FDA Pharmacoviligance Course in Sweden

Global Regulatory Utilization of Vaccine Safety Surveillance (GRUVSS):
“Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines”
 

The Center for Biologics Evaluation and Research (CBER) launched a new initiative, Global Regulatory Utilization of Vaccine Safety Surveillance (GRUVSS), which is designed in part to support the Global Vaccine Safety Blueprint Project under a CBER-WHO memorandum of understanding. One goal of GRUVSS is to help national centers build capacity to make effective regulatory decisions when confronted with vaccine postmarketing safety surveillance data.

In collaboration with the World Health Organization (WHO) / Uppsala Monitoring Centre (UMC), FDA CBER hosted a two-day training seminar, “Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines” in Uppsala, Sweden in June 2012. The training seminar built upon the foundation created by the WHO UMC course, “Pharmacovigilance: the study of Adverse Drug Reactions and Related Problems”. Representatives from multiple national centers applied principles learned in the UMC course to explore methods used by FDA scientists to assess postmarketing safety data and to inform subsequent regulatory actions taken for vaccines and other biologics. FDA CBER Division of Epidemiology (DE) staff described strengths and limitations of FDA data sources and analytic methods. Some of the topics discussed included vaccine passive surveillance report review, data mining, safety signal hypothesis generation, interpretation of controlled epidemiologic studies, review of reporting from manufacturers and review of pharmacovigilance plans. DE staff provided recent examples of public communications, postmarketing requirements, and other regulatory decisions.

The goal of this training initiative is safer medicines, safer use of medicines, safer patients and safer public health both globally and domestically.

Presentations

• Overview of U.S. FDA Center for Biologics Evaluation and Research
• Prelicensure Safety Assessment and Pharmacovigilance Planning
• Required Postmarketing Studies
• Adverse Event Reporting: VAERS and WONDER
• Framework for Evaluating Passive Reporting
• Vaccine Adverse Event Reporting System Data Mining
• Overview of FDA's Active Surveillance Programs and Epidemiologic Studies for Vaccines
• Putting It All Together: How Safety Data Becomes a Signal
• Public Communication Activities Under FDA's Safety Authority
• Beyond Pharmacovigilance: Overview of Biologics Inspections and Compliance
• Publicly Available Pharmacovigilance Resources