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The Pharmacovigilance Podcast

The Pharmacovigilance Podcast

Julia Appelskog
Veröffentlicht: 2025-09-25
© Julia Appelskog
The Pharmacovigilance Podcast - QR Code
GratisNeu
16 Folgen
Audio
Anhören auf Apple Podcasts
GratisNeu
16 Folgen
Audio
Anhören auf Apple Podcasts
Veröffentlicht: 2025-09-25
© Julia Appelskog
Aktuelle Folge
Inside XEVMPD: Data, Safety and Strategy

Inside XEVMPD: Data, Safety and Strategy

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, the
Länge: 18:58
Abspielen
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
Folgen-ID: 1000728369835
GUID: 7b5b13fe-737d-489c-aaa5-691b16b9e3a5
Erscheinungs­datum: 25.9.2025, 10:47:28

Beschreibung

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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