#pharmacovigilance companies

[chemxpert]

Why is Data Critical in Life Sciences and the Emerging Trends in 2024

The life  sciences industry covers sectors such as pharmaceuticals, biotechnology, healthcare, and medical devices, and the sector has been rapidly evolving in the last few years based on the interaction of  data analytics, AI, and other corresponding digital technologies. The growth of precision medicine, a desire for better efficiency in drug development, and a growing focus on patient outcomes are part of the reason why data has become so critical to innovation in the life sciences industry today.

[medvoice]

Pharmacovigilance Services in USA | MedVoice

Pharmacovigilance Services in USA | MedVoice Empower your drug discovery process, enhance research accuracy, and elevate product quality with MedVoice's meticulous pharmacovigilance services. Pharmacovigilance Services, Pharmacovigilance Solutions, Pharmacovigilance Services Providing Company, Pharmacovigilance In USA

[lambdatherapeutic]

Lambda is one of the best Drug Safety and Pharmacovigilance services to our regional customers as per client requirements. Our teams are focused on safety in clinical trials and other activities and are ready to help with your project.

[turacozsworld]

Turacoz was named after a brightly colored bird Turacos, found in sub-Saharan Africa. The quality of not migrating despite of hardships drew us to this name.

[insightslicelive]

Pharmacovigilance Market Fundamental Dynamics & Comprehensive Assessment to 2032 | Cognizant, FMD K&L, IBM Corporation, ICON plc, Accenture

Pharmacovigilance Market Fundamental Dynamics & Comprehensive Assessment to 2032 | Cognizant, FMD K&L, IBM Corporation, ICON plc, Accenture

The research report studies the Global Pharmacovigilance market 2023-2032 using a robust research methodology to provide accurate and in-depth information about the industry. For a clearer understanding, it is structured into several chapters and sections to cover different aspects of the industry. The data analysts have used primary and secondary research to seek authentic information for the…

[bobv48-blog]

Paul Hennessy/SOPA/Getty Images

June 14, 2023

Horowitz: Confidential Pfizer document shows the company observed 1.6 million adverse events covering nearly every organ system

Daniel Horowitz

Over 10,000 categories of nearly 1.6 million adverse events – many of them serious and debilitating – brought to you by Pfizer!

You might not have heard it in the news, but in recent months, Pfizer’s pharmacovigilance documents requested by the European Union’s drug regulator, the European Medicines Agency, have been released. They show that Pfizer knew about a sickening level of injury early on. An August 2022 document shows that the company already had observed the following scope of vaccine injury:

508,351 individual case reports of adverse events containing 1,597,673 events;

One-third of the AEs were classified as serious, well above the standard for safety signals usually pegged at 15%;

Women reported AEs at three times the rate of men;

60% of cases were reported with either “outcome unknown” or “not recovered,” so many of the injuries were not transient;

Highest number of cases occurred in the 31-50 year age group, and 92% did not have any comorbidities, which makes it very likely it was the vaccine causing such widespread, sudden injury.

These numbers alone suggest that all COVID shots should be defunded and Congress must immediately remove liability protections from the manufacturers. But a more recent document released by the Europeans is even more devastating, because it breaks down the 1.6 million adverse events observed by Pfizer by category and subcategory of ailment and injury.

The 393-page confidential Pfizer document, dated Aug. 19, 2022, shows that Pfizer observed over 10,000 categories of diagnosis, many of them very severe and very rare. For example:

Pfizer was aware of 73,542 cases of 264 categories of vascular disorders from the shots. Many of them are rare conditions.

There were hundreds of categories of nervous system disorders, totaling 696,508 cases.

There were 61,518 AEs from well over 100 categories of eye disorders, which is unusual for a vaccine injury.

Likewise, there were over 47,000 ear disorders, including almost 16,000 cases of tinnitus, which even Mayo Clinic researchers observed as a common but often devastating side effect early on.

There were roughly 225,000 cases of skin and tissue disorders.

