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 new 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:

• Determine which EU and country-specific drug safety reporting rules apply — including how to properly analyze the seriousness, expectedness and causality of events
• Know what inspectors will look for in your reporting practices and documentation
• Comply with the differing notification requirements for investigators, ethics committees and regulatory authorities
• Create the air-tight SOPs needed to maintain drug safety reporting compliance
• Use proven tips to improve compliance in areas such as collecting, validating and maintaining safety data
• And much more

Drug Safety Reporting in the EU: From Clinical Trials to Postmarket Pharmacovigilance is available in print or PDF format for $377 each.

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Your risk is zero when you purchase under our money-back guarantee. Not satisfied with Drug Safety Reporting in the EU? Return the hard copy within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.