Medfiles

As the festive season approaches, we would like to thank our clients and industry colleagues for a successful year. We wish everyone a season filled with warmth, relaxation and joy. Happy Holidays and a peaceful and prosperous New Year! 💝

Haemme lääketurvatiimiimme lääketurva-asiantuntijaa (Pharmacovigilance & Medical Information Expert). 🔍 Tarjolla on monipuolinen asiantuntijatehtävä kansainvälisessä, joustavassa ja innostavassa tiimissä. Tehtäviisi kuuluvat ihmis- ja eläinlääkevalmisteiden lääketurvallisuuteen sekä lääkinnällisten laitteiden turvallisuuteen liittyvät tehtävät. Voit sijoittua Vantaan, Tampereen tai Kuopion toimistollemme, ja joustava hybridityöskentely on mahdollista. 𝐊𝐢𝐢𝐧𝐧𝐨𝐬𝐭𝐮𝐢𝐭𝐤𝐨? Lue lisää tehtävästä ja hae paikkaa 12.1. mennessä. Toimi nopeasti – täytämme paikan heti sopivan henkilön löydyttyä! ➡ https://lnkd.in/eBT47Tqx #workatmedfiles #lääketurva #lääketurvallisuus #rekry

Meet Ingrid Hagberg, our toxicology reinforcement from Canada! 💎 Ingrid has worked for Health Canada and the Canadian Food Inspection Agency for many years and has a strong background in food toxicology and risk assessment. At Medfiles, Ingrid's work covers a wide range of areas including toxicology, risk assessment and regulatory affairs for food and feed. Her diverse career has also given her a strong background in regulatory compliance in Canada, the US and the EU. Read more about Ingrid's work and expertise ➡️ https://lnkd.in/eBdp8VP5 #workatmedfiles #toxicology #riskassessment #regulatorycompliance #food

💊 The safety of food supplements is a hot topic in the EU. Recently, the Working Group “Food Supplements” of Heads of Food Safety Agencies gathered a list of 117 substances with potential health risks. While harmonised legislation covers vitamins, minerals, and authorised novel foods, the "other substances" category requires unique knowledge of the target market. Key points for compliance of other substances in food supplements involve: 🔹Around a dozen substances, including e.g. tryptophan and piperine, are recommended to be prioritised in a potential evaluation process by EFSA. 🔹National approaches vary across the Nordics – for instance, melatonin is regulated differently in Finland, Sweden, and Norway. 🔹Compliance involves both EU-level and national requirements, and oftentimes, both qualitative and quantitative aspects are needed for determining the regulatory status. Read the full blog post on compliance of other substances used in food supplements ➡️ https://lnkd.in/dhZG7j8Q #foodsupplements #foodregulatory #foodsafety #foodingredient

Not sure how to successfully submit your clinical trial application via the CTIS portal? Our practical guide is created to provide clarity and support. It covers the following topics: ✔ What is the CTIS portal ✔ EMA system registrations & activations ✔ Submission procedure ✔ Required data and documents ✔ Requests for information (RFIs) ✔ Substantial modifications ✔ Product management ✔ Safety reporting Download for free: https://lnkd.in/gwWDcEKi #CTIS #CTISportal #clinicaltrials #clinicalresearch

Determining whether a food ingredient is 𝐧𝐨𝐯𝐞𝐥 𝐨𝐫 𝐧𝐨𝐭 can be challenging. If the status is unclear, companies can submit 𝐚 𝐜𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐭𝐢𝐨𝐧 𝐫𝐞𝐪𝐮𝐞𝐬𝐭 to an EU Member State or to the UK. 💡Since 2018, more than 110 consultation conclusions have been issued in the EU, with around 40 % classified as not novel. A consultation request can save your company time, resources and the lengthy novel food authorisation process, making it a valuable option to consider. Read our blog to learn more about the process ➡️ https://lnkd.in/ebTKKbqv P.S. Medfiles experts have years of experience with novel foods, including 10 submitted consultation requests, and are happy to help! #novelfood #consultationrequest #foodingredient #foodregulation

In 2021, WellO2 Oy started their first clinical study to investigate the benefits of the device for people with asthma. That’s when WellO2 started working with Medfiles. The clinical investigation was successfully completed in 2022. ✅ Katri Lindberg, Respiratory Specialist at WellO2, says they relied heavily on Medfiles’ help. Medfiles helped with applying for the research permit and designing the required documents, trained the study site staff, carried out the monitoring visits at the study site and helped to ensure patient safety. In addition to managing the project as a whole and coordinating different parts of it, Medfiles also helped WellO2 with the small details and practicalities. Read more about how Katri describes the cooperation ➡ https://lnkd.in/e6_uM9Ey #clinicalinvestigation #clinicalstudy #clinicaltrials #medicaldevice

🌱 The current global changes have many effects on feed products and the entire feed sector, including: • challenges in agriculture • development of alternative protein sources and green development • changes in regulatory requirements. Read our blog for our views on the recent developments in the feed sector ➡️ https://lnkd.in/eAgbF_Ei #animalfeed #feedregulatory #agriculture #feedindustry

What should be included in the marketing authorisation application in the EU? 💊 The application must be comprehensive and contain all the necessary documentation and data that regulatory authorities require to evaluate the safety, efficacy, and quality of the medicinal product. Each section of the application is critical to the overall evaluation of the product by regulatory authorities. Read about the key components included in the dossier ⬇ #marketingauthorization #regulatoryaffairs #pharmaceuticals #pharmacovigilance

In May 2024, new Veterinary Medicines Regulations (VMR), as amended, came into effect in GB. 🇬🇧 Periodic Safety Update Reports (PSURs), Adverse Event Reporting and Detailed Description of the Pharmacovigilance System (DDPS) have seen the most substantial changes. These often align with the EU Veterinary Medicines Regulation 2019/6, but our Veterinary Pharmacovigilance Unit has taken care to ensure compliance in both the EU and GB is maintained. A brief glimpse of some implementation changes we can support our clients with: ▪ Updating SOPs to ensure 30-day UK Adverse Event reporting compliance ▪ Conduct PSMF summary submissions to VMD during the DDPS to Pharmacovigilance System Master Files (PSMFs) change, ensuring full PSMFs are available for inspections. ▪ Make reviews of existing PSUR DLPs to ensure smooth transition to the new Signal Management and Annual Benefit-Risk Report System (BRSR). The area of Veterinary Pharmacovigilance is ever-changing and at Medfiles, as both PV experts and animal lovers, we are excited to be part of both small and large-scale projects related to the improvement of companion and livestock health. With six months left before the transition deadline, if you need assistance in reaching compliance with the new GB VMR, as amended, our animal health PV team is happy to help. Read about the EU Veterinary Medicines Regulation 2019/6 3 years on ➡ https://lnkd.in/eF39QjK9 Read about our post-authorisation PV services for veterinary medicines ➡ https://lnkd.in/dJNtpeR2 #pharmacovigilance #PV #drugsafety #animalhealth #veterinarymedicine