WHO Regional Workshop on Quality Assurance and Safety of Plasma Derivatives, AMRO (2001)
Havana, Cuba; 23 - 26 October 2001
Background
The first WHO Regional Workshop on Quality Assurance and Safety of Blood Products in Latin America aimed to harmonize regulatory policy for assuring appropriate control of quality and safety of plasma-derived products in the Region. Argentina, Brazil, Chile, Costa Rica, Cuba, Guatemala, Mexico, Paraguay, Uruguay, Venezuela sent participants from National Medicines Regulatory Authorities, coordinators of national blood programme and plasma fractionators. Guidance was provided on 1) quality and safety of human plasma; 2) plasma fractionation technologies including validation and implementation of viral reduction procedures; 3) contract plasma fractionation programmes; 4) evaluation and control of plasma derived medicinal products.
In addition to this workshop technical support at country level was given to Cuba, Venezuela, Brazil and Argentina on appropriate procedures, technologies and information to prepare and advance the licensing requirements of facilities and products, validation of processes, viral inactivation procedures and plasma contract fractionation activities.