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
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
- Implications for changes to processes and SOPs
- A new quality standard of ICH GCP (R2)
- 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 approaches
- Case study
- Monitoring plans
- 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
Dr Dr. Laura Brown,
Pharmaceutical Management and Training Consultant,
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. Laura has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
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.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.