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Upcoming Events Regulatory Affairs Newsletter Archive

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Improve your URRA with Expert Advice

Open Forum: Use-Related Risk Analysis Q&A   Tuesday ,Nov, 18, 2025 | 9:00 AM - 10:00 AM CST Join our subject matter experts, Merrick Kossack, senior research director; Frauke Schuurkamp, managing human factors specialist; and Rachel Aronchick, managing human factors specialist, from Emergo by UL’s Human Factors Research & Design team on Nov. 18, 2025, from 9–10 a.m. CST for…
Ben Kemp
November 13, 2025
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Eudamed Workshop – 3rd December 2025, Brussels

Introduction to the EUDAMED Workshop The European Commission is organising two free hybrid workshops to support the onboarding of all concerned actors to EUDAMED, in preparation for the mandatory use of Actors, UDI/Devices, Notified bodies and Certificates and Market surveillance modules. The workshop provides an overview of the obligations under the Medical Devices Regulations (Regulation (EU) 2017/745 — MDR, and Regulation (EU) 2017/746 — IVDR). These workshops are a…
Ben Kemp
October 22, 2025
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Premarket to Postmarket: Navigate Global Cybersecurity Expectations with Confidence

Strategic Cybersecurity for Regulatory Success—Are You Aligned?   12 and 14 November 2025  •  9:00 AM - 5:00 PM ET  •  12.0 RAC Credits   Health authorities spanning the US, European Union, Australia, Canada, and Japan have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes…
Ben Kemp
September 25, 2025
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UK NEQAS Microbiology and Parasitology webinar on POCT

UK NEQAS is holding a six-part pan-disciplinary webinar series Quality Standards in Point of Care Testing. The second webinar will take place on 1 October 2025 and registration is now open at https://us06web.zoom.us/webinar/register/WN_a1-uMaqNThitDqJ0F-k1OA The webinar will include the following presentations – Professor Peter L. Chiodini Malaria Antigen Rapid Diagnostic Tests, what a dipstick! With apologies to "Only Fools and Horses”…
Ben Kemp
September 25, 2025
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Big Changes Coming: North American Packing Laws…

Thursday, September 18 10 AM ET  /  7 AM PT  /  4 PM CET Extended producer responsibility (EPR) laws are moving fast across the U.S. and Canada, and manufacturers are already on the hook for product end-of-life management. The cost of inaction? Fines, lawsuits, and potential loss of market access. Join our upcoming webinar to get clear on what these…
Ben Kemp
September 12, 2025
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A Deep Dive into Regulatory Intelligence in Europe

Advance with Insight. Lead with Intelligence. In an era of accelerated innovation and ever-changing global requirements, regulatory intelligence requires more than just knowledge — it demands foresight. The 2025 Regulatory Intelligence Conference Europe, an immersive two-day conference hosted by TOPRA and RAPS, is designed to equip you with the strategic insights and tools to stay ahead. Here’s a sneak peek…
Ben Kemp
August 28, 2025
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TOPRA Symposium 2025: 30 September – 1 October, and Masterclass

TOPRA are holding their 2025 Symposium in Berlin from 30th September - 1st October. The event promises to cover some of the most important topics affecting IVDs and medical devices, particularly those affecting the EU. You can find the agenda and booking information here. Please find below information related to TOPRA's IVD masterclass later on this year. Regulation of In-Vitro…
Ben Kemp
August 13, 2025
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Register for the next IFCC Webinar: “The Role of Machine Learning in Advancing Pediatric Laboratory Medicine” – 30 June, 2025

The next IFCC webinar: "The Role of Machine Learning in Advancing Pediatric Laboratory Medicine" - will be held on June 30, 2025. Machine learning, is a powerful tool within artificial intelligence, which is revolutionizing diagnostics and predictive modeling across various medical fields. However, its application in neonatology and pediatrics, is still in its early stages. To accelerate its integration into…
Ben Kemp
June 26, 2025
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Webinar – 2 July | Companion Diagnostics in Pharma studies

Details: 🗓️ Date: 2 July 2025 ⏰ 4:00 - 5:00 PM CET | 3:00 - 4:00 PM GMT 🔗 Register Now and Save Your Spot! This webinar will discuss regulatory requirements for using Clinical Trial Assays and Companion Diagnostics in pharmaceutical clinical studies and share best practices for overcoming typical challenges. Learning objectives Understand the regulatory requirements for using Clinical Trial…
Ben Kemp
June 13, 2025
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Join the Next R&D Leaders Circle on June 26!

The MDIC-Deloitte R&D Leaders Circle Returns June 26! Join us at our next gathering of the MDIC-Deloitte R&D Leaders Circle, a unique community of practice for seasoned and emerging leaders in medical device Research and Development and Project and Portfolio Management. Our next virtual meeting will include a dynamic panel discussion exploring how AI is transforming MedTech innovation and product development.…
Ben Kemp
June 9, 2025
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