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 Sponsor’s 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 Post market ADRs as safety of the public is in the balance.
This webinar by expert speaker Charles H. Pierce, MD, PhD FCP, CPI will help you learn the nature of the various Post approval surveillance processes through:
Who Should Attend
This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry who may be called upon to conduct a Post-Market Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance persons. In CRO’s and sites, those benefiting the most would be: Principal Investigators and sub investigators, Clinical Research Scientists (PKs, Biostatisticians ...), Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), QA / QC auditors and staff, & Clinical Research Data managers.
Charles H. Pierce, MD, PhD, FCP, CPI
From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...
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