Navigating ICH GCP (Good Clinical Practice) E6 (R3): What You Need to Know Training Course (ONLINE EVENT: September 12, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Navigating ICH GCP (Good Clinical Practice) E6 (R3): What You Need to Know Training Course" training has been added to ResearchAndMarkets.com's offering.

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.

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.

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

Who Should Attend:

• 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

Key Topics Covered:

• 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

Speakers:

Laura Brown
Pharmaceutical QA and Training Consultant
University of Cardiff

Dr 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.

For more information about this training visit https://www.researchandmarkets.com/r/2nni0x

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