Global Inspection Body To Check Value Of Exchanging Data On ‘Borderline Compliance’ Cases
The 2021 work plan of PIC/S, the international group of pharmaceutical inspectorates, includes renewed efforts to carry out projects that could not be completed due to the coronavirus pandemic.
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A new guideline has been adopted by PIC/S, the group representing international pharmaceutical inspectorates, to help regulators assess whether GMP compliance at foreign sites has been established by the hosting competent authority, without the need for an on-site visit.
The Netherlands-based GetReal Institute builds on seven years of multi-stakeholder collaboration to promote greater understanding of real-world evidence.
With the COVID-19 pandemic exacerbating the challenges of recruiting patients for studies targeting catastrophic diseases and rare cancers, regulators are becoming more receptive to new ways of using real-world evidence in clinical trials.