The New ICH GCP E6 R2 Guideline

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.

In-house Training Services and Consultancy

NEWLY FINALISED!

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 info@falconbury.co.uk 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.

Sample programme

Understand the background to ICH GCP (R2) guideline

  • Why the revision?
  • ICH and its importance
  • The links of ICH GCP (R2) and other relevant EU and FDA guidelines and documents including the new EU Clinical Trial Regulation

Overview of the changes of the new ICH GCP (R2) guideline and how these will impact on clinical trials

  • New definitions
  • New sections on investigator responsibilities and oversight
  • Significant changes to sponsor oversight
  • Quality management
  • Risk based monitoring
  • Computer validation
  • Serious breaches
  • Clarification of the contents of the TMF
  • Proposed important changes of overcoming the problems of the Directive
  • Implications for changes to processes and SOPs
  • A new quality standard of ICH GCP (R2)

Sponsor implementation

Quality management

  • Implementing a quality management system
  • Critical processes and data identification
  • Risk process: identification, evaluation, control, reporting, communication, mitigation

Oversight of CROs

  • New requirements for sponsor oversight of vendors/CROs
  • Implications for the selection, contracts, management and performance of CROs
  • Practical approaches to how to demonstrate sponsor oversight compliance

Risk- based monitoring

  • Definitions of Risk- based monitoring
  • Risk based monitoring approaches
  • Virtual clinical trials case study
  • Monitoring plans
  • Remote monitoring of informed consent – case study

Electronic systems

  • Validation processes
  • Certified copies of documents
  • SOPs needed for electronic trial data handling

Serious breaches of GCP

  • What are serious breaches and how should these be reported?
  • Case study examples of serious breaches
  • How to carry out and document corrective and preventative action (CAPA) to comply with ICH (R2) to manage serious non-compliance of GCP

Investigator study site oversight

  • Investigator responsibilities for supervision of individuals activities which are delegated
  • Ensuring appropriate qualifications of staff
  • Responsible for trial data including source data is attributable and complete

Trial Master File and preparation for inspection

  • What additional documents should the TMF contain?
  • Maintaining a record of the location of essential documents irrespective of storage system or media
  • Investigator control of essential documents
  • EMA draft TMF expectations for the TMF including e-TMF
  • How to prepare for inspection of the new requirements
  • What questions inspectors may ask and how to answer these?

Recommended trainer

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.