The pharma world is expecting a new regulatory “earthquake”. GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as “game changing”. Clinical trial design, conducting, oversight, recording and much more is added now to GCP.
Let us review the main points.
For better understanding what new sections were added in the Addendum, Cyntegrity offers a Mind Map (Updated, VER. 3.0), which categorizes and simplifies the new information (download the PDF):
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