U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Study Data Standards Update for CBER: Your Guide to a Successful Submission - 10/05/2022
  1. News & Events for Human Drugs

Webcast | Virtual

Event Title
Study Data Standards Update for CBER: Your Guide to a Successful Submission
October 5, 2022

Date:
October 5, 2022
Time:
1:00 PM - 2:00 PM ET

 

Topic & Presentations

Speakers

Study Data Standards Update for CBER: Your Guide to a Successful Submission

 

Study Data Standards Update for CBER: Your Guide to a Successful Submission

Lisa Lin
Study Data Standards Manager
Data Standards Branch
Office of Regulatory Operations | CBER | FDA

Clinical Data: CBER Study Data Standards Validation Process

Gabriela Lopez Mitnik
Project Manager
Data Standards Branch
Office of Regulatory Operations | CBER | FDA

Q&A Discussion Panel

Lisa Lin and Gabriela Lopez Mitnik

 

 

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND) , which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog. FDA will discuss the brief background of the new requirement and how SEND will aid CBER reviewers. The webinar will also address common issues in submission data.

INTENDED AUDIENCE

  • Regulatory science and regulatory affairs professionals working on clinical and non-clinical data submissions for BLAs/NDAs/ANDAs/INDs to CBER
  • Consultants focused on clinical and non-clinical data submission
  • Healthcare professionals specializing in clinical and non-clinical data
  • Foreign regulators

TOPICS COVERED

  • CBER requirement and support date for SEND
  • SEND data common issues
  • CBER study data standards validation process
  • Clinical data common issues

FDA SPEAKERS

Lisa Lin, MBA
Study Data Standards Manager
Data Standards Branch | Office of Regulatory Operations | CBER | FDA

Gabriela Lopez Mitnik, MS, MPhil
Project Manager
Data Standards Branch | Office of Regulatory Operations | CBER | FDA

FDA RESOURCES

Event Materials

Title File Type/Size
Study Data Standards Update for CBER: Your Guide to A Successful Submission pdf (1.67 MB)
Back to Top