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Mercure Hotel Amsterdam City

04 dic 2019 8:00 a.m. - 05 dic 2019 5:00 p.m.

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

Transparency in the U.K. & Brexit

Sheuli Porkess, MD, MRCP, FFPM

The Association of the British Pharmaceutical Industry (ABPI), United Kingdom

Executive Director Research, Medical & Innovation

Amanda  Hunn, MA

Transparency in the U.K. & Brexit

Amanda Hunn, MA

AJ Hunn Associates, United Kingdom

Self-employed Advisor/Formerly Head of Policy and Public Affairs At the HRA

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