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Tuesday, June 21 • 9:15am - 10:15am
#209: New EU Clinical Trial Regulation: Experience So Far

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-544-L04-P ; CME 1.00; RN 1.00

This session will discuss the EU Clinical Trials Regulation (Regulation (EU) No 536/2014; CTR) and Clinical Trial Information System (CTIS) promote research and innovation and improve transparency on clinical trials in the EU and providing for harmonised submission, assessment and supervision of clinical trials in the region. Clinical trial data become gradually available to scientists and the public through CTIS.

Learning Objectives

Describe the purpose and benefits of the EU Clinical Trials Regulation (CTR) for research, innovation, and public health; Discuss how the Clinical Trial Information System (CTIS) provides a single tool for clinical trial sponsors and authorities to facilitate and harmonize clinical trial application submission, assessment and supervision; Explain how CTR and CTIS improve transparency on clinical trials for healthcare professionals, patients and the public.

Chair

Fia Westerholm, DVM, MSc

Speaker

Moderator
Sabine Haubenreisser, PhD, MSc

The Clinical Trials Regulation: Transforming Clinical Trials in Europe
Kristof Bonnarens, MPharm

Potential of CTR to Advance Research and Innovation in EU, with CTIS as the Collaborative Tool
Marianne Lunzer, DrMed

First Experiences with CTR and the Use of CTIS as the Single Entry Point for Clinical Trial Application Submissions in EU
Scott Feiner



Speakers
avatar for Kristof Bonnarens

Kristof Bonnarens

Policy Officer Pharmaceuticals, European Commission, Belgium
Kristof is an industrial pharmacist. Being a Belgian national, he started working for the Belgian Federal Agency of Medicines and Health Products in 2005, and in 2009 he took up the responsibility for the Research and Development division, in charge of clinical trial applications... Read More →
avatar for Scott Feiner

Scott Feiner

Senior Manager, Clinical Records Management, Strategic Clinical Operations, AbbVie, United States
Scott has over a decade of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization... Read More →
avatar for Marianne Lunzer

Marianne Lunzer

Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
avatar for Fia Westerholm

Fia Westerholm

Programme Assurance Manager, European Medicines Agency, Netherlands
Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences... Read More →


Tuesday June 21, 2022 9:15am - 10:15am CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   09: Regulatory, Session |   04: MedAffairs-SciComm, Session |   02: ClinTrials -ClinOps, Session