Medfiles

Individual Case Safety Report (ICSR) handling is a cornerstone of pharmacovigilance. However, ICSRs are not always complete, and this can limit evaluation of suspected adverse reactions.   📅 On 1st February 2025, EMA’s new guideline Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQ) came into effect. This outlines the requirements for the Specific AR FUQ, helping Marketing Authorisation Holders (MAHs) to standardise their processes.   🔍 Core takeaways for Specific AR FUQs: · Used for safety concerns that may impact the benefit-risk balance · Provided to reporter in their local language with prefilled information · Included as part of RMP Annex 4 or PSUR · Implementation of effectiveness assessments that are ready for competent authority requests · Encouraged sharing of questionnaires to other MAHs   Read the full EMA guideline: https://lnkd.in/eVJ_4e5p   ➡️ Need expert support? See how Medfiles can help you with your pharmacovigilance activities: https://lnkd.in/e5ZpnReZ #ICSR #caseprocessing #drugsafety #pharmacovigilance #EMA

In Finland, every company that holds a medicinal product wholesale dealer’s licence needs to have a responsible pharmacist. ✅ This role is essential for compliance with both EU and Finnish pharmaceutical regulations, and for foreign clients poses two challenges: the language barrier and the specific qualification for the role. That's why LEO Pharma has Medfiles’ expert as its Responsible Pharmacist (RP) for Finland. “The role of the responsible pharmacist is a critical position, especially due to the language barrier. Not many of LEO Pharma’s Nordic colleagues understand and speak Finnish, which makes Medfiles’ support invaluable”. Read what LEO Pharma’s Kristien Vanelderen, Head of Quality International, says about working with Medfiles ⬇️ #regulatoryaffairs #RP #responsiblepharmacist #pharmaindustry

💡 Miten etenevät aamiaisdirektiivien päivitys, Nutri-Score-uudistus ja vihreiden väittämien direktiiviehdotus? Mitä tulisi tietää metsäkatoasetuksesta sekä EU:n uudesta pakkaus- ja pakkausjäteasetuksesta? Entä missä mennään ravintoaineiden täydentämisen enimmäismäärien osalta? Näihin ja moniin muihin kysymyksiin saat vastauksia Elintarvikelainsäädännön ajankohtaispäivässä 2025! Puhujina ovat mm. asiantuntijat Ruokavirastosta, ympäristöministeriöstä ja maa- ja metsätalousministeriöstä. 📅 Livewebinaari ke 19.3. klo 9–15.15 🎥 Ilmoittautuneet saavat myös 𝐰𝐞𝐛𝐢𝐧𝐚𝐚𝐫𝐢𝐭𝐚𝐥𝐥𝐞𝐧𝐭𝐞𝐞𝐧 Viikko aikaa ilmoittautua! ➡️ https://lnkd.in/dx7_G9a6 #ELAP #elintarvike #elintarvikeala #elintarvikkeet

Approximately 166 million European households share their home with at least one animal companion.🐾 That’s a lot of cats and dogs! But we can’t forget the millions of birds, horses, fish, reptiles and small animals that we also consider a part of our families. 𝐖𝐞 𝐜𝐚𝐧’𝐭 𝐟𝐨𝐫𝐠𝐞𝐭 𝐭𝐡𝐞𝐦 𝐢𝐧 𝐝𝐫𝐮𝐠 𝐬𝐚𝐟𝐞𝐭𝐲 𝐞𝐢𝐭𝐡𝐞𝐫. In veterinary medicine, PV legislation and requirements are applicable for 𝐚𝐥𝐥 animals – livestock and companion, big and small. Whether your product is marketed for a honey bee, tortoise, cat or cattle, the Medfiles Pharmacovigilance Unit can assist you in ensuring a fully compliant PV system. Read about our post-authorisation PV services for veterinary medicines ➡ https://lnkd.in/dJNtpeR2 #pharmacovigilance #PV #drugsafety #animalhealth #veterinarymedicine

Medfiles announces the successful completion of the sale of its R&D and Analytical service business to Eurofins BioPharma Product Testing Finland Oy, effective as of 28 February 2025. This strategic transaction signifies Medfiles’ commitment to enhancing its focus on core services, including Regulatory Affairs, Pharmacovigilance, and Clinical Study services, while ensuring that its laboratory operations continue to flourish under Eurofins’ esteemed leadership. “We are excited about this transaction, which allows Medfiles to sharpen its focus on our core business areas, Regulatory Affairs, Pharmacovigilance, and Clinical study services, while ensuring that the laboratory services continue to thrive under Eurofins’ leadership,” said Nino, Norifumi Ninokata, CEO of Medfiles. Read the full announcement ➡️ https://lnkd.in/eiDW3rgc #Medfiles #Eurofins Eurofins

