Why Pharmacovigilance (Phase IV Trials) will be increasingly seen: What do they tell us and why are (Clinical Compliance )
Venue: Online Event
|Event Date/Time: Nov 02, 2011||End Date/Time: Nov 02, 2011|
Why Should You Attend:
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 â€œRisk Minimization Action Plansâ€ and â€œGood Pharmacovigilance Practices and â€œPharmacoepidemiologic Assessmentâ€ and there is also the ICH E2E Guidance of Pharmacovigilance Planning. The likelihood of Data Monitoring Committees being required is also expected.
Learning Objectives :
- 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 of DMCs in post-market studies.
- Operational strategies for successful studies that meet the requirements.
- Methodsworking in the post-approval arena even when guidance is unclear.