Real Chemistry’s Post

Sign up for our next insight to impact masterclass with 8foldGovernance Discover how to leverage and translate your current efforts in digital healthcare compliance to gain a competitive edge in both UK and international markets. The webinar will cover important topics, including: ▶ What are International Standards ▶ How a compliance and regulatory strategy can support fundraising strategies ▶ How International Standards can provide a competitive advantage to digital health businesses ▶ How businesses with International Standards can expedite compliance against the DTAC into the NHS Register for free: https://lnkd.in/dbTeNvCd

An important reading for improving patient safety and quality health care, by Martin Fletcher and colleagues in Australia. The authors conclude that: """"The framework continues to evolve, building upon the key strengths of Ahpra’s Regulatory Intelligence function: cross-directorate teamwork, co-regulatory collaboration, and the active contribution of insights from a wide range of sources. This collective effort shifts the healthcare regulatory paradigm to one that applies an upstream systems approach prioritising proactive actions and early intervention whilst balancing safe consumer access. We offer these insights from our collaborative practice to inform the work of other countries and improve healthcare globally."""""

How much clinical data is enough for EU compliance? Too many MedTech companies overdo it and waste resources. Others fall short and face non-compliance. Join us on November 19, 2024, at 9:00 AM ET for a webinar that cuts through the noise. ✅ Navigate EU regulations with clarity. ✅ Understand when clinical data is truly needed. ✅ Optimize your compliance strategy to avoid costly mistakes. Featuring insights from: 👉 Bassil Akra from AKRA TEAM 👉 Chris Rush from Greenlight Guru Register now to make informed decisions and strengthen your compliance game. https://bit.ly/48QIy9h

🚨 What’s on the EU health policy radar for 2025? After 2024’s legislative slow-down, Brussels is kicking off the new year with a packed agenda: 🧑💻 Hospital Cybersecurity & Critical Medicines Act – Two major health files are expected within the first 100 days of the new Commission. Tackling drug shortages is Health Commissioner Olivér Várhelyi’s top priority, but delivering the Critical Medicines Act by early March will be a race against time — especially since key stakeholder recommendations won’t land until mid-February. ⚙️ Medical Devices Regulation (MDR) – The ongoing headache for medtech companies gets an evaluation this year. Will reforms finally come? The pressure is mounting from MEPs, industry, and clinicians alike. 💊 Pharma Package – Crunch time is here. The Polish Presidency is leading Council discussions on pharma incentives. If they don’t secure a position, the baton passes to Denmark. Either way, trilogues likely won’t conclude before 2026. 💥 Compulsory Licensing – Quietly contentious. Trilogue talks on IP rights are expected to kick off towards the end of Feb. The proposal to force companies to share trade secrets during a crisis is sparking concerns across pharma and biotech. The clock is ticking in Brussels. Ready for the ride? 💼

Our Inaugural "State of the Medical Industry in Zimbabwe" Magazine is Now OUT! 🌟 We are thrilled to announce the release of our very first edition of the State of the Medical Industry Magazine in Zimbabwe, centered around the theme: Professionalism and Compliance: Creating a Strong Foundation for Industry Harmony and Collaboration. This issue dives deep into crucial discussions impacting the future of healthcare, including: 🔍 Exploring the Impact of Technology on Patient Privacy and Compliance 💡 Combating Corruption and Conflict of Interest in Healthcare 🤝 The Role of Professionalism in Building Trust in Healthcare This is just the beginning! Don’t miss out on insightful articles, expert opinions, and the latest trends shaping the medical industry. Click the link to view the full magazine now: 👉 https://rpb.li/ndtV6

🤔 When is it justified to use the most harmful substances? Today, The EU Commission published its communication on the “Essential Use" concept. This clarifies the need to phase out the most harmful substances and that uses cannot be considered essential if alternatives are available. We hope this will make the regulation of hazardous substances more effective and that the implementation of relevant regulations will not be further delayed. 🤓 After a quick read, here are some of the positive things we see: 👉  Clarity reigns supreme: The focus on preventing harm from the most harmful substances is crystal clear. 👉 We're thrilled they're adopting "our" terminology – asking if the use of harmful substances can be justified is spot on! 👉  Original criteria stay put, and alternatives are still a key consideration. No alternatives? No essential use, even in healthcare. Bravo! 👉  Embracing a broad definition of alternatives – it's not just about products but anything delivering the same function. Read more: https://lnkd.in/dkFsFedy

The healthcare and life sciences sector in the EU and Germany will undergo several important regulatory changes in 2025, such as the introduction of the EU Health Technology Assessment, amendments to the EU Variation Regulation, the introduction of the Electronic Patient Record and the Medical Research Act in Germany. Our life sciences team has summarized some of the key developments. https://lnkd.in/eCS3u6FE #AOShearman

🔴 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗡𝗼𝘄 𝗳𝗼𝗿 𝗡𝗼𝗕𝗼𝗖𝗮𝗽 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆 𝗦𝘂𝗺𝗺𝗶𝘁! 🔴 Mark your calendars for September 24-25, 2024, and join us in Brussels for two days of high-level dialogues and sessions on MDR/IVDR regulations and innovation in MedTech. Hear the speakers discuss building your knowledge about MDR\IVDR requirements, gain insights from EC Representatives on the evolving EU regulatory environment, and participate in workshops and panel discussions. Connect with innovators, SMEs, and Notified Bodies through engaging sessions and networking opportunities. Join NoBoCap Community Summit to stay ahead in the evolving regulatory landscape and ensure your innovations comply with MDR/IVDR requirements. 🔗 𝗟𝗲𝗮𝗿𝗻 𝗺𝗼𝗿𝗲 𝗮𝗻𝗱 𝗿𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗵𝗲𝗿𝗲: https://lnkd.in/dYTzpv-C #NoBoCap project is co-funded by European Union through #EU4Health programme. #EU4Health #NoBoCap #NotifiedBodyIncreasedCapacity #project #Qualify2Certify #HealthUnion #HaDEA #NoBoCapCommunity #NoBoCapSummit #MedTech #Innovation #MDR #IVDR #Regulations #Brussels #Networking #ExpertInsights #Regulatory #Landscape

The World Health Organization’s (WHO) new framework aimed at strengthening clinical trial systems addresses a global issue of “major research waste,” including four critical issues. Speaking at the Outsourcing in Clinical Trials (OCT) DACH 2024 conference, which took place in Zurich, Switzerland from 29 to 30 October, Moorthy noted: “All the WHO Member States agreed that this was a big problem.” “We see inefficiency in the way that the regulator and the ethics systems work together.” A lot of improvements could be made with multi-agency approval processes, the timelines for approving large, multi-site, multinational studies, he added. https://gag.gl/cSRJuw

Is your organization prepared for the JCA changes coming in 2025?    At ISPOR Europe 2024 in Barcelona, a key focus was the upcoming changes in Health Technology Assessment (HTA) regulations. As the new Joint Clinical Assessment (JCA) rules are set to take effect in January 2025, stakeholders across the healthcare sector are raising critical questions.    Lumanity’s article summarizes some of the key insights from the conference. Check it out here: https://lnkd.in/gEX9sdd6    #HealthEconomics #OutcomesResearch #HTA #ISPOREurope