Medfiles

What does the change in classification of medical devices and IVDs mean? How will these devices be classified in the future? And what are the transition periods for the changes? We have written a comprehensive blog to answer these important questions. Click to read ➡️ https://buff.ly/3Kum6HG #MDR #IVDR #medicaldevice #IVD

Would you like to explore the key changes and requirements introduced by the EU Veterinary Medicinal Products Regulation? 🐾 Watch our free webinar and · Gain a comprehensive overview of variation management and timelines. · Get tips on the best practices for QRD 9 template updates. · Learn more about the requirements for PV systems of veterinary medicines, as well as the related quality assurance activities. ➡️ Download for free: https://buff.ly/45cIDCa #veterinarymedicine #regulatoryaffairs #pharmacovigilance #pvsystem #variation #QRD

Do you work with medical devices and need information on the MDR/ISO 14155:2020 good clinical practice requirements? 📘 The MDR states that clinical investigations must be performed according to good clinical practice. In addition to observing the requirements set in the MDR itself, sponsors must also be aware of the requirements set in the ISO standard. We have created a guide on what you need to know about the good clinical practice requirements regarding the clinical investigation set-up, monitoring and ending phase. ➡️ Download for free: https://buff.ly/4e5Seit #MDR #GCP #medicaldevice #clinicalinvestigation #goodclinicalpractice

Food, feed or cosmetic operator: enhance your expertise during the summer months with our complimentary webinars! The webinars cover a range of regulatory topics and are available for you to watch at any time: 🥬 Novel food classification and route to novel food authorisation in the EU: https://buff.ly/3KwQnFF 🍓 How to get health claims approved in the EU? https://buff.ly/3Re2aMU 🏷️ Overview of food labelling in the EU: https://buff.ly/3XdOlBP 🧃 FSMP – an overview of EU legislation and regulatory classification: https://buff.ly/3JxkSuF 🐾 Regulatory aspects of feed labelling in the EU: https://buff.ly/3VxfQFt 💄 Overview of cosmetics regulatory requirements & package labelling: https://buff.ly/3X6Lafo #food #FSMP #animalfeed #cosmetics #novelfood #healthclaim #labelling

The delegated regulation amending Regulation (EC) 1234/2008 and addressing variations to marketing authorisations has been published in the Official Journal of the European Union. The objective of the amendments is to make the life-cycle management of medicines more efficient and to simplify the processing of variations by the authorities, through for example the following measures: 🔍 The term "super-grouping of variations" will be introduced in the Regulation, although super-grouping has already been used for type IA/IAIN variations for groups of products with different RMSs, as guided by the CMDh. The updated Regulation will include purely national marketing authorisations in the super-grouping, to harmonise national marketing authorisations in different member states. 🔍 A risk-based approach will be implemented for handling variations by reclassification of some changes into lower categories, e.g. the extension of an approved design space can be applied as type IB instead of type II variation. 🔍 Submitting IA variations as annual updates or parts of grouping of variations will be encouraged. A proposed amendment to the guidelines on the details of the different categories of variations and operation of the variation procedures has been published for comments from the stakeholders. For more detailed information, visit our website ➡️ https://buff.ly/45NzCA4 #regulatoryaffairs #variations #EURegulation #pharmaceuticals #medicines

Tenboron Oy has been collaborating with Medfiles since 2015 to produce an antibody-boron conjugate molecule for cancer treatment. The production of the molecule is a two-step process, in which the boron part of the boron carrier is produced under Medfiles’ licence and quality system. According to Juha Jouhki, CEO of Tenboron, outsourcing is a sensible solution for a company that does not have a steady and constant need for manufacturing. He highlights that outsourcing offers advantages in terms of risk management and cost efficiency. Read more on how Juha describes the cooperation ➡ https://lnkd.in/eF7pji84 #cancerresearch #drugdevelopment #pharmaceuticals #BNCT #qualitysystem #GMP

We would like to express our sincerest thanks to our clients and industry colleagues for a successful first half of the year. We wish you a summer season filled with warmth, relaxation, and joy! ☀

