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CASSS Community News - October 31 2019
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CE PHARM | NLAB | REGIONAL FORUMS | CMC VIRTUAL LATIN AMERICA


CE Pharm Presentation Slides and Roundtable Discussion Notes Available

Thank you to all that participated and helped make CE Pharm 2019 a success! The speaker slides and roundtable notes from this meeting are now available.

Speaker Presentations

Roundtable Discussion Notes


Netherlands Area Biotech Discussion Group Program Update

Revision of ICH Q2(R1) and New ICH Q14 Guidance - Opportunities for the Development and the Life Cycle Management of Analytical Procedures
Christof Finkler, F. Hoffmann - La Roche AG

The Netherlands Area Biotech Discussion Group is back with a new afternoon of discussion and networking. Join us 12 December 2019 at Vrije Universiteit Amsterdam to discuss ICH Q14 and Q2.


Northern California Regional Forum Registration Closing

Fast-to-Market CMC Strategies
Wednesday, November 13, 2019
South San Francisco Conference Center

Registration for this forum will be closing on Monday, November 4. Discussions will include different perspectives and molecules, evaluating the different deliverables required throughout development and through initial licensure. To view the full program, click here.


NEW! CMC Strategy Forum Virtual Session
Latin America 2019


Regulations for Post Approval Changes in Biotherapeutics
- Global Developments and Opportunities for the Region


This 90 minute Virtual Session will be the first ever for CASSS members.

Presentations will be featured from:
• ANVISA-National Health Surveillance Agency
• FIFARMA-Federacion Latinoamericana de la Industria Farmaceutica
• Health Canada
• SINDUSFARMA-Syndicate of Pharmaceutical Products in São Paulo
• WHO-World Health Organization

Speakers will cover issues with respect to the approved guideline on procedures and data requirements for changes to approved biotherapeutic products. Presentations will be followed by questions and discussion from online participants.

View Scientific Program


Upcoming CASSS Meetings


TIME IS RUNNING OUT TO REGISTER

REGISTER TODAY FOR CMC/WCBP 2020

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more Calendar

9/14/2020 » 9/17/2020
Mass Spec 2020

9/28/2020 » 10/1/2020
CE Pharm 2020

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