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.
27 Feb 2018
& 25 Sep 2018
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.
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
Overview of the changes of the new ICH GCP (R2) guideline and how these will impact on clinical trials
Investigator study site oversight
Oversight of CROs
Non-compliance of GCP and CAPA
Trial Master File and preparation for inspection
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. She 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. She is co-author of several books on management including ‘Developing the Individual’, ‘The Ultimate Book of Business Skills’ and ‘Pharmaceutical Project Management’.