Alison Dennis

Alison co-heads our international life sciences team. 

Alison is recognised as a top regulatory and transactional life science lawyer in Europe and is qualified in England & Wales and the Irish Republic. She works with mid-sized and large medical device and pharmaceutical 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 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 in Europe and beyond. Her experience has encompassed complex regulatory matters, 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:

• For multiple medical devices and IVD clients, drafting Field Safety Notices and Field Safety Corrective Actions and negotiating these with regulators across many European countries, the Middle East and Asia: engaging with the TW products team in undertaking any consequential recall of products.
• An international pharmaceutical company on responding to a PMCPA complaint and successfully appealing the decision.
• A medical device company on an investigation of the activities of its sales and marketing teams in relation to engagements with HCPs and HCOs, undertaking the investigation and advising on changes to policies, processes, procedures and training.
• A pharmaceutical company on gearing up with sales agreements and compliance activities, including extensive training, before placing their pharmaceutical product and their medical device on the market across Europe.
• An IVD company on interactions with the MHRA and with government departments: steering a course to settle regulatory issues on a commercially acceptable basis.
• On the VPAS scheme for pharmaceuticals, and regarding the size of the rebates payable under it.
• Acting on the disposal of assets from an international manufacturer to a large medical device company, dealing with the issue of "frozen" MDD certificates and working with the notified body to facilitate the acquisition from a regulatory perspective.

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