Overview of the Office of Vaccines Research and Review (OVRR)
Overview of the Office of Vaccines Research and Review, its organizational structure, laws and guidance, review of the regulated products, and OVRR’s research programs.
Pre-Licensure Review of Preventive Vaccines
Detailed discussion on the pre-licensure review of preventive vaccines, including pre-clinical and clinical evaluation, review process, and the manufacturing and characterization of vaccines.
Regulatory Considerations in the Safety Assessment of Adjuvants and Adjuvanted Preventive Vaccines
Detailed discussion covering adjuvants and adjuvanted vaccines, definitions, product characteristics, Investigational New Drug (IND) requirements, and safety.
Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases
Discussion on preventive vaccines for global infectious diseases, the regulatory pathway, epidemiological considerations, fast track programs, pediatric assessments, and safety monitoring.