Hosted by Julia Appelskog · 🇺🇸 US · EN · 24 episodes
Established thought leaders with verified media credentials.
The Pharmacovigilance Podcast is your gateway to understanding how technology, regulation, and innovation converge to safeguard patient safety. Our discussions span legislative updates and the practical application of AI in pharmacovigilance workflows. Stay ahead of the curve with The Pharmacovigilance Podcast, where safety meets innovation.
Julia Appelskog hosts The Pharmacovigilance Podcast, a health show with 24 episodes published.
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 A
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 fr
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 comp
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 Stephani
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‑
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,
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 lon
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 ex
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 Dic
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 fa
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
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
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 si
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
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
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
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
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 Clin
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 conse
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: B
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The Pharmacovigilance Podcast is hosted by Julia Appelskog. The show is categorised under health (fitness) and has published 24 episodes.
The Pharmacovigilance Podcast has published 24 episodes.
The Pharmacovigilance Podcast regularly covers health, fitness, medicine. It sits in the health category, with a fitness focus.
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Episodes of The Pharmacovigilance Podcast average 16 minutes. a focused format where a clear narrative arc and tight preparation matter most.
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