Day One Agenda
Tuesday, February 7

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00  OPENING ICE BREAKER: SHARING INSIGHTS INTO RECENT REGULATORY CHANGES IN THE US  & BEYOND
The opening ice breaker will kick-off the event with an opportunity for all participants to move around the conference room to meet new delegates and engage in short and targeted discussions. In this interactive session, attendees are encouraged to briefly share on new or updated regulatory requirements recently come across, pertinent to the US market or elsewhere. Furthermore, participants in this warm-up session have the chance to build contacts with industry peers at the very start of the event, kicking off the program networking platform.
Gail Gasior, Director, Clinical Compliance, HOLOGIC
Sandra De Kozlowski, Scientific Affairs Manager, GREINER BIO ONE

CHAPTER: NOTIFIED BODY EXPERIENCES DISCLOSED
9:30   PART 1 – 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
Alex Laan, Head of IVD Notified Body, BSI GROUP

10:15   COFFEE & NETWORKING BREAK

10:45   PART 2 -INTERVIEW: SHEDDING LIGHT ON NOTIFIED BODY REVIEW TIMELINES, PERSPECTIVES & EXPECTATIONS TOWARDS THE INDUSTRY
With ongoing areas of uncertainty related to whether or not more notified bodies will be IVDR certified in the near future, handling the constraints due to lengthy review timeframes or overall performance evaluation data acceptability, as well as differing perspectives from one body to the next, regulatory and clinical affairs professionals are given the unique opportunity to address questions to notified body speakers to receive transparent feedback, providing clarity into concerns of critical importance.
INTERVIEWEES:
Julien Senac, PhD, Director of Medical and Health Services Americas, TÜV SÜD
Claire McKenna, Project Manager, DEKRA CERTIFICATION B.V.
Haijuan Jane Li, IVD Product Reviewer, GMED North America
INTERVIEWER:
Irene Hsieh, Sr. Director of Regulatory Affairs & Clinical Affairs, EUROIMMUN AG

11:30   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

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30 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
Russell Henderson, Sr. Director Regulatory Affairs, MYRIAD GENETICS

2:15   OVERCOMING CONSTRAINTS WITH THE LACK OF GLOBAL REGULATORY HARMONIZATION
• Remaining abreast of continuous changes internationally
• Expediting the interpretation & integration of new rules
• Ensuring continuous training on evolving regulations
Heather Thompson, Senior Manager, Regulatory Affairs, SYSMEX INOSTICS, INC.

3:00   COFFEE & NETWORKING BREAK

3:30   PANEL DISCUSSION: UTILIZING REGULATORY INTELLIGENCE TO UPHOLD COMPLIANCE
• Leveraging RI efficiently to alleviate pressure on RA
• Defining successful RI applications & roles
• Demonstrating the effectiveness of a RI strategy
Raya Zerger, BECKMAN COULTER
Gail Gasior, HOLOGIC
Sherma Winston, PRECISION FOR MEDICINE

4:15   MASTERING CLINICAL STUDY DESIGN TO ENSURE SUCCESSFUL DATA OUTCOMES
• Clarifying the link between design & evidence generation
• Precise definition of desired study end-points
• Review & pros/cons of traditional trial types
• Best practices in maximizing study data generation
Janet Farhang, Vice President, Clinical Affairs, LUMINEX CORPORATION

5:00   Closing Remarks & End of Day One

Day Two Agenda
Wednesday, February 8

Closing Remarks & Conference Conclusion8:00   REGISTRATION & WELCOME COFFEE

8:20  CHAIRPERSON’S OPENING REMARKS

8:30   DEEP DIVE: INSTITUTING EFFECTIVE STRATEGIES FOR SUCCESSFUL PATIENT ENROLLMENT IN TRIALS
• Overcoming challenges in patient profiling & identification
• Analysis of effective communication strategies with patients
• Expediting patient enrollment & ensuring participants’ adherence
Sandra DeKozlowski, Scientific Affairs Manager, GREINER BIO ONE

9:15   UNDERSTANDING THE IMPACT OF RECENT SOFTWARE DEVELOPMENT & CYBERSECURITY FDA GUIDANCE ON IVD PRODUCT CONSIDERATIONS
• Recent updates to the cybersecurity & software development guidance documents
• Implementation of patching procedures & SBOM development on IVD products
• Clarifying the use of risk analysis in validation of development tools
Jennifer Dickey, PhD, Vice President, Regulatory Affairs and Quality, PERSONAL GENOME DIAGNOSTICS

10:00  COFFEE & NETWORKING BREAK

10:30   SMALL GROUP DISCUSSION: EXCHANGING & BUILDING KNOWLEDGE IN DIAGNOSTICS INCLUDING SOFTWARE OR AI
With the exceptional influx of software and AI in the diagnostic industry, the need for compliance and a structure of framework becomes a pressing issue. By directly exchanging experiences and lessons learned from peers, participants in each group will gain deeper understanding and practical advice to meet framework and expectations.
GROUP 1: Software Dx & AI compliance basics
Jennifer Dickey, PhD, Vice President, Regulatory Affairs and Quality, PERSONAL GENOME DIAGNOSTICS
GROUP 2: Software Dx & AI advanced knowledge
Irene Hsieh, Sr. Director of Regulatory Affairs & Clinical Affairs
EUROIMMUN AG

11:30   IMPLICATIONS OF THE CLINICAL DECISION SUPPORT FINAL GUIDANCE FOR CLINICAL GENOMIC TESTING
• Review FDA’s Final CDS Guidance
• Implications for NGS interpretive software
• Potential consequences for clinical using CDS software
Gail Javitt, Director, HYMAN, PHELPS & MCNAMARA PC

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30   ESTABLISHING STRATEGIES TO ADAPT TO THE IMPLEMENTATION OF THE VALID ACT
• Overview of the VALID Act, new IVCT category & impact on the industry
• Review of next steps & opportunities for legislation
• Outline of the current strategic implications
Raya Zerger, Senior Staff, Legislative Initiatives, Regulatory Affairs, BECKMAN COULTER

2:15   NAVIGATING COMPANION DIAGNOSTICS REGULATIONS & FRAMEWORK
• Regulatory challenges for companion diagnostic companies
• Differences between EU vs US regulations
• Navigating technical aspects for manufacturers
• Potential regulatory support from the pharma companion
Eunice Lee,VP, Regulatory Affairs, GUARDANT HEALTH

3:00  CLOSING REMARKS & CONFERENCE CONCLUSION 

A Special Thanks to Our Sponsors: