Menu Back toJoint Session 1 – Part II: CTR Transparency – Business Considerations

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.


Joint Session 1 – Part II: CTR Transparency – Business Considerations

Session Chair(s)

Scott  Feiner

Scott Feiner

  • Senior Project Manager, Disclosure
  • AbbVie, United States
Rose-Marie  Swallow

Rose-Marie Swallow

  • Senior Manager, EU Regulatory Policy & Intelligence
  • Bayer Plc., United Kingdom
The second part of this opening session will concentrate on the transparency aspects of the Clinical Trial Regulation and what this will mean in practice for Sponsors of clinical trials in the future. Following on from the demonstration of the public view of CTIS given in Part 1, this session will examine what this will mean to Sponsors in practice. The session will try to clarify what documentation will be published and when, what data protection considerations Sponsors need to be aware of and what opportunities will be available for Sponsors to use to protect their intellectual property in the future. The panel discussion at the end will afford an opportunity for attendees to raise questions and for further discussion of this topic with representatives of the main stakeholders including, the Commission, EMA, Member States and Sponsors.

Speaker(s)

Ruediger  Pankow, DrSc

Sponsor Preparedness – Points to Consider

Ruediger Pankow, DrSc

  • Principal Consultant, Regulatory Affairs
  • Parexel International, Germany
Elke  Stahl, PhD

Panel Discussion, with the participation of:

Elke Stahl, PhD

  • CTFG Co-Chair, Clinical Trials expert
  • Federal Institute For Drugs and Medical Devices (BfArM), Germany
Pierre-Frédéric  Omnes, MPharm

Contributing Panelist

Pierre-Frédéric Omnes, MPharm

  • Executive Director, Site Start-Up & Regulatory
  • Syneos Health, France
Laura  Pioppo

Contributing Panelist

Laura Pioppo

  • Scientific Administrator, CTIS expert
  • European Medicines Agency, Netherlands
Nick  Sykes, MS

Contributing Panelist

Nick Sykes, MS

  • Senior Director, Global Regulatory Affairs
  • Pfizer, Inc., United Kingdom
Ruediger  Pankow, DrSc

Contributing Panelist

Ruediger Pankow, DrSc

  • Principal Consultant, Regulatory Affairs
  • Parexel International, Germany
Kristof  Bonnarens

Contributing Panelist

Kristof Bonnarens

  • Policy Officer - Pharmaceuticals, Directorate-General for Health and Food Safety
  • DG SANTE, European Commission, Belgium

Contact us

Registration Questions?

Send Email
+41 61 225 51 51