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Regulatory Affairs & Life Science

Regulatory Affairs & Life Science

By: Di Renzo Regulatrory Affairs
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About this listen

 The Di Renzo Regulatory Affairs podcast for pharmaceutical companies, for manufacturers of medical devices, cosmetics, food supplements and disinfectants. News from our blog and from our weekly magazine ISI, Information Health.Di Renzo Regulatrory Affairs Economics Leadership Management & Leadership
Episodes
  • What are orphan drugs?

    What are orphan drugs?
    Dec 2 2025
    Developing Orphan Drugs is a true undertaking! 🧐 In our latest episode, we dive deep into the market challenge for pharmaceutical companies and the crucial role of the European Regulation (EC 141/2000). Discover how the 'Orphan Drug' designation and incentives are changing the lives of patients with rare diseases. Don't miss it! 👇
    https://en.direnzo.biz/orphan-drugs-description/

    OrphanDrugs #PharmaceuticalRegulation #EMA #Innovation #HealthPodcast
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    6 mins
  • EUDAMED Countdown: Are You Ready for the 2026 UDI Mandate?

    EUDAMED Countdown: Are You Ready for the 2026 UDI Mandate?
    Nov 28 2025
    🗓️ Starting 28 May 2026, UDI registration in EUDAMED will become mandatory for all medical devices marketed in the EU. What does this mean for manufacturers, importers and Regulatory Affairs professionals? Find out in the new episode as we break down deadlines, obligations and the practical impact of the latest EU decisions.
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    4 mins
  • EMA PMS Update: Navigating the New Era of Product Data

    EMA PMS Update: Navigating the New Era of Product Data
    Nov 12 2025
    New podcast episode out now! Let’s dive into the latest updates from the European Medicines Agency (EMA) on the Product Management Service (PMS) database — key changes on the XEVMPD migration, deadlines, ISO-IDMP requirements, and their impact on MAHs.

    A must-listen for professionals in regulatory affairs across pharma. Don’t miss it!

    #regulatoryaffairs #PMS #EMA #pharma #regulatoryconsulting
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    7 mins
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