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Tower Hall Funabori

Apr 17, 2017 9:00 AM - Apr 18, 2017 6:00 PM

4-1-1 Funabori, Edogawa-ku, Tokyo, 134-0091 Japan

11th DIA Asia New Drug Conference in Japan

Agenda

Day 1 Apr 17, 2017

9:40 AM — 10:10 AM

Keynote Speech

10:10 AM — 11:50 AM

[Session 1] Update on Regulatory Environment in East Asia

1:05 PM — 2:45 PM

[Session 2] Regulator’s Perspective for Drug Development Using Asia MRCT

3:15 PM — 5:15 PM

[Session 3] Industry’s Perspective for Drug Development Using Asia MRCT

Day 2 Apr 18, 2017

9:00 AM — 9:50 AM

[Special Lecture] Regulatory Environment in ASEAN

9:50 AM — 10:40 AM

[Session 4] Changes and Benefits ICH E17 will Bring about

11:10 AM — 12:00 PM

[Session 5] Lessons Learned from Actual Experience - Case Example of Drug Approval in Asia through Global Development -

1:15 PM — 3:30 PM

[Session 6] Drug Development in China; Recent Regulatory Changes and the Impacts

4:00 PM — 5:25 PM

[Session 7] Development and Management of Strategic Labeling and Risk

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