June 4 and 6, 2013.
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 final workshop of that series. This webinar was directed to anyone who is involved in the conduct of target animal safety or effectiveness studies or the submission of data and reports from those studies to FDA’s Center for Veterinary Medicine (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.
This webinar provided training and stimulated discussion on the factors that can impact the quality of target animal safety and effectiveness data submitted to CVM. The webinar defined critical characteristics of high quality data, identified significant control points in the collection of that data, and used information developed in conjunction with industry to describe procedures that should result in higher quality data for evaluation by CVM. The presentations and attendant discussions covered 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. This webinar provided participants with insights and considerations in critical areas related to data collection where improvements would be most effective.
CVM hosted the webinar and made the presentations. The webinar was made available publicly using Adobe Connect software through the web browser on the participant’s computer. There was no formal registration for this webinar. Webinar participants gained 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 were made available at least one week before the webinar.
The agenda, presentations, written transcript of the presentations, and written answers to all questions raised during, and immediately following, the webinar are available.
Presentations and Presenters:
Building Quality Data: Introduction
Marty Schoenemann, Ph.D.
Building Quality Data: Protocol Development
Eden Bermingham, D.V.M., M.S.
Building Quality Data: Prior to Live and Live Phases
Emily Smith, D.V.M.
Building Quality Data: Reporting and Submitting
Veronica Taylor, Ph.D. and Marty Schoenemann, Ph.D.