5th Annual
EU IVD Clinical & Regulatory Conference
October 19-20, 2023 | Brussels, Belgium
5th Annual
EU IVD Clinical & Regulatory Conference
October 19-20, 2023
Brussels, Belgium
Managing Priorities & Timelines in the Progression Towards IVDR Compliance, Engaging with NBs to Overcome Common Areas of Challenge, all while Focusing on Optimizing Clinical Data Generation & Collection
Notified Bodies:
Catherine Holzmann
Certification Division Manager IVDs
GMED
Judith Prevoo
Regulatory Lead
BSI GROUP
Marta Carnielli
Head of Certification IVD
TÜV SÜD
Alexander Stock
Project Manager IVD Medical Device Testing
TÜV SÜD PRODUCT SERVICE
Industry Experts:
Erik Vollebregt
Partner
AXON LAWYERS
Neil Plumridge
Chair of Environmental Regulatory Work Party
BIVDA (British In Vitro Diagnostics Association)
Elena Kyria
Director & Founder
ELEMED
Melissa Finocchio
Former Chief Regulatory Officer & PRRC
Amanda Ode
Applied Hematology Manager
BOULE DIAGNOSTICS
Roshni Kasturi
Clinical Lead MDR/IVDR
ASCENSIA DIABETES CARE
Fabien Roy
Partner
HOGAN LOVELLS
Philippe Auclair
Sr Dir. Regulatory Strategy, Abbott Quality & Regulatory
ABBOTT
Silvia Anghel
Associate Director & Head of IVD Group
VERANEX
Stuart Angell
Regulatory Affairs Programme Manager
BIVDA (British In Vitro Diagnostics Association)
Andrew Rutter
Senior Manager, Regulatory Affairs
QUIDELORTHO
Irene Hsieh
Sr. Director of Regulatory & Clinical Affairs
EUROIMMUNE
Julianne Bobela
Senior Consultant
VERANEX
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
Silvia Anghel, Associate Director & Head of IVD Group
VERANEX
9:00 HIGHLIGHTS FROM RECENT REGULATORY UPDATES & MDCG GUIDANCE APPLICABLE TO IVDs
• Refresher on the staggered approach to IVDR compliance dates
• IVDR-relevant takeaways from 2022 & 2023 MDCG guidance
• Clarifying the recent sell-off date removal proposal
• Forthcoming releases & expectations from the industry
Philippe Auclair, Senior Director Regulatory Strategy, Abbott Quality & Regulatory
ABBOTT
9:45 DEVELOPMENTS IN EU IN-HOUSE MANUFACTURED IVDS UNDER THE MDCG 2023-1 GUIDANCE
• Requirements overview & partially deferred IVDR requirements
• Defining “health institution” & mandatory use within the legal entity
• Scope of devices & outlining when is a health institution manufacturing IVDs
• Mapping out & delineating an appropriate manufacturing QMS
• Justification for the impossibility to meet target patient group needs with an equivalent device
Erik Vollebregt, Partner
AXON LAWYERS
10:30 COFFEE & NETWORKING BREAK
11:00 MASTERCLASS: OPPORTUNITIES IN FILLING DATA GAPS FOR LEGACY PRODUCTS
• Identifying clinical data gaps for IVDR compliance
• Determining the need for new performance testing
• Usability & relevance of existing post-market data
• Pros & cons to literature reviews for IVD products
• Defining a “sufficient” amount of data for NBs
Julianne Bobela, Senior Consultant
VERANEX
11:45 ACHIEVING COMPLIANT POST-MARKET PERFORMANCE FOLLOW UP & EVALUATION PLANS
• Practical approach to outlining the ideal blueprint
• Focus on reporting timelines & team structures
• Debating the practicality of various data collection methods
• Use & acceptability of RWE in post-market claims
Roshni Kasturi, Clinical Lead MDR/IVDR
ASCENSIA DIABETES CARE
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:30 FOCUS ON INTENDED PURPOSE & NECESSARY DATA TO SUPPORT CLAIMS
• Clarifying Article 2(12) & backing claims with data
• Practical insight into useable evidence to support claims
• Benefits in narrowing down the scope of claims
Erik Vollebregt, Partner
AXON LAWYERS
2:00 REALISTIC APPROACH TO THE PRRC ROLE: OPPORTUNITIES & LIMITATIONS
• Documentation: From the acceptance letter to procedures
• Continuous availability & having delegates
• Combining management responsibilities & PRRC
• Dissecting potential conflicts & pitfalls
• If things go wrong; personal responsibility & taking action
Melissa Finocchio, Former Chief Regulatory Officer & PRRC
2:30 ECONOMIC OPERATORS: FOCUS ON SPECIFIC AREAS OF CHALLENGE IN ACHIEVING COMPLIANCE
• Setting control mechanisms across the supply chain
• Systematic verification of imported products
• Clarifying sampling & batch requirements
• Linkage of one operator to the following
Fabien Roy, Partner
HOGAN LOVELLS
3:30 SMALL GROUP DISCUSSIONS: SHARING STRATEGIES TO SUCCESSFULLY ACHIEVE QMS COMPLIANCE
Given the IVDR requirements pertinent to the establishment and maintenance of a comprehensive QMS, many organizations are still in the process of updating corporate quality strategies. This small group discussion format enables participants to engage with one another to learn more through peer-to-peer experience sharing, with a focus on challenges encountered along the way and solutions to overcome difficulties.
