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
  • Biocides in 2025 New Rules, New Responsibilities

    Biocides in 2025 New Rules, New Responsibilities
    Oct 3 2025
    In this episode, we clarify the transition from Directive 98/8/EC to Regulation (EU) 528/2012 (BPR), the European framework that regulates the placing on the market and use of biocidal products. We’ll explore the differences between the Directive and the Regulation, the role of PMCs in Italy, and the new obligations for businesses. Step by step, we will discuss how to obtain authorization, ensure compliant labeling and advertising, and successfully manage the regulatory transition. An essential episode for manufacturers, importers, and industry professionals who want to stay up to date and compliant.
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    8 mins
  • MIR 7.3.1: Everything Manufacturers Need to Know Before November 2025

    MIR 7.3.1: Everything Manufacturers Need to Know Before November 2025
    Sep 19 2025
    The new version of the Manufacturer Incident Report (MIR 7.3.1) is now available and will become mandatory in the EU and Switzerland starting November 2025 for the reporting of serious incidents involving medical devices and IVDs. In this episode we cover:
    • the main updates (new fields, IMDRF codes, geographical and technical changes);
    • key differences from the previous version;
    • what manufacturers should do now to prepare.
    A must-listen to stay ahead of the changes and ensure compliance by the deadline.
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    5 mins
  • Pharmacovigilance Goes Social

    Pharmacovigilance Goes Social
    Sep 12 2025
    Social media isn’t just about likes and shares anymore—it’s becoming a powerful tool in pharmacovigilance. In this episode of Regulatory Affairs & Life Science, we dive into how online conversations can reveal valuable insights about drug safety and real patient experiences. Join us as we explore:
    • why social networks are a game-changer for collecting safety data,
    • the regulatory and practical challenges of monitoring digital platforms,
    • and how companies can turn social media into a reliable ally for pharmacovigilance.
    If you work in pharma—or you’re simply curious about how the digital world is reshaping drug safety—this episode is for you.


    https://www.direnzo.biz/it/en/pharmacovigilance-social-networks/
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    5 mins
  • Classification of medical devices in Italy

    Classification of medical devices in Italy
    Aug 21 2025
    In this episode, we explore the essentials of medical device registration under Italian law and the EU Medical Device Regulation (MDR 2017/745). We cover everything you need to know about the Italian medical device database, the Repertorio, the CND classification system, and the future role of EUDAMED. 🔑 Keywords & Topics:
    • Medical device registration process
    • Italian Ministry of Health requirements
    • EU MDR compliance
    • CND code and Repertorio explained
    • EUDAMED implementation timeline
    • Regulatory strategy for manufacturers and distributors
    👩‍⚕️ Whether you’re a manufacturer, authorized representative, importer, distributor, PRRC or RAQA professional, this episode will help you avoid mistakes and stay compliant with the latest medical device regulations. 👉 Listen now and stay updated on regulatory affairs for medical devices.

    #MedicalDevices #RegulatoryAffairs #MDR745 #EUDAMED #MedicalDeviceCompliance #HealthcareRegulation #RAQA #PRRC
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    4 mins
  • Top Registration Mistakes That Could Cost Your Medical Device Approval

    Top Registration Mistakes That Could Cost Your Medical Device Approval
    Jul 30 2025
    In this episode, we examine the most frequent mistakes made by companies and economic operators during the registration of medical devices.

    From selecting the correct UDI code to properly designating the economic operator, we provide a clear and practical overview of the key issues to avoid in order to ensure a compliant and effective registration process.

    A valuable episode for industry professionals looking to approach European regulations with greater confidence.
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    8 mins