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