RAPS UK Local Networking Group

Hello RAPS UK!! Looking for people with expertise in post-market surveillance and yellow cards in the UK to participate in an on-line workshop for BSI's ContestAI research project. Please message me on here on LI or email me at [email protected] thank you!!

The U.S. Food and Drug Administration (#FDA),#HealthCanada, and the Medicines and Healthcare products Regulatory Agency (#MHRA) have jointly issued the “𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬.” The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles builds upon the "𝐆𝐨𝐨𝐝 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 (𝐆𝐌𝐋𝐏) 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" and the"𝐏𝐫𝐞𝐝𝐞𝐭𝐞𝐫𝐦𝐢𝐧𝐞𝐝 𝐂𝐡𝐚𝐧𝐠𝐞 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐏𝐥𝐚𝐧𝐬 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" both published jointly by the FDA, Health Canada and MHRA. Transparency across health care must be an international priority. Read documents here: https://lnkd.in/dK-X6-Zw https://lnkd.in/ejqWRmV3

𝐌𝐇𝐑𝐀: 𝐒𝐭𝐚𝐭𝐞𝐦𝐞𝐧𝐭 𝐨𝐟 𝐩𝐨𝐥𝐢𝐜𝐲 𝐢𝐧𝐭𝐞𝐧𝐭: 𝐢𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐫𝐞𝐜𝐨𝐠𝐧𝐢𝐭𝐢𝐨𝐧 𝐨𝐟 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬 21 May 2024 The statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices. This statement and proposed framework applies to medical devices in Great Britain. 📔 Read full document here: https://lnkd.in/d4nWf3QP #regulatoryaffairs #medicaldevices #mdr #ivdr #MHRA #ukca

𝐑𝐄𝐂 𝐕𝐢𝐫𝐭𝐮𝐚𝐥 𝐄𝐯𝐞𝐧𝐭: 𝐓𝐡𝐞 𝐍𝐞𝐰 𝐒𝐮𝐩𝐞𝐫𝐡𝐞𝐫𝐨 𝐨𝐧 𝐭𝐡𝐞 𝐇𝐨𝐫𝐢𝐳𝐨𝐧 – 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐫𝐞𝐚𝐝𝐲 𝐟𝐨𝐫 𝐞𝐂𝐓𝐃 𝐯𝟒.𝟎? Register here: https://lnkd.in/es7V7BWs This Explorer Class is designed to provide you with a comprehensive understanding of the Electronic Common Technical Document (eCTD) v4.0 submission process. We will start by introducing the 5 key principles that will form the blueprint of your #eCTD v4.0 journey. You will learn how to identify and effectively manage the challenges in implementing a new standard and how to navigate the required activities sustainably. We will look at the expectations of the pharmaceutical industry and global health authorities. Our experts will provide you with a comprehensive understanding of the industry’s expectations and how you can leverage eCTD v4.0 to meet them. This Explorer Class is specifically designed for regulatory affairs professionals who want to stay ahead of the curve and gain the knowledge that can support your organizations compliance. This event is free for Regulatory Affairs Professionals Society (RAPS) members! Take advantage of your member benefits and gain RAC credit! #pharmaceuticals #medicines #regulatoryaffairs #regulatorycompliance

𝐌𝐇𝐑𝐀 𝐠𝐫𝐚𝐧𝐭𝐬 𝐟𝐢𝐫𝐬𝐭 𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐯𝐢𝐚 𝐭𝐡𝐞 𝐧𝐞𝐰 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐑𝐞𝐜𝐨𝐠𝐧𝐢𝐭𝐢𝐨𝐧 𝐏𝐫𝐨𝐜𝐞𝐝𝐮𝐫𝐞 𝐢𝐧 𝟑𝟎 𝐝𝐚𝐲𝐬 The IRP allows the #MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process. As a result, medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, resulting in a more rapid, efficient, and cost-effective process for life sciences companies. https://lnkd.in/e7Xz9Ukp #medicines #pharmaceuticalindustry #ectd

See British In Vitro Diagnostics Association (BIVDA) and MedTech Europe working together: https://lnkd.in/eMr9wYxG

Dame June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that she will be stepping down in the Autumn following five years in the role. She took up the post in August 2019, following a career in medicines regulation. https://lnkd.in/eTq6KgGC #MHRA #medicines #medicaldevices

𝐓𝐞𝐚𝐦-𝐀𝐁 announces formation: a non-profit collaborative association that represents the UK Approved Bodies for medical devices and IVDs in their dealings with associated stakeholders. Key stakeholders include the MHRA, other UK Government departments, the European Commission, industry associations, or the media. The Team-AB forum permits the sharing of experience, co-ordination of practice and discussion on aspects of the medical device regulation and conformity assessment between member certification bodies. #notifiedbody #mhra #medicaldevices #regulatorycompliance #approvedbody

𝐓𝐞𝐚𝐦-𝐀𝐁 announces formation: a non-profit collaborative association that represents the UK Approved Bodies for medical devices and IVDs in their dealings with associated stakeholders. Key stakeholders include the MHRA, other UK Government departments, the European Commission, industry associations, or the media. The Team-AB forum permits the sharing of experience, co-ordination of practice and discussion on aspects of the medical device regulation and conformity assessment between member certification bodies. #notifiedbody #mhra #medicaldevices #regulatorycompliance #approvedbody

⏰ Register for the Medicines and Healthcare products Regulatory Agency's upcoming MedTech Regulatory Reform Webinar ⏰ 📅 05 March 2024, 10:30-12:00 (GMT) Obtain insight into their intentions for the future medical device regulations, with presentations on: 📗 Updates to the scope of the regulations 📘 Changes to the classification of general medical devices, in vitro diagnostic devices and software as a medical device 📙 Changes to essential requirements This webinar will provide manufacturers, trade associations and healthcare professionals with an opportunity to learn about the upcoming updates and to ask questions 🗣️ 🛈 A recording of the webinar will be added to the MHRA website after the event, for anyone who is unable to attend live. To register, visit ➡️ https://bit.ly/3SqdANv #mdr #ivdr #diagnostics #medicaldevices #MHRA #EMA #regulatorycompliance #regulatoryaffairs #samd