FDAnews Announces -- REMS Regulatory Developments and Best Practices Webinar, Mar. 22, 2019

Friday, March 8, 2019 Press Release
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Keep up with REMS regulatory developments and best practices? Find out here…

FALLS CHURCH, Va., March 8, 2019 /PRNewswire-PRWeb/ -- REMS Regulatory Developments and Best Practices **An FDAnews Webinar**

Friday, March 22, 2019, 1:30 p.m. - 3:00 p.m. EST http://www.fdanews.com/medicalimaging

We've had 10 years of REMS, but is everyone up to date… think again. This January the FDA released a draft guidance on REMS assessment plans, advising sponsors to include both process metrics and outcomes measures. Sponsors can use postmarket adverse event data, drug use data, and observational or epidemiological data, in addition to stakeholder input for their REMS assessments.

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. Attendees will 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 the 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

Attendees will 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.

Meet Your Presenter: 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.

Who Will Benefit:

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

Webinar Details: REMS Regulatory Developments and Best Practices **An FDAnews Webinar** Friday, March 22, 2019, 1:30 p.m. - 3:00 p.m. EST http://www.fdanews.com/medicalimaging

Tuition: $287 per site

Easy Ways to Register: Online: http://www.fdanews.com/medicalimaging By phone: 888-838-5578 or 703-538-7600

About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

 

SOURCE FDAnews



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