Webinar: How will ICH E8 (R1) and E6 (R3) make oversight more efficient?

Tuesday, August 31, 2021  |  1:00 – 2:00 PM EDT

Access the webinar recording on-demand following the live event

As the complexity of clinical trials continues to increase, so does the importance of CROs to the pharmaceutical industry. Outsourcing allows pharmaceutical companies to utilize on-demand services, improving operational efficiencies by accessing therapeutic expertise and geographic reach. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.

ICH-based regulations have traditionally led to more overhead in the form of processes, headcounts and systems. These regulations concerning oversight cascade to all stakeholders further increasing complexity and associated costs.

Register for this webinar to hear about the forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines, which renew the focus on efficiencies in conducting clinical trials and provide tools to do so – significantly impacting oversight.

In this webcast, we will explore:

• The intended purpose of ICH regulations—to implement industry best practices, and not to add additional burdens on clinical research staff.
• The tools provided by ICH E6 and E8 guidance’s to drive efficiencies in clinical trials.
• Strategies for quick, relatively straightforward adoption of the new guidelines and best practice approaches to implement these tools now.
• How technology can assist in risk management and vendor oversight.
• How by applying critical thinking to risk management, organizations can improve their operational efficiencies by minimizing duplicate quality-assurance steps.

This webcast is applicable to:

• Sponsor and CRO roles who are responsible for:
  • Vendor oversight
  • Clinical data management, collecting and evaluating trial metrics
  • Project management of studies and operational excellence

Presenters

JANIS HALL
Senior Consultant
WCG Avoca

ANDY LAWTON
Consultant
Risk Based Approach Ltd

ELVIN THALUND
Director, Industry Strategy
Oracle Health Sciences

Hosted by Oracle Health Sciences

Moderated by xTalks