Jacqueline Bore#9276

Dr Jacqueline Bore

Senior Professional Support Lawyer - Life Sciences, A&O Shearman
Jacqueline is a senior lawyer with many years’ experience in advising companies in the life sciences sector on the challenges they face in developing and bringing new medicines and medical devices to the market. She has advised clients on the regulatory pathway for medicines and medical devices in Europe, in particular advising on:

Clinical trials, including transparency issues
Paediatric investigation plans,
Marketing authorisations,
Orphan medicinal products,
Manufacturing and wholesale distribution authorisations,
Supply chain issues including novel direct to patient solutions,
Parallel trade
Advertising and promotion
Relations with healthcare professionals, including bribery and corruption
Pricing and market access, including NICE submissions and appeals
Product liability, including managing substantial multiparty actions.
Jacqueline has advised on a number of judicial reviews challenging regulatory decisions of both MHRA and the EMA and has defended product liability claims in the House of Lords, Supreme Court and the Court of Justice of the European Union.
Jacqueline practiced medicine for 8 years before qualifying as a solicitor.
Contributed to

2

EU Paediatric medicines
EU Paediatric medicines
Practice Notes

This Practice Note provides an overview of the EU legal regime for paediatric medicines. It discusses the obligations and incentives to stimulate the development of paediatric medicines, including the paediatric investigation plan (PIP), the paediatric studies, the paediatric-use marketing authorisation (PUMA), the paediatric extension (PE), the orphan reward, the regulatory data and marketing protection, the partial fee exemption, as well as research funding, free scientific advice and protocol assistance. This Practice Note also explains the post-authorisation obligations, such as the obligation to place on the market, the annual deferral reports and the publication of paediatric studies. It finally introduces the sanctions imposed on companies which do not comply with the obligations on paediatric medicines.

Paediatric medicines
Paediatric medicines
Practice Notes

This Practice Note provides an overview of the EU and UK legal regimes for paediatric medicines. It discusses the obligations and incentives to stimulate the development of paediatric medicines, including the paediatric investigation plan (PIP), the paediatric studies, the paediatric-use marketing authorisation (PUMA), the paediatric extension (PE), the orphan reward, the regulatory data and marketing protection, the partial fee exemption, as well as research funding, free scientific advice and protocol assistance. This Practice Note also explains the post-authorisation obligations, such as the obligation to place on the market, the annual deferral reports and the publication of paediatric studies. It finally introduces the sanctions imposed on companies which do not comply with the obligations on paediatric medicines. It further includes a brief overview of the US framework and key international standard developments.

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 1995

Experience

  • Trainee solicitor, Theodore Goddard (1993 - 1995)
  • Assistant solicitor, Theodore Goddard (1995 - 1999)
  • Senior assistant solicitor, CMS Cameron McKenna (1999 - 2005)
  • Senior associate, Arnold & Porter (2005 - 2011)
  • Partner, DLA Piper (2011 - 2012)
  • Director, Senior Regulatory Lawyer, Celgene International, Switzerland (2013 - 2017)

Membership

  • Full registration with the General Medical Council (1981)
  • Member of the Royal College of General Practitioners (1995)

Education

  • Kings College London, Postgraduate diploma in European Union law (2011)
  • College of Law, York and London (1990-1991)
  • Guy’s Hospital, M.B., B.S. (1983)
  • Oxford University, MA in Jurisprudence (1980)

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