Dear All,
Please join us on Friday, Sept 27 for an engaging virtual panel discussion on "Challenges and Opportunities in the ICH Q14 Implementation." This session seeks to share:
• Industry and FDA's experiences with ICH Q14 as well as potential challenges and opportunities
• Expectations to establish acceptance criteria and confidence limit
• The tools used to facilitate analytical changes based on ICH Q14.
• Opportunities to provide submissions with enhanced conditions (ECs).
• Opportunities for post-approval changes with EC developments
(see attachment for details - no pre-registration is needed!)
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Andrea Schirmer
Sr. Research Fellow - CMC Expert
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield CT
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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