Alison co-heads our international life sciences team. 

Alison is recognised as a top regulatory and transactional life science lawyers in Europe and is qualified in England & Wales and the Irish Republic.  She works with mid-sized and large pharmaceutical and medical device manufacturers, helping them to design new product offerings to meet regulatory requirements and to facilitate product commercialisation across the UK and EU.  Alison frequently negotiates optimal positions for pharma and medical device companies with regulators such as competent authorities, notified bodies, and industry bodies with voluntary codes.

Alison’s analytical understanding of strategy and business, which comes from over 25 years helping hundreds of life sciences companies manage the range of legal challenges that arise in putting medicinal products and medical devices on the market has encompassed corporate, competition, IP and compliance with anti-bribery laws and codes.  She applies this breadth of knowledge to help companies achieve their business goals at the same time as regulatory and compliance requirements and she is consequently known for providing highly pragmatic advice.

Alison's recent experience includes advising:

  • A pharmaceutical company on gearing up with sales agreements and compliance activities before placing their pharmaceutical and device on the market across Europe.
  • On the VPAS scheme and in particular regarding the size of the rebates payable under it.
  • A pharmaceutical company on responding to a PMCPA complaint.
  • An IVD company on interactions with the MHRA and with government departments:  steering a course to settle regulatory issues on a commercially acceptable basis.

Thomson Reuters, Stand-out Lawyers 2022 - Identified by in-house lawyers as one whom they rated above all others that they interact with.

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最新新闻和观点

医疗器械

GB International recognition for medical devices

2024年5月22日

作者 Alison Dennis

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Artificial intelligence

From the White Paper to the AI Safety Summit - what is the UK's regulatory position on AI? | Tech Me Up! Session #5

Tech Me Up! Session #5

2023年11月8日
In-depth analysis

作者

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酒店与休闲

Updated post-market surveillance (PMS) rules for medical devices in the UK: differences from the EU regulations

2023年10月10日
In-depth analysis

作者 Alison Dennis 以及 Alice Matthews

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酒店与休闲

Making sense of timelines and certificate extensions for placing medical devices on UK and EU markets

2023年9月5日
In-depth analysis

作者 Alison Dennis

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