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

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>

White Papers

Accelerate Your Database Lock Using Clean Patient Optics

Bioclinica

Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data are clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data. However, this can be challenging when manually reviewing study data, particularly with larger studies.
More info >>

 
Industry Events

RDD Asia 2018

14-15 November 2018, Grand Hyatt Kochi, Kerala, India

A must-attend meeting for pulmonary and nasal researchers, inhaled product developers and vendors active in this important pharmaceutical niche.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement