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Session 2: The Role of Regulatory Affairs During Drug Development
Session Chair(s)
Diptee A. Gajjar, PhD
Intercontinental Regulatory Strategy Lead
Bristol-Myers Squibb Company, United States
- Phases of Drug development/lifecycle of medicines
- Scientific advice
- Clinical trials
- Pediatric regulation
- Orphan regulation
- Good regulatory practices - Good Manufacturing Practice (GMP)
- Good Clinical Practice (GCP)
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