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Day One – 16 June 2025 - CEST Time Zone
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
With the transition deadlines approaching fast for all diagnostic risk classes, how are we progressing in certifying IVDs under the IVDR?
Impact of 2024/1860
Has the new transition times alleviated capacity and transition concerns?
Which areas still remain a pain point and what steps are in place to aid this?
Current regulatory status and Commission’s priorities for the next year
- Rob Laport - Project Manager and Certification Manager Medical Devices, DEKRA Certification B.V.
Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
After so many years of anticipation, has industry finally got the answers to their UK questions?
How will IVDs be regulated within the UK?
How does this compare to EU?
How can they streamline workload for both regions?
- Steve Lee - Director, Diagnostics Regulation, ABHI
Understanding the key elements of the metrological traceability concept described in ISO 17511
Learning why global test standardization (first choice) or harmonization (second best) should be accomplished in laboratory medicine
Learning about the rationale for global medical test (panel) standardization/harmonization and its strategic importance for the EHDS
With EURLs now being designated, what can we expect for IVD approvals?
Which diagnostics are affected?
How does this change working processes for manufacturers, notified bodies and regulators?
Working example: certifying IVDs with the involvement of EURLs
- Heike Möhlig-Zuttermeister - Global Director in-vitro Diagnostics (IVD), TÜV SÜD
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar
- Lakshman Ramamurthy, PhD - Vice President, Regulatory Affairs, GRAIL
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
- Rolf Thermann - Section Manager IVD and Companion Diagnostics Lead, TUV Rhineland
- Vihanga Pahalawatta - Director Regulatory Affairs Companion Diagnostics, AbbVie
What actually classifies as a structured dialogue under IVDR?
Who can have one?
What can be discussed during one?
What do they aim to achieve?
Current experiences with structured dialogues and lessons learned
Best practices for getting the most out of them
- João Martins - Associate Director Regulatory Affairs Strategy, Abbott
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
With IVDR having been in place for a few years, what are industry’s current experiences of managing portfolios?
How do they manage cyclical workload for all diagnostics?
What are their tips for optimising and streamlining workload?
Risk and mitigation strategies for anticipating regulation changes
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina
- Ranka Milojkovic - Principal Project Manager, Quality, Abbott