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Clinical Trial Regulation Conference

Join experts from regulatory, ethics bodies, sponsors and patients to discuss the launch of the Clinical Trial Regulation and new trends of Clinical Trials in Europe.


Session 4: Practical Aspects of the EU CTR and CTIS

Session Chair(s)

Monique  Al

Monique Al

  • Team Coordinator National Clinical Trial Office
  • Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Ruediger  Pankow, DrSc

Ruediger Pankow, DrSc

  • Principal Consultant, Regulatory Affairs
  • Parexel International, 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

How to manage a Multinational Clinical Trial under the new CTIS, EU CTR - From an Operational Point of View

Ruediger Pankow, DrSc

  • Principal Consultant, Regulatory Affairs
  • Parexel International, Germany
Pierre-Frédéric  Omnes, MPharm

Practical Aspects of Complex Clinical Trials

Pierre-Frédéric Omnes, MPharm

  • Executive Director, Site Start-Up & Regulatory
  • Syneos Health, France
Ilona  Reischl, PhD, MPharm

Practical Aspects of Clinical Trials Involving Medical Devices/IVD

Ilona Reischl, PhD, MPharm

  • Biologics Quality Assessor
  • Federal Office for Safety in Health Care(BASG), Austria

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