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