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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)
Fia Westerholm, DVM, MSc
Programme Assurance Manager, European Medicines Agency, Netherlands
EMA CTIS Training Programme – Concept and Content
Marieke Meulemans
Founder & CEO, GCP Central, Netherlands
Development of the Training Materials
Fatima Pimentel
Director, Regulatory Consulting, Syneos Health, Spain
Development of the Training Materials
Stéphanie Kromar
Senior Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Development of the Training Materials