to me, because it’s demystifying actual use cases of generative AI,” says Emerson Brooking, a resident fellow at the Atlantic Council’s Digital Forensic Research Lab. While there’s valid concern about how AI might be used as a tool to spread political misinformation, this network demonstrates how content mills are likely to focus on uncontroversial topics when their primary aim is generating traffic-based income. “This report feels like it is an accurate snapshot of how AI is actually changing our society so far—making everything a little bit more annoying.”

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americanmysticom · 2 years ago

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“THIS IS TRAGIC, ABSOLUTELY TRAGIC” - THE RISE OF ‘TURBO CANCER’

Sudden Death + Turbo Cancer: Canadian Doctors Speak Out

“When parts of your body become gangrenous, you have to cut it out”

https://rumble.com/v1tn9xu-sudden-death-turbo-cancer-canadian-doctors-speak-out.html

download mp4; https://icedrive.net/s/DZFzv8x8Z7xuaN37fi5gkvDXP36F

See Also

Pfizer's History of Fraud, Corruption, and Using Nigerian Children as 'Human Guinea Pigs'

How did Pfizer manage to rebrand itself as the savior of humanity?

https://kanekoa.substack.com/p/pfizers-history-of-fraud-corruption

One of the most significant cultural transformations of the last two years has been the newfound glorification of the pharmaceutical industry.

An industry plagued by decades of fraud, corruption, and criminality managed to quickly rebrand itself as the savior of humanity during the covid-19 crisis.

But nothing inherently changed. Big Pharma still values shareholders’ profits more than people’s lives.

The regulatory agencies still operate as revolving doors to the pharmaceutical giants they are said to regulate.

Big Pharma still dominates lobbying efforts in Washington DC and spends billions each year advertising pharmaceutical products.

Millions will die; https://rumble.com/v1acoaa-up-to-100-million-will-die-from-cv19-vax-by-2028-dr-david-martin.html download mp4; https://icedrive.net/s/XvAxN8ht469Bfai7kyAfQXbC8xjb

https://americasfrontlinedoctors.org/medical

https://www.canadiancovidcarealliance.org/

https://childrenshealthdefense.org/

https://rumble.com/user/childrenshealthdefense

see also: https://covid19criticalcare.com/treatment-protocols/

#turbo cancer #pfizer fraud #corporate gangrene #it's not a vaccine

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mportal · 7 months ago

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I uh…accidentally went wild on this one 😅 Having worked in the field, I can say most of this would never happen (but unfortunately not the costs info, depending on the drug), but it was fun to write anyway

Once upon a time, you wanted to be a research scientist. Not a doctor, as your parents had hoped (a brief stint as a junior EMT had helped you with that decision), but something medical where you might be able to help somebody. You were only two years in when everything fell apart. Cancer took your father early, and stress made a shell out of your mother, finally taking her a year later. Student loans kept you in school, but they weren’t a joke, and suddenly all that mattered was graduating on time with a workable degree that would get you a salary immediately. Failing Orgo 1 a second time made it all the more urgent.

The communications school was always accepting students from other majors. They even accepted all your current class credits.

It was an easy call.

Several years later found you languishing at a desk job. With your (limited) chem background and handful of summer internships, the pharmaceutical advertising agencies had snapped you right up. It was interesting work, and it paid the bills, but there were only so many ways to market oncology drugs without getting demoralized.

Coffee in the morning and wine in the evening helped. And the bonus you got every January for growing the agency’s contract with your client certainly never hurt.

You were in the middle of trying to grow that business right now, in fact.

“How long until we get the first shots back for review?” your client asked.

You bit back the urge to snap that you were literally still at the photoshoot, weren’t you? and gave them a well-rehearsed sympathetic look instead. “I know there’s a lot of pressure for the new campaign, and we’ll get you the initial shot list as quickly as we can. I can’t know for sure until the creative team takes a look, but probably Wednesday.”

“Wednesday!” Your client took a breath and ran a nervous hand through their hair. “Wednesday. Okay.” They took another breath. You could see how hard they were trying to control themselves. Seemed like the feedback your boss gave on their temper during last month’s review was having an effect. You wondered how long that effect would last. “Okay. But if you have a working shot list earlier than that and want to send it my way, just between the two of us, I’d be happy to give early input.”

You smiled easily and unfeelingly. “Of course. If I get a working list,” which you would, “then I’ll pass it over,” which you wouldn’t. Well, maybe a few photos that you knew would be favorites. But the timeline was already crunched and the creatives didn’t need to worry about an extra round of feedback to incorporate.

You looked at the executive team posing in front of the company logo and bitterly wondered what they were expected to turn around by Wednesday.

“You’re still planning to take some shots in the lab, right?” your client probed, cutting in on the thought.

“I saw you approved the budget. Did you also get the permissions?” You looked at your client when they didn’t answer right away. They were on their phone, probably checking to see if the lab manager had responded. Seemed a bit late to be doing that, but they controlled the money so you didn’t comment.

Your client looked up at the ceiling and sighed. No permissions, then. Cool.

“Look, forget about the permissions,” they eventually said. “The revenue tied to our campaign last year made this year’s research budget, so I’m giving you my permission.” You were pretty sure it didn’t work that way but, well…small pharma companies worked fast and loose compared to more established ones, and it would be on your client if anything went wrong. Plus, you really didn’t want to sacrifice this year’s bonus.

“Can you send that to me in writing?”

Your client was tap-tapping away on their phone even as you spoke. Yours buzzed in your back pocket. New email.

“Done,” your client said.

They led you up three flights of stairs to a glass cube containing more glass cubes all sitting in the middle of an empty floor. It was very futuristic looking, like a lab built expressly to impress investors and management.

The photographer ate it up, and you had to admit the first shots through the outer walls were already looking promising. And the next set of shots from inside the lab were even better. So what if you had to wear some protective suit that wrinkled your new blazer all while suffering frustrated side glances from the bothered scientists? You’d be out of there soon enough.

“How about a shot of the new manufacturing array?” your client asked, pointing through a locked door. “It’s in the inner room.”

You tried to peer into the room but strange disks embedded in the semi-transparent walls obstructed your view. Even so, you could make out the vague silhouettes of researchers bent over their tables and the slow moving mechanical arms they controlled, but could see nothing of what they were manipulating. “Can we really go in there?”

“Absolutely. The new corporate campaign needs to be striking. Completely different. We need shots of the array.”

You shrugged. “Sounds good.”

But it wasn’t good. You had been in the industry long enough to know that, though it was easy to ignore when the reward was high. And when your client was so practiced at making the alternative unpleasant. Purposely forgetting everything outside driving results for analytics reports and budget meetings had become second nature. It was survival. But reality didn’t forget. Diseases didn’t grow content. Nature, true nature, didn’t discriminate. A body was a body was a body.

The mistake was a simple one. A hand on the wrong surface at the wrong time, a delayed reaction, a broken vial. Easily understood, and unforgiving all the same.

