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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:
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.
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.
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