Current position and relevant professional experience:
Current experience
- 3 years as Director of Diagnostics Regulation at ABHI
- Supporting work commissioned by the UK Life Sciences Council on devices regulatory reform - including international regulatory recognition.
- Setting up a member group on IVD regulations.
- Various webinars, conferences and updates to members on the latest regulatory issues.
- Setting up a working agreement between ABHI and TOPRA
Previous experience
- 10 years as a IVD Team Manager for Devices Division at MHRA supporting post market activities and providing expert advice, guidance and patient safety information.
- 5 years as Senior Regulatory Policy Manager for Devices Division at MHRA providing expert support plus scientific and regulatory advice to a range of internal and external stakeholders
- 3 years running my own regulatory consultancy company to support diagnostics businesses develop and implement regulatory strategies
- 10 years on the European Commission's IVD working group (including 6 years as chair)
- 2 years as member of CH/212 the BSI mirror committee responsible for IVD standards writing
- 11 years as School Governor including 4 years as Chair leading the School to an improved Ofsted rating.
Current or previous involvement in TOPRA activities:
TOPRA specific contributions:
- Regular contribution to IVDR Masterclass
- Regular contribution to MedDev MSc
- Speaking and attending TOPRA annual symposia
- Co author of an article for Regulatory Rapporteur on Companion Diagnostics
- Recipient of the 2019 TOPRA award for regulatory excellence
Other contributions:
- Working closely on potential implications of international regulatory recognition for the UK
- Multiple frequent conference presentations (MedTech Summit, BINMHRA, NEQAS, BIVDA, AHWP, CAMD, HFEA, Festival of Genomics, Pistoia Alliance, RCPath, PGSMN etc etc etc)
- Co-author of MHRA guidance documents on 'Point of Care Testing', 'Management of IVDs' and 'Medical Device Software'
- Author of MHRA guidance documents on 'IVDs used in combinations' and 'Health Institution Exemption'
- Regular internal MHRA training courses and workshops on IVDD and IVDRI completed TOPRA MSc studies in 2007.
Personal statement:
As a candidate for TOPRA Director, I can bring leadership, technical expertise, and a track record of successful contributions to the industry. I am a former Chair of a European Commission working group, where I led the group to a more harmonious implementation of regulations across the EU. I have actively supported TOPRA through contributions to training modules, the symposium, and co-authoring articles. I have full alignment with TOPRA's goals, gained from decades of work in international regulatory affairs, and I can provide unique insights. I aim to foster new talent, address industry challenges, and help TOPRA to navigate regulations for new and existing health technologies.
Nomination information
Proposer: Phil Brown; Seconders: Nicole Small, Michael Kipping