ABHI Regulatory Conference 2021
22 Nov 2021
9:30 am - 3:45 pm
The future of HealthTech regulation is front and centre like never before. We are now just 18 months away from the current deadlines for the new UK regulatory regime, and critical to its success will be ensuring the post-Brexit attractiveness of the UK market.
This year, ABHI’s flagship conference aims to address the myriad of unanswered questions that are uppermost in your minds as regulatory professionals and business leaders.
On the process side, how do we achieve CA Marking and how will it compare with other global regulatory processes? What does progress look like as we head towards the 1st July 2023 deadline?
From a strategic perspective, what can we expect from our regulator and conformity assessment bodies? And, arguably most important of all, will we learn from the pandemic experience by ensuring patient access to safe, new and innovative technologies?
The consultation on the new CA Mark has provided a mechanism for all stakeholders to have their say in what the future looks like, but this is just the start. Post-consultation, we will need to collectively consider the secondary legislation that will adapt our current sovereign regulation, whilst integrating the patient voice. And at the same time, the MHRA is re-structuring.
We have assembled a panel of speakers from across industry, regulators and conformity assessment bodies, to provide a thought-provoking and insightful view of the present, and crucially, the future. If ever there was a time to engage with the regulatory process, that time is now.
Confirmed speakers include:
- Oliver Bisazza, Director General, Industrial Policies, MedTech Europe
- Phil Brown, Director, Regulatory and Compliance, ABHI
- Dr Alison Cave, Chief Safety Officer, MHRA
- Baroness Julia Cumberlege CBE DL, Chair, Independent Medicines and Medical Devices Safety Review
- Camilla Fleetcroft, Interim Group Manager – Devices Regulatory Group, MHRA
- Diana Johnson, VP Regulatory Affairs, Medtech Canada
- Phil Kennedy, Managing Director, Eschmann Technologies & Chair, ABHI
- Jessica Kirby, Trade, Regulation and Analysis, Office for Life Sciences
- Jeanette Kusel, Director, Scientific Advice, NICE
- Sharon Lamb, Partner, McDermott Will & Emery
- Steve Lee, Director, Diagnostics Regulation
- Gary Slack, SVP Global Medical Devices, BSI Group