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Forward Progress Through Collaboration: Internal and External to the FDA
Session Chair(s)
Kevin Bugin, PhD, MS, RAC
Deputy Director of Operations, Office of New Drugs, CDER
FDA, 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
FDA, United States
Deputy Director, Office of Combination Products, OCPP, OC
Harmonizing Global Regulatory Agency Collaboration in Pediatric Drug Development
Andrew Mulberg, MD
Neurogene, United States
Senior Vice President
Collaborative Development of 2-Hydroxypropyl-ß-Cyclodextrin for Niemann-Pick Disease, Type C
Forbes D. Porter, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development, United States
Seniior Investigator
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