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Conversation Starters

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Conversation Starters – New for 2023!
Sessions tagged as “Conversation Starters” are main conference sessions that offer a Solutions Circle (which may occur before or after main session) that takes a deeper dive of its topic. Attendance of the main conference session is not required to attend the Solutions Circle.

*Program and facilitators subject to change. Please check back frequently for updates.

Conversation Starters

  • Monday, Oct 2nd
    8:30 AM - 4:00 PM EDT
    Common Pitfalls in Manufacturer Technical Documentation Submissions to Notified Bodies; Ways to Overcome These.
    Location/Room: 511F
    Presenter: Purvi S. Patel, PhD, CEng, MIMechE – BSI Group
    Presenter: Vishal Thakker, MEng – BSI Group
    Presenter: Rachel Mead, BEng MIET – BSI Group
    Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
    Presenter: Gareth Enright, MEng – National Standards Authority of Ireland
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Monday, Oct 2nd
    8:30 AM - 4:00 PM EDT
    Communication Toolkit for a Successful Regulatory Compliance Strategy
    Location/Room: 510A
    Presenter: Corinne Delorme, MS, RAC – nexialist
    Presenter: Vincent Castéras, PhD – nexialist
    Presenter: Florianne Torset-Bonfillou, MS, RAC – GMED North America
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Tuesday, Oct 3rd
    8:30 AM - 4:00 PM EDT
    IVDR Technical Documentation Pre-conference Workshop
    Location/Room: 511F
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Tom Patten – NSAI
    Presenter: Catherine Holzmann – GMED Certification Division
    Presenter: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Tuesday, Oct 3rd
    8:30 AM - 4:00 PM EDT
    PRRC – A New EU Requirement
    Location/Room: 510A
    Workshop Leader: Bassil Akra, phD – Akra Team GmbH
    Presenter: Danielle Giroud, MSci – MD-CLINICALS SA
    Presenter: Keith Morel, PhD – Qserve Group
    Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
    Presenter: Erik R. Vollebregt – Axon Lawyers
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Tuesday, Oct 3rd
    8:30 AM - 4:00 PM EDT
    US Regulatory Essentials for Devices and IVDs
    Location/Room: 511E
    Presenter: David Chadwick, PhD, RAC, FRAPS – Independent
    Presenter: Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A.
    Presenter: Etienne Nichols, PMP, CSM – Greenlight Guru
    Presenter: Tony Blank – AtriCure, Inc.
    Presenter: Christie Hughes, MPH, MLS(ASCP) – Qserve Group
    Presenter (Remote): Larry Pool – Cook Incorporated
    Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    8:00 AM - 9:15 AM EDT
    EU-MDR Implementation: Latest News
    Location/Room: 511E
    Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
    Moderator: Bassil Akra, phD – Akra Team GmbH
    Presenter (Remote): Peter Bischoff-Everding – European Commission, Directorate-General Health and Food safety
    Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
    Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    8:00 AM - 9:15 AM EDT
    Risk Management – The Importance of Lifecycle Traceability
    Location/Room: 510A
    Session Leader: Kimberly A. Trautman, MS – MEDIcept
    Presenter: Brian Siroka – MEDIcept Inc.
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    12:05 PM - 12:35 PM EDT
    Solutions Circle: Medical Device EU MDR Lessons Learned with Two Different Notified Bodies
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Lucy Tan, MBA – Abbott
    Facilitator: Jenny Chan, MS, RAC, PMP – Abbott
    Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    12:45 PM - 1:15 PM EDT
    Solutions Circle: Annex XVI State of Play
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
    Presenter: jayanth K. Katta, PhD – BSI
    Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    12:45 PM - 1:15 PM EDT
    Solutions Circle: Getting it Right the First Time - Where Regulatory and Design Intersect; Accuracy/Acceptance Criteria
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Diane M. Ward, PhD – Qserve Group US
    Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    Anatomy of a Tweet – How to Promote on the Socials in a MedDev Regulatory Environment.
    Location/Room: 511F
    Session Leader: Jennifer Ng Ain Kin – Abbott Laboratories
    Presenter: Hillary VanderBand, MBA – Abbott Laboratories
    Presenter: Erik R. Vollebregt – Axon Lawyers
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape
    Location/Room: 510B
    Moderator: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific
    Presenter: Scott Goates, PhD. – Abbott
    Presenter: Korinne Jew, PhD – Medtronic
    Presenter: Alexandra Massoud – Exact Sciences
    Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    UDI & Global Supply Chain Compliance
    Location/Room: 510A
    Session Leader: Brian Scogland, MS, MBA – Veeva MedTech
    Presenter: Jay Crowley, MS – USDM Life Sciences
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    Advancing Health Equity, a Strategic Priority for FDA/CDRH and Health Canada
    Location/Room: 513B
    Moderator: Amra Racic – Veeva Systems
    Presenter: Sally Prawdzik – Health Canada
    Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    EU-MDR Notified Body Forum
    Location/Room: 511E
    Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
    Moderator: Bassil Akra, phD – Akra Team GmbH
    Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
    Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
    Presenter: Andreas Stange – TUV SUD
    Presenter: Catherine Holzmann – GMED Certification Division
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    FDA Forecast 2024: What Device and Diagnostics Regulatory Professionals can Expect from FDA Next Year
    Location/Room: 510A
    Presenter: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ
    Moderator: Amra Racic – Veeva Systems
    Presenter: Laura DiAngelo, MPH – POLITICO's AgencyIQ
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    Regulatory Framework of AI/ML Enabled Medical Devices in the U.S. and EU.
    Location/Room: 511F
    Presenter: Monika Bhatt, LL.M, RAC – Siemens Healthineers
    Presenter: Kenneth Fuh, PhD – TÜV SÜD GmbH
    Moderator: Erik R. Vollebregt – Axon Lawyers
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    4:45 PM - 5:45 PM EDT
    Efficient Product Master Data Management: FDA , EUDAMED, and other Medical Device Registry submission/Syndication.
    Location/Room: 510A
    Session Leader: Jeff Holzman – Item Alignment Inc.
    Presenter: Jay Crowley, MS – USDM Life Sciences
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    4:45 PM - 5:45 PM EDT
    Latest Updates on Clinical Evidence – Panel Discussion with a Consultant and 3 Notified Bodies
    Location/Room: 511F
    Session Leader: Matthias Fink, MD – Akra Team Inc.
    Presenter: Tonia Jeiter, Dr. med. – TÜV SÜD Product Service GmbH
    Presenter: Richard G. Holborow – BSI
    Presenter: Christoph Ziskoven, MD – TÜV Rheinland LGA Products GmbH
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Wednesday, Oct 4th
    4:45 PM - 5:45 PM EDT
    When to “Factor” in Human Factors
    Location/Room: 511E
    Presenter: Rita Lin – Agilis by Kymanox
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    Drug-Device Combination Products: The Why Behind the Regulatory Strategy
    Location/Room: 510B
    Session Leader: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – Takeda
    Presenter (Remote): Theresa Jeary, BSc (Hons), MSc – BSI Group
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    Medical Device Cybersecurity: Planning a Global Strategy
    Location/Room: 513B
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    What can Legacy Manufacturers Learn from Effective PMS and PMPF Implementation in Order to Prepare to Become IVDR compliant?
    Location/Room: 510A
    Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
    Presenter: Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH
    Presenter: Robin McMillan – Abbott
    Presenter: Tom Patten – NSAI
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: EU/MDR State of Play
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
    Facilitator: Matthias Fink, MD – Akra Team GmbH
    Facilitator: Bassil Akra, phD – Akra Team GmbH
    Facilitator: GERRIT WILLEM BOS, FRAPS – Qservegroup
    Facilitator: Suzanne Halliday, MSc. D.Phil. – BSI
    Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
  • Thursday, Oct 5th
    12:05 PM - 12:35 PM EDT
    Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Azam Khorshidi – DEKRA
    Facilitator: Catherine Holzmann – GMED Certification Division
    Facilitator: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
    Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
  • Thursday, Oct 5th
    12:05 PM - 12:35 PM EDT
    Solutions Circle: The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
    Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.
    Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
  • Thursday, Oct 5th
    12:45 PM - 1:15 PM EDT
    Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Anja Wiersma, PhD – mi-CE consultancy
    Facilitator: Tom Patten – NSAI
    Facilitator: Stefan Burde, PhD – TÜV SÜD America Inc.
    Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
  • Thursday, Oct 5th
    2:00 PM - 3:00 PM EDT
    IVDR Transition and Implementation: What Have We Learned from the MDR?
    Location/Room: 511F
    Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
    Presenter: Amélie Chollet
    Presenter: Erik R. Vollebregt – Axon Lawyers
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    2:00 PM - 3:00 PM EDT
    Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market Access
    Location/Room: 510A
    Session Leader: Daniëlle Motta, MSc. – Qserve Group BV
    Presenter: Balazs Bozsik – SGS North America Inc.
    Presenter: Phil Brown – ABHI
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    2:00 PM - 3:00 PM EDT
    Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?
    Location/Room: 511E
    Moderator: Anja Wiersma, PhD – mi-CE consultancy
    Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Tom Patten – NSAI
    Presenter: Catherine Holzmann – GMED Certification Division
    Presenter: Azam Khorshidi – DEKRA
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23)
    Location/Room: 510A
    Moderator: Keith Morel, PhD – Qserve Group
    Presenter: Leo Hovestadt – Elekta
    Presenter: Balazs Bozsik – SGS North America Inc.
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions
    Location/Room: 511E
    Session Leader: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
    Presenter (Remote): Patrick Axtell, PhD – FDA
    Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
    Devices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    Understand the Evolving Role of Real World Evidence
    Location/Room: 513B
    Moderator: Olga van Grol-Lawlor, MPhil – Boston Scientific
    Presenter (Remote): Daniel Caños, PhD, MPH – US Food and Drug Administration
    Presenter: Heather M. Colvin, MPP – Johnson & Johnson MedTech
    Speaker: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
    Speaker: Monika McDole-Russell, MS, RAC – Medtronic Endoscopy
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    4:45 PM - 5:45 PM EDT
    Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation Process
    Location/Room: 511E
    Presenter: Judith Prevoo – BSI
    Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency
    Presenter: James Hewitt – TÜV SÜD
    Presenter: Chelsea Welch – ARUP Laboratories
    Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    4:45 PM - 5:45 PM EDT
    Predetermined Change Control Plans (PCCPS) are Now Codified in FDORA - What should you do?
    Location/Room: 511F
    Session Leader: Nancy J. Morrison, RAC – RQM+
    Presenter: Hrishikesh Gadagkar, PhD – RQM Plus
    Devices (includes Medical Devices and In Vitro Diagnostics)
  • Thursday, Oct 5th
    4:45 PM - 5:45 PM EDT
    Streamlining Conformity Assessment in Medical Device Review: the FDA's ASCA Program
    Location/Room: 513B
    Moderator: Kimberly A. Trautman, MS – MEDIcept
    Presenter: Gail M. Rodriguez, Ph.D. – US Food and Drug Administration
    Presenter: Scott Colburn, MS, BSN – US Food and Drug Administration
    Devices (includes Medical Devices and In Vitro Diagnostics)