Optimizing REMS Planning and Integrating Patient Adherence Programs for Product Success

Request access to watch On-Demand. Originally recorded May 25, 2010.

The majority of risk evaluation and mitigation strategies (REMS) come with fairly straightforward elements—but what about those that require elements to assure safe use (ETASUs)? How does the complexity of a REMS program impact access to a therapy and healthcare providers’ willingness to prescribe it?

Join us on for the second presentation in our five-part webcast series, “Ensuring Patient Access to Products in the Evolving Healthcare Market.”  Terri Madison, Vice President – Epidemiology and Risk Management for Xcenda, and Derek Cothran, Senior Director for Lash Group, will discuss how a successful REMS program should be designed to minimize burden for healthcare providers and other stakeholders who must follow it. Madison and Cothran will also explore how an effective REMS program can provide timely metrics, real-world outcomes evidence and support key product objectives, like therapy adherence and patient access.

Other topics for discussion will include:

• Evolving FDA requirements
• Emerging trends driving the need for an operationally innovative REMS program that goes beyond minimum requirements
• Identifying internal and external stakeholders for effective REMS program integration
• The process for building a REMS program for products nearing approval
• Developing partnerships with healthcare professionals in order to assure appropriate use of medications
• Case examples that highlight tactics of a successful REMS program and ongoing assessments to measure program success

Speakers:

Terri Madison, PhD, MPH
Vice President, Epidemiology and Risk Management
Xcenda

Derek Cothran, MHA
Senior Director, Lash Group

< View more webcasts, podcasts, and webisodes