There were roughly 190,000 cases of respiratory disorders.

Disturbingly, there were over 178,000 cases of reproductive or breast disorders, including disorders you wouldn’t expect, such as 506 cases of erectile dysfunction in men.

Very disturbingly, there were over 77,000 psychiatric disorders observed following the shots, lending credence to Dr. Peter McCullough’s research observing case studies showing psychosis correlating with vaccination.

3,711 cases of tumors – benign and malignant

Of course, there were almost 127,000 cardiac disorders, running the gamut of about 270 categories of heart damage, including many rare disorders, in addition to myocarditis.

There were over 100,000 blood and lymphatic disorders, for both of which there’s a wealth of literature linking them to the spike protein.

When reading what Pfizer knew early on juxtaposed to independent studies, it’s clear that nobody could have mistaken most of these AEs for mere incidental ailments. Here is a list of 3,129 case studies chronicling vaccine injury in every organ system observed in this Pfizer document.

What is so jarring is that there are hundreds of very rare neurological disorders that reflect something so systemically wrong with the shots, a reality that was clearly of no concern to the manufacturers and regulators alike. One of the infamous cases of vaccine injury was Maddie de Garay, an Ohio teen who became disabled for life immediately after participating in the Pfizer clinical trial. Her story is chronicled in chapter 16 of my book. I checked this confidential document and found that they knew of 68 cases of her rare diagnosis, chronic inflammatory demyelinating polyneuropathy.

[alpexpharma]

Pharma Company Best Standard to Follow - Alpex Pharma

Pharmaceutical companies are subject to various regulations and standards to ensure the safety, efficacy, and quality of their products. Here are some of the best standards that pharmaceutical companies should follow:

Good Manufacturing Practices (GMP): GMP is a set of regulations that ensure that pharmaceutical products are consistently produced and controlled according to quality standards. Compliance with GMP is mandatory for pharmaceutical manufacturers in many countries.

Good Clinical Practice (GCP): GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.

International Organization for Standardization (ISO): ISO is a set of international standards for quality management systems. ISO 9001:2015 is a specific standard for the pharmaceutical industry that helps ensure that products and services consistently meet customer requirements and regulatory requirements.

Pharmacovigilance: Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Pharmaceutical companies are required to have a pharmacovigilance system in place to monitor the safety of their products.

Ethical Marketing: Pharmaceutical companies are expected to follow ethical marketing practices and adhere to the principles of the World Health Organization (WHO) Ethical Criteria for Medicinal Drug Promotion.

Environmental Sustainability: Pharmaceutical companies should consider the environmental impact of their products and operations, and strive to reduce their carbon footprint and waste.

Adherence to these standards can help ensure that pharmaceutical products are safe, effective, and of high quality, and that companies operate in an ethical and sustainable manner.

[chemxpert]

Unlocking Pharma Insights : Chemxpert Database for Compliance & Market Access

Explore the latest pharma industry trends and streamline your compliance efforts with Chemxpert Database. Access critical resources from the FDA website to stay compliant with GMP in the pharmaceutical industry. Harness the power of data analytics in the pharmaceutical industry to optimize manufacturing and distribution. Simplify pharmaceutical market access strategies and stay ahead in the competitive landscape with Chemxpert’s comprehensive solutions. Your go-to tool for staying compliant and competitive!

[missus-me]

Well actually…. (adjusting my nerd glasses), that‘s not exactly whats happening here. Pharma companies are obligated by law to follow up on adverse events which could be related to the use of their products. This is called pharmacovigilance and very important to help us find out how safe a drug really is. Drugs are tested in clinical trials, which are usually relatively small and only include a subsample of the people who later use the drug in real life. That means we can miss a lot of adverse events, either because they pccur rarely or because we they only happen in a suset of people who have not been included in the clinical trial.

If you work for a pharma company, you have to report any adverse event you encounter. And the companies usually look through social media mention of their products. The follow up is very time consuming but also IT SAVES LiFES! Often the data collected from those types of reports can lead to an adaption to how a drug is prescribed and to label changes.

