Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER - July 13th 2017 - 1:00pm - 2:45pm (Eastern)

Image of SBIA Webinar 2016

 

This event is FREE 

 

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.
 

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation.  The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
 

CDER invites you to view our webinar: Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER that was held on July 13th, 2017.

Join us as our FDA experts provided an overview of recent updates made to FDA’s Study Data Technical Conformance Guide and well as important information and recommendations from the Center for Biologic Evaluation and Research (CBER) review staff to help you optimize your study data submission to CBER, by understanding required standards and expectations in order to aid the efficiency of the review process and avoid technical rejection.  Presentations included:

  • Updates to the Study Data Technical Conformance Guide
  • Providing Clinical Study Data to the Office of Vaccines
  • Perspectives from CBER’s Office of Compliance and Biologics Quality (OCBQ)

 

Speakers:

Updates to the Study Data Technical Conformance Guide
Ron Fitzmartin, Ph.D., M.B.A.
Senior Advisor
Office of Strategic Programs | CDER
CDER eData Team at: eDATA@fda.hhs.gov

Providing Clinical Study Data to the Office of Vaccines
Brenda Baldwin, Ph.D.
Primary Reviewer | Regulatory Project Manager
Division of Vaccines & Related Product Applications
Office of Vaccines Research and Review | CBER
CBER CDISC Contact: CBER.CDISC@fda.hhs.gov 
 
Kirk Prutzman, Ph.D.
Primary Reviewer | Regulatory Project Manager
DVRPA | OVRR | CBER   
CBER CDISC Contact: CBER.CDISC@fda.hhs.gov 

Perspectives from CBER’s Office of Compliance and Biologics Quality (OCBQ)

Bhanu Kannan
Bioresearch Monitoring Branch
Office of Compliance and Biologics Quality (OCBQ)| CBER
CBER CDISC Contact: CBER.CDISC@fda.hhs.gov
 

Live Q&A Session
Panelists include above speakers and

Virginia Hussong

Data Standards Program Manager
Office of the Director | CBER

 

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits
towards a participant’s RAC recertification upon full completion.

Please note that the credit is only available for participation in the live
            event and not for watching the recording afterwards.

For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707

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Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER - Slides

Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER - mp4

Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER - mp3

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