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Strengthening clinical development activities and preparedness for vaccine manufacturers from emerging countries: Results of a survey by Simonetta Viviani; Paul Willems; Sonia Pagliusi is a Medicine article available to read on EtoBox.

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Vaccine development, in most cases, is a long, complex process, often lasting years and involving a combination of public and private stakeholders. Particularly, the vaccine clinical development process is highly regulated by several guidelines, regulatory pathways and science-based recommendations from experts. Designing and executing a successful clinical development plan for any candidate vaccine requires a solid scientific, medical, operational and regulatory knowledge and expertise, to comply with regulations and assure adequate benefit-risk balance for the product to be used in mass vaccination of healthy populations. The purpose of this study was to assess the approaches and practices related to Clinical Development functions, and related activities among vaccine manufacturers based in emerging countries, and to identify industry needs in terms of organizational development and training needs. A structured questionnaire designed specifically for assessing indicators of clinical activities, in the last five years, comprised of four sections aimed to collect information on (1) the organizational structure and the activities conducted by the clinical functions; (2) the clinical

Who reads Strengthening clinical development activities and preparedness for vaccine manufacturers from emerging countries: Results of a survey?

Author

Simonetta Viviani; Paul Willems; Sonia Pagliusi

Publisher

Elsevier BV

Published

2023

Language

EN

Field

Medicine (Health Sciences)