Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Oct 1, 20232 min read

EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation

Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...

Jul 24, 20232 min read

EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation

The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...

May 7, 20232 min read

EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS

Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...

May 8, 20221 min read

Guide to Clinical Trials conducted under the CTR in Ireland

Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...