My Language Connection Ltd’s Post

Even after 4 Years, Navigating the Post-Brexit UK Regulatory Landscape for European Veterinary Businesses Remains a Maze. The post-Brexit UK market has introduced new challenges for European Union veterinary manufacturers, who must now find the right balance to stay compliant in both markets while navigating two distinct regulatory frameworks. In our latest article, Leonardo Giraudo explains these changes and provides insights on how to thrive in both the EU and UK markets. Read it here 👇: https://hubs.ly/Q03422YS0

Mark your calendars! Don't miss our webinar: “Ensuring Excellence – Implementing Quality in Veterinary Clinical Trials" to learn how to maintain high quality standards in your trials and improve data reliability. Key topics we will discuss: - Understanding quality in veterinary trials - Differentiating quality control from quality assurance - Practical examples and the role of audits When: November 14th at 16:00 CET Register here: https://hubs.li/Q02QfxyD0 Join us for an insightful webinar on quality assurance and control measures, and learn how to maintain the highest standards throughout every stage of your trial. #VeterinaryTrials #QualityAssurance #CRO #CDMO

We are thrilled to share our latest VacciCheck Performance Data! VacciCheck by Biogal Labs is supported by robust clinical studies conducted by leading veterinary institutions in the United States and worldwide. These studies highlight its scientific validity, ensuring reliable and evidence-based diagnostic results. With a foundation in rigorous research, VacciCheck meets the highest regulatory standards, including USDA approval, reinforcing its trustworthiness and accuracy. If you have any questions about our veterinary diagnostic products or would like to discuss the science behind them, feel free to reach out to me directly! This version highlights the scientific backing as a key strength of the product. Let us know if you'd like further refinements! #Biogal #VacciCheck

🐾 From four-legged friends to feathered, finned, and scaled companions, veterinary #pharmacovigilance ensures the safety and efficacy of medicines used in animals.     When it comes to activities like ADR reporting and sharing important safety information, what are the differences and similarities between the worlds of veterinary and human pharmacovigilance?        James Mount (Medical Products Agency Läkemedelsverket) will join the #DrugSafetyMatters podcast to unpack the complexities of monitoring animal drug safety in a special two-part series.      💬 Here's your chance to #AskUsAnything — comment with your questions below👇 by 5 December!

🇬🇧 Brexit has caused a domino effect across various industries, including veterinary safety data reporting. With new regulatory frameworks emerging, Life Science companies must navigate separate systems set by the UK's Veterinary Medicines Directorate (VMD) and the European Medicines Agency (EMA). Read Nic Pillinger's latest blog post to learn about the key challenges and proactive strategies to stay compliant in a post-Brexit world. 💡 👉 Read the article: https://lnkd.in/gdFifqsm #Brexit #LifeSciences #RegulatoryCompliance #VeterinarySafety #EMA #VMD

EMA’s CVMP met with Stakeholders on 22 May in Amsterdam With around 50 in-person attendees, including CVMP members, stakeholders, and EMA staff, and an additional 40 joining online, the meeting facilitated significant discussions on veterinary medicinal products. ✅ Nancy De Briyne, representing FVE, updated CVMP members on the #AMR Training workshops. Among other topics discussed were: ✅ Setting Maximum Residue Limits (MRLs) for #EssentialOils ✅ Environmental risk assessment for pet #parasiticides ✅ List of essential products for #equines and the #aquatic list (to be ready later this year), ✅ Collecting of Real-World Evidence and the 3Rs (Replace, Reduce, Refine) in Animal Testing.

Kick off 2025 with our latest white paper on veterinary drug residue testing in food, where we explore the global regulatory landscape for Veterinary Medicinal Products (VMPs). ⬇️https://okt.to/zcfO4j In this insightful white paper, created with the expertise of food analysis expert John Points, you will discover: ✔️ A comprehensive overview of residue surveillance plans around the world ✔️ Regulatory requirements for testing methods ✔️ Guidelines for international trade approval for food exporters #AntimicrobialResistance #FoodAnalysis #DrugResidues #whitepaper

Propentofylline is a drug that has been around since the early 1990s (marketed first as the brand Vivitonin and also more recently as Vitofyllin). The marketing authorisation supports the products' use for improving "dullness, lethargy and overall demeanour in dogs" and the BSAVA Small Animal Formulary suggests using it for treating age-related behaviour problems. A subscriber asked us to look into the evidence behind propentofylline. You'll see that we found clinical evidence difficult to track down. This has highlighted a lack of transparency about the basis for the authorisation of veterinary medicines that have been on the market for a long time. The lack of access to the clinical information assessed during the authorisation process (beyond the brief summary in the SPC/data sheet) limits the application of evidence in practice and impairs vets' ability to communicate transparently with clients about the value of a treatment. Click below to see what we were able to find out about propentofylline in the latest module Propentofylline - what does it do? (log in or subscribe) https://zurl.co/x7N5 #veterinarymedicines #prescribing #transparency #EBVM

It's knoell's last veterinary regulatory affairs update for 2024! A festive feast of veterinary regulatory news awaits you in knoell's EU update for November and December. A couple of CVMP guidelines have been adopted and will come into effect in 2025 - on stability testing for variations to MAs of VMPs, and a first revision of the guideline on the evaluation of the benefit-risk balance of VMPs. Several revised VICH Guidelines relating to the efficacy of anthelmintics were also adopted by CVMP in November. There are links to information and reference documents relating to EMA's New Fee Regulation which comes into force on 1st January; MAHs and Applicants should be sure to check how the changes impact their planning. Presentation slides and recordings from recent EMA events have been made available online, and a couple of events for 2025 are already notified. Happy reading and our good wishes for the season! #knoell #animalhealth #VeterinaryMedicine #RegulatoryAffairs https://lnkd.in/eprznk5m

Animalcare Group has completed the acquisition of Australian equine veterinary business, Randlab, for £62.2m. The York-based supplier of veterinary pharmaceutical products used cash from existing resources and committed debt facilities, as well as £20m, to fund the deal, which was announced last month #animalcaregroup #randlab #investment #acquisition