CDDF & Oncology News

The European Medicines Agency has published for public consultation the ICH M15 Guideline on general principles for model-informed drug development. This guideline provides general recommendations for planning, model evaluation, and documentation of evidence derived...

We are pleased to announce that the ICH E6(R3) principles and Annex 1 have been finalised and published on the ICH website. This is a rewrite and reorganisation of the R2 version of the guideline on Good Clinical Practice (GCP), which sets international standards for...

We are pleased to announce the launch of the ACT EU consultation on clinical trials training needs for academia and SMEs. As a reminder, the consultation stems from ACT EU initiative’s Priority Action on clinical trials training aiming to deliver a clinical trials...

EMA has opened the public consultation on the draft Annex 2 of ICH E6(R3), following its adoption by EMA’s Committee for Medicinal Products for Human Use (CHMP). As part of the ICH E6 suite, this document addresses Good Clinical Practice (GCP), an international...

As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 and acknowledging the important role of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficiency...

All clinical trials expected to continue beyond 30 January 2025 must be transitioned to the EU Clinical Trials Regulation (CTR) via the Clinical Trials Information System (CTIS). This date marks the end of a three-year transition period that began when the CTR became...