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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
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, 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)
Ruediger Pankow, DRSC
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany
Opening: How is CTIS doing after 2 Years?
Gabriella Di Matteo
CTRSE EUCTR Advocacy Lead & Strategic Execution, Pfizer, Belgium
Industry Perspective
Fatima Pimentel
Director, Regulatory Consulting, Syneos Health, Spain
CRO Experience
Andrea Seidel-Glaetzer, MA, RN
Head of Project Management , Coordination Centre For Clinical Trials Heidelberg (KKS), Germany
Academia Perspective
Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
CA Experience – As panelist
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