Regulatory Affairs & Life Science
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.
Medical Devices and IVD in Spain: introduction to the RECOPS database
In the regulatory landscape of medical devices in Europe, Spain is introducing significant updates. In this episode, we clarify the transition that led to the decommissioning of the old CCPS database and the introduction of the new RECOPS portal (Registro de comercialización de productos sanitarios) by AEMPS.
We will analyze what changes for manufacturers and economic operators, the fundamental link with the European database EUDAMED (specifically module 2), and the timelines and obligations to comply with for marketing MDs and IVDs in Spanish territory. We will also discuss notification procedures, exemptions for custom-made devices, and how to manage m...
AI and Promotional Materials in the Pharma Sector: The New AIFA Guidelines
Generative Artificial Intelligence is transforming the way pharmaceutical companies create content and scientific information. But how can technological innovation be reconciled with the current regulatory framework?In this new podcast episode, we analyze the recent AIFA Guidelines published by the Drug Information and Advertising Vigilance Unit.What we cover in this episode:
Responsibility remains unchanged: Why the use of AI does not alter the nature of promotional material nor the obligations of the Marketing Authorization Holder (MAH) and the Scientific Service Responsible Person (RSS).Certified sources and verifiability: The requirement to...
Biocides and Co-formulants: How to Prepare for ECHA’s New Guidance
The European Chemicals Agency (ECHA) has released a new draft guidance dedicated entirely to the identification and assessment of Substances of Concern (SoC) in biocidal products under the Biocidal Products Regulation (BPR - Regulation EU No 528/2012).In this episode, we break down this major regulatory update and what it means for the chemical and manufacturing industries.
MDR Turning Point: What Changes with the Proposed Revision of the Medical Device Regulation?
A few years after the entry into force of Regulation (EU) 2017/745 (MDR), the European Commission is taking action to make the system more sustainable. With the amendment proposal COM(2025)1023, Europe aims to cut red tape and boost the competitiveness of the medical sector—without compromising the strict safety standards of medical devices.In this podcast episode, we analyze the impact of this upcoming revision on manufacturers and industry operators.What we discuss in this episode:Process Digitalization: How the transition to electronic documentation and digital workflows (linked to EUDAMED) will reduce the paperwork burden....
Svolta MDR: cosa cambia con la proposta di revisione del Regolamento Dispositivi Medici?
A distanza di qualche anno dall'entrata in vigore del Regolamento UE 2017/745 (MDR), la Commissione Europea corre ai ripari per rendere il sistema più sostenibile. Con la proposta di modifica COM(2025)1023, l'Europa punta a ridurre la burocrazia e a migliorare la competitività del settore medicale, senza però intaccare i rigorosi standard di sicurezza dei dispositivi.In questo episodio del podcast analizziamo l'impatto di questa imminente revisione sui fabbricanti e sugli operatori del settore.Di cosa parleremo in questa puntata:Digitalizzazione dei processi: come l'uso di documentazione elettronica e flussi digitali (legati a EUDAMED) ridurrà il cari...
EUDAMED and UDI Codes: A Practical Guide to Getting It Right
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 and correctly assign the UDI code (codice udi)—from the Basic UDI-DI all the way down to individual commercial packaging—to ensure full traceability and compliance with MDR and IVDR regulations. Whether you are a manufacturer, authorized representative, or importer, discover prac...
Importers and Distributors: When Do Manufacturers' Obligations Start? (MDR/IVDR)
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 compliance in the MedTech sector, you can't miss this episode.
Let's analyze together:
👉 The 3 key scenarios in which the automatic change of legal role is triggered.
👉 The key exceptions (when label translation and repackaging do not...
The importance of GMP audits for the production of "Human" and "Vet" pharmaceuticals
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 discover the concrete benefits for companies (and marketing authorization holders), what auditors really look for when they enter a manufacturing facility, and why—after the pandemic—on-site inspections have once again become an indispensable requirement compared to remote digital controls.
If y...
Drug Shortages: What changes for MAH holders? 💊
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 strategies to prevent disruptions in patient care.Essential listening for Regulatory Affairs and Quality Assurance professionals.
🎧 Listen to the episode now to stay compliant and informed!
AIFA guidelines for SOP and OTC
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!
Packaging & Compliance: Why Design Alone Isn’t Enough
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: T...
The New Face of Veterinary GMPs
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.
ACC System: The New Rules for "Intermediate Dates"
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:...
What are orphan drugs?
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
EUDAMED Countdown: Are You Ready for the 2026 UDI Mandate?
🗓️ 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.
EMA PMS Update: Navigating the New Era of Product Data
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
Biocides in 2025 New Rules, New Responsibilities
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.
MIR 7.3.1: Everything Manufacturers Need to Know Before November 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.
Pharmacovigilance Goes Social
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—thi...
Classification of medical devices in Italy
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 processItalian Ministry of Health requirementsEU MDR complianceCND code and Repertorio explainedEUDAMED implementation timelineRegulatory 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...
