'21 cfr 312' presentation slideshows

634 views • 51 slides

THE UNIQUE ROLES OF IRB IN MEDICAL DEVICE CLINICALL TRIAL

THE UNIQUE ROLES OF IRB IN MEDICAL DEVICE CLINICALL TRIAL. Chiu Lin, Ph.D. CITI, May, 2009. The World of Medical Device Industry. Venture Oriented Diverse > 20,000 firms world wide Produce > 80,000 brand products Rapidly Expanding Becoming very innovative and high-tech.

503 views • 34 slides

FDA Regulation of Bacterial Vaccines

FDA Regulation of Bacterial Vaccines. Scott Stibitz, Ph.D. Center for Biologics Evaluation and Research (CBER), FDA Bethesda, Maryland. Types of Bacterial Vaccines. Live, attenuated: Salmonella Ty21A Inactivated: Diphtheria and Tetanus toxoids

675 views • 21 slides

HIC Human Research Subjects Protection Compliance Program

301 views • 13 slides