Webinar: Multi-faceted Approaches to Meet Payer and Regulatory Evidence Requirements

Webinar: Multi-faceted Approaches to Meet Payer and Regulatory Evidence Requirements

Recent regulatory updates to EMA-mandated PASS requirements and FDA-mandated Post-Marketing Requirements (PMRs) have changed the way safety research is performed. New themes are also emerging for late stage development.

As industry dynamics shape study design, it is important to understand the new opportunities and challenges. UBC’s Krista Payne, Executive Director, Sr. Research Scientist, Value Demonstration, and Janine Collins, Senior Director, European Risk Management, will be conducting a webinar on Wednesday, March 19th at 11 a.m. EDT to explore this topic.

During this interactive webcast you will learn:

• What is a Post-Authorization Safety Study? What is a Post-Marketing Requirement?
• How can these multi-purpose studies efficiently achieve both safety and value demonstration research objectives?
• What new trade-offs or considerations must be addressed when collecting both patient-reported safety as well as patient-reported effectiveness outcomes in the context of mandated post-market studies?
• Will EU studies need to comply with the standards set forth by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)? 
• How could these new study designs affect the sponsor’s internal processes (e.g., as they relate to the Periodic Benefit-Risk assessment report)?

 
Register for free here.