Regulatory Affairs & Life Science

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...

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...

🎙️ 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...

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.

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...

🎙️ 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...

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...

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...

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.

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...

🎙 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...

🎙 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...

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...

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.

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.

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...