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Session 5: CTIS with One Transition Year Ahead: Sponsor End User Operational and Disclosure Aspects
Session Chair(s)
Scott Feiner
Senior Manager, Trial Disclosure
AbbVie, United States
Ruediger Pankow, DrSc
Regulatory Affairs Expert, CTIS SME and PO
Germany
This session provides general experiences with new trials but also with transition trials on the operational use of the system. Views from commercial and academic sponsors, CROs as well as from the Member States perspective will be shared and discussed.
Speaker(s)
Opening: How is CTIS doing after 2 Years?
Ruediger Pankow, DrSc
Germany
Regulatory Affairs Expert, CTIS SME and PO
Industry Perspective
Gabriella Di Matteo
Pfizer, Belgium
Director CTRO Team Manager
CRO Experience
Fatima Pimentel
Syneos Health, Spain
Director, Regulatory Consulting
Academia Perspective
Andrea Seidel-Glaetzer, MA, RN
Coordination Centre For Clinical Trials Heidelberg (KKS), Germany
Head of Project Management
CA Experience – As panelist
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
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