Medfiles

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

Tutkijalääkäri Teemu Murtola johtaa tutkimusryhmää, joka selvittää rasva-aineenvaihdunnan merkitystä eturauhassyövän hoidossa. 🩺 Medfiles tukee tutkimusta vastaten tutkimuslääkkeiden valmistuksesta ja siihen liittyvistä prosesseista, kuten lähtöaineiden hankinnasta, materiaalitoimittajien kvalifioinnista, laadunvalvonnasta, QP-vapautuksesta sekä tutkimuslääkkeiden toimituksesta tutkimuskeskuksiin. Teemu on ollut tyytyväinen noin kuusi vuotta jatkuneeseen yhteistyöhön ja kuvaa Medfilesin roolia lääketoimittajana keskeiseksi tutkimuksen onnistumiselle. 🤝 Lue tarkemmin, kuinka Medfilesin ‘avaimet käteen’ -palvelu mahdollistaa tämän tärkeän tutkimuksen toteutumisen: https://lnkd.in/es9D-TFE #tutkimuslääke #IMP #kliininentutkimus #lääketutkimus

Greetings from #Medica2024 in Düsseldorf, Germany! 🇩🇪 Yesterday offered valuable discussions with professionals across the medical device sector. With two days remaining, there’s still time to connect with Medfiles’ Head of Operations for Medical Devices, Eric Schwandt. Reach out to arrange a meeting and explore potential opportunities! #medicaldevices #MDR #IVDR

Meet Elina Krannila, our experienced Regulatory Affairs Expert who's been working with veterinary medicines for over a decade. 💎 Get to know her through an interview: 🐾 𝐖𝐡𝐚𝐭 𝐭𝐚𝐬𝐤𝐬 𝐝𝐨𝐞𝐬 𝐲𝐨𝐮𝐫 𝐕𝐄𝐓-𝐫𝐞𝐥𝐚𝐭𝐞𝐝 𝐰𝐨𝐫𝐤 𝐢𝐧𝐜𝐥𝐮𝐝𝐞? I mainly handle regulatory tasks related to marketing authorisations (MA) of veterinary medicines. Our team works daily with veterinary MA applications and maintenance tasks which concern veterinary medicinal products approved in the EU through various procedures. We follow the latest news in the field closely and are well-versed in veterinary legislation and the applicable regulatory guidance, such as the EU Veterinary Medicinal Products Regulation, UK VMD guidance and the US FDA guidance. 🐾 𝐖𝐡𝐚𝐭 𝐚𝐫𝐞 𝐲𝐨𝐮𝐫 𝐜𝐨𝐫𝐞 𝐜𝐨𝐦𝐩𝐞𝐭𝐞𝐧𝐜𝐞𝐬 𝐚𝐧𝐝 𝐬𝐭𝐫𝐞𝐧𝐠𝐭𝐡𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐕𝐄𝐓 𝐟𝐢𝐞𝐥𝐝? My core competence is in ensuring compliance with veterinary medicines regulations. My strengths are interpreting the regulatory requirements and communicating with a multidisciplinary team of experts, including the competent authorities. This means having an eye for detail and at the same time, being able to analyse the best approach and schedule for the overall regulatory process. Gaining approval for an MAA or a variation or bringing a veterinary product to the market is always a group effort, in which an experienced RA plays a crucial role. 🐾 𝐇𝐨𝐰 𝐢𝐬 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐯𝐞𝐭𝐞𝐫𝐢𝐧𝐚𝐫𝐲 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬 𝐝𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭 𝐟𝐫𝐨𝐦 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐡𝐮𝐦𝐚𝐧 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬? The most significant difference is having completely different implementation deadlines and procedures for variations not requiring assessment (VNRAs) which are now handled for VET medicines via a separate portal, namely the UPD. Another significant practical difference is that in some countries the competent authority is different for VET and HUM medicinal products. Although there are great differences from the HUM regulations compared to the current VET regulation, the benefit with the current common VET Regulation is that within Europe, there is less variation from country to country as the regulation is in force as such and there are clear guidelines and templates in use specifically for VET medicines. 🐾 𝐁𝐞𝐬𝐭 𝐭𝐡𝐢𝐧𝐠 𝐚𝐛𝐨𝐮𝐭 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐚𝐭 𝐌𝐞𝐝𝐟𝐢𝐥𝐞𝐬? My colleagues: to be surrounded and supported by such friendly, enthusiastic and professional colleagues is heartwarming and something I truly enjoy every day. Also, the variety of interesting and meaningful projects: My favourite tasks are related to products reaching new markets. It is always a joy to be a part of such teamwork and to be able to contribute to this with my own expertise – and to gain more expertise along the way. Meet also the other members of the animal health team ➡ https://shorturl.at/dmEUX #veterinarymedicine #regulatoryaffairs #animalhealth #workatmedfiles

