 In collaboration with the World Health Organization and the Egyptian Government, the World Federation of Hemophilia hosted a Joint Workshop of the WFH and WHO on Regulatory Issues Relating to Plasma-Derived Products, in Cairo this September. Thirty-nine regulators and blood bankers from 18 countries in the Middle East and Africa participated in this third regulators workshop. The WFH organizes the workshops to educate national authorities about the evaluation and selection of hemophilia treatment products.
Workshop participants heard about plasma-derived treatment products, looking at the manufacturing process, safety factors, efficacy, and various licensing and regulatory systems. The workshop was chaired by WFH president Mark Skinner and Vice President Communications David Page. Australian regulator Albert Farrugia, WFH Blood Safety advisor and author of the WFH’s popular publication Guide to the Assessment of Clotting Factor Concentrates for the Treatment of Hemophilia, also shared his vast knowledge of regulatory issues with the audience. Other speakers at the workshop included international experts in the manufacturing, viral inactivation, and regulation of plasma-derived products.
The participating countries have very different economies and the state of hemophilia care varies greatly. The workshop was a chance for regulators from those countries to get specific information on how to make the difficult choices about safety and efficacy, and the regulators were eager to learn how to make these decisions rationally and responsibly in the context of their own healthcare systems.
The WFH plans to hold more regulatory workshops around the world in an effort to educate regulators about plasma-derived hemophilia treatment products and to enable them to make the best choices, in terms of safety and efficacy, for their national healthcare systems to ensure appropriate treatment for people with hemophilia. Based on feedback from the participants, Prof. Farrugia is updating the clotting factor assessment guide for re-issue next year.
In addition to the collaboration of the WHO and the Egyptian Ministry of Health and Population, the Workshop was generously sponsored by: Banque Saudi Fransi; Baxter; International Plasma Fractionation Association (IPFA); Laboratoire français du Fractionnement et des Biotechnologies (LFB); Plasma Protein Therapeutics Association (PPTA); Talecris; Viral Inactivated Plasma Systems (VIPS); Wyeth; and ZLB Behring.
Last Updated: October 2006 |
