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Mercure Hotel Amsterdam City

2019 年 12 月 02 日 9:00 上午 - 2019 年 12 月 03 日 6:00 下午

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Clinical Trial Regulation Conference

Status update, what we still need to know and the way forward

Session 1: Status on implementation of the CTR and how to keep momentum

Session Chair(s)

Nick  Sykes, MS

Nick Sykes, MS

Policy Advisor, Regulatory Strategy

EFPIA, Belgium

Status on implementation of the CTR and how to keep momentum

Speaker(s)

Judith  Creba, PHD

Latest Status of the CTReg

Judith Creba, PHD

Novartis Pharma AG, Switzerland

Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU

Elke  Stahl, PHD

Panel Discussion with Q&A from Audience

Elke Stahl, PHD

Federal Institute For Drugs and Medical Devices (BfArM), Germany

Senior Expert, Clinical Trials Department

Judith  Creba, PHD

Judith Creba, PHD

Novartis Pharma AG, Switzerland

Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU

Stéphanie   Kromar

Stéphanie Kromar

European Organisation for Research and Treatment of Cancer (EORTC) , Belgium

Senior Regulatory Affairs Manager

Sini  Eskola, MPHARM, MS, MSC

Sini Eskola, MPHARM, MS, MSC

Takeda, Belgium

Head of International Regulatory Policy and Innovation

Monique  Al, PHD

Monique Al, PHD

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

Special advisor CCMO

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