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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 10 Track 2: Complying with EU CTR: Managing Business Change and Submissions in CTIS

Session Chair(s)

Cary  Smithson, MBA

Cary Smithson, MBA

Senior Director, Business Transformation & Systems Management

Cencora Pharmalex, 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
  • 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


Hans  van Bruggen, MSc

Clinical Trials Information System

Hans van Bruggen, MSc

Qdossier, a Celegence Company, Netherlands


Richard  Durrance

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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