Silvia Anghel, Associate Director & Head of IVD Group
VERANEX
4:15 OVERCOMING CHALLENGES WITH SOFTWARE & CYBERSECURITY REGULATORY COMPLIANCE & TESTING APPROACHES
• Main areas of regulatory consolidation: IVDD vs IVDR
• Critical cybersecurity considerations:
» In product design, development & upgrading
» Product lifecycle focus
• Importance of high quality test evidence for a successful conformity assessment
Alexander Stock, Project Manager IVD Medical Device Testing
TÜV SÜD PRODUCT SERVICE
5:00 SMALL GROUP DISCUSSION: EXCHANGING & BUILDING KNOWLEDGE IN DIAGNOSTICS INCLUDING SOFTWARE OR AI
With the exceptional influx of software and AI in the diagnostic industry, regulatory and clinical professionals seek clear insight to ultimately reach and maintain compliance with the evolving EU regulatory framework. By directly exchanging experiences and lessons learned from peers, participants in each group will take away practical and readily applicable advice.
GROUP 1: Software Dx & AI compliance basics
Roshni Kasturi, Clinical Lead MDR/IVDR
ASCENSIA DIABETES CARE
GROUP 2: Software Dx & AI advanced knowledge
Irene Hsieh, Sr. Director of Regulatory & Clinical Affairs
EUROIMMUNE
5:45 Closing Remarks & End of Day 1
Day Two Agenda
Friday, October 20
8:00 REGISTRATION & WELCOME COFFEE
8:20 CHAIRPERSON’S OPENING REMARKS
Elena Kyria, Director & Founder
ELEMED
8:30 CASE STUDY: GAINING EFFICIENCIES THROUGH PRACTICAL LEARNINGS IN THE TRANSITION TO IVDR
• Mapping out a comprehensive regulatory transition
• Achieving necessary performance evaluation data
• Interaction with notified bodies for file reviews & audits
• Encountered pitfalls & implemented solutions
Amanda Ode, Applied Hematology Manager
BOULE DIAGNOSTICS
9:15 CHAPTER: SHEDDING LIGHT ON NOTIFIED BODY EXPERIENCES & PERSPECTIVES
PART 1 – INTERVIEW: CLARIFICATION OF COMMON IVDR COMPLIANCE & GRACE PERIOD MISCONCEPTIONS
In the midst of the IVDR transition, regulatory teams raise increasingly precise interrogations pertinent to notified body readiness in managing submissions, as well as expectations for manufacturers to accurately prioritize necessary steps in the time left to reach full conformity. Participants are given the unique opportunity to address questions to notified bodies through this interview format, providing clear and definite answers necessary to carve out timely compliance action plans.