You woke up in the hospital. First, the nurses and doctors came to talk to you. Then some executives came. Then the lawyers.

Your photographer was dead. Your client was dead. The scientists who had been working the inner room were all dead.

But you? You were healthier than you ever had been. Supposedly because of your smaller frame or something to do with genetics—or was it a combination of the two? They weren’t sure—the concentration of the aerosolized therapy was sufficient to overpower your body’s immediate immune response.

Your earring holes had healed. You had grown back your appendix. The scars on your knees from years of soccer were gone.

They wanted you to sign a contract and promised to keep the police out of it. After all, the deaths had already been ruled accidental and the company executives had been advised on a settlement cost, so no one had to be blamed. It could be written off as an unfortunate tragedy and nice company tax break... provided you cooperated. And there would be benefits if you did, of course.

You had a bachelors degree, a used Honda civic, a rented 2nd story one-bedroom, and a handful of plants. You had no close family left, no kids. No pets since Marshmallow, and that was back in high school. Your boss would wonder what exactly had happened, but that was easily handled. And maybe the guy you had been seeing would, too, though the way you left it after last week’s disaster of a date, maybe he wouldn’t.

There was no one to fight for you. And, honestly, not much to fight for.

It was an easy call.

Cooperation turned out to mean moving into a very nice apartment in their on-site facility, maxing out your disability time, and then quitting your job, all under the advice of the company lawyers. You went in for weekly blood tests and tissue samples, and took whatever pills they handed you, but you received a nice monthly stipend and endless amenities. It was all worth it, according to the executives. A very neat and mutually beneficial contract, as stated by the lawyers.

During your weekly exams, you tried to be unaffected by the looks the treatment team shot at you. They hadn’t worked closely with any of the researchers that died, but they still seemed to have opinions about it. In your free time, you worked hard to ignore what felt like constant buzzing under your skin and slept fitfully in an unfamiliar bed with overly starched sheets. You didn’t have to worry about accidentally cutting yourself with kitchen knives or careless burns from the curling iron anymore, but you cooked less and less and never dressed up. There didn’t seem to be any point.

Within a few months, their research had been launched forward by a decade. Before you had even adjusted to your new reality (unending guilt and isolation, no longer needing to wear contacts) they were already moving the therapy into clinical trials.

The first time you met one of the patients, a trial participant, willing and desperate and considering themselves so lucky, you felt like maybe there was a point after all.

She wasn’t much older than you, but she had a family and she wanted to live. And when she learned about your role in the study, she hugged you and thanked you profusely. Her gratitude felt unearned. And it didn’t seem right that you would live, and she wouldn’t, unless she received the treatment (“Your treatment,” she had called it). If she received it. And if it took, rewiring her immune cells and fibroblasts and everything else just like the researchers (who were left) thought it would. And it did take, for the participants who ended up in the right trial arm. It took quickly, too, within days.

But not for that young mother, apparently. Two weeks later, she was still coming in for tests. And she didn’t improve. And, eventually, she was admitted.

You spent more time together after that. As you got to know each other, you worked up the courage to ask if she had been in the control arm. She gave you a weak smile.

“Nope. I was one of the lucky ones. Just not lucky enough. I’m too far along for the treatment to work, they think. If it were years down the line, after a few more trials, when they get the concentration right, closer to how it is in your body…then maybe it would work for someone like me. But who has that kind of time?” She laughed. You didn’t.

“It’s ok,” she said, comforting you and wasn’t that strange. “Really. Maybe just by being in the study, I’ll have helped them make a better treatment. Maybe in a few years, it really will work for someone like me, because of me. That’s not so bad.”

But it felt hollow. It felt like somewhere someone had messed up, switched your fates. If only you could have given her your healing ability. If only they could match the concentration of the treatment to what was in your own body. The thought gnawed at you.

It wasn’t an easy call. It felt right, though. Or, you thought it did, at the time.

It had been years since your EMT days, but you started to pay attention during your usual blood draws. You asked more questions. You watched when they swapped out your friend’s empty blood bags, trying to fight the ongoing bleeds as her body slowly shut down.

You waited until you felt something close to confident, and slipped in at midnight. Nursing staff was minimal. The physicians were on home call, disturbed only in emergencies. You had your own pass. You were there all the time, after all. You were under contract.

Your friend’s room was dark but she knew it was you immediately. “I can’t,” she said, when you made the offer. “Okay, I can,” she relented, when you reminded her that her daughter’s graduation was coming up.

The needles slid in with almost no resistance. Within minutes, it was all set up. Your blood came flooding out, and her body eagerly accepted it. It was fine. It was right, you told yourself. And not a bad way to go, if that’s what it came to.

You woke up in the hospital. First, the nurses and doctors came to talk to you. Then some executives. Then the lawyers.

She was dead. You weren’t. After almost bleeding out, your body repaired the needle hole and replenished itself. Your friend’s body went wild in its immune response, something the doctors called a cytokine storm. Your healing factor hadn’t been enough, not at the concentration they found in her body, not at your relative sizes.

The idea had some merit, but she was going to die anyway, your usual doctor whispered to you as you sobbed into a scratchy hospital pillow. But it had been recklessly done. Unthinking, unstudied. He looked at you hard as your breath came out ragged. Maybe if she had been smaller…he trailed off, finished checking your vitals, and left. When you finally gathered the strength to sit up, you saw he had left a jello cup on your bedside table. It was red. You liked red.

When the lawyers came back the next morning it was with the executives. That was new. It turned out to also be bad. Someone had talked to the media and you were going to be transferred into government care. What did that mean? No one knew, but it was all over the news. The truth about the freak accident at the lab, the freak lady who wouldn’t die, the company executives’ freakish decision to conceal deaths and progress and money.

Your doctor came by again later to check on you. He left another jello cup.

They’re sending you to the military. Get out, read a piece of paper folded beneath it.

Midnight, and the hospital was a skeleton crew. You didn’t have a pass anymore but it didn’t matter. You opened your room window. Below you was the back alley between the old main building you were in and the newer outpatient center. It was dark in the space between, secluded, with only a dumpster. You were pretty sure you could line yourself up right.

Even if you couldn’t, it was still an easy call.

You jumped.

You are a supervillain with healing powers. The only reason you are labelled a supervillain because the American healthcare system is intimidated by you.

#writeblr #writers on tumblr #writing prompts #writers #short story #superhero #my writing #trigger warning #eating disoder trigger warning #suicide trigger warning #trigger warning ed

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darkmaga-returns · 1 day ago

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All of the news today was around the election so this Substack today is a short one. I am sure you all know Trump won.

