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