Conference Keynote Speakers and
Tutorials
Keynote Speaker 1: Peter Bachmann, DrSc
European and International Affairs Member of the CMDh
(Co-ordination Group for Mutual Recognition and
Decentralised Procedures - Human) on the Latest Regulatory Environment in
EU - from Development to Post-Marketing.
Keynote Speech 2: Takao
Yamori, PhD
Director of Center for Product Evaluation, Pharmaceuticals and Medical
Devices Agency (PMDA) to discuss the New Drug Development of Japan Origin
through Industry-Academia Collaboration.
Tutorials:
Tutorial 1: Company Core Data Sheets Prepared by Western Companies
Tutorial 2: Roundtable Discussion: What are Preferable Skill Sets in
Clinical Development
Tutorial 3: Group Work: Action Learning for Six Sig
Tutorial 4: Risk Management Plan - Standard (As of 10/30/2012)
Tutorial 5: Leadership and Philosophy: Best Practice
Tutorial 6: Basic Understanding of Bioequivalence
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