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May 14, 2014

FoREMS & More: Preparing for Patent Expiry of Products with ETASU REMS

Patent expiry for products with Risk Evaluation and Mitigation Strategies (REMS) triggers events for industry and regulators. In the case of REMS with Elements to Assure Safe Use (ETASU), patent expiry triggers a series of events and questions that are relevant to risk management professionals in both the branded New Drug Application (NDA) holder company as well as Abbreviated New Drug Application (ANDA) sponsor companies.  This webinar will provide an overview of upcoming patent expirations, a discussion of what NDA holders and ANDA sponsors of products with ETASU REMS should do to prepare for patent expiration, a review of operational considerations for single shared system (SSS) REMS, and a discussion of what impact this has on industry.

The presenter panel for this webinar includes experts related to various phases of SSS REMS planning and implementation:
  • Jemma Contreras, Director, Risk and Program Management at Campbell Alliance
  • Mike Menta, Managing Director at Campbell Alliance
  • Jeff Fetterman, President, ParagonRx
This webinar will address the following questions regarding preparing for patent expiry of products with ETASU REMS:
  • What strategic decisions should NDA holders and ANDA sponsors consider and when?
  • What are the regulations for SSS REMS and what needs to happen once a SSS REMS has been defined?
  • What are the implications for risk management professionals in industry?

To view the webinar replay for this event, click here.

To view the slides presented during this webinar, click here.

To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email