World of Compliance (October 20, 2011)
Course Outline:
- Lesson 1: Office of Compliance Overview
- Lesson 2: Manufacturing and Product Quality
- Lesson 3: Scientific Investigations
- Lesson 4: Bioequivalence and Good Laboratory Practice Inspection Programs
- Lesson 5: Enforcement Responsibilities
- Lesson 6: Risk Management and Drug Surveillance
World of Generic Drugs (October 20, 2011)
Course Outline:
- Lesson 1: Generic Drugs Overview
- Lesson 2: Abbreviated New Drug Review Process
World of New Drugs (November 14, 2011)
Course Outline:
- Lesson 1: Role of Office of New Drugs
- Lesson 2: The Drug Review Process
- Lesson 3: Biologics Review
- Lesson 4: Pediatric Regulations
World of Drug Safety (April 13, 2012)
Activities and responsibilities of CDER’s Office of Surveillance and Epidemiology (OSE)
Web Site / Source: check for updates
provided by U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)
More trainings and information at www.comes-services.com