Wednesday, June 9th, 2010

Building REMS into Your Organization

"How should we build REMS into our organization?" has become a frequent question raised among our clients. This reflects a large issue developing throughout the pharmaceutical and biotech industries today. We thought it was time to open this discussion in our Wednesday FoREMS webinar series. In this session, two leaders in this emerging field share their different approaches to incorporating REMS into an organization.

  • James Nickas, PharmD, Head Regional Center Americas, Drug Safety Operations, Genentech, Inc. Jim is managing the process of embedding REMS into Genentech in a manner that builds risk evaluation and mitigation thinking into the entire culture of clinical development itself.
  • Art Morelli, Vice President Medical Affairs Operations (REMS) at Covidien. Art will discuss how Covidien uses a REMS Coordination Office and cross-functional teams to ensure that REMS is a central part of the commercialization process.

Learn what other organizations are doing to incorporate REMS into the development and commercialization of new and existing drugs.

 

Webinar Slide Set

 

Session Replay



 

Previous page: Webinars Next page: Video / Podcasts
 
Register for periodic industry updates: