It has been generally assumed within the industry that the FDA Amendments Act of 2007 (FDAAA) would increase the number of observational studies required by the FDA to monitor the long-term, real-world safety of new products (whether as part of a Risk Evaluation and Mitigation Strategies (REMS) plan or as a standalone study). Based on the post-marketing commitments included in new product approvals over the past year, however, it is not clear where the FDA will ultimately settle regarding interventional vs. observational safety studies.Complimentary Webinar:
Future Directions of Observational Research: What we expected or plotting a new course?This webinar reviews the merits and strengths of observational research in terms of safety surveillance, real-world product effectiveness, patient-reported outcomes and health economic measures.
Jul 30, 2009
2:00 PM - 3:00 PM EDT
Presented by: Dave Provost; Vice President, Global Post-Approval; INC Research
Dave Provost is responsible for management of the operational unit as well as for providing strategic consulting to clients regarding the design and implementation of their global late phase programs. He has nearly 20 years of pharmaceutical industry experience, all within the peri- and post-approval areas, and offers deep expertise in program design and implementation strategies. In addition to clinical research, Provost also has a background in health outcomes, market research and data collection and presentation technologies.Click here to register.