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Hosted by Unknown Host · EN · 35 episodes
Established thought leaders with verified media credentials.
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.
Unknown Host hosts Regulatory Affairs & Life Science, a business show with 35 episodes published.
The European Chemicals Agency (ECHA) has released a new draft guidance dedicated entirely to the identification and assessment of Substances of Concern (SoC) in biocidal products under the Biocidal Products Regulation (B
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 t
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
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 Re
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. Toget
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 responsibilit
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
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 mus
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 Regula
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
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
🗓️ 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 t
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 require
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 differ
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 devic
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 i
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 datab
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 operato
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
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 under
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Regulatory Affairs & Life Science is hosted by Unknown Host. The show is categorised under Business (entrepreneurship) and has published 35 episodes.
Regulatory Affairs & Life Science has published 35 episodes.
Regulatory Affairs & Life Science regularly covers Business, Entrepreneurship. It sits in the Business category, with a entrepreneurship focus.
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