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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)
Introduction to the Clinical Trials Information System (CTIS)
Fia Westerholm, DVM, MSc
European Medicines Agency, Netherlands
Programme Assurance Manager
Ana Rodriguez Sanchez Beato , PhD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
Sponsor User Management – Principles and Concepts
Ana Rodriguez Sanchez Beato , PhD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
Role Matrix - Principles, Concepts and Sponsor Roles
Ana Rodriguez Sanchez Beato , PhD
European Medicines Agency, Netherlands
Head of Clinical and Non-Clinical Compliance, CTIS expert
Panel Discussion with Q&A and the additional participation of:
Kristof Bonnarens, MPharm
European Commission, Belgium
Policy Officer Pharmaceuticals
Panel Discussion with Q&A and the additional participation of:
Stéphanie Kromar
European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Senior Regulatory Affairs Manager
Ruediger Pankow, DrSc
Germany
Regulatory Affairs Expert, CTIS SME and PO
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