Fundamentals on FDA Regulations of Bioresearch Monitoring
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FDA's bioresearch monitoring program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas.
Regulations addressing requirements of clinical investigators, sponsors and monitors of human drugs and biologics studies (21 CFR Parts 312 and 314) were published on March 19, 1987, and became effective on June 17, 1987. The animal drug regulations (21 CFR Parts 511 and 514) were published on May 27, 1975. Regulations for clinical investigations of devices (21 CFR Part 812) were published on
January 18, 1980, and for premarket approval of medical devices (21 CFR Part 814) on July 22, 1986.
These regulations establish specific responsibilities of sponsors for ensuring (1) the proper conduct of clinical studies for submission to FDA and (2) the protection of the rights and welfare of subjects involved in clinical studies. The specific responsibilities of sponsors of clinical studies include obligations to:
Why should you Attend:
- Obtain agency approval, where necessary, before studies begin.
- Manufacture and label investigational products appropriately.
- Initiate, withhold, or discontinue clinical trials as required.
- Refrain from commercialization of investigational products.
- Control the distribution and return of investigational products.
- Select qualified investigators to conduct studies.
- Disseminate appropriate information to investigators.
- Select qualified persons to monitor the conduct of studies.
- Adequately monitor clinical investigations.
- Evaluate and report adverse experiences.
- Maintain adequate records of studies.
- Submit progress reports and the final results of studies.
To gain a fundamental understanding of FDA regulation of bioresearch monitoring.
Areas Covered in the Session:
Who Will Benefit:
- Identify objectives of FDA's bioresearch monitoring program
- Identify FDA regulations that apply to bioresearch monitoring
- Define specific roles in clinical trial monitoring
- Compliance Manager
- Validation Manager
- Regulatory Manager
- QC Managers
- QA Managers
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.
Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products.
Dr. Colonna's consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.