This *In-house* programme will show your team the new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites all at a location of your choice. Our expert comes to you and running this programme for your whole team is extremely cost-effective.
With the new ICH GCP E6 Revision 2 changes now finalised and needing to be implemented, it is important for organisations running clinical trials to understand the changes, the reasons behind them, and how they will be affected.
The new guideline includes a number of “hot” GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are aimed at increasing efficiency and reducing costs of clinical trials.
This In-house programme will show your team the new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites all at a location of your choice. Our expert comes to you and running this programme for your whole team is extremely cost-effective.
Your next step is to call us now on +44 (0)20 7729 6677 or email us at firstname.lastname@example.org or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.
Understand the background to ICH GCP (R2) guideline
Overview of the changes of the new ICH GCP (R2) guideline and how these will impact on clinical trials
Oversight of CROs
Risk- based monitoring
Serious breaches of GCP
Investigator study site oversight
Trial Master File and preparation for inspection
Dr Laura Brown is an independent QA and Training Consultant and Director of the MSc in Clinical Research, School of Pharmacy at the University of Cardiff and Course Director of the MSc Regulatory Affairs, TOPRA. She has many years’ experience in the Pharmaceutical Industry. She has worked for several companies including Glaxo Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a Clinical Research Manager, Audit Director and as Head of a Training Department.
Laura is an international expert on GCP requirements. She was Chairman of the Institute of Clinical Research GCP Forum for six years, and writes regularly on clinical research regulatory requirements. She is a member of the Editorial board of SCRIP Clinical Research Journal. She is author of SCRIP’s latest GCP guide, a practical guide to the Clinical Trial Directive and has written a chapter on GCP in International Pharmaceutical Product Registration (2009), and several articles on the new EU Clinical Trial Regulation in 2014 and 2015.