Compliance with the New ICH GCP revised 2 Guidelines

Why Should You Attend:

With the new ICH GCP E6 Revision 2 changes now needing to be implemented it is important for organizations 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 webinar will cover these new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

Areas Covered in the Webinar:

• Understand the new requirements of the updated ICH GCP R2 guideline
• Consider the challenges and opportunities in implementing the new guidance
• Review the new requirements for Sponsor Oversight
• Understand requirements for CROs and quality systems
• Explore risk based approaches
• Consider changes for the TMF
• Review best practice of these additional new GCP requirements

Who Will Benefit:

The session is relevant for professionals working in pharmaceutical, biotechnology, CRO, regulatory authorities and study sites including investigator initiated studies involved in clinical trials and all other professionals who want to know more about the new ICH GCP (R2) guideline.

This course is recommended for:

• Clinical research
• Clinical operations
• Clinical trial personnel (Clinical trial supply, Quality assurance, Document management, Legal etc.)
• Regulatory affairs
• Pharmacovigilance

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

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. Laura 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.

She 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 (Informa 2005), a chapter on “GCP in International Pharmaceutical Product Registration” (Informa, 2009), several articles on the new EU Clinical Trial Regulation in 2014 and 2015, and a chapter on Drug Development for the Clinical Research Manual to be published by Euromed Communications in early 2017.

Follow us :