Which means someone in the PV departement of Allegra had the unglamourous job to follow up on this shit post to find out if it was based on an actual experience.

tldr: report all adverse events to save lifes and annoy pharma companies.

[lambdatherapeutic]

Lambda's Bioavailability/Bioequivalence Studies offer global access to 800+ clinical beds inclusive of 85+ specialized beds designed for specific studies. Robust recruitment & housing options enable us to provide customized sponsor/study requirements. Till date, over 50 successful inspections by leading regulatory agencies across all Lambda facilities have been completed.

[shriramnursingcollege]

Who Controls Pharmacovigilance Programme In India?

Pharmacovigilance is a critical component of public health that ensures the safety and efficacy of medicines. In India, the responsibility for overseeing pharmacovigilance lies with the Central Drugs Standard Control Organization (CDSCO). This government body plays a pivotal role in safeguarding public health by monitoring and assessing the safety of pharmaceutical products.

## CDSCO Oversees Pharmacovigilance in India

The CDSCO, functioning under the Ministry of Health and Family Welfare, is the national regulatory authority responsible for drug approval and monitoring. It ensures that pharmaceutical companies adhere to safety regulations and that medications available in the market do not pose risks to public health. By implementing rigorous pharmacovigilance practices, CDSCO aims to minimize the adverse effects of drugs on patients and improve the overall safety profile of medicines.

## Ensures Safety and Compliance Standards

One of the primary roles of CDSCO in pharmacovigilance is to establish safety and compliance standards for all pharmaceutical products. This includes developing guidelines for the systematic monitoring of adverse drug reactions (ADRs) and ensuring that healthcare professionals report these incidents promptly. By enforcing compliance with these standards, CDSCO helps maintain the integrity of the healthcare system and ensures that medications are safe for public use.

## Monitors and Analyzes Safety Data

CDSCO is responsible for the ongoing monitoring and analysis of safety data related to pharmaceutical products. This involves collecting data from various sources, including healthcare providers, patients, and clinical trials, to identify potential safety concerns. By continuously assessing the safety of medications, the organization can take timely action to mitigate risks, which may include issuing warnings, updating product labels, or even withdrawing unsafe drugs from the market.

## Encourages Adverse Event Reporting

Encouraging adverse event reporting is a crucial function of CDSCO in the pharmacovigilance program. The organization promotes a culture of transparency and accountability by urging healthcare professionals and patients to report any adverse reactions they experience after taking medications. This information is vital for the effective monitoring of drug safety and can lead to important regulatory actions, ultimately protecting public health.

## Regular Signal Detection Activities Conducted

Signal detection activities are integral to pharmacovigilance, and CDSCO regularly conducts these activities to identify potential safety signals related to medications. This process involves analyzing data from various sources to detect patterns that may indicate safety concerns. By identifying these signals early, CDSCO can implement necessary measures to address potential risks and ensure the continued safety of drugs on the market.

## Conducts Risk Management and Mitigation

Risk management and mitigation are key components of the pharmacovigilance program managed by CDSCO. Once safety signals are detected, the organization assesses the risks associated with specific medications and develops strategies to mitigate these risks. This may include updating guidelines for safe usage, providing additional warnings, or implementing risk communication plans to inform healthcare providers and the public about potential dangers.

## Promotes Continuous Safety Surveillance

CDSCO emphasizes continuous safety surveillance as part of its pharmacovigilance efforts. This involves ongoing monitoring of the safety profiles of all marketed drugs throughout their lifecycle. By maintaining vigilance over pharmaceutical products, the organization can respond promptly to emerging safety issues, ensuring that the benefits of medications outweigh their risks.

## Ensures Public Health Protection

The overarching goal of pharmacovigilance in India is to protect public health. By effectively managing the safety of pharmaceutical products, CDSCO ensures that patients receive effective treatments without undue risk. The organization’s efforts in monitoring, reporting, and mitigating drug-related risks contribute to the overall safety of healthcare in India.

