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

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/

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

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