Big Pharma is literally shaking in their boots, preparing for unleashing of RFK Jr on them...by Sasha Latypova - I cannot express my joy at RFK Jr. being brought in to the Trump administration. I think he will finally be able to prove that vaccines are making our children sick and to get rid of the corruption and conflict of interest in our health agencies. I would rather he shut them down but I will be happy if he cleans them up. First, line of business is to fire everyone in HHS/NIH/CDC/FDA. ARTICLE

Archbishop Viganò: Trump’s victory is a formidable setback for the New Word Order - ARTICLE

"Now we can all breathe easy and put the murderers like Gates, Fauci and other evil elites in jail." - ARTICLE

With RFK Jr. Poised to Assume Key Role in Public Health, Kids Could Finally Have an Ally in Washington - remember the woman in the CNN interview is paid by big pharma advertising. I would like her to tell a room full of mothers whose children were perfectly normal, walking, talking, playing, laughing, potty trained that turned into fully dependent children who no longer could walk, talk, laugh, use a potty or even know who the mother is after getting vaccinated that the vaccine had nothing to do with it. ARTICLE/VIDEOS (1=3 min., 1=3 min.)

Trump Defeats Everything - by Tom Woods ARTICLE

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agnivesh09 · 2 months ago

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Top 7 Regulatory Services Changes Pharma Businesses Should Prepare for in 2024

The pharmaceutical industry is navigating an era of unprecedented regulatory transformation. As we approach 2024, several critical regulatory changes are set to impact the pharmaceutical sector significantly. Staying ahead of these changes is essential for businesses aiming to maintain compliance, streamline operations, and ensure continued market access. Here are the top seven regulatory services changes pharma businesses should prepare for in 2024.

1. Enhanced Drug Approval Processes

In 2024, regulatory agencies like the US FDA and EMA are expected to implement streamlined drug approval processes to accelerate the availability of new therapies. The focus will be on implementing adaptive regulatory pathways and real-world evidence (RWE) to expedite approvals. Pharma companies must be prepared to engage with these new frameworks, which may involve more frequent interactions with regulatory bodies, greater emphasis on early-phase data, and the integration of post-market surveillance data to support ongoing efficacy and safety profiles.

2. Increased Emphasis on Digital Health Technologies

With the rapid advancement of digital health technologies, regulatory agencies are anticipated to tighten regulations surrounding digital therapeutics, mobile health apps, and other tech-based health solutions. Companies developing these technologies will need to ensure compliance with new standards for data security, patient privacy, and clinical validation. The EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are likely to become more stringent, requiring comprehensive documentation and rigorous testing of digital health products.

3. New Standards for Pharmacovigilance

Pharmacovigilance is undergoing significant changes to enhance drug safety monitoring. In 2024, regulatory bodies will impose stricter requirements for adverse event reporting and risk management plans. Companies will need to invest in advanced pharmacovigilance systems to manage and analyze large volumes of data efficiently. Additionally, there will be an increased focus on the integration of data from various sources, including electronic health records (EHRs) and patient registries, to improve safety signal detection and risk assessment.

4. Tighter Environmental Regulations

Environmental sustainability is becoming a critical focus for regulatory agencies. New regulations are expected to address the environmental impact of pharmaceutical manufacturing and disposal. Companies will need to adopt greener practices, such as reducing waste, minimizing the carbon footprint, and ensuring proper disposal of pharmaceutical products. Compliance with environmental regulations will not only be a legal obligation but also a growing expectation from stakeholders and consumers concerned about sustainability.

5. Stricter Transparency Requirements

Transparency in clinical trial application and drug development processes is gaining prominence. Regulatory bodies are increasingly requiring pharma companies to disclose detailed information about clinical trial results, including both positive and negative outcomes. In 2024, there will likely be stricter guidelines on data sharing and transparency, aimed at preventing selective reporting and enhancing public trust. Companies will need to implement robust systems for data management and ensure compliance with new transparency requirements to avoid regulatory penalties and reputational damage.

6. Revised Labeling and Advertising Standards

Regulatory changes in labeling and advertising standards are on the horizon, reflecting a shift towards more comprehensive and transparent communication about drug products. New guidelines will likely mandate clearer information on drug indications, contraindications, and potential side effects. Additionally, there will be stricter controls on advertising practices to prevent misleading claims and ensure that promotional materials are accurate and substantiated. Pharma companies must update their labeling and marketing strategies to align with these evolving standards.

7. Focus on Personalized Medicine Regulations

Personalized medicine is a rapidly growing field that requires tailored regulatory approaches. In 2024, regulators are expected to refine guidelines related to genomic data, biomarker-driven therapies, and companion diagnostics. The emphasis will be on ensuring that personalized treatments are safe, effective, and accessible. Pharma companies developing personalized medicines will need to navigate complex regulatory requirements, including validation of genomic tests and integration of personalized treatment plans into clinical practice.

Preparing for 2024: Key Strategies

To navigate these regulatory changes effectively, pharma companies should consider the following strategies:

Invest in Regulatory Expertise: Ensure that your regulatory affairs team is well-versed in the latest guidelines and changes. Ongoing training and consultation with regulatory experts can help anticipate and address compliance challenges.

Enhance Data Management Systems: Implement advanced data management and analytics systems to handle increasing volumes of data from clinical trials, pharmacovigilance, and digital health technologies.

Adopt Sustainable Practices: Integrate environmental sustainability into your business operations and comply with new environmental regulations to meet both legal and ethical expectations.

Promote Transparency: Develop robust procedures for transparent reporting and data sharing, and align your practices with the latest transparency requirements.

Update Labeling and Marketing: Revise labeling and advertising materials to ensure compliance with new standards and to communicate information accurately and transparently.

Stay Informed: Regularly review regulatory updates and participate in industry forums to stay ahead of changes and adapt your strategies accordingly.

In conclusion, 2024 is set to be a pivotal year for the pharmaceutical industry, with significant regulatory changes shaping the landscape. By proactively preparing for these changes and adopting strategic measures, pharma companies can ensure compliance, maintain operational efficiency, and continue to deliver innovative therapies to the market.

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Medical Device services

Regulatory Software

Regulatory solutions

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nayanvision21 · 6 months ago

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How to Take PCD Pharma Company?

Are you considering venturing into the pharmaceutical industry? Starting a PCD Pharma Company can be a lucrative business opportunity. This model allows individuals or entities to promote and distribute pharmaceutical products under their brand name while leveraging the manufacturing capabilities of established pharmaceutical companies.

Here's a step-by-step guide on how to take on this venture by Nayan Vision, a trusted Eye Drops PCD Franchise Company in India. The post mentions all the key stages involved in the making of a PCD Pharma Company in the Pan India region. Read the points below to get valuable insights.

Market Research: Conduct thorough market research to identify the demand for pharmaceutical products in your target region. Analyze the competition, understand customer preferences, and assess market trends to determine the viability of your business idea.

Regulatory Compliance: Familiarize yourself with the regulatory requirements for starting a pharmaceutical business in your country or region. Obtain necessary licenses, permits, and certifications from regulatory authorities such as the FDA (Food and Drug Administration) or equivalent agencies.

Business Plan: Develop a comprehensive business plan outlining your company's objectives, target market, product portfolio, marketing strategies, and financial projections. A well-defined business plan will serve as a roadmap for your PCD Pharma Company's growth and success.

