Why Pharmacovigilance (Phase IV Trials) will be increasingly seen:What do they tell us and why are t

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
Aug. 11, 2011 - PRLog -- 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 “rareâ€� 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.

Price List: Live : $189.00 Corporate live : $499.00 Recorded : $249.00, CD:$299.00

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

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Tags:Compliance Training, Conference, E-learning, Education, Event, Fda, Web Seminar, Webinar, Compliance2go, Medical Device
Location:Houston - Texas - United States
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