The Pharmacovigilance Podcast

This episode offers a concise guide to IRIS at the EMA for managing post-authorization procedures. It outlines key changes, timelines, and required actions to ensure a smooth transition.

Highlights:

1. SIAMED Replacement: By December 2024, IRIS will fully replace SIAMED in managing procedures for centrally and nationally authorized products (CAPs and NAPs).

2. Transition Timeline: Submissions before the cutoff date stay in SIAMED; post-transition, they move to IRIS.

3. Submission Process: Submission methods remain unchanged; IRIS focuses on post-submission management.

4. User Roles: Assign roles like Manager or Contributor in IRIS for access and management. Individual email addresses are mandatory—no generic mailboxes.

5. QPPVs and Collaboration: QPPVs are encouraged to register in IRIS to support safety referrals. IRIS replaces Eudralink for secure document sharing and procedure management.

Actions for MAHs: Ensure personnel have EMA accounts and IRIS roles. Replace generic mailboxes with personal email addresses. Attend training webinars and review guides to master IRIS.

The IRIS transition improves transparency, streamlines communication, and efficiently manages post-authorization procedures. This episode prepares MAHs to adapt to and thrive in the updated regulatory environment.

In episode #4 of The Pharmacovigilance Podcast, titled “ A New Era for Drug Safety”, we explore the impact of artificial intelligence AI on drug safety. From automating routine processes like case processing and literature monitoring to enhance advanced analyses such as signal detection and risk assessment, AI is reshaping the field of pharmacovigilance.

We also delve into critical topics like AI governance and regulatory compliance (including the EU AI Act), highlighting that combi ning AI with human expertise can deliver optimal results.

Discover the specific AI tools and platforms to gain insights into the future of AI in pharmacovigilance.

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Don't miss this opportunity to explore how AI is transforming drug safety processes and revolutionizing pharmacovigilance for organizations of all sizes!

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.

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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