Partnership with Manufacturing Units: Identify reliable pharmaceutical manufacturing units or contract manufacturing organizations (CMOs) to produce your products. Establish partnerships with manufacturers who adhere to quality standards and have the capacity to meet your production requirements.

Product Selection: Choose a range of pharmaceutical products to include in your portfolio based on market demand, therapeutic categories, and competitive analysis. Ensure that the selected products comply with regulatory standards and have the potential for sales growth.

Branding and Packaging: Invest in branding and packaging design to create a distinct identity for your products. Develop labels, packaging materials, and promotional materials that reflect the quality and efficacy of your pharmaceutical offerings.

Distribution Network: Build a robust distribution network comprising wholesalers, retailers, pharmacies, hospitals, and healthcare professionals. Establish strategic partnerships with distributors to ensure widespread availability of your products in the market.

Promotional Activities: Implement effective marketing and promotional strategies to increase awareness and visibility of your brand. Utilize a mix of digital marketing, traditional advertising, sales promotion, and medical representative interactions to reach your target audience.

Sales and Distribution Management: Implement efficient sales and distribution management systems to track inventory, manage orders, and monitor sales performance. Utilize technology solutions such as ERP (Enterprise Resource Planning) software to streamline operations and optimize efficiency.

Quality Assurance: Prioritize quality assurance and compliance throughout the entire supply chain. Conduct regular quality control checks, adhere to Good Manufacturing Practices (GMP), and ensure that all products meet prescribed quality standards.

Conclusion

Starting a PCD Pharma Company requires careful planning, regulatory compliance, and strategic execution. By conducting thorough market research, forging partnerships with reliable manufacturers, building a strong distribution network, and implementing effective marketing strategies, you can establish a successful pharmaceutical business. However, it's essential to prioritize quality, compliance, and customer satisfaction to thrive in this competitive industry. With the right approach and dedication, your PCD Pharma Company can become a trusted provider of high-quality pharmaceutical products, contributing to the healthcare needs of your target market while achieving sustainable growth and profitability.

#eyedrops #eyedropspcdfrancihse #pharmacy #pharmaindustry

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thirdpartymanufacturers · 6 months ago

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Third Party Medicine Manufacturer

In the dynamic environment of the pharma industry, companies are continuously looking for efficient and cost-effective methods to bring their medicines to market. Among the myriad alternatives available, third party medicine improvement has plays as an important role for pharma companies. This article delves into the realm of third party pharma manufacturing, include its significance, processes, and benefits.

Understanding Third Party Pharma Manufacturing

Definition and Scope

Third Party Pharma Manufacturing, also called third-celebration manufacturing, involves outsourcing the manufacture of medicine to out of doors contractors These manufacturers are primarily based in a corporation equipped with specialized assets and understanding in location of a pharmaceutical approach. This strategy enables pharmaceutical companies to leverage the capabilities of professional pharmaceutical agencies, while specializing in core abilities along with research, improvement and advertising

Role of Third Party Manufacturing Companies

Pharma Contract Manufacturing Companies

Pharmaceutical settlement production companies serve as strategic partners to groups in search of to streamline their production processes. These companies put money into brand new facilities, adhere to stringent excellent requirements, and appoint professional professionals to make certain the seamless manufacturing of pharmaceutical products. By entrusting manufacturing responsibilities to those specialized entities, pharmaceutical groups can mitigate dangers, reduce operational expenses, and expedite time-to-market.

Key Aspects of Third Party Manufacturing

Product Range

The wide variety of product categories that third party groups cowl, the various therapeutic ones, is however of the examples. They are able to produce drugs, pills, drugs, and injections as well as ointments amongst other forms of formulations. This flexibility gives pharmaceutical companies the capacity to transport on market opportunities and make certain that healthcare experts and patients' needs are addressed to the maximum quantity.

Quality Assurance

Compliance with regulatory standards and guidelines is important for Third Party Medicine Manufacturers, as quality assurance is considered of paramount importance in the pharmaceutical industry These companies are following stringent procedures quality control and a robust quality control system. There is no room for the compliance compromise, and third party manufacturers carry through the thorough procedures to excel quality and safety.

Benefits of Third Party Pharma Manufacturing

Cost Efficiency

Outsourcing to third party companies provides significant cost advantages for pharmaceutical companies. By implementing increased economies of scale and operational efficiencies by contracting companies, internal production costs can be reduced. Moreover, third party manufacturing allows for better cost predictability, as expenses are often fixed or based on a transparent pricing structure.

Focus on Core Competencies

By delegating manufacturing responsibilities to specialized corporations, pharmaceutical companies can allocate assets greater efficaciously and recognition on core abilities together with research, development, and advertising. This strategic alignment enables groups to beautify innovation, boost up product development cycles, and make stronger their competitive role inside the market.

Conclusion

In end, Pharmaceutical Third Party Manufacturing performs a pivotal role inside the pharmaceutical industry surroundings. By partnering with specialized settlement producers, pharma organizations can streamline production approaches, make sure product quality, and power value efficiencies. As the industry continues to adapt, third party manufacturing will stay a cornerstone approach for businesses seeking to optimize their operations and deliver tremendous pharmaceutical merchandise to marketplace.

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laxmankodadala · 6 months ago

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Take Control of Search Engines: SEO Services in Hyderabad with a Proven Track Record – Geekschip

The world is going digital! So,our digital marketing company will take your business to the world.We digitally explore your market and take your business to global customers using our phenomenal digital marketing strategies that are meticulously designed by the competent teams of Geekschip. We have clients from wide business verticals, such as Infra,Pharma,Manufacturing, IT enterprises, Fashion and Beauty,Spiritual, B2B, B2C,and more,from India,the US,U.K,Canada, Singapore,etc.it is a trusted digital marketing Agency in Hyderabad that helps you find new markets to trade your products and services to global customers with a small investment. We analyse and accordingly suggest to you the services of digital marketing that suit your business.

Welcome to Geekschip – your trusted partner in navigating the dynamic world of digital marketing. As a leading digital marketing company based in Hyderabad, India, we specialize in crafting customized strategies to help businesses thrive in the digital age.

Who We Are

At Geekschip, we pride ourselves on being more than just a digital marketing agency in Hyderabad – we're your partners in success. With a team of seasoned professionals and a wealth of industry experience, we have the expertise and know-how to elevate your brand and drive tangible results.

What We Do

Our comprehensive range of digital marketing services in Hyderabad is designed to meet the diverse needs of businesses in Hyderabad and beyond. From search engine optimization (SEO) and pay-per-click (PPC) advertising to social media marketing and content creation, we offer a holistic approach to digital marketing that delivers real, measurable results.

Search Engine Optimization (SEO)

In an increasingly crowded online landscape, standing out from the competition is essential. Our SEO services are designed to improve your website's visibility on search engine results pages (SERPs), driving organic traffic and boosting your online presence.

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With our targeted PPC advertising campaigns, we help you reach your ideal audience at the right time and place. Whether you're looking to increase website traffic, generate leads, or boost sales, our PPC experts will create tailored campaigns that deliver maximum ROI.

