Why Post-market Pharmacovigilance trials are increasingly seen : What do they tell us & why are the

July 18, 2011 - PRLog -- Summary
FDA-mandated post-market studies are coming. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy of negotiating post-market commitments with sponsors - and will now set mandatory objectives and timelines. There is no one-size-fits-all guidance to help a particular drug or drug class prepare for the studies. There are, however Guidance documents for ?Risk Minimization Action Plans? and ?Good Pharmacovigilance Practices and ?Pharmacoepidemiologic Assessment? and there is also the ICH E2E Guidance of Pharmacovigilance Planning. The likelihood of Data Monitoring Committees being required is also expected.

Details
Discount : Get 15 % Discount as a early bird registrations. Use Promo code CGO15

Why should you attend : To know and understand the reasons why there is and has been an increase in Post-Approval Phase IV type studies

Areas Covered in the Session:

What is the rationale for such large studies
What is Pharmacovigilance and what questions are answered
The design and scope, of the types of Phase IV studies
What will be the role and value of DMCs in post-market studies
Operational strategies for successful studies that meet the requirements
What is the rationale for such large studies
The Nature of the I/E criteria in Phase IV studies
How does the Safety Monitoring Plan differ in Phase IV
What constitutes a “rare” adverse event?
Why large studies are needed to uncover rare Serious adverse events
What endpoints is the FDA looking for once they have approved a drug/device
Who will benefit (Titles): Those benefiting the most would be: Holders of the IND for new products i.e. the Sponsors.  Also, Principal Investigators and sub investigators, Clinical Research Scientists (PKs, Biostatisticians, ...),  Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers.

Target Audience: All parties engaged in the drug development process such as the Pharmaceutical Companies, Biotech Companies, CROs, and the Clinical Research sites.

Instructor: Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message (via Webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.From an original Master’s thesis (Pharmacology) in 1961 through a Doctorate in Surgery-Pharmacology in 1974 and continuing throughout 40+ years in the practice of clinical medicine as a family physician (7 years as an ER doc). He has been in the Clinical Research Industry for 20+ years, Investigator and staff GCP training, and medical monitoring in both drug and device studies.




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