REMS Regulatory Developments and Best Practices - Webinar Recording/Transcript

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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.

  • Regulatory and quality professionals
  • Executive suite
  • Regulatory affairs/compliance
  • Medical affairs/pharmacovigilance
  • Product lifecycle managers
  • Labeling specialists
  • Risk managers
  • General/corporate counsel
  • Outside attorneys

Lynn Mehler, Partner, Hogan Lovells
Lynn Mehler,partner in the Hogan Lovells Pharmaceutical and Biotechnology practice, advises clients on a range of FDA and DEA regulatory matters. Drawing on her 12 years with the FDA's Office of the Chief Counsel, Lynn has a deep understanding of the FDA. She advised the agency on drug safety matters, including at approval and those leading to labeling changes, REMS, and product withdrawal.  Lynn works with a range of clients on REMS matters, from developing, assessing and modifying REMS, to negotiating shared REMS with generic applicants.