INTERVIEWEES:
Catherine Holzmann, Certification Division Manager IVDs – GMED
Judith Prevoo, Regulatory Lead – BSI GROUP
Marta Carnielli, Head of Certification IVD – TÜV SÜD
INTERVIEWER:
Irene Hsieh, Sr. Director of Regulatory & Clinical Affairs, EUROIMMUNE
10:00 COFFEE & NETWORKING BREAK
10:30 PART 2 – LEARNING FROM COMMON FINDINGS IN TECH FILE REVIEWS & AUDITS
• Technical file frequent missteps & areas of confusion
• Data formatting considerations to assist in NB review
• Meeting NB expectations towards audit readiness
• Focus points rendering positive vs. negative outcomes
Judith Prevoo, Regulatory Lead
BSI GROUP
11:15 WORKSHOP: CLARIFYING THE FRONTIER BETWEEN A NON-SIGNIFICANT VS SIGNIFICANT CHANGE
With the goal of shedding light on the interpretation mechanism in play when determining whether a change to a diagnostic product falls under the category of “significant” in accordance with article 110 (3), this interactive workshop will enable participants to look into distinct scenarios and collaborate to take away practical insight and actionable advice from the session.
Andrew Rutter, Senior Manager, Regulatory Affairs
QUIDELORTHO
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:30 UKCA: CLARIFYING THE UPCOMING LEGAL FRAMEWORK FOR DIAGNOSTICS & IMPLEMENTATION STATUS
• Upcoming UK legislation & comparison with IVDR
• Transition of notified bodies to authorized bodies
• Clarification of MHRA interim approval specifics
• Practical approach to preparedness for new rules
Stuart Angell, Regulatory Affairs Programme Manager
BIVDA
2:15 CARVING SOLUTIONS TO EU CHEMICALS & ENVIRONMENTAL REGULATORY CHALLENGES
• Upcoming impact of the EU Green Deal
• Focus on CLP, RoHS, REACH & more
• Practical insight to prepare & maintain compliance
Neil Plumridge, Chair of Environmental Regulatory Work Party
BIVDA (British In Vitro Diagnostics Association)
3:00 Closing Remarks & Conference Conclusion
Previous Attendees Include:
VP Divisional Regulatory Affairs, Abbott Diagnostics
Business Development Manager, Alcediag
Regulatory Manager, Ascensia Diabetes Care
Director of Regulatory Affairs, BioFire Diagnostics
Regulatory Affairs Manager, BioMérieux
Director, BMS
Global Head of IVD, BSI
Chief Regulatory Affairs Officer, Buhlmann Laboratories AG
IVDR Certification Manager, DNV GL
Global Regulatory Affairs Manager, EKF Diagnostics
Manager, Regulatory Affairs, Foundation Medicine
Director, Global Regulatory Affairs, Gilead Sciences
Senior Regulatory Affairs Clinical, Leica Biosystems
Quality Assurance Director & PRRC, Medicon Hellas
Director Regulations & Industrial Policy, MedTech Europe
Senior Quality Engineer, Mobidiag
Director Global Regulatory Affairs, Medical Devices, Novartis
Technical Director RA, Ortho Clinical Diagnostics
Head of Clinical Regulatory Affairs, PerkinElmer Dx
VP, Regulatory Affairs & Quality, Personal Genome Diagnostics
Clinical Scientist, Philips
QA/RA Manager, Plantvision
Vice President of Product Realisation, QuantuMDx Group
Senior Clinical Surveillance Manager, Radiometer
Head of Regulatory Affairs, Immunoassay, Radiometer
Regulatory Affairs Manager, Tecan
VP Global Regulatory Affairs, Tecan
Regulatory Affairs Manager – IVDR, The Binding Site
Clinical, Reimbursement & Quality Director, The eNose Company
Senior Regulatory Affairs Officer, Tosoh Bioscience Diagnostics
Global Director – IVD Focus Team, TÜV SÜD
Vice President MHS global IVD, TÜV SÜD
IVD Technical Director, TÜV SÜD
RA/QA Manager, Visiopharm
and many more!
Who should attend:
Executives working within diagnostic manufacturing corporations and laboratories that will find this program of greatest relevance are those currently working to meet compliance with the In Vitro Diagnostic Regulation, as well as further requirements relevant to the European market.
- Regulatory Affairs or IVDR
- Clinical Affairs
- Performance Evaluation
- Compliance
- PRRCs
- Authorized Representatives
