Wednesday, December 11, 2019
The ICH GCP E6 revised guideline was issued to reflect on the current research landscape: increase in globalization, studies complexity, and technological capabilities. The updated ICH GCP E6 (R2) Addendum is more descriptive than the previous ...
Besides being a new expectation by regulatory agencies Good Clinical Practice (GCP), Quality by Design (QbD) and Risk-Based Quality Management (RBQM) concepts are receiving attention world-wide. According to FDA and EMA guidelines, Key Risk ...