Zobrazeno 1 - 5
of 5
pro vyhledávání: '"Mic McGoldrick"'
Autor:
Nora Dellepiane, Sonia Pagliusi, Prashant Akut, Sebastian Comellas, Norbert De Clercq, Shubhangi Ghadge, Thierry Gastineau, Mic McGoldrick, Ida Nurnaeni, Lorenz Scheppler
Publikováno v:
Vaccine: X, Vol 6, Iss , Pp 100075- (2020)
A comparison of the regulations and guidelines from 33 countries, across different regions, on the requirements and procedures for the management of chemical, manufacturing and control (CMC) changes for vaccines, also known as post- approval changes
Externí odkaz:
https://doaj.org/article/46b229cc8edd444ca6e8e075bdd48a84
Autor:
Paul Lucas, John McKnight, Agata Chodynska Piatkowska, Mic McGoldrick, Lou Antinori, Mary Mueller, Gianluca Ronzon, Marina Draper, Ruth Schulz, Isabelle Lequeux
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::634a3b566550ccb0316b309e5175089b
https://doi.org/10.46220/2021reg003
https://doi.org/10.46220/2021reg003
Autor:
Mic McGoldrick, Thierry Gastineau, Diane Wilkinson, Cristiana Campa, Norbert De Clercq, Andrea Mallia-Milanes, Olivier Germay, Jyothsna Krishnan, M Van Ooij, Michael P Thien, Peter J. Mlynarczyk, Edward Saltus, Florence Wauters, Philippe Juvin, Didier Clenet, Ana Basso, Nora Dellepiane, Sonia Pagliusi, Monique Collaço de Moraes Stávale, Venkatraman H Sivaramakrishnan, Samir Desai
Publikováno v:
Vaccine. 40(9)
Vaccine discovery and vaccination against preventable diseases are one of most important achievements of the human race. While medical, scientifictechnological advancements have kept in pace and found their way into treatment options for a vast major
Publikováno v:
Vaccine. 39(5)
Vaccines continue to play a central role in our ability to prevent disease, save lives, and improve health. The scientific community, including our own researchers, are driven by a shared purpose to improve vaccine technologies and bring the benefits
Autor:
Thierry Gastineau, Norbert De Clercq, Mic McGoldrick, Shubhangi Ghadge, Ida Nurnaeni, Prashant Akut, Nora Dellepiane, Sonia Pagliusi, Lorenz Scheppler, Sebastian Comellas
Publikováno v:
Vaccine: X
Vaccine: X, Vol 6, Iss, Pp 100075-(2020)
Vaccine: X, Vol 6, Iss, Pp 100075-(2020)
Highlights • Assessment of regulations and guidelines from 33 countries reveals complexity. • Variability of regulatory guidance for review and approval of manufacturing changes. • Reliance on the regulatory approval in the country of origin of