SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

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FDA REdI Annual Conference 2019
May 29-30, 2019

Continuing Education Credit

  • This two-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • This event has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
  • Attendance is required for attendance certificates which are only available during the two weeks after the event.
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.

Link to Final Evaluation & Certificate of Attendance

The above link will only be available until June 14.

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
    View Recording
  • Meetings: Pre-submission and Special Programs – Callie Cappel-Lynch
    View Recording
  • NDA and BLA Application Process: A Brief Overview – Swati Patwardhan
    View Recording
  • Basic Components of New Drug Application/ Biologics License Application (NDA/BLA) Submission – Lois Almoza
    View Recording
  • 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
    View Recording
  • Ready to Launch: Essentials of Submitting Initial Materials to the Office of Prescription Drug Promotion – Rachael Conklin
    View Recording
  • 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
    View Recording
  • 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
    View Recording
  • Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program – Scott Colburn
    View Recording
  • 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
    View Recording
  • Corrective and Preventive Action (CAPA) Case Study – Tonya Wilbon
    View Recording
  • Quality System: FDARA, 21st Century Cures Act, and Recent Postmarket Policy Updates – Vidya Gopal
    View Recording
  • Medical Device Single Audit Program (MDSAP) Overview – Kenneth Chen
    View Recording
  • 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