Events Therapeutics Legal Co. Tech. UCSD's RA Program is widely regarded as an important basic training resource for employees of the regional biotech community.
UCSD students are now the classroom minority, however.
Gratefully recalling his own mentor, a former FDA senior official at Amgen, he is gratified to share his knowledge. Trainees learn to apply pharmacopoeia definitions, and master files of product processes, to represent their company's human use product specifications in INDs, NDAs, and BLAs. Informed by the perspectives of biotech patent law and bioethics, as well as a curriculum that presents FDA requirements relevant to product development and approval processes, graduates say they get a real handle on RA work. Enrollees value the course's practical suggestions for effectively working with the FDA, from preparation for site inspections, to compliance with post-market controls. Ingrid Cabalza, a UCSD major in biochemistry and cell biology, credits the Regulatory Compliance course for imparting knowledge important to her work as a QC intern at Gen-Probe in San Diego.