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Session 8: Transparency in Drug Regulatory Affairs
Session Chair(s)
Diptee A. Gajjar, PhD
Intercontinental Regulatory Strategy Lead
Bristol-Myers Squibb Company, United States
- Freedom of information
- Public assessment report
- MRI – Product Index
- Cooperation between regulatory agencies
- Information exchange
- Confidentiality agreement
- Mutual recognition agreement
- Parallel-/co-assessment during drug development, marketing authorization, post-marketing
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