Describe the procedures/authorization process that allowed this approval to occur. Provide a regulatory timeline of events from the initial: Regulatory Affairs and Validation Assignment, TUS, Ireland
|University||Technological University of the Shannon (TUS)|
|Subject||Regulatory Affairs and Validation|
- Describe the procedures/authorization process that allowed this approval to occur.
- Provide a regulatory timeline of events from the initial approval of the vaccine until now which outlines the changes made to the Marketing Authorisation. Describe a number of the changes made, the benefit of making these changes, and the regulatory mechanism for making these changes.
- The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) meets on a regular basis to assess and monitor the safety of human medicines. Outline one aspect related to the Comirnaty Covid-19 vaccine which was discussed during a PRAC meeting and the associated recommendation of this evaluation.
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