EMA Proposes Extending Remote QP Batch Certification Post-Pandemic
Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to COVID-19-related travel restrictions to continue on a routine basis.
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Drug companies unable to continue with standard reporting of suspected adverse reactions to the EU pharmacovigilance database can temporarily prioritize their reporting activities to focus on COVID-19 related safety events.
Qualified persons should respond to the complexities of globalization by leveraging quality systems rather than confirming every detail, Pfizer official says. Proposed revision to Annex 16 of EU GMPs defines numerous tasks QPs can delegate.
Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.