Pharmacovigilance

Effective assessment of risks and benefits

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As patient safety always comes first, Eurotrials Pharmacovigilance team can support you during the entire lifecycle of your product, having a deep insight on the benefit-risk profile of the product.

We provide high quality, efficient and reliable services not only during clinical development, but also during post-marketing surveillance. Our highly experienced local teams are committed to deliver the best solutions complying with the latest local and international regulations.

With offices in Europe and Latin America, we can monitor safety and risk management throughout the product lifecycle, giving you an integrated and competitive advantage with a top class consulting service.

Our services cover medicinal products, medical devices and cosmetics.

From Clinical Development to Post-Marketing:
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Clinical Development

Safety is a crucial part of the clinical program:

  • AEs/ADRs management
  • SAEs processing and reporting
  • DSUR writing,  reviewing and submission
  • Benefit-risk assessment and management

Post-Approval

Safety continues to be a concern once product gets on the market:

Medicinal Products:

  • Qualified Person for Pharmacovigilance / Back-up
  • ICSR collection, processing and reporting
  • EudraVigilance registration and reporting
  • Global/ Local literature surveillance
  • Benefit-risk assessment
  • PSUR writing, reviewing and reporting
  • RMP writing and reviewing
  • Development and implementation of educational materials
  • Development and implementation of pharmacovigilance systems
  • SOP writing and reviewing
  • PSMF writing and reviewing
  • Pharmacovigilance-targeted audits
  • Preparation for regulatory inspections

 

Medical Devices:

  • Incidents reporting
  • Implementation of applicable corrective actions
  • Periodic reporting

 

Cosmetic Products:

  • Responsible Person
  • Undesirable effects collection, assessment and reporting
  • Product Safety Reports

 

Supplements:

  • Undesirable effects collection and reporting

Continuous Improvement

Prepare yourself and your teams for Pharmacovigilance compliance!

  • Pharmacovigilance training courses.