Pharmacovigilance for Animal Health Medicinal Products – Regulatory Frameworks and Signal Management

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Pharmacovigilance for Animal Health Medicinal Products – Regulatory Frameworks and Signal Management

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

Navigating Evolving Regulatory Landscapes and Signal Management Excellence

The veterinary pharmaceutical industry faces unprecedented regulatory complexity. The implementation of EU Volume IXB and Regulation 2019/6, divergent post-Brexit UK requirements, and continued EMA updates for centrally authorized products have fundamentally transformed pharmacovigilance and signal management processes. The absence of comprehensive regulatory guidance has created compliance risks and operational uncertainties for many organizations.

This comprehensive training course addresses these critical challenges by bringing together leading pharmacovigilance experts and regulatory specialists who will demystify current regulatory requirements, share practical insights from frontline experience, and provide actionable guidance for compliance and excellence.

Participants will benefit from:

  • Clarity on regulatory requirements – Understand the latest changes in EU, UK, and global regulations and their practical implications for your organization
  • Risk mitigation strategies – Identify compliance gaps and implement robust processes to reduce regulatory and safety risks
  • Real-world insights – Learn from expert practitioners and case studies that demonstrate how leading organizations successfully navigate complex signal management scenarios
  • Practical problem-solving – Engage in interactive workshops to work through real examples learning the methodology to develop specific solutions for your individual challenges
  • Confidence and competence – Build expertise in signal detection, validation, assessment, and communication to support organizational preparedness and inspection readiness
  • Industry networking – Connect with regulatory experts, and industry peers to strengthen your professional network and share best practices


By the end of this course, participants will have the knowledge, tools, and confidence to effectively manage pharmacovigilance and signal management in this evolving regulatory environment.

meet the training leaders
Rae Knight, B.Sc., DVM, MRCVS
Former Regulatory Advisor Pharmacovigilance for Elanco Animal Health
Camilo Giraldo, DVM
Former Director of Global Pharmacovigilance – Signal Management, Elanco Animal Health
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Pharmacovigilance for Animal Health Medicinal Products online training organized by Fleming_Agenda Cover
Pharmacovigilance for Animal Health Medicinal Products online training organized by Fleming_Agenda Cover
Pharmacovigilance for Animal Health Medicinal Products online training organized by Fleming_Agenda Cover
key training

Topics

Key requirements for Veterinary Good Pharmacovigilance Practices (VGVP)

Global PV regulations and latest changes

PV System Master File (PSMF)

Adverse event (Individual case safety report-ICSR) reporting

Periodic reporting and documentation

Signal Detection & Signal Management

Data Mining best practices

Risk assessment and management strategies

PV Inspections – What to expect

Digital disruption in PV, trends and implication

Case studies

Benefits of attending

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