REMS Regulatory Developments and Best Practices - Webinar Recording/Transcript
REMS Regulatory Developments and Best Practices
Is your REMS program compliant with new FDA expectations?
Lynn Mehler — partner in the Hogan Lovells pharmaceutical and biotechnology practice — will address the FDA’s current expectations in designing a program to assess REMS, and how to make your program compliant with those expectations. You’ll learn about:
- How REMS assessments have changed over the more than 10 years since REMS was enacted
- The FDA’s current expectations in designing a program to assess REMS and how to make your program compliant
- The REMS assessment process, including what goes on behind the scenes
- How REMS assessments can lead to additional requirements, separate and apart from modifications to a REMS
- How to use REMS assessments to build a case for REMS modification including elimination of requirements
- How to comply with two significant recent guidances, Development of a Shared System REMS and Waivers of the Single, Shared System REMS Requirement
You’ll come away with a deeper understanding of the FDA’s current approach to REMS, including the increased focus on and complexity of the REMS assessment process.