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DIA Global Center

14 sep 2017 8:15 a.m. - 15 sep 2017 4:15 p.m.

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

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

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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