Presenter: Dale M. Cooper, CVM, MS, Dipl. ACLAM
Session: Documentation in the Preclinical Research Environment
Description:
This session will provide an overview of the regulatory oversight and documentation requirements for preclinical research. This should provide participants with an appreciation for the work involved in developing medical treatments, the level of control for data quality and animal welfare, and insights on how to find data associated with drug development.
Learning Objectives
1. Biomedical research is a heavily regulated endeavor.
2. Animals are used in preclinical research when scientifically justified, and their use is overseen by veterinarians and other qualified professionals.
3. Data quality and integrity are regulated by the FDA and EPA, as well as OUS agencies.
4. There are additional regulatory requirements for study designs, safety, drug diversion control, and protection of animal resources.
5. Many records generated in drug development are proprietary, but some are available, including summary information for all approved medical treatments.
Bio:
Dale has worked for 31 years as a veterinarian in preclinical drug development, at all stages of the pipeline, including academic and pharmaceutical drug discovery, lead optimization, IND enabling preclinical safety, and post-IND safety. He is familiar with general laboratory documentation practices, Good Laboratory Practice standards, controlled substances documentation, and requirements for USFW, CITES, OSHA, domestic and international shipping, veterinary medical records, and USDA, NIH, and AAALAC animal welfare compliance.