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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

Program Presenters:

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

A Special Thanks to Our Sponsors:

Day One Agenda
Thursday, October 19

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

11:45   CASE  STUDY 2
Melissa Finocchio, Chief Regulatory Officer 
SOPHiA GENETICS

12:30   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30   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
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