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DIA Global Center

Oct 01, 2018 8:15 AM - Oct 02, 2018 5:05 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: Considerations and Requirements for Global Regulatory Strategy Development

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

What is the meaning of global regulatory strategy today?
Market Access considerations: Beyond regulatory approval
Target market identification
Strategizing with local affiliates
Product classification
Regulatory pathways
Special regulatory provisions
Special considerations: CMC, Nonclinical, Clinical
Sourcing of Product

Certificate of Pharmaceutical Product

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