Webinar: Multi-faceted Approaches to Meet Payer and Regulatory Evidence Requirements
Payer and regulatory evidence requirements are converging, resulting in both opportunities and challenges for real-world study designs. European pharmacovigilance legislation was revised in July 2012, defining Post-Authorization Safety Study (PASS) requirements and presenting the opportunity to collect real-world effectiveness outcomes. This includes resource utilization and Patient Reported Outcomes (PROs), which typically have not been part of such research. Similarly, the FDA has become more open to the inclusion of non-safety data collection in its safety surveillance mandates.
Covering both perspectives from Europe and the United States, discussion leaders describe how traditional health economic and outcomes research variables can be included in EMA-mandated PASS requirements and FDA-mandated Post-Marketing Requirements (PMRs).
Webinar release date: March 2014
Contact us to discuss the latest approaches to meet payer and regulatory evidence requirements.