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

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:

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.