CMC Community

Please join us on 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)

Thank you forthe this topic, I look forward tot he discussion. How do I register for the virtual discussion?

Please join us on 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)

Please join us on 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)