Identify FDA Impact on REMS
Friday December 14th, 2018
The FDA has taken significant strides to improve REMS in terms of patient safety and access. At the 11th Risk Evaluation & Mitigation Strategies Summit, you will have the opportunity to hear firsthand from the FDA to analyze the patient perspective in regards to specific diseases and their treatments, along with the risks and burdens that are critical to patients.
Discuss Patient-Focused Drug Development (PFDD) and Potential Relationships to REMS
Sara Eggers, Operations Research Analyst, U.S. FOOD & DRUG ADMINISTRATION — CDER
Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE
Our adept speaking faculty will deliver insights into new regulations and emerging issues associated with REMS, including standardization, evaluation, and structured product labeling. Understand the FDA’s increased involvement in the process going forward, including shared REMS and waivers to shared REMS programs.
Panel: Concerns Providing/Obtaining Product Samples in ETASU REMS or Restricted Distribution
Elaine Lippman, Regulatory Counsel, FOOD & DRUG ADMINISTRATION
Brian Malkin, FDA Counsel, ARENT FOX
Click here to view the detailed program that has everyone talking.
Take advantage of our Early Bird rate — a $200 discount — by registering today. Don’t forget to use Priority Code 798819EM6.
Showcase your services or property to this senior-level group of industry leaders.
There are limited exhibition and sponsorship opportunities at this event, and we anticipate selling out, so if you are interested in engaging with REMS professionals in an intimate, non-tradeshow-like setting, contact Arthur Butler at firstname.lastname@example.org.
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