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
Industry Experts:
Erik Vollebregt
Partner
AXON LAWYERS
Ashleigh Batchen
Head of Regulatory Affairs
BIVDA – THE BRITISH IN VITRO DIAGNOSTIC ASSOCIATION
Neil Plumridge
Environmental, Social & Governance Lead
EKF DIAGNOSTICS
Yannis Bekatoros
Senior Regulatory Affairs Officer
TOSOH BIOSCIENCE
Melissa Finocchio
Chief Regulatory Officer
SOPHiA GENETICS
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
Pooya Sahandifar
Senior Validation Engineer
BOULE DIAGNOSTICS
Andrew Rutter
Senior Manager, Regulatory Affairs
QUIDELORTHO
Sarah Chavez
Director, IVD & Scientific Writing Services
CRITERION EDGE
Irene Hsieh
Sr. Director of Regulatory & Clinical Affairs
EUROIMMUNE
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 OPENING ICE BREAKER: MAKING “V-I-P” CONNECTIONS & SHARING INSIGHTS
In this interactive kick-off session, attendees are encouraged to rate themselves as a V-”Veteran” in the industry, I-”Intermediate” or P-”Potential”, and meet with 2 other participants of different ranks in order to form a V-I-P group and build new contacts. Additionally, each participant is welcome to briefly share on new or updated regulatory requirements recently come across, pertinent to the European market.
9:30 HIGHLIGHTS FROM RECENT REGULATORY UPDATES & MDCG GUIDANCE APPLICABLE TO IVDs
• Refresher on the staggered approach to IVDR compliance dates
• IVDR-relevant takeaways from 2022 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
10:15 COFFEE & NETWORKING BREAK
10:45 DEVELOPMENTS IN EU IN-HOUSE MANUFACTURED IVDS UNDER THE NEW 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
11:15 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
12:00 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:15 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
2:00 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
2:30 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
Silvia Anghel, Associate Director & Head of IVD Group
VERANEX
3:15 COFFEE & NETWORKING BREAK
3:45 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
4:30 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
5:30 Closing Remarks & End of Day 1
Day Two Agenda
Friday, October 20
8:30 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 PRACTICAL INSIGHT INTO AN IVDR QMS AUDIT : PREPARATION, CONDUCT & OUTCOMES
• Steps taken to ensure IVDR QMS audit readiness
• On-site audit experience & areas of focus from the NB
• Specifics as an Authorized Rep for a Japanese organization
• IVDR QMS audit findings & remediation strategies
• Lessons learned from the manufacturer’s standpoint
Yannis Bekatoros, Senior Regulatory Affairs Officer
TOSOH BIOSCIENCE
9:45 STAY FOCUSED: THE PURPOSE OF THE SRV & TIPS FOR BUILDING A STRONG PER FOUNDATION
• Clearly define what information should vs should not be presented within the Scientific Validity Report
• How the systematic literature review process supports & connects the SVR, CPR, & APR by leveraging published data
• How to conduct gap assessments to assess IVDR readiness & develop strategies to increase efficiencies in the performance evaluation process
Sarah Chavez, Director, IVD & Scientific Writing Services
CRITERION EDGE
10:30 COFFEE & NETWORKING BREAK
11:00 MULTIPLE CASE STUDIES: GAINING EFFICIENCIES THROUGH PRACTICAL LEARNINGS FROM PEERS’ 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
CASE STUDY 1
Pooya Sahandifar, Senior Validation Engineer
BOULE DIAGNOSTICS
SOPHiA GENETICS
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:30 SMALL GROUP DISCUSSION: EXCHANGING & BUILDING KNOWLEDGE IN DIAGNOSTICS INCLUDING SOFTWARE OR AI
GROUP 1: Software Dx & AI compliance basics
GROUP 2: Software Dx & AI advanced knowledge
Irene Hsieh, Sr. Director of Regulatory & Clinical Affairs, EUROIMMUNE
2:15 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
3:00 COFFEE & NETWORKING BREAK
3:20 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
Ashleigh Batchen, Head of Regulatory Affairs
BIVDA – THE BRITISH IN VITRO DIAGNOSTIC ASSOCIATION
4:05 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, Environmental, Social & Governance Lead
EKF DIAGNOSTICS
4:55 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
