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Home » Store » Webinar Recordings » REMS Regulatory Developments and Best Practices - Webinar Recording/Transcript

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REMS Regulatory Developments and Best Practices - Webinar Recording/Transcript

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Webinar Recordings

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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.

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