Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

Why Should You Attend:

Pharmacovigilance is an activity that permeates the use of any pharmaceutical (branded, generic, or over-the-counter), biological agent, vaccine, or medical device during both development and after marketing approval has been granted. There are a number of stakeholders in post-marketing drug safety: Sponsor staff, health care providers, health care payers, regulators, and most importantly, patients. Post marketing pharmacovigilance begins with the creation of the product's label. The label is a distillation of what is known about the safety and use of the product.

This webinar will start with consideration of pharmacovigilance from the moment that the label is completed. This webinar will:

• Introduce key documents such as the PSUR.
• Discuss the paradigm for collecting safety data in the post-marketing phase in the context of Good Pharmacovigilance Practices and Good Pharmacoepidemiology Practices.
• Describe the means by which safety data are processed using MedDRA (Medical Dictionary for Regulatory Activities) and the WHO Drug Dictionary.
• Consider tools such as registries (product and subject) and pharmacoepidemiology observational studies and will refer the regulations requiring such activities.
• Describe the structure of the pharmacovigilance world, including the ICH, the FDA, CIOMS, MHW, EudraVigilance, among other key members of the pharmacovigilance community.

Areas covered in the Webinar:

• Structure of pharmacovigilance community (ICH/CIOMS/EudraVigilance/FDA/etc.).
• Collection and analysis of post-marketing approval safety data.
• Key guidance documents and regulations.
• Notable reference documents.
• Roles and responsibilities in post-marketing development pharmacovigilance.
• Key regulatory post-marketing approval safety reports.

Who Will Benefit:

• Healthcare Providers Engaged in Patient Care
• Clinical Development Personnel
• Product Marketing Staff
• Medical Affairs Personnel
• Quality Assurance Professionals
• Legal Department Personnel
• Regulatory Affair Professionals
• Journalists Engaged in Reporting on Pharmaceutical and Related News

Instructor Profile:

Dr. David E. Lilienfeld, is an internationally recognized authority in pharmacovigilance. During his more than two decades of experience in the pharmaceutical industry (contract research organizations, major pharmaceutical and small pharmaceutical companies, and start-ups), he has practiced pharmacovigilance as a safety physician, pharmacoepidemiology, and safety department head. He has written about drug safety issues and presented at numerous industry and professional society meetings on pharmacovigilance, and has served on the Board of Directors of the International Society for Pharmacoepidemiology, which he co-founded.

Topic Background:

Pharmacovigilance is the surveillance for collection of data about assessment of, and prevention of adverse effects of pharmaceuticals, biological compounds, vaccines, and medical devices. During both clinical development and after marketing approval has been granted, it is the pharmacovigilance function under which collection and analyses takes place of information regarding adverse events, as well as their prevention using Risk Evaluation and Mitigation Strategies (REMS) programs.

While clinical safety concerns the collection, processing, and analysis of adverse event reports from investigators using the product in the tightly controlled setting of clinical research, post-marketing safety concerns these same activities in the context of how the product is actually used in the community. Distribution of the product is wider, and while some safety information from development programs are helpful, the clinical development setting does not allow for the detection of relatively infrequent events--a key component of post-marketing approval safety activities.

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