Understanding the Draft Guidance on Postmarketing Safety Reporting for Combination Products – An Interactive Analysis with FDA and Industry

Join the Conversation

May 31st 31 May 2018 (9:00 am-3:00 pm EST)
Amgen Inc.
601 13th St NW
Washington, DC 20005

Join Virtually


The Final Rule on Postmarketing Safety Reporting for Combination Products goes into effect 19 July 2018. You have the opportunity to add your input and hear directly from FDA regarding their interpretation of the applicable requirements, and other topics important to anyone who works in this space.

Objectives

  • Understand key takeaways from the Final Rule and best practices for risk management.
  • Assess challenges to effective implementation and address remaining gaps.
  • Discuss potential solutions and recommendations that will require FDA and industry collaboration.

Who Should Attend

This program is intended for individuals working at all professional levels in the drug, device, biologic and combination product space. Anyone involved in post-market safety, pharmacovigilance, medical device reporting, and all other quality, regulatory, or compliance issues will greatly benefit from attending.