Kal Elhoregy | Independent Global Pharmacovigilance & Quality Risk Management Expert / REMS Industry Consortium (RIC) Advisor
Independent

Kal Elhoregy, RPh., PA, is a senior pharmaceutical industry consultant with more than 25 years of experience leading global Risk Management, Pharmacovigilance (PV) Compliance, and PV Quality Governance across multinational organizations. He is recognized for developing enterprise governance models that integrate risk minimization, inspection readiness, and quality oversight while safeguarding patient safety and regulatory compliance. Kal is the founder and principal of Quality Risk Management Consulting (QRM), through which he provides independent advisory services in global pharmacovigilance, risk management, and quality governance to pharmaceutical and biotechnology organizations. He advises clients on building and operating shared and individual Risk Evaluation and Mitigation Strategies (REMS) programs, developing Risk Management Plans (RMPs) and additional risk minimization measures (aRMMs), and translating evolving global regulatory expectations into scalable, inspection-ready operating models supporting clients through health authority inspections and long-term compliance sustainability. A founding member and former Chairman of the Board of the REMS Industry Consortium (RIC), Kal continues to serve as an advisory committee member, helping shape industry best practices and regulatory dialogue around Risk Evaluation and Mitigation Strategies. He also serves on the DIA PV & Risk Management Conference Program Committee and the World Drug Safety Congress America Advisory Board. Kal is a Registered and Licensed Pharmacist in New Jersey and a Public Accountant, bringing clinical insight and financial discipline to his advisory work.

Appearances:

Day 0: 13th October @ 13:00

Workshop - Inspection Readiness in Action: A Hands-On Workshop for Industry Teams

13.00 - 13.30 Module 1: Inspection Readiness Reality Check

Interactive Poll + Discussion

What inspectors actually look for vs. what teams over-prepare
Recent inspection trends and recurring findings
Readiness myths that hurt inspection outcomes

13.30 - 14.00 Module 2: Building an Inspection-Ready Organization

Hands-On Framework Walkthrough
People: roles, training, behaviour under inspection
Process: SOPs, deviations, CAPAs, vendor oversight
Data: traceability, documentation, data integrity

14.00 - 15.00 Module 3: Mock Inspection Role-Play

15.30 - 16.00 Module 4: Handling Findings & Difficult Moments

Case-Based Discussion

483s, inspection observations, and critical findings
When to push back vs. when to acknowledge
Aligning internal teams during inspection stress

Exercise:

Draft a real-time response to a mock inspection observation.

16.00 - 16.30 Module 5: Post-Inspection Success & Continuous Readiness

Practical Takeaways
Turning findings into sustainable improvements
CAPAs inspectors trust
Maintaining readiness between inspections (not just before)

Kal Elhoregy, Independent Global Pharmacovigilance & Quality Risk Management Expert / REMS Industry Consortium (RIC) Advisor, Independent

Sharon Reid, Director Risk Management Product Lead, Pfizer

Jamie Wilkins, Head- Risk Management Center of Excellence- Worldwide Safety, Pfizer

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