Webinar Details

The EU Clinical Trial Regulations become mandatory in January 2023, meaning companies conducting clinical trials in EU member countries need to begin using the Clinical Trials Information System (CTIS) to share clinical and regulatory information with EU regulatory agencies.

This webinar will review the new requirements and mechanics of using the CTIS portal and the process and technical implications for Sponsors.

Concepts covered include:

• How the system creates the need for new ways of working and processes
• What the changes mean to TMF management
• System functionality considerations - eTMF and RIM

About the Presenters

Marion Mays brings extensive experience in Inspection Readiness and supports clients in their efforts to become fully inspection-prepared. Marion is a dynamic, inspirational leader in the Life Sciences space with over 30 years of experience. Offering a unique combination of both strategic and operational abilities she also has in-depth experience with quality and compliance processes in the pharmaceutical industry with focus on supporting organizations through GCP regulatory inspections with FDA, MHRA, EMA, and PMDA. Her experience working for sponsors, CROs, software vendors and directly helping sponsors manage inspections make Marion uniquely positioned to offer valuable insights into this process.

Toban Zolman has extensive experience solving complex business challenges using software. Toban was an early employee at Regulatory software pioneer ISI, helping shape the transition to electronic submissions. He has worked with dozens of the largest global pharmaceutical companies to define business processes around clinical and regulatory processes. Toban is CEO of Kivo, a software provider focused on streamlining the drug development process for emerging life science companies.