Katarzyna Burdan, PhD

The SME Office Annual Report 2024 is out! Since 2005, EMA’s SME Office has been supporting small and medium-sized enterprises (SMEs) by addressing their specific regulatory needs, helping them bring innovative new medicines to patients across Europe. Highlights from this year's annual report include: ✅ Increased success rates for marketing authorisations submitted by SMEs; ✅ Higher SME registration figures, especially for veterinary companies; ✅ Increased regulatory assistance; ✅ High representation of SMEs in PRIME products and scientific advice received for orphan medicines (PRIME is a scheme run by EMA to enhance support for the development of medicines that target an unmet medical need). 🔗View the entire report here: https://lnkd.in/eb4Huk44 #SME #medicine #innovation

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RaySearch Laboratories receives first order for DrugLog! The Polish company Medim has placed an order for the product #DrugLog as a result of Medim winning a tender from The Children's Memorial Health Institute in Warsaw, Poland's largest and most well-equipped children's hospital. “This is an important milestone for our partnership with RaySearch. The new customer is a proof of how our joint efforts and expertise create concrete results in the market,” says Mateusz Nejman, Director of New Technologies Department, Medim. “We are pleased to announce that The Children's Memorial Health Institute in Warsaw, Poland is purchasing DrugLog. Medim is our first customer for DrugLog, which we acquired at the beginning of the year to complement our existing product offering. DrugLog represents a further step towards the vision of providing software support for all types of cancer treatments, including chemotherapy and surgery,” says Johan Löf, founder and CEO, RaySearch. DrugLog is RaySearch's cost-effective solution for quickly and efficiently verifying the identity and concentration of compounded injectable medications used, for example, in cancer treatment with cytostatic drugs (chemotherapy). DrugLog is used to detect errors in the preparation of drugs, which reduces the risk of medication errors. DrugLog is a unique combination of cutting-edge software and reliable well-established hardware for absorption spectroscopy. Read more: https://bit.ly/3DGtyiE #AdvancingCancerTreatment

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The acquisition of the Grupa Scanmed, conducted by the American Heart of Poland (AHP) Group, part of the Gruppo San Donato and GKSD Investment Holding, operating in the Polish public healthcare system, has been completed. Scanmed operates across over 30 locations and serves over 300,000 patients annually. This acquisition brings the total number of Gruppo San Donato facilities to 161, marking a significant milestone in the mission to deliver exceptional healthcare worldwide. In a joint statement, Kamel Ghribi, GKSD President, and Paolo Rotelli, GSD Vice President, stated: “This acquisition represents a continuation of a strong and consistent growth path for us. Poland is a country we look to with great interest, because of its desire and ability to grow and innovate and therefore deserves trust and investment.” #GruppoSanDonato #Acquisition #ItalianGroup #Healthcare  

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🏭 Over 50% of medicine shortages are due to manufacturing issues. Accessing medicines shouldn’t be a Herculean task. While we are proud of our cutting-edge medicines made in the EU, we need to be vigilant about keeping generic drug production in Europe. Our Critical Medicine Act aims to:  💊 ensure that essential medicines are always available to EU patients, filling gaps where the market falls short  🇪🇺 boost local production  🧪 improve security of supply of key ingredients The EU's pharmaceutical industry needs more stability.   Because even a day without necessary treatment takes its toll. Learn more 👉 https://europa.eu/!kfBrmn  

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