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17th Annual

IVD Clinical & Regulatory Affairs Conference

May 21-22, 2024 | Chicago, IL
Hyatt Centric Magnificent Mile

 

17th Annual

IVD Clinical & Regulatory Affairs Conference

May 21-22, 2024
Chicago, IL
Hyatt Centric Magnificent Mile

Continuously Remain Compliant by Assessing the Impact of Evolving Requirements in the US & Abroad, Including the FDA’s Proposed LDT Rule & Finalized QMSR as well as Recent Amendments to the EU IVDR, all while Successfully Navigating Complexities with Performance Evaluation Studies in the Pre & Post-Market Setting

Program Presenters:

Regulatory Body Experts:

Lisa M. Dwyer
Partner, FDA and Life Sciences
Former FDA Official
KING AND SPALDING

Azam Khorshidi
IVD Regulatory Professional and Biocompatibility SME
DEKRA CERTIFICATION

Alex Laan
Head of IVD Notified Body
BSI GROUP

Marta Carnielli
Head of Certification IVD
TÜV SÜD

Haijuan Jane Li
IVD Product Reviewer
GMED NORTH AMERICA

Industry Experts:

Jason Russell
Senior Associate Global Regulatory
HOGAN LOVELLS

Adhiraj S Mamak
Senior Manager, Global Quality Strategy & Alliances
ILLUMINA

Adrienne Lenz
Principal Device Regulatory Expert
HYMAN, PHELPS & MCNAMARA

Hassan Tetteh
Heart Surgeon and Clinical Informaticist
CEO, Human Care Technologies, Inc

Jody M. Schulz
Senior Director, Regulatory Affairs
THERMO FISHER SCIENTIFIC

Carol Lindsay
Regulatory Affairs Program Manager
PROMEGA CORPORATION

Colleen Adams
Senior Director, Regulatory & Clinical Affairs
WATERS CORPORATION

Irene Hsieh 
Senior Director, Regulatory & Clinical Affairs 
EUROIMMUN US

William Clarke
Deputy Director of Pathology; Quality and Regulatory Affairs
JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE

Colleen Watson
Senior Director Regulatory Affairs, Clinical Diagnostics Division
THERMO FISHER SCIENTIFIC

Lindsay Darling
Director, Companion Diagnostics Portfolio Management & Operations
REGENERON

Karin A. Hughes
Diagnostic Industry Leader

Dennis Robbins
Former National Fund for Medical Education Fellow, Visiting Scholar & Research Fellow in Medical Ethics
HARVARD SCHOOL OF PUBLIC HEALTH

Gail H. Javitt
Director
HYMAN, PHELPS & MCNAMARA

Roshni Kasturi
Clinical Lead, MDR/IVDR
ASCENSIA DIABETES CARE

Shree Koushik
Vice President, Regulatory Affairs
SENSIBLE DIAGNOSTICS

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
Olga Tkachenko, Policy Officer
EUROPEAN COMMISSION

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
William Clarke, JOHNS HOPKINS UNIVERSITY
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, Diagnostic Industry Leader

(Former) Vice President, Clinical and Regulatory Strategy
BIOMÉRIEUX

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:

Previous Attendees Include:

Executive Director, ADVAMED
Companion Diagnostics Regulatory Affairs Manager, AMGEN
VP Regulatory Strategy, Policy and Intelligence, BD
VP Regulatory, Quality & Clinical Affairs, BIOFIRE DEFENSE
Vice President Global Regulatory & Clinical Affairs, CEPHEID
Manager, Regulatory Affairs, DIVERSIGEN, INC
Senior RA Specialist, EXACT SCIENCES
Manager, Regulatory Affairs, EXACT SCIENCES
Sr Director, Clinical Affairs, EXACT SCIENCES
VP, Clinical Affairs, EXACT SCIENCES
Sr. Regulatory Affairs Specialist, EXACT SCIENCES
Vice President Regulatory Affairs, GRAIL
Quality Manager, ILLUMINA
Director, Regulatory Affairs, LABORATORY CORP. OF AMERICA
Clinical Studies Manager, LUMINEX CORPORATION
Director, Clinical Development, LUMINEX CORPORATION
Sr. Director, US Regulatory Affairs, MEDTRONIC
Senior Manager Regulatory Affairs, MEDTRONIC
Regulatory Affairs Associate III, MYRIAD GENETIC
VP, Regulatory Affairs and Quality, PERSONAL GENOME DIAGNOSTICS
Sr. Regulatory Affairs Specialist, QUIDEL
Sr Dir., Regulatory Affairs (CDx), REGENERON PHARMACEUTICALS
As. Dir. Regulatory Affairs (CDx), REGENERON PHARMACEUTICALS
Sr. Manager Regulatory Affairs, SYSMEX INOSTICS
CISO, SIEMENS
VP-BD, THE ABIS GROUP
Vice President MHS Global IVD, TÜV SÜD
Global Regulatory Affairs Devices IVD Head, UCB

….And Many Many More

Who should attend:

Executives that will find this program of greatest relevance are those currently working within the diagnostic industry, with a specific focus on IVDs. Job titles of executives that will find this program to be most applicable to their job functions include:

Job titles for this meeting include VPs, Directors, and Managers of:
● Regulatory Affairs
● Clinical Affairs
● Medical or Scientific Affairs
● Performance Evaluations