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Virtual

Nov 18, 2020 1:45 PM - Nov 19, 2020 7:00 PM

(Central Europe Standard Time)

Clinical Trial Regulation Conference

Session 6: CTIS Training Modules

Session Chair(s)

Christopher  Price, MA

Christopher Price, MA

Senior Manager, Global Regulatory Oncology, Global Regulatory Affairs

Merck Healthcare, Germany

Nick  Sykes, MS

Nick Sykes, MS

Policy Advisor

EFPIA, Belgium

This session aims to provide an overview of EMA’s plans to develop and deliver training materials for users of the CTIS. It will also include some initial perspectives from Member States and sponsors on the materials delivered to date and the approach being taken to ensure users can interact correctly with the system. A Q&A session will also provide participants with opportunities to seek answers to outstanding questions they may have on CTIS training.

Speaker(s)

Fia  Westerholm, DVM, MSc

EMA CTIS Training Programme – Concept and Content

Fia Westerholm, DVM, MSc

European Medicines Agency, Netherlands

Programme Assurance Manager

Marieke  Meulemans

Development of the Training Materials

Marieke Meulemans

GCP Central, Netherlands

Founder & CEO

Fatima  Pimentel

Development of the Training Materials

Fatima Pimentel

Syneos Health, Spain

Director, Regulatory Consulting

Stéphanie   Kromar

Development of the Training Materials

Stéphanie Kromar

European Organisation for Research and Treatment of Cancer (EORTC) , Belgium

Senior Regulatory Affairs Manager

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