January 28, 2025
ICH E6(R3) Step 5 Adoption Announced by EMA
The European Medicines Agency (EMA) has announced the adoption of the ICH E6(R3) Guideline for Good Clinical Practice (GCP) at...
News & Events
All news & events
January 27, 2025
Pharmity & Qlarix at Farmaforum 2025: Don’t Miss the Clinical Research Forum!
Join us on 17-18 September 2025, in Madrid for the Farmaforum – Clinical Research Forum. Discover key insights into the...
January 27, 2025
Training Material on ICH GCP E6 (R3)
Looking for must-read training material on ICH GCP E6(R3)? Check out the Step 4 presentation published by ICH GCP –...
January 14, 2025
Guideline for Good Clinical Practice ICH E6 (R3)
The ICH E6 (R3) Guideline reached Step 4 of the ICH process on 06-Jan-2025. This marks a major milestone in...
January 14, 2025
FDA Draft Guidance Protocol Deviations for Clinical Investigations
In December 2024, the FDA published a draft guidance titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and...
January 7, 2025
FDA Issues Draft Guidance on AI Use in Regulatory Decision-Making
Yesterday 6th January 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Use...