Discover an informative webinar that will explore the structural and content changes introduced in ICH E6 R3 and their impact on current systems and processes.
On January 6, 2025, a new revision (R3) was finalized and is now in the implementation phase, during which regulators will define its mandatory adoption timeline.
A key focus of this webinar will be the revised roles and responsibilities of clinical research organizations (CROs) and sponsors, including shifts in study oversight, risk-based quality management and accountability. Experts will provide insights on adapting to these changes to ensure continuous compliance and regulatory acceptance while optimizing trial efficiency and integrity.
Register for this webinar to gain expert insights on navigating ICH E6 R3 and staying ahead in clinical trial compliance.
Speakers
Dr. Elsa Ferrão (GCP Principal Consultant, ADAMAS Consulting)
Dr. Elsa Ferrão is a skilled pharmaceutical professional with over eight years of experience as a regulator. She has played an instrumental role in the development of regulatory guidance and health legislation, as well as conducting inspections for the Portuguese National Authority for Medicines and Health Products (INFARMED, I.P) across GxPs, GCP inspections on behalf of the EMA and joint inspections with the MHRA, USA FDA and Health Canada. Currently serving as a GCP Principal Consultant at ADAMAS Consulting, Dr. Ferrão has conducted numerous audits for sponsors, CROs, vendors and clinical investigator sites.
Message Presenter
Penelope Hutton, MSc BSc, Cert CRGCP, MRQA (GCP Senior Consultant, ADAMAS Consulting)
An accomplished quality professional with over 20 years of experience, Penelope Hutton began her career as a Clinical Data Manager specializing in clinical pharmacology and pediatric studies. Her passion for GCP led her to become certified early in her career. As a member of the Compliance and Training Team, she served on the GCP Compliance Committee, led the Corrective and Preventive Action (CAPA) management process and authored position papers on areas of high regulatory interest.
Penny began her training as a GCP and GVP auditor in 2012 and has conducted over 100 audits, including Investigator, GCP/GVP Vendor, GCP/GVP Affiliate and GCP Process audits across Europe, China, Russia and the USA. In her role before joining ADAMAS, Penny developed the quality strategy for molecules in both the development and marketed settings while also supporting regulatory inspections by the MHRA, EMA, FDA and PMDA.
At ADAMAS, she is actively involved in advancing the data analytics approach to quality and providing QA consultancy services.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical research professionals
- Regulatory affairs and compliance experts
- Sponsors involved in study oversight and quality management
- Medical Monitors and Investigators
- Data Managers and Biostatisticians
What You Will Learn
Attendees will learn about:
- The most impactful changes in ICH E6 R3 and how they affect trial oversight
- Strategic approaches to implement updated GCP requirements effectively
- Ensuring compliance and quality by meeting the evolving regulatory expectations
- Enhancing collaboration between sponsors and CROs under the revised guidelines
Xtalks Partner
ADAMAS
ADAMAS Consulting is a leading global specialist consultancy providing independent quality assurance (QA) and quality management (QM) services across GCP, GVP, GLP, CSC and GMP. With offices across three continents, we deliver expert compliance solutions to pharmaceutical, biotech and healthcare organizations worldwide. For over 25 years, ADAMAS has conducted thousands of GxP audits in >100 countries for >750 international clients, ensuring the highest regulatory and quality standards. Our team of experienced professionals supports clients in maintaining compliance, integrity and operational excellence in clinical research and pharmaceutical development.
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