Life Sciences PSL – London
Tel +44 20 3088 1379
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 the EMA and the MHRA and has defended product liability claims in the Court of Justice of the EU, the UK House of Lords, and the UK Supreme Court.
Jacqueline practised medicine for 8 years before qualifying as a solicitor.
Posts by: Jacqueline Bore
- CJEU upholds withdrawal of orphan designation based on increased availability
- MHRA provides further guidance on no-deal Brexit plans
- General Court confirms strict significant benefit test on the grant of an orphan marketing authorisation
- Rethinking the Growth Capital Challenge in UK Life Sciences
- European Commission opens public consultation on Orphan and Paediatric Regulations
- European Commission’s proposal for a Regulation on Health Technology Assessment clears another hurdle
- Federal Circuit upholds finding that Broad Institute CRISPR patents in plant and animal cells do not overlap with UC Berkeley patents
- Getting ready for the EU MDR: New guidance documents available for manufacturers
- UK government publishes plans for the Life Sciences sector in the event of a no-deal Brexit
- Medical devices industry calls for more time to implement EU Medical Devices Regulation
- European Medicines Agency suspends clinical data publication
- Brexit White Paper: UK’s proposals on future relationship with EU acknowledge the needs of the Life Sciences industries
- EMA publishes revised guideline for gene therapy medicinal products
- Brexit and the medical devices industry: coping with uncertainty
- EMA Transparency Policy upheld by General Court: companies unable to show that submissions to EMA are confidential
- CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?
- Brexit: EMA’s regulatory guidance on centrally approved medicinal products – the present state of play
- Proposals for reform of EU Paediatric Regulation postponed - EC to take another look at orphan incentives for paediatric medicines
- European Commission opens public consultation on SPCs and patent research exemptions
- European Commission assesses bids for the relocation of the European Medicines Agency
- European and UK medical device industry bodies urge post-Brexit regulatory alignment
- UK issues Brexit position paper on collaboration in science and innovation
- UK Life Sciences sector articulates post-Brexit vision
- The Great Repeal Bill: a ‘smooth and orderly transition’ for Life Sciences companies?
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