ELENA BARBONI

As part of the 2020 Pharmaceutical Strategy for Europe, the Commission is reviewing the current rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for medicines products for human use, with the purpose to make the lifecycle management of medicines more efficient and future proof and ensuring the protection of public health in the European Union. In this context, the Commission has proposed a draft delegated Regulation amending Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and its annexes (Variations Regulation) within the existing legal framework of Regulation (EC) No 726/2004 and Directive 2001/83/EC. 

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Unlock the potential of #pharmaceutical #sourcing with Italy's regulatory framework and Invimeds. Discover the procurement of high-quality Reference Listed Drugs (#RLDs) and #biologics while navigating Italy's robust regulatory landscape. Elevate your pharmaceutical supply chain and ensure reliability with Invimeds, facilitating seamless sourcing of RLDs from Italy while adhering to stringent regulatory standards. Follow Invimeds for more insights and explore how we can optimize your pharmaceutical sourcing process. #PharmaceuticalSourcing #RLDSourcing #RegulatoryFramework #InviMedsHealth #PharmaceuticalSupplyChain #QualityAssurance #LogisticsExcellence https://bit.ly/3XcaDnt

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📆 AVC experts have been invited to contribute to three EMA veterinary concept papers. The deadline for comments is 31 October 2024. 1️⃣ European Medicines Agency has released a concept paper addressing the revision of the guideline on dossier requirements for #anticancer medicinal products for dogs and cats, originally adopted in 2009. This guideline outlines the necessary conditions and data requirements to demonstrate the quality, safety, and efficacy of anticancer veterinary medicines for pets. Despite an increasing interest in anticancer products and minor revisions in 2021 to align with new regulations, the scientific content of the guideline has not been updated since its inception. This concept paper aims to conduct a thorough revision focusing on scientific advancements to better support the authorisation of such products via both centralised and decentralised procedures. 2️⃣ A second concept paper focuses on revising the guideline for the conduct of #bioequivalencestudies for veterinary medicinal products. Initially adopted in 2001 and last revised in 2021 to incorporate administrative changes under Regulation (EU) 2019/6, this guideline outlines the methodology for demonstrating that two medicinal products are bioequivalent. 3️⃣ The third concept paper pertains to the revision of the guideline on #usersafety for pharmaceutical veterinary medicinal products. This revision seeks to update the guideline in accordance with Regulation (EU) 2019/6 and related legislation, ensuring it reflects current definitions and regulatory experiences. It also aims to align the guideline more closely with those for topically administered veterinary medicines and to incorporate the principles of the #3Rs (Replacement, Reduction, and Refinement) and alternative testing approaches. The goal is to enhance the adequacy of user risk assessments and mitigation measures to better protect users handling these veterinary medicinal products. #associationofveterinaryconsultants #stakeholderengagement #veterinarymedicines #conceptpaper #guidelines #regulation2019 #animalhealth #humanhealth #onehealth

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Our monthly life sciences newsletter - Life Sciences News in Italy - is now available. Stay up to date on the latest developments in the Italian Life Sciences sector and gain brief and valuable insights from our Italian team. Covering a wide spectrum of practice areas, highlights from this issue include: • Regulatory  • WCC/Compliance  • IP  • Data, Privacy & Cybersecurity  • Antitrust  • Tax Want to read more? Click the following link https://lnkd.in/dXqN6RkZ To subscribe to the newsletter and be part of our community click here https://lnkd.in/d2eHQUZk #LifeSciences #Newsletter #DLAPiperItaly

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🚨 New Pharma Warning Letters Alert! 🚨 Stay ahead in the pharmaceutical world with the latest updates on warning letters issued by regulatory authorities. 📜 🔍 Recent Highlights: Glenmark Pharmaceuticals Europe: Atomoxetine recall due to out-of-specification results. Fresenius Kabi Limited: Labelling error on Hartmann’s Solution for Injection BP. Aspen Pharma Trading Limited: Error in the Patient Information Leaflet for Co-trimoxazole suspension. Stay informed and ensure compliance by visiting Pharmatching for detailed information on these and other recent warning letters. 👉 Visit Pharmatching now to stay updated with the latest in the pharma industry! #Pharma #Pharmaceuticals #Compliance #RegulatoryUpdates #Pharmatching

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