The ICH GCP E6 (R3) guideline represents a significant evolution in the conduct of clinical trials, emphasising flexibility, risk-based approaches, and the integration of innovative technologies. This one-day training course is designed to provide clinical research professionals with a comprehensive understanding of the updated guidelines, ensuring compliance and enhancing the quality of clinical trials.
Through a combination of expert-led lectures and group discussions, you will engage in practical exercises to reinforce key concepts and application to real-world scenarios. This training is ideal for all clinical research professionals committed to maintaining GCP compliance in their work. By the end of the course, you will be well-prepared to navigate the regulatory requirements and effectively implement the new GCP requirements.
Benefits of attending
- Understand the key updates and principles of ICH GCP E6 (R3)
- Recognise the roles and responsibilities of stakeholders, including sponsors, investigators, and ethics committees
- Implement risk-based approaches in clinical trials
- Prepare for regulatory inspections and ensure ongoing compliance
- Stay compliant and ahead of GCP regulatory changes
- Gain practical strategies to implement ICH GCP (R3)
- Network and share insights with peers
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
- Introduction to ICH GCP E6 (R3)
- Core principles of ICH GCP E6 (R3)
- Stakeholder responsibilities
- Roles of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
- Investigator obligations
- Sponsor responsibilities
- Service providers
- Risk-based approaches
- Data governance and integrity
- Data and records
- Investigator brochures
- Protocols
- Essential records
- Preparing for regulatory inspections
- Implementation considerations
Course Provider
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
Who Should Attend
This session will be beneficial to anybody who is involved in clinical research. It is applicable to pharma, clinical research organisations (CROs), service providers and investigator sites.This course is ideal for:
- Clinical Research Associates (CRAs)
- Clinical trial managers and project managers
- Regulatory affairs professionals
- Quality assurance personnel
- Investigators and site staff
- Data managers
- Anyone involved in the planning, execution, or oversight of clinical trials
