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Navigating Combination Product Pathways: Industry Experiences and FDA’s Role

November 30 @ 8:15 am 9:15 am

Industry experts and regulatory officials will share real-world experiences associated with the intersection of drugs and device topics including: regulatory pathways, interactions with CDER/CDRH, approaches to establish shelf life/stability, risk management, quality management systems, and drug-biologic-device compatibility. Join FDA, FDA Jurisdictional Officers, and industry in this blended panel discussion!


  • Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech
  • Rumi Young, Director, Regulatory Policy, BD


  • Chelsea O’Connell, Director, Global & Regulatory and R&D Policy at Amgen
  • Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER) FDA
  • Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
  • Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC
1300 Houston Street
Fort Worth, Texas 76102 United States
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