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Forward Progress Through Collaboration: Internal and External to the FDA
Session Chair(s)
Kevin Bugin, MS, RAC
Head of Global Regulatory Policy and Intelligence, Amgen, United States
The FDA’s Center for Drug Evaluation and Research utilizes multiple processes and methods to collaborate. This forum will review select processes and provide a forum to discuss case studies in which a high level of collaboration was achieved.
Learning Objective : Discuss ways the FDA can work with internal and external partners; Recognize evidence of internal and external FDA collaboration; Apply practices for increasing stakeholder engagement and bolstering effective communication.
Speaker(s)
Internal Consultative or Collaborative Reviews at FDA
Patricia Love, MD, MBA
Deputy Director, Office of Combination Products, OCPP, OC, FDA, United States
Harmonizing Global Regulatory Agency Collaboration in Pediatric Drug Development
Andrew Mulberg, MD
Senior Vice President, Neurogene, United States
Collaborative Development of 2-Hydroxypropyl-ß-Cyclodextrin for Niemann-Pick Disease, Type C
Forbes D. Porter, MD, PhD
Seniior Investigator , Eunice Kennedy Shriver National Institute of Child Health and Human Development, United States
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