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 Natiyal, 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 MAHs and subcontractors
• What needs to change in audit plans, contracts, and quality systems
• Practical tips to stay compliant without over-auditingConnect with Pankaj on LinkedIn: https://www.linkedin.com/in/pankaj-nautiyal-b5565912/
Read the regulation here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32025R1466
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 XEVMPD (Article 57 data) is critical for regulators, MAHs, and clinical trial sponsors.
How data interconnects across EMA platforms like PMS, OMS, and IRIS.
Practical insights for marketing authorization holders on managing submissions, business operations, pack size descriptions, and shortages reporting.
Common challenges with QPPV and PSMF updates and how to handle them effectively.
What’s changing in 2025 and how organizations should prepare.
Dr Lungu also shares training resources and advice for MAHs.
Links to Dr. Calin Lungu's profile: linkedin.com/in/calin-lungu-2b613a7
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
Practical steps for implementing AI tools in clinical research
The evolving role of data in driving smarter, faster decision-making
What the future CRO playbook looks like for sponsors and partners
Follow The Pharmacovigilance Podcast to stay ahead of the curve in drug safety, regulatory science, and healthcare innovation.
Guest: Lindsay Mateo, Chief Commercial Officer of AI-native regulatory platform Weave Bio
LinkedIn: https://www.linkedin.com/in/lindsay-mateo-mba-72aa5b12/
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 both opportunities and challenges in adopting AI for drug safety monitoring.
Host: Julia Appelskog
Guest: Artem Horilyk, DrugCard
Subtitle:
What works, what doesn’t, and what’s coming
Links: https://drug-card.io/
LinkedIn: https://www.linkedin.com/in/artem-horilyk/
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.
Q&A: Questions and answers on termination of MAH EV pilot
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:
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.
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.
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:
🎧 Tune in and stay compliant, informed, and ahead of the curve!
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 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 for access and management. Individual email addresses are mandatory—no generic mailboxes.
QPPVs and Collaboration: QPPVs are encouraged to register in IRIS to support safety referrals. IRIS replaces Eudralink for secure document sharing and procedure management.
Actions for MAHs: Ensure personnel have EMA accounts and IRIS roles. Replace generic mailboxes with personal email addresses. Attend training webinars and review guides to master IRIS.
The IRIS transition improves transparency, streamlines communication, and efficiently manages post-authorization procedures. This episode prepares MAHs to adapt to and thrive in the updated regulatory environment.
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 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 the future of AI in pharmacovigilance.
📘 Want to dive deeper? Check out my new book, Artificial Intelligence in Pharmacovigilance: A New Era For Drug Safety, available now on Amazon: https://a.co/d/hyKnmJf
Take advantage of the free promotion period from December 26th to 28th, or mark your calendar for another chance on January 15th and 16th.
Don't miss this opportunity to explore how AI is transforming drug safety processes and revolutionizing pharmacovigilance for organizations of all sizes!
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
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