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Regulatory Affairs & Life Science

Regulatory Affairs & Life Science

De : Di Renzo Regulatrory Affairs
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 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 Direction Economie Management et direction
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    Épisodes
    • ACC System: The New Rules for "Intermediate Dates"

      ACC System: The New Rules for "Intermediate Dates"
      Jan 26 2026
      Description: In this episode, we analyze the recent technical updates to the Conventions and Congresses Authorization System (ACC), effective January 19. The introduction of the "Intermediate Dates" field is more than just a software update; it is a new procedural requirement impacting compliance for pharma companies and providers.Join the experts at Di Renzo Regulatory Affairs as we dive into:
      • Technical Specs: How to enter intermediate dates and when it is unnecessary (e.g., 365-day FAD).
      • Time Constraints: Mandatory deadlines for calendar changes (FAQ no. 32).
      • Managing Discrepancies: Preventing Agency RFIs through correct scientific program mapping.
      • Compliance Strategy: The role of Regulatory departments in ensuring a smooth authorization flow.
      Useful Links: 📌 Full Article: https://en.direnzo.biz/update-congress-conventions/
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      4 min
    • 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 min
    • 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 min
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