The Pharmacovigilance Podcast

Roadmap to Regulatory Excellence in Pharmacovigilance – Episode 3

Are you ready to take the next step in mastering regulatory intelligence for pharmacovigilance? This episode of Roadmap to Regulatory Excellence in Pharmacovigilance focuses on what makes an effective and future-ready pharmacovigilance system.

This episode discusses the book Pharmacovigilance Regulatory Intelligence: A Journey from Strategy to AI-Powered Implementation by Julia Appelskog. We explore key themes, including why pharmacovigilance is more than just compliance—it’s about protecting patients, building trust, and ensuring systems are equipped to handle the ever-changing pharmaceutical landscape.

We’ll also discuss practical strategies for building a strong regulatory intelligence framework. From setting clear objectives and assembling the right team to leveraging tools that make smarter, faster decisions possible, we cover the actionable steps you need to take.

One of the highlights of this discussion is how artificial intelligence is reshaping pharmacovigilance. Learn how AI tools can automate tasks, analyze vast datasets for safety signals, and enhance compliance processes—all without sacrificing quality or integrity.

📚 Want to explore the full picture? Get your copy of Pharmacovigilance Regulatory Intelligence: A Journey from Strategy to AI-Powered Implementation on Amazon https://a.co/d/6OZKStf

🎧 Catch Episode 3 now and discover the roadmap to regulatory excellence!

Episode #2 explores the EMA and HMA 2024 workshop on AI in medicine, focusing on pharmacovigilance (PV).

This event brought together experts to discuss the safe and responsible integration of AI in monitoring and ensuring drug safety.

Key topics included:

- AI in ICSR Management

- Regulatory Perspectives: Insights into the EU AI Act and the EMA's AI Reflection Paper, outlining the legal and regulatory frameworks guiding AI applications in PV.

- Collaborative Initiatives: Updates on the FDA/EMA cluster on AI in Pharmacovigilance

The importance of stakeholder collaboration to ensure AI technologies are harnessed effectively to protect public health.

Link to YouTube: https://youtu.be/TpVrxWhoaqc?si=bExf93lw8vgHu2ns

Link to EMA https://www.ema.europa.eu/en/events/hma-ema-multi-stakeholder-workshop-artificial-intelligence-ai-enabling-safe-responsible-use-ai#documents-70605

In this 1st episode of The Pharmacovigilance Podcast, we examine the groundbreaking AI Act (Regulation (EU) 2024/ 1689), a European Union regulation designed to establish a comprehensive framework for the governance of AI systems.

The AI Act categorizes AI systems into two key groups: high-risk systems and general-purpose AI models. We’ll discuss how these categories are defined and explore the stringent requirements imposed on high-risk AI systems, such as those used in healthcare, including pharmacovigilance processes.

We’ll also examine the special rules for general-purpose AI models, subject to transparency and accountability requirements. Focusing on managing systemic risks, these rules seek to ensure that AI development aligns with fundamental EU values, including privacy and human rights.

Link to AI ACT: Regulation - EU - 2024/1689 - EN - EUR-Lex