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2022 ISPE Annual Meeting & Expo

SES03c - A Joint Industry & Regulatory Panel on ICH Q2(2) and Q14


Nov 1, 2022 10:45am ‐ Nov 1, 2022 12:15pm


Description

The panel discussion will focus on ICH Q2(2) and Q14 but recognizing that these guidance documents build on the foundation outlined by ICH Q8, Q9, Q10, Q11, and especially Q12, experience with any of these guidance documents is a real plus for the discussion. We anticipate that session attendees will have questions about established conditions (building on Q12 guidance), content recommendations for CTDs, and regulatory changes.

Speaker(s):

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