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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
    10:45 AM – 11:15 AM EDT
    Solutions Circle: A Roadmap of Expedited Pathways in Europe - The Fast for the Curious
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Farhad Amiri, PhD, FAHA – Parexel International
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    10:45 AM – 11:15 AM EDT
    Solutions Circle: Biosimilar Regulations in Middle East - Challenges and Proposed Solutions
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Guriqbal Singh – Regweb Consulting Services Inc.
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    10:45 AM – 11:15 AM EDT
    Solutions Circle: eCTD Module 3, How Much Detail Do I Submit?
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Robert L. Waterland, PhD – Certara Drug Development Solutions
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    10:45 AM – 11:15 AM EDT
    Solutions Circle: How Soon Can I Implement This? "Navigating FDA Submissions and Review Logistics: A One-Stop Guide
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
    Facilitator: Myriam Triest, PhD – CMC-RX Consulting
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    11:25 AM – 11:55 AM EDT
    Solutions Circle: 5 Ways that an RA Department Will be Impacted by IDMP Data Standards
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Niels B. Leander, PhD – NNIT
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    11:25 AM – 11:55 AM EDT
    Solutions Circle: Enabling Earlier Access to Medicines in Latin America by Rationalizing Legalization Requirements
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Cammilla Gomes – Roche
    Facilitator: Pedro Franco, PhD, MSc, PharmD. – Merck KGaA
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    11:25 AM – 11:55 AM EDT
    Solutions Circle: Q&A on the EU General Pharmaceutical Legislation Revision
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Joao Duarte, MSc MPharm – Alexion, AstraZeneca Rare Disease
    Solutions Circle
  • Wednesday, Oct 4th
    11:25 AM – 11:55 AM EDT
    Solutions Circle: Regulatory Strategy for Market Entry to China for Drug Master Filing (DMF)
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Hamish King, RAC, LLB – Cisema
    Facilitator: Victoria Caldy – Cisema
    Solutions Circle
  • 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
    12:05 PM – 12:35 PM EDT
    Solutions Circle: Methodologies for Building a Software Predetermined Change Control Plan and Algorithm Change Plan for AI/ML
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Alex W. Smith, RAC, MBA – Hogan Lovells LLP
    Solutions Circle
  • Wednesday, Oct 4th
    12:05 PM – 12:35 PM EDT
    Solutions Circle: Sourcing Comparators and Other Study Drugs for Global Clinical Trials
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Jamie L. Robinson, RAC, MBA – Genentech, Inc.
    Solutions Circle
  • Wednesday, Oct 4th
    12:05 PM – 12:35 PM EDT
    Solutions Circle: Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource Augmentation
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Cham Williams, MS – IQVIA
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • 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
    12:45 PM – 1:15 PM EDT
    Solutions Circle: Regulatory Intelligence Solutions Circle
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Rosanne Middleton – Lifescan
    Facilitator: Dinar Suleman, RAC – Lifescan
    Solutions CircleSkill Building
  • Wednesday, Oct 4th
    12:45 PM – 1:15 PM EDT
    Solutions Circle: US Combination Products Updates: What You Need to Know!
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Kimberly A. Trautman, MS – MEDIcept
    Facilitator: Richelle Helman, RAC – MEDIcept
    Solutions CircleBroad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
  • 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
    11:25 AM – 11:55 AM EDT
    Solutions Circle: How to Improve Your Regulatory Interactions by Practicing Speaking and Active Listening Skills
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Yoshiko Stowell, PhD – Neuron23, Inc.
    Facilitator: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.
    Solutions CircleSkill Building
  • Thursday, Oct 5th
    11:25 AM – 11:55 AM EDT
    Solutions Circle: Trends on Orphan and Pediatric Regulatory Frameworks
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Joao Duarte, MSc MPharm – Alexion, AstraZeneca Rare Disease
    Solutions Circle
  • 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
    12:05 PM – 12:35 PM EDT
    Solutions Circle: The Journey to RAC!
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Rani Maloney, MBA, PMP, RAC – Integrated Project Management
    Facilitator: Gregory L. Palagi, PMP DASM CSM – Integrated Project Management, Inc.
    Facilitator: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
    Solutions CircleSkill Building
  • Thursday, Oct 5th
    12:05 PM – 12:35 PM EDT
    Solutions Circle: Transparent, Translucent, and Opaque: How Global Health Authorities Make Information Publicly Accessible
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Chris Whalley, cwhalley@seagen.com – Seattle Genetics
    Solutions CircleSkill Building
  • 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
    12:45 PM – 1:15 PM EDT
    Solutions Circle: Using Situational Leadership to Manage Yourself and Others
    Location/Room: Exhibit Hall: Solutions Circles
    Facilitator: Jacqueline Torfin – Quality and Regulatory Expert Partners, LLC
    Solutions CircleSkill Building