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 - Medical Devices, 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
- Current status of EUDAMED database
- Modules available and current status of those yet to be released
- Case study: EUDAMED in practice
- Richard Houlihan - Founder & CEO, EirMed
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 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
- Class Ds
- Expected timelines for manufacturers to transition
- 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
- Daniele Bollati - Product Conformity Assessment, IMQ
- 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
- Beau Rollins - Director, Quality Services, ConvaTec
- 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
- Beau Rollins - Director, Quality Services, ConvaTec
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- 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
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 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
- Beau Rollins - Director, Quality Services, ConvaTec
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- 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
- Chris Bray - Head Global Regulatory Affairs, Precision Medicine & Companion Diagnostics, Merck Group
- 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
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- 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
- Beau Rollins - Director, Quality Services, ConvaTec
- Beau Rollins - Director, Quality Services, ConvaTec
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 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
- Silke De Zolt - Section Manager IVD Devices, TÜV Rheinland Group
- 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