The Pharmacovigilance Podcast
Episodes
From Finance to Pharmacovigilance: Lessons from Two Regulated Worlds
13 Mar 2026
Contributed by Lukas
In this episode of The Pharmacovigilance Podcast, host Julia Appelskog speaks with Sabita Mukherjee, COO and Joint Owner, Essjay Solutions Ltd & S...
Transforming Benefit-Risk Assessment with AI
10 Feb 2026
Contributed by Lukas
New episode of The Pharmacovigilance PodcastGuests: Romain Clément and Olivier Merle from ArcaScienceBenefit–risk assessment is at the core of phar...
Inside PV Quality System: From Reactive QMS to AI-Supported Audits
02 Feb 2026
Contributed by Lukas
In this episode of The Pharmacovigilance Podcast, we go inside modern PV quality systems and explore how organisations can move from reactive QMS mode...
From Freelancer to Award-Winning Founder: How to Build a Thriving Business in Pharma
19 Dec 2025
Contributed by Lukas
In this episode #20 of The Pharmacovigilance Podcast, host Julia Appelskog sits down with Dr. Stephanie Jones, Founder & Chief Medical Officer of ...
MedDRA Matters: Behind the Scenes of International Standards
08 Dec 2025
Contributed by Lukas
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 privil...
E2D(R1) Explained: Modern Safety Data Management Unpacked
26 Nov 2025
Contributed by Lukas
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...
Risk-Based Auditing in Pharmacovigilance: What Changes with EU Regulation 2025/1466?
06 Nov 2025
Contributed by Lukas
In this episode, we discuss the new auditing requirements in pharmacovigilance and how risk-based auditing is transforming the way companies conduct t...
Inside XEVMPD: Data, Safety and Strategy
25 Sep 2025
Contributed by Lukas
In this episode, host Julia Appelskog discuss with Dr. Calin Lungu, a pharmacovigilance expert with two decades of experience working with EMA systems...
The new CRO Business Playbook in the Age of AI
11 Sep 2025
Contributed by Lukas
In this episode of The Pharmacovigilance Podcast, we explore how Contract Research Organizations (CROs) are reshaping their strategies in today’s AI...
AI-Powered Literature Monitoring in Drug Safety
03 Sep 2025
Contributed by Lukas
In this episode 14, host Julia Appelskog talks with Artem Horilyk from DrugCard about the role of artificial intelligence in literature screening for ...
Clinical Trial Safety Reporting: What the 2025 UK Regulations Mean for You
29 Aug 2025
Contributed by Lukas
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 even...
EU Pharmacovigilance Regulation 2025/1466: Key Changes Explained
05 Aug 2025
Contributed by Lukas
This episode covers the most important updates introduced in the new EU Implementing Regulation 2025/1466. We look at changes in PV audits, subcontrac...
What Changed for UK Medicines After the Windsor Framework?
07 Jun 2025
Contributed by Lukas
In this episode # 11, host Julia Appelskog and expert Jackie Roberts explain the complexities of the UK's pharmacovigilance landscape following th...
Data Protected: Inside EMA & OMS
28 May 2025
Contributed by Lukas
Episode 10: Data Protected: Inside EMA & OMSIn this episode, we break down the EMA's Data Protection Notice, published on 19 May 2025 (EMA/565...
The AI Safety Shift — EMA’s 2025–2028 Agenda
08 May 2025
Contributed by Lukas
Episode 9: The AI Safety Shift — EMA’s 2025–2028 AgendaIn this episode, we explore how artificial intelligence and data-driven strategies are se...
EMA Guidance on Anonymisation and Redaction of RMPs
25 Apr 2025
Contributed by Lukas
Episode 8 – EMA Guidanceon Anonymisation and Redaction of RMPsIn this episode, we discuss the latest EMA guidance on anonymising and redacting Risk ...
EU Clinical Trials Regulation: The Full Implementation of the EU CTR
04 Feb 2025
Contributed by Lukas
This Episode #7 "EU Clinical Trials Regulation: The Full Implementation of the EU CTR" explores the full implementation of the EU Clinical Trials Regu...
Navigating ICH E6(R3)
31 Jan 2025
Contributed by Lukas
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 Pra...
IRIS Transition simplified: Practical Guidance for MAHs
27 Dec 2024
Contributed by Lukas
This episode offers a concise guide to IRIS at the EMA for managing post-authorization procedures. It outlines key changes, timelines, and required ac...
A New Era For Drug Safety
25 Dec 2024
Contributed by Lukas
In episode #4 of The Pharmacovigilance Podcast, titled “ A New Era for Drug Safety”, we explore the impact of artificial intelligence AI on drug s...
Roadmap to Regulatory Excellence in Pharmacovigilance
03 Dec 2024
Contributed by Lukas
Roadmap to Regulatory Excellence in Pharmacovigilance – Episode 3 Are you ready to take the next step in mastering regulatory intelligence for pharm...
EMA AI Workshop: Safe & Responsible AI Use in PV
28 Nov 2024
Contributed by Lukas
Episode #2 explores the EMA and HMA 2024 workshop on AI in medicine, focusing on pharmacovigilance (PV). This event brought together experts to discu...
The AI Act: What It Means for Pharmacovigilance
26 Nov 2024
Contributed by Lukas
In this 1st episode of The Pharmacovigilance Podcast, we examine the groundbreaking AI Act (Regulation (EU) 2024/ 1689), a European Union regulation d...