The Pharmacovigilance Podcast

In this episode, I speak with Daniel Kapfer, CEO of Jenly AI, about how AI is reshaping regulatory reporting and PV processes. We discuss real use cases, quick efficiency wins, and the risks you can’t ignore, including AI hallucinations and validation challenges. The key message: AI can accelerate pharmacovigilance, but humans remain essential. The future is “human in the loop.” What you’ll learn:...

In this episode of The Pharmacovigilance Podcast , host Julia Appelskog speaks with Sabita Mukherjee, COO and Joint Owner, Essjay Solutions Ltd & Sagittal Pharma Consulting Ltd. Sabita shares his unusual career journey from more than 30 years in financial services to working in pharmacovigilance. Drawing on experience from two highly regulated industries, he discusses how governance, accountab...

New episode of The Pharmacovigilance Podcast Guests: Romain Clément and Olivier Merle from ArcaScience Benefit–risk assessment is at the core of pharmacovigilance. More data, faster development timelines, increasing complexity, and rising expectations from regulators andLeadership is challenging traditional approaches that rely heavily on manual review and retrospective analysis. In this new episo...

In this episode of The Pharmacovigilance Podcast, we go inside modern PV quality systems and explore how organisations can move from reactive QMS models to proactive, AI-supported audit frameworks. I’m joined by Stephanie Martin, Founder of SMPV Limited and a global PVQA audit expert with extensive experience supporting pharma and biotech companies through audits and inspections worldwide. Togethe...

In this episode #20 of The Pharmacovigilance Podcast, host Julia Appelskog sits down with Dr. Stephanie Jones, Founder & Chief Medical Officer of Pharmora, to trace her path from independent consultant to leading a high‑performing medical services company supporting clinical development and pharmacovigilance worldwide. We discuss early pivots, the leadership habits that scale quality, and why...

What’s the one thing about MedDRA that most people overlook? That’s where this episode #19 of The Pharmacovigilance Podcast begins. It’s a privilege to feature a thoughtful and insightful conversation with Vitali Chevts, one of the field’s most respected MedDRA experts and a member of the ICH MedDRA Steering Committee. This discussion is a reminder of why this work matters — clear thinking, deep e...

In this episode, we explain one of the most important guideline updates of the decade: the revision and implementation of ICH E2D(R1) on post-approval safety data management. The original guideline from 2003 could no longer keep up with the rise of digital platforms, patient support programs, market research programs, and the massive increase in safety data. E2D(R1) changes that. It introduces mod...

In this episode, we discuss the new auditing requirements in pharmacovigilance and how risk-based auditing is transforming the way companies conduct their operations. Our guest, Pankaj Nautiyal , is a pharmacovigilance expert with over 18 years of experience in global pharmacovigilance compliance and PV auditing. We discuss: • What risk-based auditing really means • How the new regulation affects...

In this episode, host Julia Appelskog discuss with Dr. Calin Lungu, a pharmacovigilance expert with two decades of experience working with EMA systems such as EudraVigilance, EVDAS, and the Extended Medicinal Product Dictionary (XEVMPD). Together, they unpack the complexities of Article 57 requirements, XEVMPD data, and the transition towards PMS (Product Management Services). You will learn: Why...

In this episode of The Pharmacovigilance Podcast , we explore how Contract Research Organizations (CROs) are reshaping their strategies in today’s AI-driven landscape. With rapid advancements in technology and AI, CROs face both challenges and opportunities as they adapt to new business models. Our guest, Lindsay Mateo , shares expert insights on: How AI is transforming traditional CRO operations...

In this episode 14, host Julia Appelskog talks with Artem Horilyk from DrugCard about the role of artificial intelligence in literature screening for pharmacovigilance. Together, they explore what AI tools can already do effectively, where the limitations remain, and what developments are on the horizon. The discussion offers practical insights for pharmacovigilance professionals, highlighting bot...

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 Implem...

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 di...

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...

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 engageme...

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 redac...

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 i...

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 guideline...

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: 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 th...

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...

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 fr...

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 regul...

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 s...