Regulatory Affairs & Life Science

As deadlines approach and new European obligations take effect, the proper management of medical devices requires unprecedented attention. In this episode, we clear up everything you need to know to successfully navigate EUDAMED registration (registrazione eudamed) without running into compliance roadblocks. We will break down the system's operational phases, explaining how to structure your data...

When does a distributor or importer become, for all legal purposes, the MANUFACTURER of a medical device? In this episode, we shed light on one of the most complex, sensitive, and controversial aspects of the European Regulation on Medical Devices (MDR 2017/745) and the European Regulation on In Vitro Diagnostics (IVDR 2017/746): Article 16 . If you work in logistics, distribution, import, or comp...

What happens before a drug reaches our hands or those of our animals? In this episode, we explore the beating heart of safety and compliance: GMP (Good Manufacturing Practice) audits in the pharmaceutical industry. Together with industry professionals, we analyze why these inspections aren't just bureaucratic procedures, but rather true safeguards for public health and business stability. We'll di...

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 strategie...

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!

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 leafl...

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 f...

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:...

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 #Pha...

🗓️ 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.

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

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...

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...

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...

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 require...

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 professio...

Welcome to a new episode of the Di Renzo Regulatory Affairs podcast, where we explore key topics from the world of pharmaceutical regulatory affairs — with clarity, professionalism, and a practical approach. Today, we’re focusing on a crucial subject for all Marketing Authorisation Holders: Local Pharmacovigilance . It’s a vital system to ensure patient safety and regulatory compliance — often und...

In this episode of the Di Renzo Regulatory Affairs Podcast, we explore a question at the heart of digital health compliance: When does your software become a medical device? Drawing from our latest article “ How to understand if the software is a medical device? ” we dissect the critical concept of intended medical purpose—diagnosis, prevention, monitoring, or treatment—and how it transforms stand...

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 multilingua...

🎙️ 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 rul...

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 r...

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 ver...

🎙️ 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 su...

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 pharmaceutica...

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...