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CMC Forum Japan 2016: Speaker Presentations
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Below you will find links to presentations from the CMC Strategy Forum Japan 2016. Please note that the slides are organized by presentation date.  Click to the right of the speakers names to obtain the speakers PDF Powerpoint Presentation.  If you have questions regarding the links, please contact the Meeting Coordinator Julie Fowle at 


Monday, 5 December

Takao Yamori Slides
Recent Trends in the Regulation of Biopharmaceutical Products
Kazuhiko Chikazawa Slides
Il Ung Oh Slides
He Bai Slides
Niklas Ekman Slides
Sarah Kennett Slides
Specifications / Potency: Test Procedures and Acceptance Criteria for Cell-based Products
Takao Hayakawa Slides 
Kazunobu Oyama Slides
Kiwamu Imagawa Slides
Carl Burke Slides
Ilona Reischl Slides
 Tuesday, 6 December
ICH Q12 Update: Established Conditions in the Manufacturing Process
Yasuhiro Kishioka Slides 
Frank Montgomery Slides
Kyoko Sakurai Slides
Toshiyuki Suzawa Slides
Patrick Swann Slides
 ICH Q12 Update: Established Conditions for Specifications: Relationship with Analytical QbD 
Rie Fujita Slides
Christof Finkler Slides
Akira Nonoyama Slides
Summary Slides

The views and opinions expressed in these PPT slides are those of the individual presenter and should not be attributed to CASSS, An International Separation Science Society, its directors, officers, employees, volunteers, members chapters, councils or affiliates, or any organization with which the presenter is employed or affiliated.

These PPT slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries.  Used by permission.  All rights reserved.  CASSS and CASSS logo are registered trademarks.  All other trademarks are the property of their respective owners.


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