COVID-19 Series

In response to the COVID-19 pandemic, the Food and Drug Administration (FDA), European Medicine Agency (EMA) and other national health authorities have published guidelines and recommendations regarding post-authorisation Adverse Event (AE) reporting during this...

Pharmacovigilance (PV) has been the rising regulatory star since the introduction of European Union (EU) legislation in 2012 which continues to be an inspiration for other regulatory authorities worldwide. Many authorities place a significant focus on PV inspections...

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 outbreak include: Rise in Good Clinical Practice (GCP) non-compliance Increase in the...

The ICH guideline for Good Clinical Practice states that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on...

Following the recent confirmation from Regulatory Authorities that GxP compliance should be maintained during the coronavirus outbreak, encouraging alternative approaches for routine regulatory oversight, remote auditing represents the viable alternative during these...

Thanks to many common place technologies, conducting remote audits has become more effective and offers a potential solution where security, travel or other factors may impose restrictions upon traditional in-person and on-site audits. While remote audits may not...

As COVID-19 Brings Global Uncertainty, Can We Maintain Certainty Regarding Our Regulatory Obligations? ADAMAS has brought together a range of specific remote service offerings which will not only ensure you can maintain compliance, but also have peace of mind that...