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CMC Forum Japan 2015: Speaker Presentations
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Below you will find links to presentations from the CMC Strategy Forum Japan 2054. Please note: slides are organized by plenary session title and/or Workshop Session. 
If you have questions regarding the links, please contact Project Coordinator Anna Lingel (


Welcome and Introductory Comments  
Introduction to CASSS Slides Introduction to CASSS Slides
Nagano Slides Nagano Slides
Recent Trends in the Regulation of Biopharmaceutical Products  
Sato Slides Sato Slides
Kirshner Slides Kirshner Slides
Sparringa Slides Sparringa Slides
Boonprasirt Slides Boonprasirt Slides
Joung Slides Joung Slides
Development of Biosimilars: Technical Aspects  
Teruyo Slides  Teruyo Slides
Yamada Slides  Not Available
Liu Slides  Liu Slides
Ekman Slides Ekman Slides
ICH Q12 Overview: Established Conditions / Approved Matters  
Kishioka Slides Kishioka Slides
Kojima Slides Kojima Slides
Nishimura Slides Nishimura Slides
Yanagihara Slides Yanagihara Slides
ICH Q12 Overview: Post-approval Change Management Protocol (PACMP)
Markovic Slides Markovic Slides
Goese Slides Goese Slides
Kawakami Slides Kawakami Slides
Summary 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 (CASSS), 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.




more Calendar

7/10/2018 » 7/12/2018
Cell & Gene Therapy Products 2018

7/16/2018 » 7/17/2018
CMC Strategy Forum Summer 2018

9/9/2018 » 9/12/2018
CE Pharm and Mass Spec 2018

Featured Members
Linda O. Narhi, Amgen Inc.Visit the CASSS News page to get to know Linda Narhi!

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