The Seminar covered the following topics:
- MHRA Software Roadmap with Johan Ordish (MHRA)
- MHRA IVD Roadmap, UKCA, and the Life Science Review with Ashleigh Batchen (BIVDA), Tom Beale (Agilent Technologies) and Camilla Fleetcroft
- MDCG Roadmap with Andrew Rutter (QuidelOrtho)
- Class D IVDs with Erica Conway (MCRA)
- BSI Standards with Rob Turpin (BSI)
- US Regulatory Process Stuart Angell (IVDeology)
The event was well attended with lots of thought-provoking discussion throughout the day!
Stuart Angell, Chair of RAWP said:
“We all had a fantastic day in Reading for the first Spring Seminar, even if the snowy weather made travel a bit more difficult. It was great to see some new faces and hear excellent insights from the range of expert speakers covering the ongoing regulatory changes and considerations for global reach. As is always the case with the Regulatory Seminars, it’s a joy to get to have these discussions in such a positive environment!”
Johan’s session on the Software Roadmap churned brilliant insights and questions from delegates, including highlighting the excellent work of the MHRA team in generating such thorough and detailed guidance on the subject.
As well as this, Rob spoke about the projects going on within BSI to strengthen standards for the industry. He also showcased the work that has been happening behind the scenes between BSI and BIVDA in generating a dynamic list of standards relevant to IVD companies. A draft list has been generated, covering IVD-specific standards, procurement standards and sustainability standards. The aim is to have a central place for member companies to identify relevant standards, with the list being updated regularly. The draft list is out for comment with the various Working Party Chairs and we hope to have it published in the coming months.
The final session of the day had Stuart discussing how to navigate the US regulatory system and providing an overview of requirements. This is in response to previous feedback from members that companies are considering moving to other markets given the complexity occurring in the UK and EU.
We would like to say a huge thank you to all of our fantastic speakers and delegates who joined us to make it such a great day!
The presentations can be viewed HERE with the exception of the Class D IVDs session which can be viewed HERE.
We would like to request that you spend a few minutes filling out the feedback survey as it will assist with future planning arrangements for the RAWP seminars.
The next Regulatory Affairs Working Party meeting will be on 16 June (10.30-1.30) at the BIVDA offices in London. This meeting has now reached capacity. We may be able to reassess depending on the level of demand received. If you would be interested in joining this meeting, please contact Ashleigh (ashleigh@bivda.org.uk) specifying whether you would be interested in joining in-person or remotely. This is not a guarantee that any changes will be made