Social Media Marketing

Social media has become a powerful tool for brand building and customer engagement. Our social media marketing services are designed to help you connect with your audience, build meaningful relationships, and drive user engagement across all major platforms.

Content Creation

Compelling content is the cornerstone of any successful digital marketing strategy. From blog posts and articles to videos and infographics, our team of content creators will develop high-quality, engaging content that resonates with your audience and drives results.

Why Choose Geekschip?

Proven Track Record: Geekschip has years of experience and a successful track record, having assisted numerous firms in reaching their digital marketing objectives. Tailored Solutions: We know that every company is different, which is why we adjust our tactics to fit your particular requirements and goals. Open and honest communication is something we strongly believe in. We'll keep you updated at every stage and make sure your requirements are our first priority at all times. Constant Innovation: It's crucial to keep ahead of the curve in the quick-paced world of digital marketing. We continually research new trends and technology in order to provide creative solutions that produce outcomes.

In digital marketing, where trends evolve at the speed of light, finding a reliable partner to navigate the ever-changing landscape is crucial. Enter Geekschip – a trailblazing digital marketing agency in Hyderabad, committed to revolutionizing the way businesses connect with their audience online.

Elevating Your Brand Presence

Unparalleled Digital Marketing Services

At Geekschip, we offer a comprehensive suite of digital marketing services in Hyderabad tailored to suit the unique needs of businesses in Hyderabad and beyond. From search engine optimization (SEO) and pay-per-click (PPC) advertising to social media marketing and content creation, our team of experts crafts customized strategies designed to elevate your brand presence and drive tangible results.

Cutting-Edge SEO Techniques

where visibility is key to online success, our SEO services in hyderabad are second to none. Through a combination of keyword research, on-page optimization, and link building, we ensure that your website ranks prominently on search engine results pages (SERPs), attracting organic traffic and boosting your online visibility.

Engaging Social Media Campaigns

Social media has emerged as a powerful tool for brand engagement and customer interaction. At Geekschip, we harness the power of social platforms to foster meaningful connections with your audience, drive user engagement, and amplify your brand's reach. From strategic content creation to influencer partnerships, we craft engaging campaigns that resonate with your target audience and drive results.

Digital marketing agency in hyderabad

Accelerating online growth is a tough row to hoe since every business faces stiff competition and the only sure shot way to stand tall is availing digital marketing services in Hyderabad. Most of the businesses are unaware of the value of online marketing and how it improves businesses.

Geekschip, the renowned Digital Marketing Company, relentless in its pace survives any business online by practicing proven digital marketing strategies. It has made its mark in the wide spectrum of all the industries in expanding them with a brand reputation to promote.

Digital marketing is a string of SEO, SMM, online reputation management, PPC marketing, etc. GeeksChip, one of the fits every pocket digital marketing agencies, perfectly blends all the strings by streamlining the effective marketing methods to pitch any business on the perfect ground.

Every business deserves to be on the top of the search engine results page. SEO services are its access window that helps to reach a broad audience where the brand credibility starts over.

Your reputation is our reputation. As a Digital Marketing Agency in Hyderabad, we realize the urgency of adopting the talent pool that listens to your customer and rolls out killer strategies for Online Reputation Management. Accordingly, we strategically devise a plan to emulate a positive reputation for your brand all the time.

We render outstanding PPC Marketing services to gain leads, sales, and hence revenue by tailoring innovative ad campaigns by targeting relevant landing pages and the target audience.

Our marketing experts know which digital strategy resonates best for your unique requirements. We stay ahead of other Digital marketing companies by implementing time-tested strategies and blend the performance of all the range of digital marketing services in Hyderabad in shaping any business as a giant.

Data-Driven Insights

In digital marketing, data is king. That's why we employ advanced analytics and tracking tools to monitor the performance of your campaigns in real-time. By analyzing key metrics and consumer behavior, we gain valuable insights that inform our strategy and drive continuous improvement, ensuring that your marketing efforts deliver maximum ROI.

Collaborative Approach

At Geekschip, we believe in the power of collaboration. We work closely with our clients to understand their unique challenges and objectives, tailoring our strategies to meet their specific needs. Our transparent communication and proactive approach ensure that we are always aligned with your goals, delivering results that exceed expectations.

Customer-Centric Focus

Customer satisfaction is at the heart of everything we do. We prioritize your needs and objectives, striving to provide unparalleled service and support every step of the way. Our dedicated team is always on hand to answer your questions, address your concerns, and ensure that you have a positive experience working with us.

Continuous Innovation

Innovation is the driving force behind Geekschip's success. We are constantly exploring new technologies, strategies, and trends to stay ahead of the curve and deliver cutting-edge solutions to our clients. From AI-powered chatbots to immersive VR experiences, we leverage the latest innovations to help your brand stand out in a crowded digital landscape.

Conclusion

In digital disruption, Geekschip emerges as a beacon of innovation, expertise, and excellence. With our unrivaled services, collaborative approach, and relentless commitment to results, we empower businesses in Hyderabad to thrive in the digital age. Partner with us today and experience the difference that Geekschip can make for your brand.

#digital marketing services #digital marketing agency #digital marketing company in hyderabad #seo services #ppc services

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marketbeam · 7 months ago

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Social Media Management for Life Sciences Companies in 2024

The Ultimate Guide to Social Media Management for Life Sciences Companies in 2024

The life sciences industry is undergoing a period of rapid transformation. From gene editing breakthroughs to the rise of personalized medicine, innovation is happening at an unprecedented pace. In this dynamic landscape, social media has become an essential tool for life sciences companies of all sizes, from pharma giants to nimble startups. This guide, for everyone who wants the knowledge and strategies to leverage social media management for the life sciences sector in 2024.

The Power of Social Media Management for Life Sciences

Social media offers a unique opportunity for life sciences companies to:

Build Brand Awareness: Social media platforms allow you to share your company's story, mission, and values with a targeted audience. This helps establish brand recognition and build trust among potential patients, investors, and partners.

Thought Leadership: Share industry insights, research findings, and expert opinions to position your company as a thought leader in the life sciences space. This attracts qualified talent and fosters collaboration opportunities.

Patient Engagement: Social media can be a powerful tool for connecting with patients and their communities. Use platforms to share educational content, address concerns, and build a supportive online environment.

Targeted Advertising: Utilize social media advertising platforms to reach a highly specific audience with laser-focused messaging. This allows for cost-effective marketing campaigns with a high return on investment (ROI).

Key Considerations in 2024 for Social media management for Life sciences

The social media landscape is constantly evolving. Here are some key trends to consider for your life sciences social media strategy in 2024:

The Rise of Short-Form Video: Platforms like TikTok and Instagram Reels are gaining immense popularity. Develop engaging, informative short-form video content to capture attention and connect with a wider audience.

Focus on Authenticity and Transparency: Audiences crave genuine connections. Be transparent about your research, address challenges openly, and showcase the human side of your company.

