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.
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

π New Podcast Episode: Clinical Trials and the New GCP E6(R3) Guidelines
π 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. π 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

π 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 youβre 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.
Weβll 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...