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Key note, Introduction to CTIS, User Access and Management
Session Chair(s)
Pieter Vankeerberghen
Head of Clinical Trials, European Medicines Agency, Netherlands
This session starts with the key note from Fergus Sweeney, head of clinial trials, EMA, followed by an introduction to the Clinical Trials Information System (CTIS). After that the user access management as well as sponsor user management – principles and concepts, role matrix - principles, concepts and sponsor roles will be outlined. Finally, the most urgent questions from the audience are answered in a panel discussion including experts from EC, EMA, industry, CROs and Academia.
Speaker(s)
Fia Westerholm, DVM, MSC
Programme Assurance Manager, European Medicines Agency, Netherlands
Introduction to the Clinical Trials Information System (CTIS)
Ana Rodriguez Sanchez Beato , PHD
Head of Clinical and Non-Clinical Compliance, CTIS expert, European Medicines Agency, Netherlands
Ana Rodriguez Sanchez Beato , PHD
Head of Clinical and Non-Clinical Compliance, CTIS expert, European Medicines Agency, Netherlands
Sponsor User Management – Principles and Concepts
Ana Rodriguez Sanchez Beato , PHD
Head of Clinical and Non-Clinical Compliance, CTIS expert, European Medicines Agency, Netherlands
Role Matrix - Principles, Concepts and Sponsor Roles
Kristof Bonnarens, MPHARM
Policy Officer Pharmaceuticals, European Commission, Belgium
Panel Discussion with Q&A and the additional participation of:
Stéphanie Kromar
Senior Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Panel Discussion with Q&A and the additional participation of:
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
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