On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
PUBLIC CONSULTATION PROCESS LAUNCHED ON DRAFT ADDENDUM TO THE GUIDELINE FOR GOOD CLINICAL PRACTICE
It is recalled that compliance with good clinical practice ("GCP") must be observed by sponsors, investigators and other participants involved in the design, initiation, conduct, recording and reporting of clinical trials that involve the participation of human subjects. This requirement is provided in the Clinical Trials Directive and the GCP Directive.
The draft addendum to the Guideline for good clinical practice (ICH) E6 is intended to introduce the following changes:
1. To encourage the implementation of an improved and more efficient approach to clinical trials that involve the participation of human subjects; and
2. To update standards concerning electronic records and essential documents which are intended to increase the quality and efficacy of clinical trials.
Some of the modifications which are reflected in the integrated draft addendum include areas such as, monitoring, validation of computerized systems, recordkeeping, the quality management system and issues of non-compliance.
Once the draft addendum to the Guideline on good clinical practice (ICH) E6 is adopted in its final form it will replace the current Guideline on clinical practice (ICH) E6.
The consultation process will remain open until 3 February 2016. Comments may be submitted by interested companies and individuals using the template form indicated on the draft addendum to the Guideline for good clinical practice to firstname.lastname@example.org.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017