ICH gives CGT developers a regulatory framework that finally matches the speed and flexibility their groundbreaking therapies ...
After its meeting in Kobe, Japan earlier this month, the International Council for Harmonization (ICH) on Friday announced it has expanded its management committee, added new members and advanced ...
Dublin, Nov. 20, 2023 (GLOBE NEWSWIRE) -- The "Statistical Elements of Implementing ICH Quality Guidelines" training has been added to ResearchAndMarkets.com's offering. This training is designed for ...
This article outlines common CMC problems that are obstacles that steal momentum and create costly detours in the development ...
On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines. The proposed R2 addendums are a significant update and feature important ...
Pharma Lessons is pleased to announce the launch of its newly revised Good Clinical Practice (GCP) online training course, now fully aligned with the latest ICH GCP E6(R3) guidance.This update ...
Optimizing icIEF identifies mAbs more accurately, while staying within European Pharmacopoeia and ICH guidelines.
The ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2). A new ICH guidance document on Analytical Procedure Development, Q14, has been introduced. The ...
On March 7, 2024, FDA published two final guidance documents regarding analytical procedures in order to facilitate regulatory evaluations and flexibility in postapproval change management of ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback