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Compliance with the New ICH GCP Revision 2 Addendum – Know the How?
With the new ICH GCP E6 Revision 2 Addendum now finalised the changes should have been implemented for organisations running clinical trials.
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.
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection.
The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year.
This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors. 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. Learning Objectives are:
- Clinical QMS implementation
- Implications of New definitions or enhancements to existing glossary terms
- Understand the requirements for quality systems with a risk-based approach
- Consider how information should be recorded, handled and stored and compliance with data integrity expectations of inspectors
- Review Clinical investigators’ qualification requirements, supervision responsibilities, record keeping and reporting
- An increased focus on risk-based monitoring
- CAPA requirements
- Ensuring vendor oversight meets the expectations of inspectors
- And much more
Overview of the webinar
This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites. This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally.
Who should attend?
- The session is specifically for auditors and other QA professionals. The session may also be relevant to those who will be audited or inspected against the new requirements such as professionals working in
- Clinical Research/Clinical Operations
- Regulatory Affairs
- Pharmacovigilance in pharmaceutical/biotechnology
- CRO
- Director of Publications
- Director of Clinical Trial Regulatory Management
- Clinical Trial Information Disclosure Directors
- Global Clinical Safety and Pharmacovigilance Officers
Why should you attend?
- Understand the new requirements of the updated ICH GCP R2 guideline
- Ensure best practice with implementing the new requirements
- Review the new requirements for Sponsor and Investigator Oversight
- Understand requirements for CROs, quality systems,
- Explore risk-based approaches for clinical trials
- Consider changes for the TMF
- Best practice for Clinical QMS
- Review best practice of these additional new ICH GCP R2 requirements
Faculty - Dr.Laura Brown
Dr. Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.
Dr. Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).