title: Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.
abstract: The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme.
authors.affiliation: Bacteriology Division, MHRA-NIBSC, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, U.K. Electronic address: mei.ho@nibsc.org.
authors.forename: Mei Mei
authors.initials: MM
authors.lastname: Ho
authors.affiliation: Centre for Biologics Evaluation, BGTD, Health Canada, Ottawa, Canada.
authors.forename: Maria
authors.initials: M
authors.lastname: Baca-Estrada
authors.affiliation: Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Conrad
authors.affiliation: Food and Drugs Board Ghana, Accra, Ghana.
authors.forename: Eric
authors.initials: E
authors.lastname: Karikari-Boateng
authors.affiliation: World Health Organization, 20 Appia Avenue, Geneva, CH-1211, Switzerland.
authors.forename: Hye-Na
authors.initials: HN
authors.lastname: Kang
mesh_terms: D017277:Drug Approval; D004341:Drug Evaluation / Q000592:standards*; D004493:Education / Q000458:organization & administration; D017408:Guidelines as Topic; D006801:Humans; D017780:Malaria Vaccines / Q000009:adverse effects* / Q000276:immunology*; D013019:South Africa; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology; D014944:World Health Organization
chemical_list: D017780:Malaria Vaccines; D014614:Vaccines, Synthetic
keywords: Guidelines; Malaria; Standardization; Vaccine; WHO