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.