Regulatory Affairs & Life Science

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 bette...

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...

🎙 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), pu...

🎙 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?...

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 establishe...

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 obligati...

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 medicati...

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 exper...