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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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  • 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
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