The release of the new draft of ICH E6(R3) guidelines prompted the industry to address the crucial question of knowledge acquisition. Now, months later, the focus has shifted to a more significant question: What actions are imperative?
This webinar brought together the following industry experts to delve into the strategic, conceptual, and operational implications accompanying the transition to risk-based monitoring outlined in the ICH E6(R3) draft guidelines:
- Dawn Niccum, Executive Vice President of QA & Compliance, inSeption Group
- Karin Rezzonico, RQAP-GCP, Senior Director of Quality Assurance Auditing, inSeption Group
- Bernadette Bowen, Director of Clinical Quality Assurance, Rhythm Pharmaceuticals
- Michele Weitz, Principal Consultant, GCP Vision Consulting
The discussion extends to proactive measures that sponsors and vendor partners should already be undertaking to thrive in the evolving landscape of clinical trial management. By watching this presentation, attendees will gain insights into key takeaways from the ICH E6(R3) guidelines, practical approaches to modernize monitoring, the identification and implementation of critical quality factors, leveraging technology for documentation integrity, and the pivotal role outsourcing partners play in ensuring quality assurance.