Simplifying Global Compliance
REMS Regulatory Developments and Best Practices - Webinar Recording/Transcript
| Quantity Discounts | 1 - 2 $287.00 | 3 - 4 $258.00 | 5 - 6 $244.00 | 7 - 9 $230.00 | 10 - 9999 $215.00 |
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.
