How is the quality of vaccines assured by the ... - The INCLEN Trust
How is the quality of vaccines assured by the ... - The INCLEN Trust
How is the quality of vaccines assured by the ... - The INCLEN Trust
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Functions <strong>of</strong> NRA<br />
‣ Functions <strong>of</strong> <strong>the</strong> regulatory system<br />
• Marketing authorization and licensing activities<br />
• Post-marketing surveillance including surveillance for<br />
Adverse Events Following Immunization (AEFI)<br />
• Lot (Batch) release process<br />
• Laboratory support for vaccine testing<br />
• Regulatory inspections <strong>of</strong> Good Manufacturing<br />
Practices (GMP)<br />
• Authorization and approval <strong>of</strong> Clinical Trials <strong>of</strong><br />
<strong>vaccines</strong>.
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