Day One Agenda
Tuesday, May 21

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   BACK TO THE PERSON: RETHINKING GOALS AND APPROACHES FOR THE IVD CLINICAL AND REGULATORY AFFAIRS PROFESSIONAL
We regulate to ensure safety, efficacy, consistency, and value. However, we often forget about the basic element of our endeavors, to help and serve the person in need. In this session, participants will learn the importance of rediscovering the person, rethinking goals and approaches, empowerment and engagement and elevating the level of discourse. Clinical and regulatory affairs professionals will understand how to transform complexity into actionable information so that each person has the needed tools to make informed decisions.
Dennis Robbins, Former National Fund for Medical Education Fellow, Visiting Scholar, and Research Fellow in Medical Ethics
HARVARD SCHOOL OF PUBLIC HEALTH

9:45   EU IVDR EXTENDED TRANSITION PERIOD: STATUS OVERVIEW AND MAKING USE OF ADDITIONAL TIME
• Background and need for extension
• Gauging key elements of the proposal
• Examining new deadlines and next steps
• Investigative the benefits of delays
Marta Carnielli, Head of Certification IVD    
TÜV SÜD

10:30  COFFEE AND NETWORKING BREAK

11:00   2-PART MODULE: NOTIFIED BODY EXPERIENCES DISCLOSED: LEARNING FROM COMMON FINDINGS AND SHEDDING LIGHT ON INDUSTRY EXPECTATIONS
Part 1 – LESSONS LEARNED
With ongoing areas of uncertainty and the various challenges in the industry, 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.
Alex Laan, Head of IVD Notified Body
BSI GROUP

11:45  Part 2 – INTERVIEW: PROVIDING CLARITY AMID ONGOING CHALLENGES
Following the Notified Body interview, the audience will break into groups to engage with the speakers in more of an informal manner. Discussions will involve data expectations for compliant performance evaluation reports, regulator’s requirements for continued post-market follow-up, and developing partnerships with certified reference laboratories
Azam Khorshidi, IVD Regulatory Professional and Biocompatibility SME  
DEKRA CERTIFICATION
Haijuan Jane Li, IVD Product Reviewer   
GMED NORTH AMERICA
Irene Hsieh , Senior Director, Regulatory & Clinical Affairs 
EUROIMMUN US

12:30   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30   OVERCOMING CONSTRAINTS WITH THE LACK OF GLOBAL REGULATORY HARMONIZATION
• Identifying clinical data gaps for IVDR compliance
• Determining the need for new performance testing
• Usability and relevance of existing post-market data
• Pros and cons to literature reviews for IVD products
• Defining a “sufficient” amount of data for NBs
Haijuan Jane Li, IVD Product Reviewer
GMED NORTH AMERICA
Carol Lindsay, Regulatory Affairs Program Manager
PROMEGA CORPORATION
Adhiraj S Mamak, Senior Manager, Global Quality Strategy & Alliances
ILLUMINA

2:15 ARTIFICIAL INTELLIGENCE AND REGULATION: INSIGHT ON DIGITAL HEALTH AND FUTURE ANTICIPATED REGULATORY OVERSIGHT
• FDA’s proposed regulatory framework
• Anticipated future regulatory oversight of digital health
• Considerations for an effective Software
Hassan Tetteh, Heart Surgeon and Clinical Informaticist
CEO, Human Care Technologies, Inc

3:00   COFFEE & NETWORKING BREAK

3:30  EXAMINING HOW THE PHARMACEUTICAL INDUSTRY IS BEING IMPACTED BY INCREASING GLOBAL REGULATIONS ON CLINICAL DIAGNOSTIC TESTING
Lindsay Darling, Director, Companion Diagnostics Portfolio Management & Operations
REGENERON

4:15  PREDETERMINED CHANGE CONTROL PLANS (PCCP) FOR MACHINE LEARNING DEVICES: GUIDING PRINCIPLES
• Advancements in digital health technologies
• Discussing the components of a PCCP
• Review of regulatory principles for PCCP
• Discussions on oversight over regulations
Roshni Kasturi, Clinical Lead, MDR/IVDR    
ASCENSIA DIABETES CARE

