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Preconference Workshops
Explore this year’s Preconference Workshops, held on Monday and Tuesday during Convergence. All workshops require a separate registration and fee.
*Program and presenters subject to change. Please check back frequently for updates.
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Monday, Oct 6th
7:30 AM - 8:30 AM ESTPreconference Workshops: Networking Breakfast & Welcome -
Monday, Oct 6th
8:30 AM - 4:00 PM ESTPreconference Workshop: Drug Development in the EU: Regulatory Standards, Supports, and New ApproachesWorkshop Leader: – Malta Medicines Authority
Workshop Presenter: – khhconsult
Workshop Presenter: – European Medicines Agency
Workshop Presenter: – NDA Partners
Workshop Presenter: – Malta Medicines Authority
Workshop Presenter: – Malta Medicines Authority
Pharmaceuticals (includes Biologics & Drugs)
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Monday, Oct 6th
8:30 AM - 4:00 PM ESTPreconference Workshop: Expand Your Knowledge to Gain Professional FlexibilityWorkshop Presenter: – AKRA TEAM
Workshop Presenter: – TÜV SÜD
Workshop Presenter: – QServe Group
Workshop Presenter: – QualityHub
Workshop Presenter: – Axon Lawyers
Devices (includes Medical Devices & In Vitro Diagnostics)
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Monday, Oct 6th
8:30 AM - 4:00 PM ESTPreconference Workshop: Claiming Your Seat at the Table: How to Be Included in All Strategic Business DecisionsWorkshop Leader: – Compliance-Alliance, LLC
Workshop Presenter:
Workshop Presenter: – Regulatory Affairs Professionals Society (RAPS)
Workshop Presenter: – Ascendis Pharma, Inc.
Workshop Presenter:
Workshop Presenter: – QuidelOrtho
Broad Interest & Skill Building
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Monday, Oct 6th
8:30 AM - 4:00 PM ESTPreconference Workshop: Locating and Analyzing Regulatory Precedent; Incorporating Research and Application Techniques in Strategic Regulatory Decision MakingWorkshop Leader: – Temple University
Workshop Presenter: – Pfizer
Workshop Presenter: – BeOne Medicines
Workshop Presenter: – Genmab US
Workshop Presenter: – Temple University
Pharmaceuticals (includes Biologics & Drugs)
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Monday, Oct 6th
8:30 AM - 4:00 PM ESTPreconference Workshop: Survivor: The FDA 510(k) Program Edition (Day 1 of 2)Workshop Leader: – DuVal & Associates, P.A.
Workshop Presenter: – DuVal & Associates, P.A.
Workshop Presenter: – DuVal & Associates, P.A.
Workshop Presenter: – RQM+
Workshop Presenter: – Intuitive
Workshop Presenter:
Devices (includes Medical Devices & In Vitro Diagnostics)
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Monday, Oct 6th
10:30 AM - 11:00 AM ESTPreconference Workshops: Networking Break -
Monday, Oct 6th
12:30 PM - 1:30 PM ESTPreconference Workshops: Networking Lunch -
Monday, Oct 6th
3:00 PM - 3:15 PM ESTPreconference Workshops: Afternoon Break -
Tuesday, Oct 7th
7:30 AM - 8:30 AM ESTPreconference Workshops: Networking Breakfast & Welcome -
Tuesday, Oct 7th
8:30 AM - 4:00 PM ESTPreconference Workshop: AI Across Pharma and Devices: Navigating Innovation, Risk, and Compliance as Regulatory ProfessionalsWorkshop Leader: – Summit Therapeutics
Workshop Presenter: – Analog Devices
Workshop Presenter: – Artos
Pharmaceuticals (includes Biologics & Drugs)
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Tuesday, Oct 7th
8:30 AM - 4:00 PM ESTPreconference Workshop: Change Management on MDR and IVDRWorkshop Leader: – AKRA TEAM
Workshop Presenter: – Johnson & Johnson Medtech
Workshop Presenter: – Medtronic
Workshop Presenter: – GMED Certification Division
Devices (includes Medical Devices & In Vitro Diagnostics)
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Tuesday, Oct 7th
8:30 AM - 4:00 PM ESTPreconference Workshop: Implement Changes to Approved Biologic Drug Manufacturing and Controls Using Risk-Based Regulatory ApproachesWorkshop Leader: – Millipore Sigma
Workshop Presenter: – Teva Pharmaceuticals
Pharmaceuticals (includes Biologics & Drugs)
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Tuesday, Oct 7th
8:30 AM - 4:00 PM ESTPreconference Workshop: Strategy and Regulatory Intelligence Primer: Constructing and Maintaining it Using Free and Fee AI ToolsWorkshop Leader: – Regulatorium
Workshop Presenter: – Recursion
Workshop Presenter: – LunarLanding.AI LLC
Workshop Presenter: – University of Maryland
Workshop Presenter:
Broad Interest & Skill Building
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Tuesday, Oct 7th
8:30 AM - 4:00 PM ESTPreconference Workshop: Survivor: The FDA 510(k) Program Edition (Day 2 of 2)Workshop Leader: – DuVal & Associates, P.A.
Workshop Presenter: – DuVal & Associates, P.A.
Workshop Presenter: – DuVal & Associates, P.A.
Workshop Presenter: – RQM+
Workshop Presenter: – Intuitive
Workshop Presenter:
Devices (includes Medical Devices & In Vitro Diagnostics)
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Tuesday, Oct 7th
10:30 AM - 11:00 AM ESTPreconference Workshops: Networking Break -
Tuesday, Oct 7th
12:30 PM - 1:30 PM ESTPreconference Workshops: Networking Lunch -
Tuesday, Oct 7th
3:00 PM - 3:15 PM ESTPreconference Workshops: Afternoon Break
