Day Two – 11 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
Day Two – 11 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
- A review of the current regulatory ecosystem within Europe
- Is this the most effective way to get devices onto the market?
- What hurdles are there with the current system?
- Which solutions are there for increasing efficiency?
- The future of regulatory
- What opportunities and risks are there with a more centralised approach?
- How would this affect regulatory teams?
- What would the knock-on affect for the wider population be?
- Erik Vollegbret - Partner, Axon Lawyers
- Alice Forde - Director, Regulatory Affairs Europe at Bausch & Lomb., Bausch & Lomb
- Oliver Hartmann - Legal and Regulatory Affairs Manager, Association of the European Self-Care Industry (AESGP)
- Nadine Nasr - Senior Manager, Regulatory Affairs, Intuitive Surgical
EUDAMED is coming with mandatory usage from Q4 2025, do not be fooled it takes a long time to correctly prepare for EUDAMED. This session will highlight some of the pitfalls, experiences to date, and what is needed to submit your data to EUDAMED while keeping budgets as low as possible.
- Richard Houlihan - Founder & CEO, EirMed
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
- Beau Rollins - Director, Quality Services, ConvaTec
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
- The beginnings of the BE
- Intent of a BE
- Definitions and foundations
- Standard intent vs regulator interpretation
- Beau Rollins - Director, Quality Services, ConvaTec
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
- Current status of diagnostics certified under IVDR
- Is there set to be a shortage of diagnostics in Europe?
- How are diagnostic and pharma companies coping with the regulations?
- Upcoming deadlines
- What has changed for all parties now the deadlines have been extended?
- Do all manufacturers classify for the extensions or is there criteria to qualify?
- Do these extensions mean people can ‘take their foot off the gas’?
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
- Patrick Fivey - Director of Precision Medicine Policy, AstraZeneca
- Vihanga Pahalawatta - Director Regulatory Affairs Companion Diagnostics, AbbVie
- João Martins - Associate Director Regulatory Affairs Strategy, Abbott
- Elizabeth Dequeker - Head of the Biomedical Quality Assurance Research Unit, University of Leuven
- With the new UK regulation coming into force from July 2025, what can we expect for placing IVDs on this market?
- Status of approved bodies
- Timelines for manufacturers
- Transition periods
- Timelines from documentation submission to gaining approval
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
- Current status of regulations for IVDs in Switzerland
- Comparison with rest of Europe
- Case study: end-to-end process of gaining approval
- Common pitfalls and solutions
- Status of FDA approved products for Switzerland
- Jessica Ruperto - Senior Regulatory Affairs Specialist, Thermo Fisher Scientific
- With the abundance of MDD devices and components still available on the market, is MDR certification always commercially necessary for a legacy device?
- What kind of maintenance and repairs can be performed without triggering a significant change?
- Planning ahead: creating a plan for maintenance and transition
- Erik Vollegbret - Partner, Axon Lawyers
- Regulatory requirements
- Who needs to have a PRRC
- Qualifications to be a PRRC
- Responsibilities and Liability of a PRRC
- Knowledge gained from interactions with Notified Bodies and Competent Authorities
- Elem Ayne - President, TEAM-PRRC
- Utilizing Design inputs
- How to properly define intended use and device categorization
- Literature search
- How to reference competitive devices
- Clinical evaluation data integration
- Group divisions and BEP creation exercise
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
- E&L test requirements and set up
- Correct Dose Base Threshold (DBT) for device
- Calculation of Analytical Evaluation Threshold (AET)
- Method Uncertainty Factor (UF), sensitivity, solvent selection
- Applying to intended use and materials
- Traditional endpoint tests and critical factors
- In-vitro vs In-vivo
- Extraction time, temp, and ratios.
- Determining gaps from E&L, literature, etc to determine appropriate endpoint test
- Group division and BEP completion
- Crystal D'Silva - Senior Manager, Pre-Clinical Toxicology, Baxter
- Brief overview of the regulatory requirements for implementing IVDs/CDx in a precision medicine trial
- Key considerations for Sponsors planning precision medicine clinical trials
- Lessons learned from using CDx in clinical trials in the EU & US
- James Lappin - Head of Clinical Compliance and Quality Assurance, ARC Regulatory Limited
- Defining LDTs
- Where are LDTs covered in both European and US legislation?
