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If you're going to conduct clinical trials or sell drugs in the EU, the way you handle safety reporting will be essential to your success.
But navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life, and it varies subtly from one member state to the next.
The only sane way to approach these requirements is to incorporate them into your company's risk-management processes and procedures.
For drug makers, biologics companies and CROs, here is a clear overview of how to comply with pharmacovigilance regulations throughout the European Union.
From what reporting requirements apply when and where … to what’s expected by European regulatory investigators … you need practical insights you can apply immediately.
This FDAnews Management Report does that for you.
It both clarifies EU and country-specific reporting requirements and explains how you can best incorporate them into SOPs and risk-management programs. You’ll quickly gain understanding of how to improve drug safety and reduce your chances of being cited for noncompliance.
Buy now for guidance on meeting EU drug safety reporting requirements throughout the entire product lifecycle, from clinical trials through postmarket monitoring, including how to:
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