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ICH GCP R2 Addendum - Compliance from 14th June 2017
- Understand the new requirements of the updated ICH GCP R2 guideline
- Hear about the future ICH major revision and expansion of ICH GCP planned for 2019
- Consider the challenges and opportunities in implementing the new ICH GCP R2 requirements internationally
- Review the new requirements for sponsors, CROs, Investigator site and inspectors
- Sponsor Oversight, Risk-based quality systems, risk-based monitoring, data management, Investigator site audit and the trial master file
- Review best practice of these additional new GCP requirements for compliance
Overview of the webinar
With the new ICH GCP E6 Revision 2 Addendum finalised and needing to be implemented by 14th June 2017 in the EU, it is important GCP for Sponsors, CROs, study sites and GCP inspectors to understand the changes and how to update processes and procedures 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.
Who should attend?
The session is relevant for professionals working 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 Development Managers and Personnel
- Clinical Operations Personnel
- Clinical Research Associates
- Clinical Research Archiving and Document Management Personnel
- Quality Assurance Managers and Auditors
- CROs using Laboratories to analyze Clinical Trial Samples
- Project Management
- Sponsors and Non-Commercial Sponsors
- Consultants
- Laboratories Analyzing samples from Clinical Trials
- Regulatory Affairs Personnel
- Legal and Regulatory Authorities
Why should you attend?
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. These new approaches are going to be areas inspectors will be focussing on.
This course will cover these new requirements for auditing and running clinical trials, evaluate the changes and discuss how these impact on clinical research. 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.
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).