- Overview of proposed rule from the FDA & impact for industry
- Replacement of proposed VALID Act
- Impact of IVDR on clinical trials
- Do commercial labs qualify?
- Sabrina Aït Allek - Quality Assurance & Regulatory Affairs Director, Stilla Technologies
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
- Lakshman Ramamurthy, PhD - Vice President, Regulatory Affairs, GRAIL
- Elizabeth Macintyre - President, Biomedical Alliance in Europe
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
- With the approval timeline expected in Q2 2024, what do we already know about the EHDS?
- Expected responsibilities of regulators, notified bodies and manufacturers
- Where does this link into the MDR & IVDR?
- Link to pharmaceutical industry
- Putting the EHDS into practice: a working example
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
- Introduction to GS1 as Issuing Agency
- Implementation of GS1 standards for Medical Devices. How to verify that the UDI-DI and B-UDI are valid? Latest information on Master UDI-DI.
- GS1 Belgium & Luxembourg solution to publish B-UDI and UDI-DI to the EUDAMED module Devices
- Patrick Ponsaerts - Manager Healthcare, GS1 Belgium & Luxembourg
- Beau Rollins - Director, Quality Services, ConvaTec
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
- E&L test reports and applying AET for compound analysis
- Acceptance criteria for traditional endpoint tests
- Common deviations
- What to do if you fail
- Beau Rollins - Director, Quality Services, ConvaTec
- Addition of all test data and results determination
- Gap assessment to data, deviations, historical testing
- Developing a final conclusion
- Group division and BER completion
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
- IVD lifecycle success requires insights-driven decisions across all stages, such as R&D, regulatory submissions, and post-market surveillance.
- Finding relevant evidence in published literature is crucial but challenging.
- Is there a place for AI in this?
- Nadège Krebs, PhD - Customer Consultant Embase, Elsevier
- Current requirements for approving CDx
- Navigating both IVDR and EMA requirements
- Route to market
- Required data and documentation
- Hurdles and solutions along the way
- Future considerations
- Jörg Engelbergs - Scientific-Regulatory Expert Targeted & Personalized Biomedicines, Paul-Ehrlich-Institut
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
- Vihanga Pahalawatta - Director Regulatory Affairs Companion Diagnostics, AbbVie
- Heike Möhlig-Zuttermeister - Director Expertise Management & Segment Manager IVD, TÜV SÜD
- Berkin Güler, B. Sc. - Manager Medical Device Consulting & Lead Auditor, NSF Medical Device & IVD Consulting
- With MDR now in full swing, how are teams coping with the workload?
- Impact of MDR on budgets and recruitment
- How can teams ensure employees remain happy and healthy at work?
- Strategies for coping with increased workloads on the same teams
- Giacomo Cargnello - Head of Quality & Regulatory, Connect&Control Solutions, Varex Imaging
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!
- Gert Bos - Executive Director & Partner, Qserve Group
- Giacomo Cargnello - Head of Quality & Regulatory, Connect&Control Solutions, Varex Imaging
- Evaluating compounds
- NOAEL/LOAEL
- Cramer categorization
- Unknown determination
- MOS calculation per ISO 10993-17
- Group division and Tox assessment
- Ron Brown - Toxicologist, Risk Science Consortium
- Beau Rollins - Director, Quality Services, ConvaTec
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar.
- How has the introduction of the IVDR influenced innovation?
- Is there a lack of innovation in Europe?
- Why?
- Pathways for industry to expedite market access – international recognition pathways
- How do innovation pathways in Europe compare to other regions?
- Future of diagnostic innovation
- How can all stakeholders encourage innovation in Europe?
- What is the risk of a fall in innovation?
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
- Rolf Thermann - Section Manager IVD and Companion Diagnostics Lead, TUV Rhineland
- Sascha Wettmarshausen - Deputy Managing Director, Verband der Diagnostica-Industrie e.V (VDGH)
- Christa Cobbaert - Head of Department of Clinical Chemistry, Leiden University Medical Center
- Olga Tkachenko - Policy Officer, EU-Commission