Aysha Amman | Senior Director, Patient Safety & Pharmacovigilance
Amneal Pharmaceuticals

Aysha Amman is a senior Pharmacovigilance leader with 15+ years of pharmaceutical experience, overseeing Global PV Operations, PV Compliance, and REMS Operations with expertise in regulatory compliance, safety governance, and Risk Management Programs.
She is recognized for building strong governance frameworks, leading global teams, strengthening compliance, and driving risk-based process transformation and operational excellence across patient safety programs.

Appearances:

Day 1: 14th October @ 14:05

Panel 6 – Safety and Risk Management for Inspection Readiness in the AI Era

As artificial intelligence (AI) continues to transform pharmacovigilance, organizations must strike the right balance between innovation, regulatory compliance, transparency, and patient safety. As AI technologies continue to reshape the way organizations operate, a key question emerges: How should inspection and audit readiness evolve in the age of AI? More importantly, How can AI itself become an enabler of continuous inspection readiness, helping organizations remain audit-ready at all times while improving efficiency, compliance, and patient safety?

Join industry leaders at the World Drug Safety Congress Americas to explore the evolving role of AI in drug safety and its impact on inspection readiness, governance, and risk management.

This session will examine critical topics including AI governance frameworks, model explainability, data integrity, and the importance of human oversight in modern pharmacovigilance systems. Discover how organizations can leverage continuous inspection readiness strategies, real-time analytics, and cross-functional collaboration to strengthen compliance and enhance decision-making across safety operations.

Learn practical approaches for integrating AI, real-world evidence, and patient insights into pharmacovigilance processes while meeting evolving global regulatory expectations. Gain valuable perspectives on maintaining transparency, traceability, and accountability in AI-enabled environments.

Join us to explore best practices, emerging regulatory expectations, and actionable strategies that will help your organization prepare for the future of AI-enabled inspections and safeguard patient safety in an increasingly digital world.

Priyanka Chhikara, Senior Director, Head of Global Risk Management, Aggregate Reports and PV Data Science, CSL Behring

Aysha Amman, Senior Director, Patient Safety & Pharmacovigilance, Amneal Pharmaceuticals