COURSE DESCRIPTION

OVERVIEW

Following the April 2018 publication of their Risk Evaluation and Mitigation Strategy (REMS) inspection program guide, FDA has ramped up focus on REMS inspections. REMS itself was established on September 27, 2007, as a new section of the Food and Drug Administration Amendments Act (FDAAA).  It authorizes FDA to require persons submitting or holding certain applications to present a proposed risk mitigation strategy if FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks.

Submission of REMS is a specific FDA requirement that impacts both US and non-US companies planning US submissions. An understanding of REMS requirements is important to avoid gaps in FDA submissions and during REMS inspections.  Furthermore, an increased focus on REMS inspections by the FDA calls for increased attention to risk mitigation activity execution and documentation.

If your company has a planned FDA submission or an existing REMS program in the US, don’t be caught off guard!  Attending this webinar will provide you with…

• A “crash course” on the REMS program
• REMS requirements as outlined by FDA
• How to execute a quality-assured REMS program
• What FDA inspectors specifically look for when evaluating compliance to an approved REMS, plus data showing inspections trends

Additionally, this course will teach you to perform an internal gap analysis or audit to proactively identify, document and mitigate any existing gaps before the FDA shows up with the new compliance guide in their pocket.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

• Understand and discuss key points of the FDA REMS Program including their new inspector guideline
• Execute a gap analysis or internal audit to identify existing gaps in your REMS
• Determine how to best document your gap analysis (and outcomes) to demonstrate due diligence considering the uptick in FDA REMS inspections