Agenda

Day 1 Oct 01, 2018

8:15 AM — 8:45 AM

Registration and Continental Breakfast

8:45 AM — 9:00 AM

Introductions

9:00 AM — 10:00 AM

Session 1: Considerations and Requirements for Global Regulatory Strategy Development

10:00 AM — 11:00 AM

Session 2: Construction of the Global Regulatory Strategy

11:00 AM — 11:15 AM

Refreshment Break

11:15 AM — 12:15 PM

Session 3: Unique Challenges: The United States and the European Union and Beyond

12:15 PM — 1:15 PM

Luncheon

1:15 PM — 2:30 PM

Session 4: Communicating with Regulators

2:30 PM — 3:45 PM

Session 5: Overview of Japan

3:45 PM — 4:00 PM

Refreshment Break

4:00 PM — 5:15 PM

Application of Learning: Group Exercise #1

5:15 PM — 5:30 PM

Wrap-Up / Questions and Answers

Day 2 Oct 02, 2018

8:30 AM — 9:00 AM

Continental Breakfast

9:00 AM — 10:15 AM

Session 6: Overview of Middle East, North Africa, South Africa, Russia, and CIS Countries

10:15 AM — 10:30 AM

Refreshment Break

10:30 AM — 11:30 AM

Session 7: Overview of China

11:30 AM — 12:00 PM

Session 8: Overview of Australia, New Zealand, India, Korea, Taiwan, and ASEAN

12:00 PM — 1:00 PM

Luncheon

1:00 PM — 2:00 PM

Session 8: Overview of Australia, New Zealand, India, Korea, Taiwan, and ASEAN (continued)

2:00 PM — 3:30 PM

Session 9: Overview of Latin America

3:30 PM — 3:45 PM

Refreshment Break

3:45 PM — 4:45 PM

Application of Learning: Exercise #2

4:45 PM — 5:05 PM

Wrap-up and Conclusion of Program

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

Agenda

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