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## FAQs

### 1. What is the role of CDSCO in pharmacovigilance in India?

The Central Drugs Standard Control Organization (CDSCO) oversees pharmacovigilance in India by monitoring and assessing the safety of pharmaceutical products. It establishes safety standards, encourages adverse event reporting, and conducts regular safety analyses to protect public health.

### 2. How does CDSCO ensure compliance with safety standards?

CDSCO ensures compliance by developing guidelines for monitoring adverse drug reactions (ADRs) and enforcing regulations that pharmaceutical companies must follow. This helps maintain the integrity of the healthcare system and ensures the safety of medications available to the public.

### 3. Why is adverse event reporting important?

Adverse event reporting is crucial for identifying potential safety concerns related to medications. It allows healthcare professionals and patients to inform CDSCO about any adverse reactions, enabling the organization to take timely action to mitigate risks and protect public health.

### 4. What are signal detection activities in pharmacovigilance?

Signal detection activities involve analyzing safety data to identify patterns that may indicate safety concerns with medications. CDSCO conducts these activities regularly to ensure prompt response to emerging safety issues and to maintain drug safety throughout their lifecycle.

### 5. How does pursuing an MSc in Clinical Research at Shriram Medical College help in pharmacovigilance?

An MSc in Clinical Research from Shriram Medical College equips students with essential skills in drug safety monitoring, clinical trials, and regulatory affairs. Graduates are well-prepared to contribute to pharmacovigilance efforts by understanding the complexities of drug safety and compliance, making them valuable assets in the pharmaceutical industry.

## Conclusion

Pharmacovigilance is an essential aspect of public health, and its effective management is overseen by the CDSCO in India. By monitoring drug safety, ensuring compliance, and encouraging reporting, the organization plays a vital role in protecting the public. The ongoing evolution of pharmacovigilance practices highlights the need for well-trained professionals in this field. Pursuing an MSc in Clinical Research at Shriram Medical College can provide the necessary knowledge and skills to excel in pharmacovigilance and contribute meaningfully to public health safety.

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[health-views-updates]

2024-2032 Pharmacovigilance and Drug Safety Software Market Revenue, Demand & Key Players

The Pharmacovigilance and Drug Safety Software Market Revenue was valued at USD 6.83 billion in 2022 and is projected to more than double, reaching USD 14.86 billion by 2030, with a robust CAGR of 10.2% over the forecast period from 2023 to 2030. The growing demand for effective monitoring, reporting, and managing adverse drug reactions (ADRs) drives the adoption of advanced pharmacovigilance and drug safety solutions globally.

Key Growth Factors

The increasing complexity of drug development processes, stringent regulatory requirements, and the rising focus on patient safety are pivotal in driving the market's growth. Organizations are leveraging pharmacovigilance software to ensure compliance with global safety regulations, enhance operational efficiency, and reduce manual errors in drug safety reporting.

Additionally, the rapid advancements in artificial intelligence (AI) and machine learning (ML) are revolutionizing pharmacovigilance systems. These technologies enable predictive analysis, real-time data monitoring, and automated ADR reporting, which enhance drug safety processes. Furthermore, the rising prevalence of chronic diseases and the surge in pharmaceutical research and development activities are contributing to the market’s upward trajectory.

Regional Insights

North America dominates the pharmacovigilance and drug safety software market, driven by advanced healthcare infrastructure, significant R&D investments, and stringent regulatory frameworks. Meanwhile, the Asia-Pacific region is poised for significant growth due to increased healthcare awareness, government initiatives, and the expanding pharmaceutical sector.

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Market Outlook

With the integration of cloud-based solutions and mobile applications, pharmacovigilance systems are becoming more accessible and cost-effective for small and medium enterprises (SMEs). The ongoing technological innovations, combined with growing regulatory emphasis on drug safety, ensure that the market will witness substantial growth over the coming years.

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