Data-Driven Decision Making: Utilize social media analytics tools to track campaign performance, understand audience demographics, and optimize your strategy for maximum impact.

Omnichannel Marketing: Integrate your social media presence with other marketing channels to create a cohesive brand experience across all touchpoints.

Building a Winning Social Media Strategy

Here's a step-by-step approach to crafting a successful social media strategy for your life sciences company:

Define Your Goals: What do you hope to achieve with social media? Increase brand awareness, attract new talent, drive website traffic, or generate leads? Clearly defined goals will guide your content creation and platform selection.

Know Your Audience: Who are you trying to reach? Doctors, patients, investors, or policymakers? Understanding your target audience's demographics, interests, and preferred platforms is crucial for tailoring your content and messaging.

Content is King: Create high-quality, informative, and engaging content that resonates with your audience. This could include infographics, patient testimonials, educational videos, or live Q&A sessions with industry experts.

Choose the Right Platforms: Don't spread yourself too thin. Focus on the platforms where your target audience spends their time. For life sciences companies, life sciences social media marketing services, life science social media marketing agency, life sciences social media marketing consultant, social media management for life sciences companies, life science social media marketing, and how to use social media to market a life science business are all important keywords to consider when selecting platforms. Consider exploring niche platforms relevant to specific areas of your expertise.

Be Social and Responsive: Social media is a two-way street. Actively engage with your audience by responding to comments and messages promptly. Participate in relevant online conversations and industry discussions.

Measure and Adapt: Track your social media performance using analytics tools. Analyze what's working and what's not. Regularly adapt your strategy based on data insights and industry trends.

Conclusion

By implementing these strategies, life sciences companies can leverage the power of social media to achieve their marketing objectives in 2024. Remember, social media is a marathon, not a sprint. For life sciences companies, navigating social media compliance can be a hurdle. Thankfully, platforms like MarketBeam streamline content approval, ensuring all marketing messages adhere to FDA and other regulations. This empowers you to leverage social media confidently, fostering brand awareness and engagement without compromising patient safety or ethical practices.

#social media marketing management tools #social media for pharmaceutical companies #pharmaceutical social media #social media pharmaceutical marketing #social media management #life science #software #social media management tool

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elysianpens · 8 months ago

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REVIEW ON PHARMACEUTICAL REGULATORY AFFAIRS

Ilamathi.A.S, M.Sc., Microbiology. Nikkila devi.R, M.Sc., Microbiology.

ABSTRACT:

Regulatory affairs in the pharmaceutical industry play an important role in ensuring the safety, efficacy, and quality of medicinal products worldwide. The pharmaceutical drug regulatory affairs profession was developed from the desire all over the world to protect public health by providing good quality medicine including safety and efficacy in the area of not only pharmacy but also in the area of veterinary medicine, medical devices, insecticides, pesticides, agrochemical, cosmetic and complementary medicine. Regulatory affairs acts as an interface between the pharmaceutical company and the regulatory agencies. The key role of regulatory affairs professions includes maintaining Compliance, Product approval, Risk management, Market access, Quality assurance. It works under proper organizational structure and various regulatory bodies around the world. Regulatory affairs professional also involves in clinical trail and R&D to develop innovative products that take advantage of new technological and regulatory developments to accelerate time to market. They can face regulatory non-compliance issues, but drug developers can also look to tech-enabled solutions to improve regulatory compliance. Regulatory affairs should explore whether the different innovation in pharma can decrease the risk of compliance issues.

Keywords: Regulatory affairs, Safety, Efficacy, Regulatory agencies, Accuracy, Clinical trail, R&D, Non-compliance.

INTRODUCTION:

Regulatory affairs covers a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. People who work in regulatory affairs negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market and to keep them there while preventing bad products from being sold.1

Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.1

Regulatory affairs in the pharma industry:

Pharma regulatory affairs professionals are key players in drug development, maintaining a vital communications link between the pharmaceutical company and regulatory agencies like the FDA in the United States, TGA in Australia, MHRA in the United Kingdom, and MCC in South Africa, to name a few.

Regulatory affairs departments interact with worldwide, federal, state, and local regulatory agencies to assure that the following activities involving pharmaceutical and medical products are conducted in compliance with all applicable rules:

• Licensing

• Registration

• Development

• Manufacturing

• Marketing

• Labeling

HISTORICAL OVERVIEW OF REGULATORY AFFAIRS:

Elixir Sulfanilamide incident:

The Elixir Sulfanilamide disaster of 1937 was one of the most consequential mass poisonings of the 20th century. Sulfanilamide, an antibacterial drug, was being used safely in the treatment of streptococcal infections. A new elixir formulation with raspberry flavour was prepared using 70% diethylene glycol (DEG) as there was a need for the drug in its liquid form. DEG can be fatal, and unknowingly the company distributed the product across the United States. The formulation resulted in the death of 105 patients who consumed the elixir.

This incident led to the enactment of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the United States in 1938.

Acts and Rules in India during 20th century:

1. 1900-1960:

• The Poisons Act, 1919 is to check and hold the control on cheap drugs available in market. This Act helps in the administered possession of substance or sale of substances as specified as poison. It also stated the sale and protected custody of the poisons, packaging and labeling of poisons, maximum quantity to be sold and inspection as well as examination of the poison sold by vendor during the year.

• The Dangerous Drugs Act, 1930 which includes the regulation of cultivation, manufacturing possession and trade of opium. In 1985, Dangerous Drugs Act 1930 and Opium Act 1878 was revoked by passing of the Narcotics and Psychotropic Substances Act.

• Drugs and Cosmetics Act, 1940: This act regulates the manufacturing distribution , import and sale of allopathic, homeopathic, unani and siddha drugs.

• Drugs and Cosmetics Rules, 1945: This act regulates manufacture of Ayurvedic drugs for sale only, and not for consumption and use or possession.

• Pharmacy Act, 1948: This law was amended in 1985 and it generally controls and regulates the profession of pharmacy in India.

• Drugs and Magic Remedies (Objectionable Advertisements) Rule. 1955: The regulates the advertisement of drugs in India.

• Drugs Prices Control Order, 1955 (DPCO) (under the essential commodities Act) : DPCO was further amended in 1995. As per this rule, government has a jurisdiction to review and fix maximum sale price for bulk drugs as well as formulation.

2. 1960-1970:

The Indian Pharmaceutical industry was not mature enough and major market share was dominated by MNC and very few Indian manufacturers were in competition. Focus on pure research and development was very little because of deficiency of patent protection. The low availability and high drug price is because majority shares depend upon the high drug import.

3. 1970-1980:

Government took control for the medicines regulation and issued few act and rules.

• Indian Patent Act 1970 (which came in force on 20 Apr 1972 and replaced Indian Patents and Designs Act of 1911): It serves as the basis for patent protection in India. Under this Act product patent was not allowed but the process and method of manufacturing of Drug substance was allowed to get the parent.

• Drug price capped: Drug Prices Control Order (DPCC) was introduced to con the high price against consumers.

