Posts by Leire Zúñiga
September 12, 2025
ICH E6(R3) in the USA: Current Landscape
On 08th September 2025, the U.S. Food and Drug Administration (FDA) published its final guidance for industry on ICH E6(R3) Good Clinical Practice. This guidance aligns with the new ICH principles and aims to support adoption of flexible, risk-based approaches, and promotes innovations in trial design, conduct, and use of technology. E6(R3) Good Clinical Practice […]
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 Step 5. The guideline is set to come into effect on 23 July 2025, allowing stakeholders sufficient time to prepare for its implementation. For more information, visit the EMA website.
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 recently adopted ICH E6(R3) and other current topics shaping clinical trials. Read the exclusive interview with our Managing Director for an in-depth look at ICH E6(R3). Interview Leire Zúñiga_Spanish_24Jan2025