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 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 Council

Q&A: Questions and answers on termination of MAH EV pilot

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

Link to EMA https://www.ema.europa.eu/en/events/hma-ema-multi-stakeholder-workshop-artificial-intelligence-ai-enabling-safe-responsible-use-ai#documents-70605

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

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:

• Why early planning for anonymisation and redaction is now more important than ever.
• What counts as personal data and CCI—and what absolutely must not be redacted.
• Step-by-step requirements for post-CHMP opinion redacted submissions.
• Common mistakes made by MAHs and how to avoid them.

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.

Link: https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/anonymisation-personal-data-assessment-commercially-confidential-information-during-preparation-rmps-en.pdf

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:

• ICH E6(R3) Guideline – ICH Official Website
• EMA GCP Guidelines – European Medicines Agency

🎧 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:

1. SIAMED Replacement: By December 2024, IRIS will fully replace SIAMED in managing procedures for centrally and nationally authorized products (CAPs and NAPs).

2. Transition Timeline: Submissions before the cutoff date stay in SIAMED; post-transition, they move to IRIS.

3. Submission Process: Submission methods remain unchanged; IRIS focuses on post-submission management.

4. User Roles: Assign roles like Manager or Contributor in IRIS for access and management. Individual email addresses are mandatory—no generic mailboxes.

5. 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!

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/

https://www.weave.bio/

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/

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 expertise, and a shared commitment to getting safety data right.

🎙️ In this episode, we cover:
• Why MedDRA is far more than a coding tool
• Subtle errors that can reshape an entire safety story
• How CMQs can strengthen AE monitoring
• What actually happens inside the MedDRA Steering Committee
• The role of AI — and the boundaries we need to respect

With more than 25 years of experience, Vitali brings clarity, nuance, and practical insight to every topic we touch.

Links:

ICH MedDRA Steering Committee⁠https://www.ich.org/page/meddra-steering-committee⁠

Vitali Chevts on LinkedIn:

https://www.linkedin.com/in/vitali-chevts-md/

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 modern definitions, clearer responsibilities for MAHs, and a new foundation for structured safety data activities through the Organised Data Collection System (ODCS).

We also look at how the guideline aligns with E2B(R3), including the three new study-type values for coding cases from PSPs, MRPs, and digital platform activities.

You’ll learn:
• why this revision was needed
• how new data sources are classified
• what ODCS really means in practice
• how to distinguish spontaneous vs. solicited reports
• what changes MAHs should expect in E2B(R3) reporting

If you work in drug safety, regulatory intelligence, or PV operations, this episode gives you the clarity you need to prepare for the 2026 implementation.

Link to ICH E2D(R1) guideline: https://database.ich.org/sites/default/files/ICH_E2D%28R1%29_Step4_FinalGuideline_2025_0819.pdf

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 MAHs and subcontractors
• What needs to change in audit plans, contracts, and quality systems
• Practical tips to stay compliant without over-auditing

Connect 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

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 episode, we explore how AI is reshaping benefit–risk decision-making and what this means for senior safety professionals today.

Together with experts from ArcaScience, we discuss:

• What AI actually changes in day-to-day benefit–risk work
• How integrated data supports earlier and more confidentdecisions
• How ArcaScience models support benefit–risk acrossdevelopment stages
• How regulators are reacting to AI-supported approaches

This conversation focuses on practical realities and on how safety teams can use AI to strengthen expertise, not replace it.

🔗 Learn more & connect

ArcaScience website: https://arcascience.ai
Romain Clément on LinkedIn: https://www.linkedin.com/in/romainclement75/

Olivier Merle: https://www.linkedin.com/in/oliviermerle/

ArcaScience on LinkedIn: https://www.linkedin.com/company/arcascience/

▶️ Subscribe

Follow The Pharmacovigilance Podcast on Spotify to stay updated on new episodes covering AI, safety leadership, regulatory thinking, and the future of pharmacovigilance.

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.

Together, we discuss:

• Why traditional, reactive QMS models no longer work

• What regulators really expect from PV quality systems today

• How to build inspection-ready, sustainable PV processes

• The role of AI in supporting audits, oversight, and continuous improvement

• Practical steps to strengthen PV quality without disrupting daily safety activities

This episode is for PV leaders, QA professionals, and anyone preparing for inspections as they navigate the future of pharmacovigilance quality.

Link to the LinkedIn profile of Stephanie Martin, Founder of SMPV Limited: https://www.linkedin.com/in/stephaniesmpv/

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 “quality without compromise” became a guiding principle for sustainable growth.

We also explore how to build a values‑aligned team, deliver consistently under pressure, and win trust as a specialist partner in lifecycle safety and medical review.

Pharmora was founded in 2010 and today serves the global pharma and biotech sectors. In 2025, the company was recognised in London’s Gherkin with the Best Pharma Contract Services award at the IAE & Euro Star Global Awards, an emotional milestone for the team and a practical lesson in long‑game execution.

You’ll learn:
• How to move from freelancing to a scalable service model in pharma
• The operational meaning of “quality without compromise” and why it compounds over time
• Hiring for values, training for excellence, and building delivery capacity that clients rely on
• Advice, pitfalls, and playbooks for would‑be founders in PV, clinical, and medical affairs

Links

• Dr. Stephanie Jones — LinkedIn profile linkedin.com/in/stephanie-j-jones
• Pharmora Pharmora | Clinical Development support | Pharmacovigilance
• IAE & Euro Star Global Awards announcement (The Gherkin, 2025) IAE Awards post

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, accountability, audits, and crisis management.

The conversation also explores the growing role of AI in regulated environments. Sabita and Julia discuss why explainability, human oversight, and strong governance are essential when adopting AI in pharmacovigilance, and how regulators are encouraging innovation while maintaining patient safety.

Topics covered:
• Career transition from finance to pharmacovigilance
• Differences in regulatory culture between finance and PV
• Governance and accountability in AI systems
• AI as a “copilot” rather than an “autopilot”
• Audits, explainability, and decision transparency
• Crisis management in regulated industries

A thoughtful conversation on how different regulated sectors can learn from each other and how AI can support professionals without replacing expert judgment.

🎧 Stay tuned and stay compliant.

Guest: Sabita Mukherjee, COO and JointOwner, Essjay Solutions Ltd & Sagittal Pharma Consulting Ltd

Essjay Solutions Ltd:  https://essjaysolutions.co.uk/

LinkedIn: https://www.linkedin.com/company/essjay-solutions-ltd/

Subscribe to AI in PV Newsletter Subscription Page: https://mailchi.mp/b65dd5bfa504/essjay_ai_newsletter

Sagittal Pharma Consulting Ltd: https://sagittal-pharma.com/

LinkedIn: https://www.linkedin.com/company/sagittalpharmaconsulting/

YouTube: https://www.youtube.com/@sagittalpharma

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:
• Where AI delivers the biggest impact in PV
• How to use tools like Copilot for quick wins
• How to manage AI risks and hallucinations
• Why human expertise is still critical

📩 Contact Daniel Kapfer:
Website: www.jenly.ai
Email: daniel@jenly.ai