Elisabethann Wright#5008

Elisabethann Wright, BL

Barrister, Cooley (UK) LLP
Elisabethann Wright specializes in EU law and regulation of pharmaceuticals and medical devices and is regularly sought-after and praised for her knowledge of the legislation, technical competence and commercial acumen. She has been practicing in the life sciences sector for over 35 years in private practice and international institutions. Elisabethann helps clients navigate the process and regulations to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU courts. 
Contributed to

2

An introduction to the regulation of medical devices—EU Directives regime
An introduction to the regulation of medical devices—EU Directives regime
Practice notes

This Practice Note introduces the regime for regulation of the manufacture and sale of medical devices in the EU under Directive 93/42/EEC on medical devices, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices. It explains how devices are classified, assessed (by completion of a conformity assessment) and CE marked. This Practice Note also considers the advertising and promotion or medical devices, counterfeit medical devices, 3D printing and mobile health.

Regulatory data protection
Regulatory data protection
Practice notes

This Practice Note explains the concept of regulatory data protection (RDP), also known as ‘data exclusivity’, provides guidance on how RDP works in practice and the impact it has on the entry into the market of generic and biosimilar medicinal products.

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 1989

Membership

  • Women's Law Network

Education

  • B.L., The Institute of Professional Legal Studies, Belfast, 1985
  • Postgraduate Diploma in EC Competition Law, King's College London, 2004
  • LL.B., The Queen's University of Belfast, 1984

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