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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
Regulatory Affairs Expert, CTIS SME and PO
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)
How to manage a Multinational Clinical Trial under the new CTIS, EU CTR - From an Operational Point of View
Ruediger Pankow, DrSc
Germany
Regulatory Affairs Expert, CTIS SME and PO
Practical Aspects of Complex Clinical Trials
Pierre-Frederic Omnes, MPharm
TransPerfect, France
Executive Director, Life Sciences
Practical Aspects of Clinical Trials Involving Medical Devices/IVD
Ilona Reischl, PhD, MPharm
Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Biologics Quality Assessor
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