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Virtual

Nov 16, 2022 7:30 PM - Nov 16, 2022 11:30 PM

(Central Europe Standard Time)

EMA Clinical Trial Information System (CTIS) Information Day

The focus of this live virtual CTIS information day is to share practical advice and best practices with regard to transitioning clinical trials, timelines in CTIS, system metrics, insights of clinical trial assessments as well as user management.

Part I - Presentations

Session Chair(s)

Laura  Pioppo, MSc

Laura Pioppo, MSc

Scientific Administrator, CTIS expert

European Medicines Agency, Netherlands

Part I - Presentations

Speaker(s)

Maria  Elgaard Sørensen

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

Marianne  Andersson

Insights of Submitting Applications in CTIS – Sponsor Perspective

Marianne Andersson

Astrazeneca, Sweden

Director Regulatory Processes, Clinical Trials

Maria  Spillane

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

Outi  Konttinen

Assessment of Clinical Trial Applications – First Insights

Outi Konttinen

National Committee on Medical Research Ethics (TUKIJA), Finland

General Secretary

Monique  Al, PhD

Assessment of Clinical Trial Applications – First Insights

Monique Al, PhD

Central Committee on Research Involving Human Subjects (CCMO), Netherlands

Special advisor CCMO

Noemie  Manent, PharmD

Timelines and Their Impact in CTIS

Noemie Manent, PharmD

European Medicines Agency, Netherlands

TDA-CTT Operations Workstream Lead

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