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DIA Global Center

Sep 14, 2017 8:15 AM - Sep 15, 2017 4:15 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets

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Session 1 and Session 2

Session Chair(s)

Michael Hamrell, PhD, RAC

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

Session 2: Construction of the Global Regulatory Strategy

Strategy components
Operational components

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