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Report of WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; H. Meyer; D. Lei; T. Jivapaisarnpong; M. Welin; A. Cheung Source: WHO, Geneva, switzerland, p.9 (2023) Health Topics: Vaccine batch conformity Vaccin lo ...
WHO Drafting Group meeting to revise WHO Guidelines on PAC- outcome of workshops
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
developing Developing Countries Europe method ON vaccine vaccines WHO Abstract: According to the European Directives 200⅛3/ EC and 2004/27/ EC, EU Member States may require to test batches of immunological ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
on animals is only required for pre-clinical studies in order to test the toxicity of the drug substance and not for routine batch release. However, for some biological medicinal products in general ...