Forum Session: A methodology to resolve overlapping rules and regulations for product-related programs

Many institutions are becoming involved in leading-edge, product-related programs that involve high-risk agents, totally new vaccines, and nearly eradicated agents where there is confusion caused by overlapping and sometimes contradictory regulations and guidelines. Mark Huza and Vibeke Halkjaer-Knudsen illustrate the Vulnerability-and-Risk Planning methodology to identify, categorize, and prioritize contradictory constraints, and make use of a systematic process for deciding which factors apply, which ones don’t, and which cost-effective mitigation measures to pursue. Current case examples are used to examine specific BSL-3, BSL-3Ag, and BSL-4 project decisions in light of WHO, BMBL, and GMP documentation.

This session qualifies for AIA CEU credit.
This session also qualifies for HSW credit.

• Mark A. Huza , Containment Systems Segment Manager - Camfil Farr
  
• Vibeke Halkjaer-Knudsen, PhD , Director - Statens Serum Institut