spacer
home > epc > autumn 2017 > compliance and modernisation
PUBLICATIONS
European Pharmaceutical Contractor

Compliance and Modernisation

The new ICH Good Clinical Practice (GCP) E6 Addendum Revision 2 (E6 R2) is the biggest amendment of the international guideline for over 20 years. The update was finalised in November 2016 and became effective in the EU on 14 June 2017, meaning organisations running clinical trials in this region should now be compliant with the new requirements.

However, in January 2017 – just two months after the new guideline was finalised – many were surprised when ICH announced that an even greater change is planned. The extra revision is being added to keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology.

Further Modernisation

ICH is proposing further updates to E6 R2 in what they are calling a ‘renovation’ – the scope of these further suggested changes will include clinical trial design, planning, management and conduct of clinical trials (1).

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Dr Laura Brown is Managing Director of a leading international training and quality assurance consultancy specialising in the pharmaceutical industry. She delivers a broad range of technical and management courses and consultancy for pharma, covering project management, ICH GCP R2, CAPA and clinical trial regulations. Laura is also Course Director, MSc Clinical Research, School of Pharmacy, Cardiff University, UK.
spacer
Dr Laura Brown
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Extremely fast chemical search in vast chemical space

Read through a poster by ChemAxon aiming to find novel analogues of known drugs among the 977 million unique entries of the GDB-13 database. The result got queried against the SureChEMBL's patent database as well.
More info >>

White Papers

e-tools enhance clinical trial performance

e-novex

In today’s ever-evolving medical business, technological changes require innovation to meet growing market demands and to bring about advances in the industry. One such development currently taking place in the field of clinical research is how e-tools are initiating a boost in the productivity of clinical trials.
More info >>

 
Industry Events

Clinical Innovation Partnerships 2018

3-4 July 2018, Radisson Blu Hotel, Zurich Airport

Clinical Innovation Partnerships is the only event for senior clinical operations and procurement professionals driving innovation in their clinical trials. It is where the pharma, CRO and vendor clinical trials ecosystem meet to drive innovation in digitalisation, tech and partnering to improve patient experience and reduce trial cost and time.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement