Episode 9: The AI Safety Shift — EMA’s 2025–2028 AgendaIn 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
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EMA Guidance on Anonymisation and Redaction of RMPs
Episode 8 – EMA Guidanceon Anonymisation and Redaction of RMPsIn 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
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EU Clinical Trials Regulation: The Full Implementation of the EU CTR
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.
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Navigating ICH E6(R3)
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!
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IRIS Transition simplified: Practical Guidance for MAHs
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.
The Pharmacovigilance Podcast is your gateway to understanding how technology, regulation, and innovation converge to safeguard patient safety.
Our discussions span legislation updates and AI's practical application in pharmacovigilance workflows.
Stay ahead of the curve with The Pharmacovigilance Podcast – where safety meets innovation.
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