The Pharmacovigilance Podcast – Details, episodes & analysis

In this episode, we break down the UK Clinical Trial Regulations 2025 with a focus on safety reporting. Learn what the new rules mean for adverse event reporting, SUSARs, DSURs, and trial modifications — and how sponsors and investigators can stay compliant under the updated framework

This episode covers the most important updates introduced in the new EU Implementing Regulation 2025/1466.

We look at changes in PV audits, subcontractor responsibilities, Eudravigilance monitoring, and the end of the signal detection pilot for MAHs.

A quick, clear breakdown of what matters and what to do next.

Link: Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council

Q&A: Questions and answers on termination of MAH EV pilot

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

In this episode # 11, host Julia Appelskog and expert Jackie Roberts explain the complexities of the UK's pharmacovigilance landscape following the Windsor Framework. They discuss the distinctions between Type 1 and Type 2 product categories, the implications for ICSRs, PSMFs, and QPPV roles, and the operational challenges companies face in aligning with both MHRA and EMA requirements. This discussion offers practical insights to help you stay compliant and informed.Host: Julia AppelskogGuest: Jackie Roberts, PharmaGuard Consultancy Ltdhttps://www.pharmaguard.co.uk/

Episode 10: Data Protected: Inside EMA & OMS

In this episode, we break down the EMA's Data Protection Notice, published on 19 May 2025 (EMA/565742/2023)

Link: EMA-I-010-DPN-Organisation Management System (OMS)

We’ll walk you through:

- Why does EMA collect personal data

- What rights do you have under Regulation (EU) 2018/1725

- How you can access, correct, or request deletion of your data

- Who to contact if you have concerns or want to object to processing

• What role does the European Data Protection Supervisor (EDPS) play

It’s your data, your rights.

Tune in to understand how transparency and compliance work with data privacy.

Episode 9: The AI Safety Shift — EMA’s 2025–2028 Agenda

In this episode, we explore how artificial intelligence and data-driven strategies are set to transform pharmacovigilance in the EU. Based on the EMA and HMA Joint Network Data Steering Group's newly released work plan for 2025–2028, we break down six strategic areas—from AI implementation and data interoperability to stakeholder engagement and international alignment.

Discover what this means for the future of drug safety and regulatory science in Europe.

📄 Read the full EMA workplan here:
https://www.ema.europa.eu/en/documents/other/network-data-steering-group-workplan-2025-2028_en.pdf

Episode 8 – EMA Guidanceon Anonymisation and Redaction of RMPs

In this episode, we discuss the latest EMA guidance on anonymising and redacting Risk Management Plans (RMPs), published on 11 April 2025.
EMA published core recommendations in the document "Guidance on anonymisation of protected personal data and assessment of commercially confidential information during the preparation and redaction of RMPs (EMA/63692/2025 Rev. 3)"—focusing on how to handle personal data (PD)and commercially confidential information (CCI) before RMPs are submitted and made public.

🎯 In this episode, you’ll learn:

• Why early planning for anonymisation and redaction is now more important than ever.
• What counts as personal data and CCI—and what absolutely must not be redacted.
• Step-by-step requirements for post-CHMP opinion redacted submissions.
• Common mistakes made by MAHs and how to avoid them.

If you're preparing an RMP for submission—or reviewing your redaction practices—this episode breaks down what matters most, and how to get it right the first time.

📌 Perfect for: Pharmacovigilance professionals, MAHs,and anyone involved in RMP preparation or compliance in the EU.

Link: https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/anonymisation-personal-data-assessment-commercially-confidential-information-during-preparation-rmps-en.pdf

This Episode #7 "EU Clinical Trials Regulation: The Full Implementation of the EU CTR" explores the full implementation of the EU Clinical Trials Regulation (CTR) No 536/2014, marking a pivotal shift from the former Clinical Trials Directive (2001/20/EC).

We focus on harmonization, transparency, patient safety and how clinical trials are transformed across the EU.

Key highlights include:
✅ The introduction of the Clinical Trials Information System (CTIS) for streamlined submissions.
✅ Enhanced measures for patient safety and ethical standards.
✅ The role of the ACT EU (Accelerating Clinical Trials in the EU) initiative in supporting smarter, more efficient trials.
✅ New processes for non-commercial sponsors and simplified multi-national trial applications.