This course is aimed at those new to their IVD regulatory career to give them the underlying principles. It covered what an IVD is, classification, conformity assessment, risk management, and the importance of regulatory affairs within a business.
Ashleigh was joined by a range of fantastic speakers including Stuart Angell (Managing Director of IVDeology, Chair of BIVDA’s Regulatory Affairs Working Party and BIVDA’s new Regulatory Affairs Programme Manager), Tom Beale (Senior Regulatory Affairs Specialist at Agilent Technologies and Chair of BIVDA’s UKCA sub-group), Eamon Doherty (Regulatory Affairs Officer at Oxford Immunotec), Jude O’Donnell (Principal Consultant at Qserve), and Jonathan Ripley (Consulting Services Director at Imed Consultancy).
The majority of the delegates had come from the pharmaceutical industry, now that they are considering working with IVD manufacturers to develop companion diagnostics. Because of this, companion diagnostics and clinical trials were hot topics for questions, along with questions relating to the new UK regulatory framework.
TOPRA courses are a fantastic way to expand existing knowledge and keep up to date on key issues affecting the sector!
Upcoming TOPRA courses and events:
- 26 September – Regulatory Careers Live 2023, London UK
- 24 October – Medical Devices/IVDs Symposium 2023, Lisbon Portugal
- 28 November – Essentials of European Medical Device Regulatory Affairs, Dublin Ireland
- 6-8 December – Drug Device Combinations and Other Technologies, London UK or virtual
BIVDA members are eligible for a 10% discount on any of TOPRA’s courses by using the code BIVDA10 when registering.
