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Session 6: CTIS Training Modules
Session Chair(s)
Christopher Price, MA
Senior Manager, Global Regulatory Oncology, Global Regulatory Affairs
Merck Healthcare, Germany
Nick Sykes, MS
Policy Advisor, Regulatory Strategy
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)
EMA CTIS Training Programme – Concept and Content
Fia Westerholm, DVM, MSC
European Medicines Agency, Netherlands
Programme Assurance Manager
Development of the Training Materials
Marieke Meulemans
GCP Central, Netherlands
Founder & CEO
Development of the Training Materials
Fatima Pimentel
Syneos Health, Spain
Director, Regulatory Consulting
Development of the Training Materials
Stéphanie Kromar
European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Senior Regulatory Affairs Manager