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Session 1 and Session 2
Session Chair(s)
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
Session 1: Considerations and Requirements for Global Regulatory Strategy Development
- What is the meaning of global regulatory strategy today?
- Market Access considerations: Regulatory approval is no longer sufficient
- Target market identification
- Strategizing with local affiliates
- Product classification
- Regulatory pathways
- Special regulatory provisions
- Special considerations: CMC, Nonclinical, Clinical
- Sourcing
- Certificate of Pharmaceutical Product Availability
- Strategy components
- Operational components