ÐÂÔÂÖ±²¥appÏÂÔØ

Introduction

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.

Useful links

Venue

Online Webinar

Online Webinar, 10777 Westheimer Suite 1100, Houston, United States

Organised by

Compliance2GO

Contact information

Compliance2GO Customer Support
10777 Westheimer Suite 1100, Houston, United States of America
877-782-4696
Contact us by email

---