💡The EU's novel food guidance is sparking debate among regulatory professionals. Dr Eskola Mari of Medfiles and Dr Jerome Le Bloch of FoodChain ID consider the implications for food supplements and innovation in the sector. Do these regulations pave the way for safety and progress, or could they slow down the development of new, beneficial products? For a deeper dive into this topic and expert insights, read the full article ⬇ #foodsupplements #foodinnovation #foodregulation #novelfoods Citeline

#MedSafetyWeek 𝐢𝐬 𝐡𝐞𝐫𝐞 𝐚𝐧𝐝 𝐭𝐡𝐢𝐬 𝐲𝐞𝐚𝐫 𝐢𝐭'𝐬 𝐚𝐥𝐥 𝐚𝐛𝐨𝐮𝐭 𝐩𝐫𝐞𝐯𝐞𝐧𝐭𝐢𝐧𝐠 𝐚𝐝𝐯𝐞𝐫𝐬𝐞 𝐫𝐞𝐚𝐜𝐭𝐢𝐨𝐧𝐬. Regulators rely on the reporting of adverse drug reactions (ADRs) to ensure that medicines on the market are acceptably safe. Unfortunately, all reporting systems suffer from under-reporting. Thus, it's important to raise awareness of pharmacovigilance systems and promote the recognition and reporting of suspected ADRs. In honour of the theme week, we'll introduce you to the important role of Medfiles' QPPV, Saara Mikkola. ⬇ A Qualified Person Responsible for Pharmacovigilance (QPPV) plays a crucial role in ensuring the safety of medicines, and the presence of a QPPV is mandatory for all marketing authorisation holders in the EU. Saara describes that the role encompasses three primary areas: 💊 𝐄𝐬𝐭𝐚𝐛𝐥𝐢𝐬𝐡𝐢𝐧𝐠 𝐚𝐧 𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐏𝐕 𝐬𝐲𝐬𝐭𝐞𝐦 “My primary responsibility is to develop and implement processes that ensure the accurate collection, assessment, and monitoring of all safety data concerning medicinal products. An essential aspect of this responsibility is maintaining the Pharmacovigilance System Master File (PSMF), which provides a comprehensive description of the entire PV system and is crucial for regulatory inspections. This system is essential for identifying potential risks as early as possible and includes ensuring compliance with EU regulations and adapting to new regulatory requirements or scientific advancements.” 💊 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐭𝐡𝐞 𝐬𝐚𝐟𝐞𝐭𝐲 𝐩𝐫𝐨𝐟𝐢𝐥𝐞𝐬 𝐨𝐟 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 “I oversee the safety of the medicinal products covered by the PV system(s) I am responsible for. This requires a comprehensive and up-to-date understanding of the risks associated with these products, including both potential and actual risks. It is crucial to continuously evaluate the benefit-risk balance of each product.” 💊 𝐒𝐞𝐫𝐯𝐢𝐧𝐠 𝐚𝐬 𝐭𝐡𝐞 𝐩𝐫𝐢𝐦𝐚𝐫𝐲 𝐥𝐢𝐚𝐢𝐬𝐨𝐧 𝐛𝐞𝐭𝐰𝐞𝐞𝐧 𝐭𝐡𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐲 𝐚𝐧𝐝 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐚𝐮𝐭𝐡𝐨𝐫𝐢𝐭𝐢𝐞𝐬 “As the EU QPPV, I am the primary point of contact between the company and regulatory authorities. This role requires maintaining an open, transparent, and consistent line of communication with all relevant health regulatory bodies. I am responsible for ensuring that all PV-related communications, including reports of adverse reactions, periodic safety updates, and responses to regulatory inquiries, are accurately and promptly submitted in accordance with legal and regulatory standards.” Read Saara's full introduction: https://lnkd.in/eBt8iZ25 #pharmacovigilance #drugsafety #PV #QPPV #workatmedfiles

🐾 How has the Veterinary Medicines Regulation changed veterinary pharmacovigilance? What valuable lessons have we learned for the future? As we approach the three-year anniversary of the regulation, now is an opportune time to reflect on its impact on the veterinary medicinal products (VMP) industry. Read our blog post for insights from an expert ➡ https://lnkd.in/eF39QjK9 #veterinarymedicines #pharmacovigilance #PV #drugsafety