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Mercure Hotel Amsterdam City

2019年12月04日 (水) 午前 8:00 - 2019年12月05日 (木) 午後 5:00

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 4: Brexit - the Use of MHRA System and Requirements

Session Chair(s)

Merete  Joergensen, MBA, MSC

Merete Joergensen, MBA, MSC

Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark

The UK has been on the forefront of transparency requirements. When the UK leaves EU after Brexit, this will have some consequences for the transparency requirements. Objectives: At the conclusion of this session, participants will be able to: • Prepare their organisation to meet the transparency requirements in the UK post Brexit • Know the standpoint from MHRA on requirements and which register to use • Prepare their organisation for the fulfilment of the transparency requirements as monitored by the UK industry association ABPI.

Speaker(s)

Sheuli  Porkess, MD, MRCP, FFPM

Sheuli Porkess, MD, MRCP, FFPM

Executive Director Research, Medical & Innovation, The Association of the British Pharmaceutical Industry (ABPI), United Kingdom

Transparency in the U.K. & Brexit

Amanda  Hunn, MA

Amanda Hunn, MA

Self-employed Advisor/Formerly Head of Policy and Public Affairs At the HRA, AJ Hunn Associates, United Kingdom

Transparency in the U.K. & Brexit

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