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Part I - Presentations
Session Chair(s)
Laura Pioppo, MSC
ACT EU Programme Manager
European Medicines Agency, Netherlands
Part I - Presentations
Speaker(s)
Transition Periods For Clinical Trials From Directive (2001/20/EC) To Regulation (536/2014) – Regulatory Considerations And Practical Aspects
Maria Elgaard Sørensen
Danish Medicines Agency, Denmark
Special advisor
Insights of Submitting Applications in CTIS – Sponsor Perspective
Marianne Andersson
Astrazeneca, Sweden
Director Regulatory Processes, Clinical Trials
Insights of Submitting Applications in CTIS – Sponsor Perspective
Maria Spillane
Eli Lilly Cork Ltd. – Global Business Solutions Cork, Ireland
Senior Trial Capabilities Associate – Austria, Germany & Switzerland
Assessment of Clinical Trial Applications – First Insights
Outi Konttinen
National Committee on Medical Research Ethics (TUKIJA), Finland
General Secretary
Assessment of Clinical Trial Applications – First Insights
Monique Al, PHD
Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Special advisor CCMO
Timelines and Their Impact in CTIS
Noemie Manent, PHARMD
European Medicines Agency, Netherlands
TDA-CTT Change Management Lead