Épisodes

  • Drug Shortages: What changes for MAH holders? 💊

    Drug Shortages: What changes for MAH holders? 💊
    Mar 20 2026
    Managing shortages is more than just a logistical challenge; it is a complex web of regulatory obligations. In this episode, we analyze the latest AIFA (Italian Medicines Agency) provisions and the specific responsibilities of Marketing Authorization Holders (MAH).In this episode, we dive into:
    • Mandatory communication timelines and procedures.
    • Penalties for failure to notify.
    • Operational strategies to prevent disruptions in patient care.
    Essential listening for Regulatory Affairs and Quality Assurance professionals.
    🎧 Listen to the episode now to stay compliant and informed!
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    9 min
  • AIFA guidelines for SOP and OTC

    AIFA guidelines for SOP and OTC
    Mar 6 2026
    Managing SOP (Non-Prescription Medicines) and OTC (Over-the-Counter) drugs requires surgical attention to regulatory details. In this episode, we explore the key points of the AIFA guidelines:
    ✅ Medicine classification.
    ✅ Requirements for online sales.
    ✅ Sticker layouts and mandatory labeling.An essential episode for Regulatory Affairs Managers and industry consultants. Enjoy the listen!
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    9 min
  • Packaging & Compliance: Why Design Alone Isn’t Enough

    Packaging & Compliance: Why Design Alone Isn’t Enough
    Feb 6 2026
    In the Pharma and Healthcare sectors, a graphic error is more than just an aesthetic flaw—it’s a significant legal risk. In this episode, we analyze why the design of pharmaceuticals, supplements, and medical devices must go hand-in-hand with Regulatory Affairs.Join our experts as we explore:
    • Pharmaceutical Sector: Managing artwork and the surgical precision required for patient information leaflets (PILs).
    • Dietary Supplements: How to communicate benefits (claims) without violating government regulations.
    • Medical Devices & Cosmetics: From CE marking to the correct management of INCI lists.
    • Advertising: The strategic advantage of creating healthcare advertising that is "compliant by design" to avoid penalties and speed up time-to-market.
    Learn how to transform regulatory constraints into a competitive advantage for your brand. If you work in marketing, quality assurance, or regulatory affairs, this episode is for you.📌 Want to dive deeper? Visit our website to read the full article and discover our compliant packaging design services.
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    5 min
  • The New Face of Veterinary GMPs

    The New Face of Veterinary GMPs
    Feb 2 2026
    The veterinary medicinal products sector is undergoing an unprecedented regulatory transformation. In this episode, we analyze the adaptation to the new veterinary GMPs (Good Manufacturing Practices) introduced by Regulation (EU) 2019/6 and subsequent directives.We explore the key points from the article by Di Renzo Regulatory Affairs, focusing on:
    • The primary differences compared to standards for medicinal products for human use.
    • Requirements for manufacturing, importation, and pharmacovigilance.
    • Critical deadlines and the importance of a risk-based approach.
    Essential listening for Quality Managers, industry professionals, and companies operating within the animal health market.
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    6 min
  • 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
  • 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 min