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The New ICH GCP E6 R2 Addendum

This seminar will enable you to meet the new international GCP ICH GCP E6 standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union, Japan, the United States, Canada and Switzerland.

Course Overview

The ICH GCP E6 revision 2 Addendum came into effect in Europe on 14 June 2017, and it is important to all involved in clinical research to understand and have implemented these changes to ensure regulatory compliance. The updated guideline includes a number of ‘hot’ Good Clinical Practice inspection topics, which are also covered in a number of other EU and FDA guidelines and documents, and a further major revision is also being planned.

This course will cover these new requirements, evaluate the changes and discuss how these should have been implemented by sponsors, CROs and study sites. This will enable you to meet the new international ICH GCP E6 revision 2 Addendum standard to ensure the clinical trial data required by the regulatory authorities internationally, including the EU, Japan, the United States and Switzerland are met.

Benefits of attending

  • Understand the new requirements of the updated ICH GCP guideline
  • Discuss challenges and opportunities in implementing the new guidance
  • Review the new requirements for Sponsor Oversight, CROs, quality systems, risk based approaches and the TMF
  • Share best practice of these additional new GCP requirements which will facilitate a broad and consistent international implementation of new methodologies for running clinical trials

Who should attend

The course is relevant for professionals working in clinical research/clinical operations, regulatory affairs and pharmacoviglance in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise/support clinical trial personnel (such as clinical trial supply, quality assurance, document management, legal, and all other professionals who want to know more about the new ICH GCP (R2) guideline.


Understand the background to ICH GCP (R2) and the new plans for further revision to the guideline

  • Why the revision and further major changes?
  • 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

  • Inspection considerations
  • New definitions
  • Certified copies
  • Key requirements for compliance

Investigator study site oversight

  • Investigator responsibilities for supervision*
  • Ensuring appropriate qualifications of staff

Sponsor implementation

  • Implications for changes to processes and SOPs
  • A new quality standard of ICH GCP (R2)

Quality management

  • Implementing a quality management system
  • Critical processes and data identification *Risk process implementation

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

  • Risk based monitoring approaches
  • Case study
  • Monitoring plans

Electronic systems

  • Validation processes
  • SOPs needed for electronic trial data handling

Non-compliance of GCP and CAPA

  • How to carry out and document corrective and preventative action (CAPA) to comply with ICH (R2) to manage serious non-compliance of GCP

Trial Master File and preparation for inspection

  • What additional documents should the TMF contain?
  • EMA draft TMF expectations for the TMF including e-TMF
  • How to prepare for inspection of the new requirements

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Abbott Products Operations AG
  • Bavarian Nordic
  • BCT
  • Biogen
  • Ferrer Internacional
  • GE Healthcare Ltd
  • Mediplex Ltd
  • Mediscribe Consulting Ltd
  • NDA Regulatory Science Ltd
  • Oxford Pharmascience Ltd
  • Procter & Gamble Technical Centres Limited
  • Smith & Nephew
  • USGI Medical
  • Vertex

Good course to have an overview of the major damages into the new ICH F6 R2 and the impact and expectations to the industry

Maria Calvo Subirats, GCP&GVP Responsible (QA Unit), Ferrer Internacional

Course content was just right, presentation was great and the speaker knowledgeable

Catherine Copse, Head of GxP Operations, GE Healthcare Ltd

The course did fulfil my expectation and it was really helpful to identify how the new ICH GCP R2 impacts Clinical research from different perspective. Delegates and speaker discussion were remarkable to exchange experiences.

Maria Calvo Subirats, GCP&GVP Responsible (QA Unit), Ferrer Internacional