Regulatory Affairs & Life Science

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!

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: The strategic advantage of creating healthcare advertising that is "compliant by design" to avoid penalties and speed up time-to-market.

Learn how to transform regulatory constraints into a competitive advantage for your brand. If you work in marketing, quality assurance, or regulatory affairs, this episode is for you.📌 Want to dive deeper? Visit our website to read the full article and discover our compliant packaging design services.

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.

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: Preventing Agency RFIs through correct scientific program mapping.
• Compliance Strategy: The role of Regulatory departments in ensuring a smooth authorization flow.

Useful Links: 📌 Full Article: https://en.direnzo.biz/update-congress-conventions/

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

🗓️ 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.

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

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.

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.

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—this episode is for you.


https://www.direnzo.biz/it/en/pharmacovigilance-social-networks/