Health agencies around the world are assessing the impact of the COVID-19 pandemic and are issuing new guidance on the management of clinical trials by sponsors and pharmacovigilance systems by MAHs at this time. The rapidly changing global environment has meant that sponsors and MAH’s need to be more vigilant and proactive in determining the effects of the pandemic and changes in authority expectations in order to minimise the impact on safety reporting and to maintain patient safety. It is now more important than ever to request revised instructions from authorities and adopt regulatory changes swiftly to minimise disruptions to clinical trials and projects. To effectively deal with this unprecedented situation, it is important to have an established and robust safety reporting solution.
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