Pharmacovigilance (PV) is the study of the safety of investigational medicinal Products / drugs under the real-life conditions of clinical use in the general population. Classically, PV focuses on the detection, assessment, understanding, and prevention of adverse effects (among other problems) related to the use of medicines after they have been approved. The prevalent view presently is that PV really starts the first time an experimental agent is given to a living being.
There is a very real increase in the mandated frequency of real-time requests by the FDA for post-marketing surveillance and actual Phase IV trials and it seems that no one is well prepared. It is now reasonable to expect that the Sponsors should include Post-approval trials as part of the development of any new Investigational Medicinal Product (IMP). Investigators, as well as all site staff, must know how to assess Pre and Post market ADRs as safety of the public is in the balance.
Why should you Attend?
With the increasing complexity of therapeutic agents now involving more biologics and an increase of use of new agents beyond the original intention and testing, it is essential to know as early as possible any untoward and unexpected Adverse Events and other serious toxicities. The well-known examples of Drugs pulled from the market after approval attests to the need for early surveillance.
The adage of Forewarned is Forearmed clearly applies. Focus areas would be how you assure Investigator involvement, site protocol adherence, appropriate safety assessments, and methods for data sampling.
The Learning Objectives of this Session are:
Who will benefit?
This webcast will be of immense value for the below mentioned Organisations and Professionals.
Dr. Charles Pierce has served as a family physician (7 years as an ER doc) and 23+ years in the medical research industry (7 years as a Principal Investigator). Charles has an experienced based knowledge of the Clinical Research part of Drug Development. Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent
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