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CMC Forum Europe 2019: Speaker Presentations
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Below you will find links to presentations from the CMC Strategy Forum Europe 2019. If you have questions regarding the links, please contact CASSS Program Specialist, (

CASSS requests permission from each presenter to make their slides available.  If the slides your are interested in are not listed below, we did not receive authorization to share them on this website. 


EBE - European Biopharmaceutical Enterprises Satellite Session
Concept Paper 2019 Updates
Annick Gervais

CRISPR-Cas9 Session
Guillaume Pavlovic
Marcos Timón

 CMC Strategy Forum Europe 2019
Regulatory Updates from the Around the World:
Part One  
Suyuan Cheng
César Hernández
Emanuela Lacana 
Nick Lee
 Workshop Session One:
Continuous Manufacturing for Biologics
Andrew Chang
Veronika Jekerle
Workshop Session Two:
CMC Challenges in Accelerated
Drug Approval Pathways 
Lisa deCardenas 
Hoefnagel, Jekerle and Welin
Andrew Lennard
Workshop Session Three:
ICH Q14 / Q2 - Trends and Concepts for QbD for Analytics and Lifecycle Management of Analytical Methods 
Tone Agasøster 
Cristiana Campa
Workshop Session Four:
ICH Q12 and Challenges of Post-approval Changes
Vandana Chauhan
Corine Dortu
Stuart Finnie
Nanna Kruse

Workshop Session Five:
Personalized Medicine and Manufacturing 4.0
 Lothar Hartmann

The views and opinions expressed in these PPT slides are those of the individual presenter and should not be attributed to 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

9/14/2020 » 9/17/2020
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9/28/2020 » 10/1/2020
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