5:00   Closing Remarks & End of Day One

Day Two Agenda
Wednesday, May 22

8:00  REGISTRATION & WELCOME COFFEE

8:20  CHAIRPERSON’S OPENING REMARKS

8:30   EXAMINING FDA’S NEW PROPOSAL TO RECLASSIFY CLASS III IVDS INTO CLASS II
• Clarifying the rationale for the reclassification proposal
• Gauging FDA’s broader action plan and initiatives
• Assessing reclassification impact on manufacturers
• Handling companion diagnostics development with LDTs
• Challenges relating to cost and volume of submissions
• Benefits and skepticism of the reclassification program
PANEL DISCUSSION:
Colleen Watson, Senior Director Regulatory Affairs, Clinical Diagnostics Division
THERMO FISHER SCIENTIFIC INC.
Shree Koushik, Vice President, Regulatory Affairs
SENSIBLE DIAGNOSTICS
Colleen Adams, Senior Director, Regulatory & Clinical Affairs
WATERS CORPORATION

9:15   PANEL DISCUSSION: INSIDE FDA’S RULE TO REGULATE LABORATORY DEVELOPED TESTS (LDTS): KEY TAKEAWAYS AND ISSUES
• Short-term and long-term impact of lab testing
• Examining costs to patients and hospitals
• Analyzing and addressing FDA compliance
• Defining and examining IVD vs LDT
• Scope and summary of proposed changes
• Timelines and impacts of proposed rule
Lisa M. Dwyer, KING AND SPALDING
Gail H. Javitt, HYMAN, PHELPS and MCNAMARA
Irene Hsieh, EUROIMMUN US
Colleen Adams,WATERS CORPORATION

10:15    COFFEE & NETWORKING BREAK

10:45   FIRESIDE CHAT: UNDERSTANDING THE IMPACT OF RECENT SOFTWARE DEVELOPMENT AND CYBERSECURITY RULES
• Recent updates to cybersecurity and software development
          » U.S. laws and requirements
          » European Regulation
• Cybersecurity challenges and mitigating risks
• Clarifying risk analysis in the validation of development tools
Jody M. Schulz, Senior Director, Regulatory Affairs
THERMO FISHER SCIENTIFIC
Gail H. Javitt, Director
HYMAN, PHELPS and MCNAMARA
Adrienne Lenz, Principal Device Regulatory Expert
HYMAN, PHELPS & MCNAMARA
Adhiraj S Mamak, Senior Manager, Global Quality Strategy & Alliances
ILLUMINA

11:30   THE NEXT BATTLE IN THE LDT WARS: SOFTWARE CHALLENGES AND RISK FACTORS
• Review of key points in FDA’s current regulatory framework for software
• Highlighting past FDA battles to prognosticate the challenges ahead
• Risk mitigation strategies enabling a proactive approach to compliance
Lisa M. Dwyer, Partner, FDA and Life Sciences; Former FDA official
KING AND SPALDING

12:00   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:00   QUALITY MANAGEMENT SYSTEM REGULATION (QMSR): FINAL RULE AMENDING THE QUALITY SYSTEM REGULATION
• Background on QSR and ISO 13485 harmonization
• Examining the rule to harmonize QMS requirements globally
• Review of updated QMS regulatory requirements and goals
• Swiftly performing a gap assessment to reach compliance
Jason Russell, Senior Associate Global Regulatory
HOGAN LOVELLS

1:30  IVD LABELING REGULATORY REQUIREMENTS: KEY DIAGNOSTIC LABELING REQUIREMENTS IN THE US AND EU
• US and EU labeling maintenance IVD requirements
• Points to consider regarding labeling submissions
• Compliance ramifications on test claims and product labeling
• Assessing when the different labeling regulations apply
• How to operationalize regulations to manage labeling
Azam Khorshidi, IVD Regulatory Professional and Biocompatibility SME   
DEKRA CERTIFICATION

2:15  COFFEE AND NETWORKING BREAK

2:45     2-PART MODULE: EXPLORING THE CDX LANDSCAPE
Part 1 – Understanding And Overcoming Common Clinical Challenges
• Differences between EU and US regulations related to IVD clinical performance studies
• Navigating EU competent authority and ethics committee applications without coordinated assessment
• Planning for substantial modifications
• Interface between the regulations on clinical trials of medicinal product and IVDs
Karin A. Hughes, Senior Vice President, Global Regulatory and Quality
BEAUFORT

3:15     Part 2 – Overcoming Common Regulatory And Clinical Challenges
• Regulatory challenges for companion diagnostic developers
• Navigating technical aspects for manufacturers
• Potential regulatory support from the pharma companion
• Updates on FDAs companion diagnostics oncology tests
Carol Lindsay, Regulatory Affairs Program Manager
PROMEGA CORPORATION
Lindsay Darling, Director, Companion Diagnostics Portfolio Management & Operations 
REGENERON

3:45   CLOSING REMARKS AND CONFERENCE CONCLUSION

A Special Thanks to Our Sponsor: