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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

  • Wednesday, Oct 4th
    8:00 AM - 9:15 AM EDT
    Drug-Led Combination Products - Submission Guidance and Contents
    Location/Room: 511D
    Presenter: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche
    Presenter: Courtney Evans
    Presenter: Douglass S. Mead, III, RAC – CP Pathways LLC
    Q&A Presenter: Nishchay Gupta – Genentech
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    FDA Expectations for using Digital Tools in Decentralized Clinical Trials
    Location/Room: 513D
    Session Leader: Junyang Wang – EMD Serono
    Presenter: Jill Lee, JD – Novo Nordisk
    Presenter (Remote): Elizabeth Kunkoski, MS – FDA
    Presenter (Remote): Andrew Potter, PhD – US FDA
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    Get the 411 on 1.14 (It's More Than Just Compliant Labeling!)
    Location/Room: 511D
    Session Leader: Mona Desai – Desai RA Consultants, LLC
    Presenter: Free Peay, RAC, Global – Peay Regulatory Affairs Consulting, LLC
    Presenter: Tabitha Elmore – Pharming Healthcare, Inc.
    Presenter: Kamana Singh, DVM, MMB, MBA, RAC(US) – APS Pharma Solutions, LLC
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    Lessons on the EU-Clinical Trials Regulation
    Location/Room: 511F
    Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
    Presenter: Sarah Bly – Worldwide Clinical Trials
    Presenter: Anabela Marcal – European Medicines Agency
    Presenter: Ben Kaspar – MMS Holdings
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • 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
    10:45 AM - 11:15 AM EDT
    Solutions Circle: Pediatric Drug Development:  Failure is not an Option
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Linda McBride, R.PH, RAC – IAA Consulting LLC
    Facilitator: Karl-Heinz Huemer, MD, PhD – khhconsulting
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: Regulatory Trends and Opportunities for Drug Delivery Combination Products
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche
    Facilitator: Nishchay Gupta – Genentech
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: What you need to know about the EU-Clinical Trials Regulation
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
    Facilitator: Sarah Bly – Worldwide Clinical Trials
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    11:25 AM - 11:55 AM EDT
    Solutions Circle: Deep Dive into Labeling Operations
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Mona Desai – Desai RA Consultants, LLC
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    11:25 AM - 11:55 AM EDT
    Solutions Circle: FDA Expectations for Digital Health Tools in Decentralized Clinical Trials
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Junyang Wang – EMD Serono
    Facilitator: Jill Lee, JD – Novo Nordisk
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)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
    Pediatric Drug Development: Failure is not an Option
    Location/Room: 513B
    Presenter: Karl-Heinz Huemer, MD, PhD – khhconsulting
    Presenter: Linda McBride, R.PH, RAC – IAA Consulting LLC
    Presenter: Kimberly Belsky, MS, FRAPS – Planning Committee Chair Convergence 2023
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • 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