4. 1980-1990:

The Indian industry has started investing in process development of APL and created production infrastructure for the same.

5. 1990-2000:

A rapid expansion in domestic market has observed in pharmaceutical industry. The companies have started entering into Research and Development.

6. 2000-2010:

This period is considered to be the Innovation and Research era . During these years, innovative research activity, patenting of the drugs formula, process, indication as well as merger of companies was started.2

Patent Amendment Act 2005:

Indian Government brought out the patents (Amendment) Ordinance, 2004 to address the issues relating to the patent in the country which was later replaced by the Indian Patent (Amendment) Act, 2005. The new Act brought some crucial changes on the legal regime of patent protection so as to address patent issue in technology, chemical and pharmaceutical sector.2

Compulsory Licenses:

Compulsory licenses can be granted for manufacture and export of the drug products “to any country having insufficient or no manufacturing capacity, for the said product, to address public health problems.”

• Drugs and Cosmetics (First Amendment) Rules, 2011: It mandates registration of Clinical Research Organization (CRO) for conducting Clinical Trials (CT).

• Clinical Trial Registry - India (CTRI): It has been set up by the ICMR��S (Indian Council of Medical Research) National Institute of Medical Statistics (NIMS).

• Pharmacovigilance Program of India (PvPI): The Central Drug Standard Control Organization (CDSCO) has launched pharmacovigilance to assure drugs safety to Indian patients.2

WHY IS REGULATORY AFFAIRS IMPORTANT IN PHARMA INDUSTRY?

1. Compliance:

The pharmaceutical industry is highly regulated to ensure the safety, efficacy, and quality of drugs. Regulatory affairs professionals ensure that companies comply with local and international regulations, standards, and guidelines set by regulatory authorities such as the FDA (Food and Drug Administration) in the United States, the EMA (European Medicines Agency) in Europe, and others globally.

2. Product Approval:

Before a pharmaceutical product can be marketed and sold, it must undergo rigorous regulatory review and approval processes. Regulatory affairs professionals are responsible for preparing and submitting applications for regulatory approval, including compiling comprehensive data on the drug's safety, efficacy, manufacturing processes, and quality controls.

3. Risk Management:

Regulatory affairs professionals help identify and mitigate risks associated with pharmaceutical products throughout their lifecycle. This includes assessing potential safety issues, managing adverse events reporting, and ensuring compliance with post-marketing surveillance requirements.

4. Market Access:

In many countries, access to pharmaceutical products is dependent on regulatory approval. Regulatory affairs professionals work to navigate the complexities of different regulatory systems to ensure timely market access for their company's products, which is critical for commercial success.

5. Quality Assurance:

Regulatory affairs professionals collaborate closely with quality assurance teams to establish and maintain high standards for manufacturing processes, packaging, labeling, and distribution of pharmaceutical products. They ensure that products meet regulatory requirements for safety, efficacy, and quality throughout their lifecycle.

6. Legal and Ethical Compliance:

Regulatory affairs professionals must stay abreast of evolving regulatory requirements, industry trends, and ethical standards. They help companies navigate legal and ethical challenges related to drug development, marketing, and distribution, ensuring compliance with laws and regulations governing pharmaceutical activities.

Overall, regulatory affairs serve as a bridge between pharmaceutical companies and regulatory authorities, ensuring that drugs are developed, manufactured, and marketed in compliance with applicable regulations to protect public health and safety.

THE ROLE OF THE REGULATORY PROFESSIONALS:

Regulatory professionals are responsible for:

1. Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products

2. Advising on legal and scientific restraints and requirements

3. Collecting, collating and evaluating scientific data

4. Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned

5. Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole

6. Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

Additionally, the regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially.4

Approval phase:

• Check progress of evaluation and anticipate questions

• Clarify raised questions, plan response and strategies with other

departments

• Plan and manage agency meetings/hearings

• Negotiate approval and Product Information with agencies

Post approval phase:

1. Compliance

Submission of variations/amendments

2. Renewals

3. Pharmacovigilance

4. Product information review

5. New indications / new formulations

Regulatory input to development plans!

6. Regulatory Intelligence

What does the future hold?

WHAT ARE THE RISKS OF REGULATORY NON-COMPLIANCE IN PHARMA?

Regulatory non-compliance is among the most significant threats to the pharmaceutical industry and can have a profound negative impact on a pharmaceutical company’s finances, reputation, and customers. Still, major pharmaceutical firms are challenged to innovate while balancing that business goal with risk mitigation. Therefore, most of the world’s leading drug companies also face similar types of risks around regulatory compliance in the pharma industry.

Rather than being satisfied with siloed views of regulatory affairs in which individual teams are responsible for ensuring regulatory compliance pharmaceutical organizations should instead strive for an enterprise-wide view of what’s happening with regulatory issues. Drug developers can also look to tech-enabled solutions to improve regulatory compliance. For instance, the use of big data in the pharma industry is increasing across the organization, from research and development to marketing. Regulatory affairs should explore whether this type of disruptive innovation in pharma can decrease the risk of pharma compliance issues.6

CHALLENGE TO REGULATORY AFFAIRS PROFESSION:

Regulatory affairs include complete dynamics:

• Multi –dimensional

• Knowledge in science and technology

• Prolific communication skill

• Deal with people with diverse background, skills, culture, and personalities

• Deal with conflicting loyalties, motivations, social and ethical, responsibilities

Case in point: submission of a dossier

During submission of a dossier a regulatory affair would be:

• Guided by various regulatory guidance

• Receiving input from various department within the firm about process capabilities and product attribute specification

• Receiving advice from peers about easy way to get approvals

• Receiving motivation from the management through incentives for achieving speedy approvals.3

ORGANIZATIONAL STRUCTURE OF REGULATORY AFFAIRS:

Not unified across the companies and is changing

• Global regulatory affairs

• Regional regulatory affairs

• Local regulatory affairs

• Manufacturing site regulatory affairs

• Drug Agency regulatory affairs

The structure will depend on size, type and culture of the company

and the personalities involved.3

REGULATORY BODIES IN THE WORLD:

Country Regulatory authorities

USA Food and Drug Administration (FDA)

UK Medicines and Healthcare Products Regulatory Agency (MHRA)

Australia Therapeutic Goods Administration (TGA)

India Central Drug Standard Control Organization (CDSCO)

Canada Health Canada

Europe European Medicines Agency (EMEA)

Denmark Danish Medicines Agency

Costa Rica Ministry of Health

New Zealand Medsafe - Medicines and Medical Devices Safety Authority

Sweden Medical Products Agency (MPA)

Netherlands Medicines Evaluation Board

Ireland Irish Medicines Board

Italy Italian Pharmaceutical Agency

Nigeria

National Agency for Food and Drug Administration and Control (NAFDAC)

Ukraine Ministry of Health

Singapore

Centre for Pharmaceutical Administration Health Sciences Authority

Hong Kong

Department of Health: Pharmaceutical Services

Paraguay Ministry of Health

Sweden Medical Products Agency (MPA)

