Shows
The Pharmacovigilance PodcastEU Pharmacovigilance Regulation 2025/1466: Key Changes ExplainedThis 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 CouncilQ&A: Q...2025-08-0512 min
The Pharmacovigilance PodcastWhat Changed for UK Medicines After the Windsor Framework?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/2025-06-0714 min
The Pharmacovigilance PodcastData Protected: Inside EMA & OMSEpisode 10: Data Protected: Inside EMA & OMSIn 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 processingWhat role does the European Data Protection Supervisor (EDPS) pl...2025-05-2826 min
The Pharmacovigilance PodcastThe AI Safety Shift — EMA’s 2025–2028 AgendaEpisode 9: The AI Safety Shift — EMA’s 2025–2028 AgendaIn 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.pdf2025-05-0809 min
The Pharmacovigilance PodcastEMA Guidance on Anonymisation and Redaction of RMPsEpisode 8 – EMA Guidanceon Anonymisation and Redaction of RMPsIn 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 mo...2025-04-2514 min
The Pharmacovigilance PodcastEU Clinical Trials Regulation: The Full Implementation of the EU CTRThis 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 effici...2025-02-0420 min
The Pharmacovigilance PodcastNavigating ICH E6(R3)Welcome to the podcast that breaks down the latest ICH GCP E6(R3) Guideline, which will help you stay ahead in the evolving world of Good Clinical Practice.
Join us for deep dives into critical topics like informed consent, data integrity, and regulatory compliance, and you'll gain the knowledge you need to navigate the complexities of modern clinical research.
🔗 Read the official guidelines:
ICH E6(R3) Guideline – ICH Official Website
EMA GCP Guidelines – European Medicines Agency
🎧 Tune in and stay compliant, informed, and ahead of the curve!
2025-01-3113 min
The Pharmacovigilance PodcastIRIS Transition simplified: Practical Guidance for MAHsThis 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:
SIAMED Replacement: By December 2024, IRIS will fully replace SIAMED in managing procedures for centrally and nationally authorized products (CAPs and NAPs).
Transition Timeline: Submissions before the cutoff date stay in SIAMED; post-transition, they move to IRIS.
Submission Process: Submission methods remain unchanged; IRIS focuses on post-submission management.
User Roles: Assign roles like Manager or Contributor in IRIS fo...2024-12-2718 min
The Pharmacovigilance PodcastA New Era For Drug SafetyIn 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 t...2024-12-2517 min
The Pharmacovigilance PodcastRoadmap to Regulatory Excellence in PharmacovigilanceRoadmap 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...2024-12-0330 min
The Pharmacovigilance PodcastEMA AI Workshop: Safe & Responsible AI Use in PVEpisode #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...2024-11-2813 min
The Pharmacovigilance PodcastThe AI Act: What It Means for PharmacovigilanceIn 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 syst...2024-11-2615 min