SQA Webinar: The Privacy Pulse of Pharmacovigilance: Adapting in a BANI Era!
This online webinar will be given via Zoom.
Presented by: Pradeep Manglani, APCER Lifesciences; Apoorv Sharma, APCER Lifesciences
Webinar Category: Compliance
Regulatory Area of Interest: PV, IT Compliance/CSV/CSA
Description: The pharmacovigilance landscape is being reshaped by brittle systems, anxious stakeholders, nonlinear developments, and incomprehensible regulatory shifts hallmarks of a BANI (Brittle, Anxious, Nonlinear, Incomprehensible) world. This webinar will explore how global data flows, and rapidly evolving data protection regulations such as the GDPR, UK DPA, and other region-specific laws are creating new challenges and opportunities for pharmacovigilance professionals.
In this focused 1-hour session, we will examine how the PDCA (Plan-Do-Check-Act) framework can be practically applied to build resilient, adaptive, and compliant pharmacovigilance systems in response to these challenges. Key takeaways will include:
1. Understanding the BANI framework and its relevance to today’s pharmacovigilance environment (10 minutes)
2. Navigating cross-border data flows and compliance with dynamic privacy regulations (15 minutes)
3. Leveraging PDCA to manage AI integration, regulatory complexity, and operational uncertainty with a case study (25 minutes)
This session is designed to provide actionable insights and will serve as the foundation for future webinars that explore specific aspects such as AI governance or regional compliance in greater depth.
RQAP Re-registration units approved: 1 non-GCP | non-GLP