WHO consultation on clinical evaluation of vaccines, 17-18 July 2014, WHO Headquarters, Geneva, Switzerland

Vaccine
Ivana KnezevicR Sheets

Abstract

A World Health Organization (WHO) consultation on guidelines for National Regulatory Authorities (NRAs) and vaccine manufacturers on clinical evaluation of vaccines was held from 17 to 18 July 2014, to review key scientific challenges that regulators have been facing since the establishment of the WHO Guidelines on Clinical Evaluation of Vaccines. The guidelines, adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2001, have served as the basis for setting or updating national requirements for the evaluation and licensing of a broad range of vaccines as well as for WHO vaccine prequalification. Regulators from Australia, Brazil, China, Canada, Germany, India, Republic of Korea, South Africa, United States of America and the United Kingdom were represented. The International Federation for Pharmaceutical Manufacturers' Association (IFPMA) and the Developing Country Vaccine Manufacturers' Network (DCVMN) provided industry representation. The consultation concluded that the guidelines should be revised to address issues that were raised in the context of vaccines that were the subject of clinical development in the past decade. Although the current guidelines have served well over time, it was recognized th...Continue Reading

Citations

Oct 27, 2015·Annals of the New York Academy of Sciences·J Sonya HawMohammed K Ali
May 15, 2015·Mathematical Biosciences and Engineering : MBE·Cameron Browne, Glenn F Webb
Mar 4, 2020·Antimicrobial Agents and Chemotherapy·Alan FarajUlrika S H Simonsson
Feb 14, 2018·Antimicrobial Agents and Chemotherapy·C Sao EmaniC Carolis
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Oct 30, 2019·Antimicrobial Agents and Chemotherapy·Chunkyu KoUlrike Protzer
Sep 21, 2018·Journal of Virology·Nurshariza AbdullahDalan Bailey
Feb 6, 2015·Pest Management Science·Aleksandra Obrępalska-StęplowskaBarbara Wrzesińska
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