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Session 4: Practical Aspects of the EU CTR and CTIS
Session Chair(s)
Monique Al, PHD
Special advisor CCMO, Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
The EU CTR applicability counts down. While the legal rules are set by the Regulation, it is the CTIS, that often defines how these requirements come into practice and will be operationalized from a business perspective. This session provides an overview on practical aspects that are relevant for stakeholders and discusses these under different business angles. The Complex Clinical trial session will further expand on how specifics of such trials may need to be considered based on CTIS initial functionalities.
The last session addresses the challenges for applicants and regulators arise on the interfaces of legislations which tend to be drafted in isolation. Clinical trials units are the first to encounter novel developments which increasingly fall under more than one legislative frame, e.g. medicines and medical devices or IVDs. The presentation will illustrate challenges encountered and open questions to be solved.
Speaker(s)
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
How to manage a Multinational Clinical Trial under the new CTIS, EU CTR - From an Operational Point of View
Pierre-Frederic Omnes, MPHARM
Executive Director, Life Sciences, TransPerfect, France
Practical Aspects of Complex Clinical Trials
Ilona Reischl, PHD, MPHARM
Biologics Quality Assessor, Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Practical Aspects of Clinical Trials Involving Medical Devices/IVD
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