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Session 10 Track 2: Complying with EU CTR: Managing Business Change and Submissions in CTIS
Session Chair(s)
Cary Smithson, MBA
Managing Partner
LeapAhead Solutions, Inc., United States
In this session, panelists will discuss sponsor approaches to comply with the EU Clinical Trial Regulations (CTR), the importance of managing business process changes, and the challenges they dealt with along the way. We will explain the mandatory use of EMA’s Clinical Trial Information System (CTIS), the redaction requirements, and the impact to sponsor business processes. We will also share anonymized screenshots of CTIS, how sponsors have used automation technologies to streamline CTIS data entry, address the dynamics between MSCs (Member State Countries), their Health Authorities and Ethics Committees.
Learning Objective : - Explain EU CTR, requirements for CTIS data / content entry, and redaction
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Discuss how sponsors have prepared their companies to comply with the regulation
- Describe how complying with EU CTR requirements impacted sponsor business processes, system use and data as well as potential challenges and ways to overcome them
Speaker(s)
Clinical Trials Information System
Hans van Bruggen, MSc
Qdossier, a Celegence Company, Netherlands
CSO
Commercially Confidential Information (CCI) & Protected Personal Data (PPD) Management in EU CTR
Richard Durrance
Pfizer, United Kingdom
Clinical Trial Transparency & Disclosure Manager
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