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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 3 and Session 4

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

Session 3: Unique Challenges Outside the United States and the European Union

Culture and communication
Requirements in local investment
Investing in infrastructure
Potential regulatory hurdles
Expectations around investigational drug availability after clinical studies

Session 4: Communicating with Regulators

Optimizing meeting opportunities
Anticipating and managing queries
Culture and communication
Crisis management and issue resolution

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