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Regulatory Affairs & Life Science

Regulatory Affairs & Life Science

Von: 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 Management & Leadership Ökonomie
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  • 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.
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