Bonnie Clemence advises clients in the life sciences and medical devices industries on UK and EU regulatory issues that arise throughout the product life cycle, including borderline classification, clinical research, authorisation, packaging and labeling, pricing and reimbursement, advertising and promotion, and pharmacovigilance. She assists companies in developing and implementing global and regional compliance programmes, conducting internal investigations into potential regulatory and compliance breaches, and formulating plans for remedial action.
Ms. Clemence has experience in public and administrative law litigation before the UK and EU Courts, advising on actions arising from the decisions of regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and assisting on challenges to public procurement tenders under the UK rules.
Ms. Clemence also advises on life sciences transactional matters, including drafting and negotiating sponsorship agreements, joint-working agreements, research and development agreements, clinical study agreements, manufacturing, distribution and supply agreements. She has been seconded to a global pharmaceutical company to provide support in relation to its commercial contracts.
- Amicus Therapeutics, Inc. (Case T-33/17) in its European General Court case in relation to transparency of clinical trial data and access to documents held by the EMA.
- European and US pharmaceutical companies in their challenges to decisions of the MHRA and the UK Health Research Authority (HRA) to release their clinical data in response to Freedom of Information Act requests.
- European pharmaceutical company in its challenge to the grant of a generic authorisation relying on its global marketing authorisation as reference.
- Global pharmaceutical company in its response to audit by the Prescription Medicines Code of Practice Authority (PMCPA), including internal compliance investigation, gap analysis and remedial action plan.
- Global pharmaceutical company in assessing legal and compliance issues arising in respect of its proposed patient support programmes.
- US pharmaceutical company in its regular medical-legal review of educational and promotional materials.
- Global pharmaceutical company in drafting a suite of template commercial agreements for use in life sciences transactions.
- A number of life sciences companies on regulatory matters concerning controlled drugs.
- Legal Practice Course, The University of Law London Moorgate, 2012
- MA, History, Cambridge University, 2012, with honours
- Graduate Diploma in Law, The University of Law London Moorgate, 2011
- BA, History, Cambridge University, 2009, with honours
- England and Wales