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CMC Forum Japan 2017: Scientific Program
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To view the preliminary scientific program, click here.

 

 


 

The CMC Strategy Forum Japan 2017 will focus on topics and regulatory updates relevant for Japan and Asia and will feature an opening regulatory session that will include presentations from PMDA, FDA, EMA and Health Canada. Other regulatory agencies that have been invited include ASEAN, China, Korea and Thailand.

Program Agenda

Monday, 4 December 2017

08:30 – 09:00
Welcome and Introductory Comments

09:00 – 15:30
Recent Trends in the Regulation of Biopharmaceutical Products

12:30 – 13:45
Hosted Lunch

15:30 – 17:30
ICH Q12 Update

17:30 – 19:00
Networking Reception

Tuesday, 5 December 2017

09:00 – 12:00
Challenges in Global Development of Drug Device Combination Product

12:00 – 13:15
Hosted Lunch

13:15 – 17:00
 
Use of Prior Knowledge to Support CMC Development in Conventional and Expedited Settings - click here to view session abstract

17:00 – 17:45
Summary and Closing Remarks 

 

Note: Program agenda is preliminary and may be subject to change. 



more Calendar

12/4/2017 » 12/5/2017
CMC Strategy Forum Japan 2017

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