Thailand Ministry of Public Health

China State Food and Drug Administration

Germany Federal Institute for Drugs and Medical Devices

Malaysia National Pharmaceutical Control Bureau,Ministry of Health

Pakistan Drugs Control Organization, Ministry of Health

South Africa Medicines Control Council

Sri Lanka SPC, Ministry of Health

Switzerland Swissmedic, Swiss Agency for Therapeutic Products

Uganda Uganda National Council for Science and Technology (UNCST)

Brazil Agencia Nacional de Vigiloncia Sanitaria (ANVISA )

Japan Ministry of Health, Labour & Welfare(MHLW)

INTERNATIONAL ORGANIZATIONS:

World Health Organization (WHO)

Pan American Health Organization (PAHO)

World Trade Organization (WTO)

International Conference on Harmonization (ICH)

World Intellectual Property Organization (WIPO)

REGULATORY AFFAIRS IN CLINICAL TRIALS:

The RA professional is the primary link between the company and worldwide regulatory agencies such as US Food and Drug Administration (USFDA & Center for Devices and Radiological Health), Medicines and Healthcare Products Regulatory Agency, United Kingdom, (UKMCA), Therapeutic Goods Administration, India Central Drug Standard Control Organization (CDSCO), Australia European Medicines Agency, Organization of Economic Collaboration and Development (OECD) and Health Canada. It also communicates and interprets the seemingly endless mace of laws, regulations and guidelines to the other departments of the company. The RA personnel develops strategies to overcome delays and presents finding of clinical trials to the regulatory bodies so as to get quick clearance, thus reducing the time for approval of new molecules. At its core, the RA professional facilitates the collection, analysis and communication about the risks and benefits of health products to the regulatory agencies, medical and health systems and the public. Operationally RA is responsible for assuring that government obligation, market driven demands and evolving scientific conventions are understood and addressed by various stakeholders.8

REGULATORY AFFAIRS IN R&D

The regulatory affairs personnel work hand in hand with marketing and R&D to develop, innovative products that take advantage of new technological and regulatory developments to accelerate time to market. With new products expected to add significant revenues to the company’s bottom lines, small decreases in time to market equate to large material gains in revenue and profit. Employing adaptive clinical trial strategies, obtaining quick approval from regulatory authorities and avoiding pitfalls in processes can accelerate development of new products and help to reduce costly errors and time lags.8

GLOBAL MARKET IS DIVIDED INTO:

1. Regulated Market:

US, EU (UK, Germany, France, Ireland, Sweden etc.), Japan, Canada, Australia, New Zealand, South Africa

2. Semi regulated Market (ROW Countries):

(a) Asia (Sri Lanka, India, Bangladesh,; ASEAN: 10 Countries group - Philippines, Vietnam, Singapore, Malaysia, Thailand, Indonesia, Laos, Cambodia, Brunei Darussalam, Myanmar

(b) African countries (Algeria, Zambia, Ethiopia, Ghana, Kenya, Malawi, Mozambique, Namibia, Nigeria, Sierra Leone, Tanzania, Zimbabwe etc.)

(d) Latin America (Mexico, Brazil, Panama, Peru, Guatemala, Argentina, Chile, Dominican Republic)

(e) CIS (common wealth of independent states): Russia, Ukraine, OFSUs (Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kirghizstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan etc.)

CONCLUSION:

In conclusion, regulatory affairs play a pivotal role in the pharmaceutical industry, serving as a crucial bridge between scientific innovation and public health. The complex and ever-evolving landscape of regulations and guidelines requires pharmaceutical companies to navigate a myriad of requirements to ensure compliance and bring safe and effective products to market.

Throughout this article, we have explored the roles of regulatory professional and their involvement in ensuring safety, efficacy, and quality of drugs. Initially we discussed about their roles in each stage of the drug development process. The historical overview, stating “Elixir Sulfanilamide incident” and various Acts and rules in India during 20th century was reviewed. We now have a great understanding about organizational structure and various regulatory bodies across the world. As we know, regulatory professionals work hand in hand with clinical trail and R&D to develop innovative product, they can also face regulatory non-compliance. It can overcome through various exploration and strategies by the professionals. Thus, we finally discussed about the global market and its division into two groups such regulated market and semi-regulated market.

REFERENCES:

1. Dinesh Kawade, Manali Sahastrabuddhe, Mahima Dubey, Mukul Gadodiya, Nayan Gore and Manish Kinkar; An overview of regulatory affairs in pharmaceutical industries, Volume 8, Issue 6. Available online at: https://www.jetir.org/papers/JETIR2106052.pdf

2. Mr. Pritam R. Salve, Mr. Vaibhav A. Jadhav, B. Pharm., Pratibhatai Pawar College of Pharmacy; Review on drug regulatory affairs and new drug approval process in India. Available online at: https://ijrpr.com/uploads/V3ISSUE7/IJRPR5798.pdf

3. Keshari Roshan; Role of regulatory affairs in pharmaceutical company: An overview. Availble online at: https://www.worldwidejournals.com/global-journal-for-research-analysis-GJRA/recent_issues_pdf/2018/January/January_2018_1515152068__76.pdf

4. What is regulatory affairs in the pharma industry, and how can technology help? Availble online at: https://within3.com/blog/what-is-regulatory-affairs-in-pharma-industry

5. What is regulatory affairs? Availble online at: https://www.topra.org/TOPRA/TOPRA_Member/What_is_regulatory_affairs.aspx

6. Orin Chisholm and Helen Critchley, Faculty of Medicine and Health, Sydney Pharmacy School, The University of Sydney, Sydney, NSW, Australia; Future directions in regulatory affairs.

7. Dhananjay D. Chaudhari, Mohit R. Koli; Drug regulatory affairs: short review.

8. Subash Philip & Ansa Philip; The Scope of Regulatory Affairs in the Pharmaceutical Industry. Availble online at: https://citeseerx.ist.psu.edu/document?repid=rep1&type=pdf&doi=358b612493ff7b225668face3e8b242dd4265645

9. CDSCO; https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/

10. US FDA; https://www.fda.gov/

11. Janjal, V., Dhamodkar, S., Jadhao, Y., Manmode, S., Pawat, A. and Khandelwal, H., 2021. Review article on Recent drug regulatory affairs and CTD module progress review for submission of pharmaceutical product.

12. Kumar, S., Panwar, R. and Singh, U., 2013. “Regulatory affairs in the pharmacy curriculum”

13. Chandra, A. and Kumar, B., 2016. A comparitive study of the drug approval process in USA, INDIA, JAPAN AND EUROPE. World journal of pharmaceutical Research.

14. Rahalkar H (2012) Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs. Pharmaceutical Regulatory Affairs S11:002. doi:10.4172/2167-7689.S11-002

15. Hasumati Rahalkar, Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs, Pharmaceutical Regulatory Affairs, Pharmaceutical Regulatory Affairs: Open Access; 2012.

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