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Wednesday, April 11 • 1:30pm - 3:00pm
Session U - GLP Track

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U-1  Enhancing Data Quality for Studies and Submissions to CVM

High quality studies and submissions are critical to the review process at the FDA Center for Veterinary Medicine (CVM).  Due to the limited number of studies used to base their regulatory studies on, CVM reviewers not only use final study reports, but also review the accompanying raw data when assessing a study.  Additionally, CVM devleoped a Quality Assurance Study Review (QASR) group to review the data quality of submissions.  By building in quality from the beginning of a study and throughout the entire submission process, Sponsors can reduce the number of questions and issues reviewers may have.  This presentation will focus on how Sponsors can build quality into their GLP and GCP studies and submissions and minimizing  protocol non-concurrence and technical section incomplete letters.

Animal Health

Level of Content:

U-2  Dealing with Emerging CVM Study Director and Protocol Issues

Protocol review and concurrence by the FDA’s Center of Veterinary Medicine (CVM) allows sponsors to receive CVM reviewer comments about the adequacy of their protocols prior to conducting the study and is viewed as highly beneficial.  However, recent protocol non-concurrence letters have highlighted issues, such as study director masking, issuing protocol amendment, or lack of independence of the QAU, that may be difficult to address or may conflict with regulatory regulations.  This presentation will highlight some issues noted on recent CVM communications about protocols and study director issues and provide suggestions for how to deal with these topics.

Animal Health

Level of Content:

U-3  Benefits and Challenges of Electronic Data Capture Systems in Animal Health Studies

Electronic data capture systems (EDCS) are useful in capturing data for submission to regulatory authorities. EDCS are commonly used in a variety of industry and regulatory environments: analytical, laboratory, and field; efficacy and safety; human, crop and animal health; EPA, FDA and USDA. Despite the common use of EDCS, there continues to be issues at the sponsor and user level. This presentation will examine these aspects from the animal health in-life data collection aspect primarily, but the concepts span the various environments.

Animal Health

Level of Content:

avatar for Fredda Shere-Valenti

Fredda Shere-Valenti

Have Passport Will Travel, Retiree and Volunteer
I'm presently happily retired and loving my volunteer work and traveling. Prior to retiring, I worked for FDA for almost 40 years, including 13 years at the Center for Veterinary Medicine in the Division of Compliance. My joy there was training the field consumer safety officers... Read More →

avatar for Damon Bradley

Damon Bradley

Data Manager, Bayer Animal Health
Damon Bradley is the data manager for Bayer Animal Health, North America. He has been involved with one aspect or another of pharmaceutical research for over 20 years including animal technician, bioanalytical chemist, monitor, and quality assurance. He has been the data manager at... Read More →
avatar for Debi Garvin

Debi Garvin

GLP/GCP Manager, Huvepharma, Inc.
I was President of Pacific Rim Consulting and Director of the West Coast Quality Training Institute from 1993-2015. I closed the businesses to take a job with FDA setting up the Quality Assurance Data Review (QASR) group. After 2 1/2 years, I accepted a job with Huvepharma, an International... Read More →
avatar for Deborah Linton

Deborah Linton

Sr. Clinical Research Coordinator, The Veterinary Consultancy, LLC
I have been in veterinary pharmaceuticals, GCP and GLP, for my entire career (30+ years!). I like clinical trials, GLP studies, and training.

Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 5&6