Category: Good Clinical Practice

GCP Renovation – Modernization of ICH E8 and Subsequent Renovation of ICH E6

“ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2).”

For detailed information please see the Reflection paper on GCP Renovation

All comments should be submitted before the closing date for public comment, which is March 11, 2017.

 

MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” …

KOMUNIKAT KOMISJI Wytyczne w sprawie przyjęcia odstępstw ogólnounijnych dotyczących wyrobów medycznych zgodnie z art. 59 rozporządzenia (UE) 2017/745

Rozporządzenie Parlamentu Europejskiego i Rady (UE) 2017/745 w sprawie wyrobów medycznych przyjęto dnia 5 kwietnia 2017 …

EMA warns against using unproven cell-based therapies

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based …