In response to the COVID-19 pandemic, the Food and Drug Administration (FDA), European Medicine Agency (EMA) and other national health authorities have published...
Pharmacovigilance (PV) has been the rising regulatory star since the introduction of European Union (EU) legislation in 2012 which continues to be an...
Introduction The COVID-19 pandemic has imposed unprecedented challenges on Sponsors, Investigator Sites and Clinical Trial participants. The potential risks of this global COVID-19...
The ICH guideline for Good Clinical Practice states that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of...
Following the recent confirmation from Regulatory Authorities that GxP compliance should be maintained during the coronavirus outbreak, encouraging alternative approaches for routine regulatory...
Thanks to many common place technologies, conducting remote audits has become more effective and offers a potential solution where security, travel or other...
