PDA Delaware Valley Knowledge Center

ARTICLES

Combination Product Hot Topics: Post Approval Device Changes and the New EU MDR Article 117 Requirements

Presented by: Doug Mead, Sr. Director, CMC RA, Devices and Combination
Products, Janssen Research & Development, LLC
Combination Product Development & Regulatory Best Practices: Drug/Biologic PMOA Perspective

Presented by: Suzette Roan, JD
Sr. Director, GRA Devices and Combination Products, Sanofi
Combination Products Risk Management and Control Strategies

Presented by: Susan Neadle
Sr. Director, Global Value Chain Quality Design
Head, J&J Combination Products CoP
Johnson & Johnson sneadle1@its.jnj.com

March 2, 2020

August 11, 2017

April 25, 2017

April 25, 2017

April 25, 2017

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