Top Registration Mistakes That Could Cost Your Medical Device Approval
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.
Local pharmacovigilance: all requirements, how to be compliant
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 underestimated, but absolutely essential across the European landscape.
What does it take to set up an effective local pharmacovigilance network? What are the specific responsibilities of Marketing Authorisation Holders?
And how can an e...
Is our software a Medical Device?
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 standalone software into a regulated medical device.
If you're developing health-focused software—whether it's tracking patient metrics, analyzing data, or offering diagnostic support—this episode guides you through the essential criteria: does your tool carry an inten...
Labelling pharmaceutical sectors
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 pack...
Are our cosmetics labels compliant
🎙️ 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...
Statistics and Post-Market Surveillance: Ensuring Medical Device Safety
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.
Food supplements regulation in Italy
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 Affair...
What Companies should know about PMCs and Biocidal Products
🎙️ 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 do...
Pharmacovigilance Responsibility: Who Watches Over Our Medicines?
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 Europ...
The use of Data Mining in PMCF data analysis and real-world questionnaires
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 imp...
Medical Devices: Rising Costs and Regulatory Complexity After Seven Years of IVDR and MDR
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.
The Role of Statistics in the Drafting of a Post-Market Clinical Follow-Up (PMCF) Plan for Medical Devices
In the new episode of our podcast, we delve into the crucial role of statistics in drafting the Post-Market Clinical Follow-Up (PMCF) plan for medical devices.
We explore how planning a PMCF study requires an accurate determination of sample size, based on identifying the target population and the prevalence of relevant events.
We discuss the importance of data analysis, carried out using advanced statistical software such as R, SAS, or SPSS, and the application of appropriate statistical tests to assess parameters such as clinical effectiveness or user satisfaction.
Additionally, we address uncertainty management through...
Good Clinical Practice new version published
🎙 New Podcast Episode: Clinical Trials and the New GCP E6(R3) Guidelines
💊 Clinical trials are a cornerstone of developing safe and effective therapies, ensuring compliance with ethical and scientific standards.
But how is this process evolving with the latest regulatory innovations? In this episode, we delve into the updates introduced by the Guideline for Good Clinical Practice (GCP) E6(R3), published by the International Council for Harmonisation (ICH) on January 6, 2025. 🔍 Topics include:Key updates compared to the previous E6(R2) version.How these changes enhance the quality and efficiency of clinical trials.The impact of new te...
Working in the pharmaceutical sector
🎙 New episode of our podcast!
In this episode, we discuss the new professional roles in the pharmaceutical sector. We analyze how transformations in the industry, driven by technological innovation and increasingly complex regulations, are creating opportunities for unique and highly specialized roles.
What are the most in-demand skills?
How is the job market evolving in the pharmaceutical field?If you’re interested in exploring the new frontiers of this industry and discovering career opportunities in this field, this episode is a must-listen!
Tune in now and find out how the pharmaceutical sector is re...
Authorisation for the organisation of Pharmaceutical Conferences and Meetings
This episode of the podcast is tailored for pharmaceutical companies planning to organize meetings, conferences, or scientific events, both in Italy and abroad.
We’ll delve into the key regulations and compliance requirements that must be met, with a particular focus on events related to the promotion of medicinal products manufactured or marketed by the same company.
In Italy, the law establishes specific procedures to ensure transparency and integrity, preventing conflicts of interest and safeguarding the quality of disseminated information. Among these is the obligation to obtain prior authorization from the Italian Medicines Agency (AI...
Parallel importation of medical devices
The Importance of Article 16 of the MDR
Article 16 represents a major advancement in the regulation of parallel imports, providing more clarity and detail than previous regulations. Specifically, it:Clearly defines what constitutes a parallel import of a medical device.Underscores the critical importance of adherence to essential requirements and harmonized standards.Imposes specific obligations on parallel importers, including verification of technical documentation and device traceability.Allows for corrective and safety measures to be taken in the event of non-compliance.
QPPV: A Guardian of Drug Safety
In this episode, we delve into the crucial role of the Pharmacovigilance Qualified Person (QPPV). We'll explore their responsibilities, qualifications, and the importance of their role in ensuring patient safety. From setting up pharmacovigilance systems to managing risk assessments and responding to regulatory inquiries, the QPPV plays a pivotal role in the post-marketing surveillance of medications.
Regulation (EU) 2017/745 (MDR)
Welcome to the new Di Renzo Regulatory Affairs podcast!In the ever-evolving landscape of medical device regulation, it is crucial to stay up-to-date. That's why today we'll delve into Regulation (EU) 2023/607, a significant amendment to Regulation (EU) 2017/745 (MDR) that introduces an extension of the transition period and defines the criteria for benefiting from it.As Regulatory Affairs experts dedicated to Class I medical devices, Di Renzo Regulatory Affairs is ready to support manufacturers in this delicate transition process.In this podcast, we will guide you through the details of Regulation 2023/607, clarifying:
Which Class I medical devices are...
