Signal detection
The European Medicines Agency (EMA) defines a safety signal as crucial information regarding a potential adverse event associated with a medicine, necessitating further investigation.
At QbD Group, we proactively employ a diverse range of sources, including spontaneous reports, clinical studies, scientific literature, and the EudraVigilance database. This comprehensive approach ensures the timely detection of safety signals.
Don’t hesitate to contact us for more information.
Why is it important?​
- Swift Identification: Detect potential adverse events promptly.
Through Investigation: Trigger investigations for root cause analysis.
Collaborative Responsibility: Shared duty among EMA, regulatory bodies, and authorization holders.
Comprehensive Data Use: Leverage diverse sources for signal detection.
Informed Decision-Making: Provide high-level knowledge for decisions.
Client Value: Offer value to key influencers.
Lifecycle Safety: Ensure safety across the product lifecycle.
Public Health Assurance: Uphold commitment to patient well-being.
Trend Vigilance: Stay aware of emerging trends.
Future Preparedness: Proactively prepare for challenges and regulatory changes.
What we offer
Our value proposition extends to key influencers within our client organizations, providing high-level know-how and knowledge.Â
This includes:
Vigilance Managers
Quality Managers
Heads of New Products
Compliance Responsibles
Medical-Legal Heads
 EU-QPPV/Deputy
Why QbD Group?
With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
Tailored solutions
The actual approach of this service is up to you. It is fully tailored to your needs.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
