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Why post-market Pharmacovigilance trials are increasingly seen : What do they tell us and why are they important?

Tuesday, August 23, 2011
Online Webinar
Houston, United States

Event Type: Training Course


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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

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

Who Will Benefit:

Those benefiting the most would be: Holders of the IND for new products i.e.the Sponsors. 1. Principal Investigators. 2. Sub investigators 3. Clinical Research Scientists (PKs, Biostatisticians) 4. Safety Nurses. 5. Clinical Research Associates (CRAs) and Coordinators (CRCs). 6. Recruiting staff. 7. QA / QC auditors and staff. 8. Clinical Research Data managers.

Areas Covered in the Seminar:

1. What is the rationale for such large studies. 2. What is Pharmacovigilance and what questions are answered. 3. The design and scope, of the types of Phase IV studies. 4. What will be the role and value of DMCs in post-market studies. 5. Operational strategies for successful studies that meet the requirements. 6. What is the rationale for such large studies. 7. The Nature of the I/E criteria in Phase IV studies. 8. How does the Safety Monitoring Plan differ in Phase IV. 9. What constitutes a “rare” adverse event? 10. Why large studies are needed to uncover rare Serious adverse events. 11. What endpoints is the FDA looking for once they have approved a drug/device.

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