SBIA Education Events

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FDA REdI Annual Conference 2019
May 29-30, 2019

Agenda & Speaker Bios

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Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available. The current version is: Version 7, published on May 21, 2019.

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Speaker Biographies

This PDF file contains brief biographies of the FDA speakers participating in the conference.

Files, Certificate & Recordings

Both of the two links above include the slides for the Keynote and Plenary.

General Session Recordings:

  • Keynote: Office of Regulatory Affairs (ORA) Update – Joseph Matrisciano Jr.
    View Recording
  • Plenary: Navigating the World of Combination Products – James Bertram & Kristina Lauritsen
    View Recording

Session Recordings: CDER (Drugs) Track

Day One:

  • Keynote: Center for Drug Evaluation and Research (CDER) Initiatives – Doug Throckmorton
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  • Meetings: Pre-submission and Special Programs – Callie Cappel-Lynch
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  • NDA and BLA Application Process: A Brief Overview – Swati Patwardhan
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  • Basic Components of New Drug Application/ Biologics License Application (NDA/BLA) Submission – Lois Almoza
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  • Electronic Common Technical Document (eCTD) and Submission of Study Data – Jonathan Resnick & Ethan Chen
    View Recording
  • A Medical Officer’s Approach to NDA/BLA Review – Virginia Sheikh
    View Recording

Day Two:

  • Regulatory Highlights for Biosimilars and Interchangeables – Eva Temkin
    View Recording
  • CDER’s Process for Reviewing Nonproprietary Name Suffix for Biological Products and Safety Considerations for Product Design, Container Labels, and Carton Labeling – Lubna Merchant
    View Recording
  • CDER’s Review of the Prescribing Information-Ann Marie Trentacosti
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  • Ready to Launch: Essentials of Submitting Initial Materials to the Office of Prescription Drug Promotion – Rachael Conklin
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  • SBIA Program Overview – Renu Lal
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  • Chemistry Manufacturing and Controls (CMC)– NDA requirements and Common Pitfalls of Biologics License Applications (BLAs) – Balajee Shanmugam & Steven Bowen
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  • The Dos and Don’ts of Pre-Approval Inspections: What to Expect When Being Inspected – Sean Marcsisin
    View Recording

Session Recordings: CDRH (Devices) Track

Day One:

  • Keynote: Incorporating a Total Product Life Cycle Approach – William Maisel
    View Recording
  • A Case Study on Medical Device Determination and Product Classification – Kim Piermatteo
    View Recording
  • 510(k) Program Updates – Angela Demarco
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  • Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program – Scott Colburn
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  • Facilitating Patient Access to Medical Devices: The Expanded Access, Early Feasibility Study, and Breakthrough Devices Programs – Maureen Dreher
    View Recording
  • Building Quality Clinical Data into Premarket Approval Applications (PMAs) – Donna Headlee
    View Recording

Day Two:

  • Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements – Joseph Tartal
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  • Corrective and Preventive Action (CAPA) Case Study – Tonya Wilbon
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  • Quality System: FDARA, 21st Century Cures Act, and Recent Postmarket Policy Updates – Vidya Gopal
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  • Medical Device Single Audit Program (MDSAP) Overview – Kenneth Chen
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  • FDA’s Import Requirements for Medical Devices – Terri Garvin
    View Recording
  • Overview of the FDA Exports Program for Medical Devices – Ethny Obas
    View Recording
  • FDA Medical Device Inspections – Maura Rooney
    View Recording