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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces Data Quality Webinar Related to 2008 ADUFA Reauthorization

June 4 and 6, 2013


Data Quality Webinar Agenda

Presentations:

Building Quality Data
Marty Schoenemann, Ph.D.

Protocol Development
Eden Bermingham, D.V.M., M.S.

Prior to Live and Live Phases
Emily Smith, D.V.M.

Reporting and Submitting
Veronica Taylor, Ph.D.

Question and Answer Session
 


 

Target Audience

This webinar will be of interest to anyone who thinks about or touches upon target animal safety or effectiveness data submitted to FDA’s Center for Veterinary Medicine (CVM). This webinar will provide participants with insights and considerations in critical areas related to data collection where improvements would be most effective.

Webinar dates/times

June 4 and 6, 2013. Both sessions will run from 9:00 a.m. – 12:00 noon EDT.

Background

CVM and the regulated industry agreed to hold ten public workshops on subjects of mutual interest as part of the 2008 reauthorization of the Animal Drug User Fee Act. This webinar on improving the quality of data submitted to CVM is the tenth and final workshop of that series.

This webinar will provide training and stimulate discussion on the factors that can impact the quality of target animal safety and effectiveness data submitted to CVM. The webinar will define critical characteristics of high quality data, identify significant control points in the collection of that data, and use information developed in conjunction with industry to describe procedures that should result in higher quality data for evaluation by CVM. The presentation and discussion will cover the lifespan of data – from the conceptualization of the need for data, through the collection and analysis of the data, to the submission of those data to CVM.

Submissions containing high quality data contribute to a decrease in the time to approval for many drugs. High quality datasets can be reviewed more quickly and efficiently because the data collected are presented in a manner that allows reviewers to easily reconstruct the study, to more efficiently determine that the data were collected in an appropriate manner, to confirm adherence to the study protocol and legal requirements, and to permit efficient analysis of the data in support of the new animal drug approval. In contrast, poor quality datasets require more time to determine whether the data are usable, slow the scientific and regulatory review, and may call into question the integrity of the collected data or conduct of the study. The additional time required for sponsors to address amendment requests or incomplete letters further lengthens the time needed for CVM to complete their assessment of the data. Delays in the review of data to support determinations of target animal safety and effectiveness inevitably increase the time to approval of new animal drugs.

Host/Venue

CVM will host the webinar and make the presentations. The webinar will be available publicly using Adobe Connect software through the web browser on the participant’s computer. There is no formal registration for this webinar. Webinar participants will gain access to the presentations on the days of the webinar by using the URL provided. Information regarding the webinar URL, the webinar agenda, and other related topics, and instructions on how to access the webinar will be available at least one week before the webinar.

Webinar presentations and other materials

The presentations will not be available before the webinar. The presentation materials, audio transcripts of the presentations, and a written transcript of questions and answers will be made available on CVM’s website within 30 days after the webinar.