Today is World Blood Donor Day – an event to raise awareness of the need for safe blood and blood products. Our volunteer donors at Medfiles regularly donate life-saving blood through the Red Cross and have been awarded a certificate for helping those in need of blood transfusions. We encourage everyone to follow in these footsteps and donate, e.g., through Red Cross centres! 💝

Before embarking on your holiday, we invite you to explore a selection of our most popular publications from the past six months! 💊 𝐇𝐮𝐦𝐚𝐧 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬 · Pharmaceutical-technological expertise ensuring successful drug development projects and manufacturing of IMPs: https://lnkd.in/eUKxpW-f · 𝐅𝐫𝐞𝐞 𝐠𝐮𝐢𝐝𝐞: tips for successful CTIS submissions: https://lnkd.in/gwWDcEKi · Six reasons to engage CMC experts in drug development at an early stage: https://lnkd.in/ekwdWCeM · Global pharma company & Medfiles: cooperation in obtaining and maintaining marketing authorisations in the EU: https://lnkd.in/eWert92d · EU QPPV ensures drug safety across Europe: https://lnkd.in/eBt8iZ25 🐾 𝐕𝐞𝐭𝐞𝐫𝐢𝐧𝐚𝐫𝐲 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬 · 𝐅𝐫𝐞𝐞 𝐰𝐞𝐛𝐢𝐧𝐚𝐫: EU Vet Regulation from the perspective of variations and the quality part of the PV system: https://lnkd.in/eEDCHegG · Best practices for QRD updates of PI texts of veterinary medicines: https://lnkd.in/eZNUx7xt · Bimeda & Medfiles: a decade of partnership in veterinary regulatory affairs: https://lnkd.in/e-byArBV 💉 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 𝐚𝐧𝐝 𝐈𝐕𝐃𝐬 · What to know about medical device and IVD class changes and transition periods? https://lnkd.in/emiy4XUj · 𝐅𝐫𝐞𝐞 𝐠𝐮𝐢𝐝𝐞: How to meet MDR Good Clinical Practice requirements in practice? https://lnkd.in/eMrvt5Tf · WellO2 & Medfiles: good collaboration smooths the path to clinical study success: https://lnkd.in/e6_uM9Ey 🍏 𝐅𝐨𝐨𝐝 · Will algae-based new foods soon feed Europe? https://lnkd.in/eyW2TXnY · For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics: https://lnkd.in/eF9cPT-n 🐄 𝐅𝐞𝐞𝐝 · Medfiles’ expert’s thoughts on animal feed trends in the changing world: https://lnkd.in/eAgbF_Ei 💄 𝐂𝐨𝐬𝐦𝐞𝐭𝐢𝐜𝐬 · 𝐅𝐫𝐞𝐞 𝐰𝐞𝐛𝐢𝐧𝐚𝐫: Cosmetics regulatory requirements & package labelling: https://lnkd.in/dyPAjanh 𝐏.𝐒. 𝐓𝐨 𝐫𝐞𝐜𝐞𝐢𝐯𝐞 𝐭𝐡𝐞 𝐥𝐚𝐭𝐞𝐬𝐭 𝐩𝐮𝐛𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐢𝐧 𝐲𝐨𝐮𝐫 𝐢𝐧𝐛𝐨𝐱, 𝐬𝐮𝐛𝐬𝐜𝐫𝐢𝐛𝐞 𝐭𝐨 𝐨𝐮𝐫 𝐧𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫: https://lnkd.in/ekjCS3zy #medicines #pharmaceuticals #medicaldevice #IVD #food #animalfeed #cosmetics

🩺 Medfiles is involved in the investigator-initiated ReGenHeart clinical trial, which is ongoing in four countries. Our clinical team has successfully submitted the CTIS transition of this somewhat complex trial into the CTIS system. The ReGenHeart trial evaluates the efficacy and safety of catheter mediated endocardial AdVEGF-D regenerative gene transfer in patients with life-limiting angina pectoris or equivalent symptom despite optimal medical therapy. 🤝 We are pleased to be involved in the study and to have received this positive feedback. Together with our clients, we are securing a healthier tomorrow. #clinicaltrials #clinicalresearch #ReGenHeart #CTIS #IIS