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- commercialisation
Zoekresultaten - 3 results
Appoaching EMA and National regulatory authorties: who, when and how.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical ...
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 Vaccines Bioprocess Development & Commercialization Workshop, MIT Center for Biomedical ...
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.
between the intention of putting a vaccine on the market and the first available commercial batch, aside from the development of the product and the Marketing Authorization (MA) process. Since OCABR in EU ...