💡 HBW Insight wrote an article about food supplements in 2025 and asked market experts a question: What will 2025 be the year of? Medfiles’ Eskola Mari (PhD, Team Leader of Regulatory Science and Reports) answered the question as follows: 2025 will be the year of possible political surprises in relation to food and dietary supplement safety in the US. It is hard to see what the possible new steps by the Trump administration will be. Already during the recent past there has been some debate that the US Food and Drug Administration should improve its dietary supplement framework. It has been discussed that it does not provide enough safety guarantees and that there are supplements on the market which should not be there. Also, GRAS has got criticism. There have been very recent voices in US Congress suggesting that the GRAS procedure should be discontinued, arguing that it allows companies to declare their ingredients as safe without FDA approval and oversight. GRAS is an important tool to get dietary supplements on the market without the NDI notification to FDA. Time will tell where this ongoing debate will lead – if anywhere. In the EU, the European Food Safety Authority continues its tasks with a slow but steady speed. Many new scientific and data requirements for the novel food dossiers, including food supplements, were communicated to us through EFSA’s new novel food guidance document. Some improvements were also seen; the experimental animal data have less prominence than before. The importance of deep understanding of the EFSA data requirements help when making the application dossiers for food supplements. Now with the new guidance even more expertise is needed when interpreting what EFSA actually needs. The EU transparency rule lives its own life and adds to the workload when preparing dossiers. The UK and Food Standards Agency are in progress of streamlining their regulatory authorization processes. It can be seen from the discussions that they aim at a simpler system than the EU one, while at the same time they want to keep food quality and safety at a high level. Undoubtedly, the EU food safety system is the strictest in the world and it is interesting to see which elements the UK will keep and which it will lose. At least the UK does not seem to want to adopt the EU transparency rule or something similar. Read the full article with expert views ⬇️ #foodindustry #foodsupplements #dietarysupplements #foodregulation

Meet Saana Lamminjoki, our dedicated Safety Manager with degrees in both pharmacy and toxicology. 💎 Get to know her through an interview: 🐾 𝐖𝐡𝐚𝐭 𝐭𝐚𝐬𝐤𝐬 𝐝𝐨𝐞𝐬 𝐲𝐨𝐮𝐫 𝐕𝐄𝐓-𝐫𝐞𝐥𝐚𝐭𝐞𝐝 𝐰𝐨𝐫𝐤 𝐢𝐧𝐜𝐥𝐮𝐝𝐞? In my work, I focus on following the safety and efficacy of veterinary medicines. The tasks include for example monitoring scientific literature, signal detection, risk management, and processing adverse event reports. We work in close collaboration with veterinarians to ensure that all safety issues are addressed at an adequate level. I’m also involved in the pharmacovigilance system master file (PSMF) and quality management system maintenance. Together with our team, we make sure that all our VET-related SOPs and processes are compliant with the current regulations. 🐾 𝐖𝐡𝐚𝐭 𝐚𝐫𝐞 𝐲𝐨𝐮𝐫 𝐜𝐨𝐫𝐞 𝐜𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐞𝐬 𝐚𝐧𝐝 𝐬𝐭𝐫𝐞𝐧𝐠𝐭𝐡𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐕𝐄𝐓 𝐟𝐢𝐞𝐥𝐝? My studies in toxicology have given me a great foundation for assessing the safety of products in different species. I approach my work with precision and efficiency, and I believe my skills in scientific writing are particularly valuable when producing reports, such as those needed for signal management. Additionally, my passion for the veterinary field in general drives me to contribute to the well-being of animals. This combination of competence and deep personal interest helps me to manage large-scale veterinary pharmacovigilance projects efficiently and with care. 🐾 𝐇𝐨𝐰 𝐢𝐬 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐯𝐞𝐭𝐞𝐫𝐢𝐧𝐚𝐫𝐲 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬 𝐝𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭 𝐟𝐫𝐨𝐦 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐡𝐮𝐦𝐚𝐧 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬? Working with veterinary medicines presents unique challenges compared to human medicines. For one, we deal with multiple species, each with its own physiological differences. Also, as animals cannot directly communicate adverse events, we must rely on observations from owners and veterinarians. This makes it more of a challenge to assess potential adverse events and safety signals. Since veterinary products have their own set of regulations, the requirements for pharmacovigilance in this field are also different from those of human medicines. 🐾 𝐁𝐞𝐬𝐭 𝐭𝐡𝐢𝐧𝐠 𝐚𝐛𝐨𝐮𝐭 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐚𝐭 𝐌𝐞𝐝𝐟𝐢𝐥𝐞𝐬? Medfiles has offered me an incredible opportunity for professional growth. Our pharmacovigilance team consists of experts with different backgrounds, and I’m happy to be able to learn and work together with them. Meet also the other members of the animal health team ➡ https://lnkd.in/eE5gKiSz #veterinarymedicine #pharmacovigilance #animalhealth #workatmedfiles

🌱 For food and feed companies looking to enter the US market, the Generally Recognised as Safe (GRAS) pathway offers a well-established regulatory pathway for ingredient approval. Unlike the FDA's full food additive approval process, GRAS allows certain substances to be used in food and feed based on expert scientific evaluation. GRAS status can be achieved through: ✔ Self-affirmation, where the company conducts its own safety assessment. ✔ GRAS notification, where the FDA reviews the safety data and provides a “no questions” response. How does GRAS compare to other regulatory frameworks, and what scientific evidence is required? Read our latest blog to explore the GRAS process in more detail ⬇️ #GRAS #novelfood #foodsafety #food #animalfeed

Elintarvikelainsäädännön ajankohtaispäivä 19.3.2025 – tärkeimmät muutokset ja tulevat kehityssuunnat viranomaisten ja elintarvikealan yritysten näkökulmasta.💡 Katso alta webinaarin 9 kiinnostavaa puheenvuoroa. Tutustu tarkemmin ohjelmaan ja ilmoittaudu – Early Bird -etuhinta on voimassa 19.2. asti! ➡️ https://lnkd.in/dx7_G9a6   #ELAP #elintarvike #elintarvikeala #elintarvikkeet 

Greetings from #AHNTIEU2025!🐾 It's been a great couple of days at Animal Health, Nutrition and Technology Innovation in London, full of insightful discussions with other operators in the animal health industry. There's still time to network - visit Annika Stigell, Saana Lamminjoki and Eskola Mari at stand 3️⃣! #AHNTI #animalhealth #veterinarymedicines #animalfeed