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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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  • Labelling pharmaceutical sectors

    Labelling pharmaceutical sectors
    Jun 10 2025
    Join us in this episode as we delve into the complex world of medicinal product labelling—a cornerstone of patient safety and regulatory compliance. We’ll explore:
    • Evolving EU requirements: product names, active substances, strengths, and routes of administration;
    • The impact of 2D QR codes and Braille: innovations for inclusive and accessible communication;
    • The regulatory evolution of multilingual labelling: how to manage multi-language content while maintaining clarity and compliance;
    • Operational challenges and practical solutions: from label design to approval, with a focus on version control and content consistency.
    This episode is tailored for regulatory affairs, quality, and packaging professionals. Expect real-life examples, best practices, and key insights to navigate complexity efficiently—reducing risk and speeding up time to market.

    Why listen:
    • Stay up to date with evolving regulations and global trends.
    • Gain actionable strategies to streamline internal processes—from creation to approval.
    • Strengthen product quality and safety, a key differentiator in a competitive market.
    Get ready to decode medicinal labelling like never before: where technology, regulation, and accessibility come together to ensure that every patient receives the right information, the right way.
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    14 Min.
  • Are our cosmetics labels compliant

    Are our cosmetics labels compliant
    May 30 2025
    🎙️ New episode of the Di Renzo Regulatory Affairs podcast! Today we’re diving into a topic that is often underestimated but absolutely essential in the cosmetics sector: labeling. 📦 What does a label need to include to be considered compliant?

    🧴 Which pieces of information are mandatory, and what mistakes should be avoided at all costs?

    In this episode, our experts walk you through the 7 key rules for correctly labeling a cosmetic product under Regulation (EC) No. 1223/2009. It’s a must-listen guide for companies, industry professionals, and anyone working in the cosmetics field.

    🔍 From identifying the Responsible Person, to correctly using INCI nomenclature, to including proper environmental and safety indications — each point will help you navigate regulatory requirements with confidence.

    🎧 Tune in to discover how labeling can become a powerful tool for compliance, transparency, and consumer trust.

    📍 Available on Spotify, Apple Podcasts, and all major platforms.
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    7 Min.
  • Statistics and Post-Market Surveillance: Ensuring Medical Device Safety

    Statistics and Post-Market Surveillance: Ensuring Medical Device Safety
    May 22 2025
    In this episode, we explore the crucial role of statistical analysis in the post-market surveillance of medical devices.

    We discuss how the collection and interpretation of data help ensure the safety and effectiveness of devices once they enter the market.

    We delve into the statistical methodologies used, common challenges, and best practices for effective monitoring in compliance with European regulations.
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    7 Min.

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