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Upcoming Events Regulatory Affairs Newsletter Archive

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Section 524B: Navigating Healthcare Cybersecurity Compliance – Webinar

The intersection of healthcare and cybersecurity has become a critical bridge in safeguarding patient data and ensuring the integrity of medical technologies. Unpack the complexities of Section 524B, a key legislative directive aimed at fortifying cybersecurity measures within the healthcare sector. You’ll gain insights, get strategic advice, and learn practical steps for complying with Section 524B for medical software development…
Ben Kemp
October 9, 2024
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UK and Ireland Association of Forensic Toxicologists Conference, 10-11th October 2024

I would like to draw your attention to the upcoming UK and Ireland Association of Forensic Toxicologists (UKIAFT) meeting on 10-11th October at Voco Hotel, Leicester (agenda attached). UKIAFT has an annual meeting focussing on post-mortem / forensic toxicology (http://www.ukiaft.co.uk/). Registration includes a tour of the Leicester Tigers stadium (adjacent to Voco) with drinks and canapes followed by the conference meal with…
Ben Kemp
October 1, 2024
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“Understanding IVDR Clinical Evidence Requirements”

Join this free webinar to get invaluable insights on how to understand the Clinical Evidence IVDR life cycle concept to ensure continuous safety and performance of state-of-the-art IVDs. Sebastian Grömminger Principal Consultant at Entourage and I will explore how to master the Clinical Evidence IVDR life cycle concept to ensure continuous supply of safe and state of the art IVDs.…
Ben Kemp
October 1, 2024
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Registration now open for webinar on Implementing the new UK Clinical Trials regulations

The Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with the Health Research Authority (HRA), is hosting a short webinar to introduce our joint plans to share draft guidance with stakeholders and to set out the anticipated timelines for implementing the new UK Clinical Trials regulations. If you sponsor clinical trials or are an interested stakeholders from academia or…
Ben Kemp
October 1, 2024
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Last Call: Register for AI in Health Care Virtual Event

Patients are rapidly adopting AI for everything from second opinions to self-diagnoses, appointment scheduling, and more. Health care organizations must act now to guide patients on using AI in order to minimize risk, boost their engagement and enhance the overall patient experience. Join us for our free virtual event on Octo‌ber 9th to hear experts in the field of AI…
Ben Kemp
September 25, 2024
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Cardiac Marker Dialogues 2024: Cardiac Biomarkers in Real Time

Don't miss the last chance to register for Cardiac Marker Dialogues 2024: Cardiac Biomarkers in Real Time - experiences and opportunities. There's not long until the meeting - book your place now! Hosted by UK NEQAS Cardiac Markers, Cardiac Marker Dialogues: Cardiac Biomarkers in Real Time - experiences and opportunities will be held in Glasgow on Thursday 26 - Friday…
Ben Kemp
September 25, 2024
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BIVDA’s Professor Mike Messenger to speak at global IVD webinar

BIVDA's Head of Regulatory Strategy Professor Mike Messenger will participate in an insightful panel event on IVD regulations alongside fellow global experts on 10 October. The event will cover regulatory landscapes across different territories, providing essential insights into regional requirements and compliance strategies. The panel of industry leaders, regulatory experts, and compliance specialists will guide you through the nuances, challenges,…
Ben Kemp
September 24, 2024
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Get Ahead of AI Regulations – EU AI Act Training

AI is becoming an integral part of our daily lives, and its governance affects everyone, from tech giants to individual users. Qserve will host a two-day AI Act training in Amsterdam, The Netherlands. Qserve and Industry Experts will explore this pivotal legislation and its implications for the medical device and IVD sectors during this training. Speakers include Gert Bos, Coenraad Davidsdochter,…
Ben Kemp
September 18, 2024
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FDA Webinar 24th October – Total Product Life cycle oversight of IVDs

FDA is hosting a webinar on 24 October on its total product life cycle (TPLC) oversight of in vitro diagnostics (IVD). Stakeholder questions need to be submitted by email by 23 September.
Ben Kemp
September 11, 2024
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