Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER
This pharmacovigilance webinar will provide attendees an understanding of postmarketing drug safety surveillance, its role in lifecycle management, and the practices and regulations governing its conduct. It will describe the structure of the pharmacovigilance world including the ICH, the FDA, CIOMS, MHW, and EudraVigilance. 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.