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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.
  • Food supplements regulation in Italy

    Food supplements regulation in Italy
    May 15 2025
    Welcome to a new episode of our podcast dedicated to the world of pharmaceutical regulatory affairs.
    Today, we’ll take a journey through time to explore the regulatory history of food supplements, a constantly evolving sector that is becoming increasingly relevant for both the industry and consumers.

    Starting from the 1980s up to the current European regulatory framework, we'll examine how the very concept of a “supplement” has developed, the key milestones in the legislative path, and the main regulatory challenges faced today.

    The episode is based on an article published by Di Renzo Regulatory Affairs, which you can find on their website — but here, we’ll walk you through the key points, with insights and reflections for professionals in the field or anyone curious to learn more. Would you like me to translate the teaser for social media as well?
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    7 Min.
  • What Companies should know about PMCs and Biocidal Products

    What Companies should know about PMCs and Biocidal Products
    May 9 2025
    🎙️ New Podcast Episode: Navigating the Transition from PMCs to Biocides In our latest episode, we delve into the evolving regulatory landscape surrounding Presidi Medico Chirurgici (PMCs) and their transition to biocidal products within the European Union. This shift, driven by Directive 98/8/EC, aims to harmonize standards across member states, ensuring enhanced safety and efficacy of products such as disinfectants, insecticides, and repellents.

    The directive introduces a comprehensive evaluation of active substances, categorizing biocidal products into 23 distinct types and necessitating rigorous assessments, including toxicological and ecotoxicological studies. This transformation presents significant challenges for companies, especially those navigating the complexities of dossier preparation and compliance during the transitional phase

    Di Renzo Regulatory Affairs offers expert guidance to companies, assisting in feasibility studies, regulatory intelligence, and the preparation of comprehensive dossiers to facilitate a smooth transition from PMCs to biocides.

    Tune in to gain valuable insights into adapting to these regulatory changes and ensuring your products meet the new European standards. 🔗 Read the full article
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    7 Min.
  • Pharmacovigilance Responsibility: Who Watches Over Our Medicines?

    Pharmacovigilance Responsibility: Who Watches Over Our Medicines?
    Apr 7 2025
    Welcome to a new episode of Regulatory Affairs & Life Science, your go-to space for deep dives into the pharmaceutical world—where regulations, innovation, and public health protection meet. Today, we’re tackling a crucial and complex topic: responsibility in pharmacovigilance.

    Who is truly accountable for the safety of medicines once they’re on the market? What are the roles of pharmaceutical companies, Qualified Persons for Pharmacovigilance (QPPVs), and regulatory authorities?

    Starting from an insightful analysis by Di Renzo Regulatory Affairs, we’ll explore how the concept of responsibility in pharmacovigilance has evolved—from European regulations to the practical implications for companies in the field.

    This is a must-listen episode for anyone working in regulatory affairs or anyone curious about how the safety of the medicines we use every day is monitored and ensured.

    Stay with us…
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    7 Min.
  • The use of Data Mining in PMCF data analysis and real-world questionnaires

    The use of Data Mining in PMCF data analysis and real-world questionnaires
    Mar 28 2025
    Welcome to this episode of our podcast, where we explore the application of data mining in the medical device sector.

    Data mining is a set of advanced techniques that allow us to extract meaningful insights from data collected during the use of medical devices. These insights are crucial for improving safety, effectiveness, and innovation in the medical field.

    Today, we will delve into how post-market data analysis and real-world questionnaires can benefit from data mining, helping us better understand the real-world performance of medical devices.

    Additionally, we will discuss regulatory implications and the challenges companies face when implementing these techniques.

    Stay with us to discover how data mining is revolutionizing the landscape of medical devices!
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    7 Min.
  • Medical Devices: Rising Costs and Regulatory Complexity After Seven Years of IVDR and MDR

    Medical Devices: Rising Costs and Regulatory Complexity After Seven Years of IVDR and MDR
    Feb 21 2025
    Over the past seven years, the medical device industry has faced increasing challenges due to the regulatory changes introduced by IVDR and MDR. In this episode, we analyze the impact of these regulations on costs, innovation, and market access, exploring manufacturers' concerns and potential solutions for the future. A must-listen for companies, industry professionals, and anyone looking to better understand the dynamics of an ever-evolving market.
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    8 Min.