Data Requirements for Phase 1 COVID-19 Vaccine Trials

26 March 2020

GMP News

Global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making.

Preclinical data required to support proceeding to FIH clinical trials

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