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2023 Combo Products Summit Workshop


Risk Management Application In Post-Market Safety & Other PMSR Hot Topics

November 28, 2023 @ 2:40 pm


5:10 pm


(Leading Facilitator) Khaudeja Bano, Vice President, Combination Product Quality, Amgen

(Leading Facilitator) Rich Wolf, Head of Pv Operations at CSL Behring

John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

Fubin Wu, Co-founder, GessNet Safety Engineering

Kate Gillespie, Sr. Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson

An interactive workshop session on post-market safety and end-to-end application of risk management principles in the post market setting. There will be discussion around PMSR (post-implementation) and the successes and challenges related to our journey as cross-functional stakeholders coming together for a bigger purpose. Through examples and practical approaches, we will explore the related people, process and technology. We will deep dive into the Information exchange about adverse events and complaints coding challenges. We look to answer:

  • “Does the quality of data submitted in the reports meet its intent and purpose?”.
  • What are the unique challenges with third party engagements, and what are the solutions to mitigate?
  • Learn about organizational models that best fit your needs to support global PMSR requirements.
  • What transformations in technology are needed to support your needs.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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