MedEngine’s Post

The European Union's new #HTA Regulation introduces the Joint Clinical Assessment (#JCA), a harmonized approach to clinical evaluations that will reshape the way biotech and medtech companies navigate the Market Authorization Application (MAA) process.    We are excited to invite you to our upcoming webinar on a key development that will transform Marketing in Europe: "How to Master both Marketing Authorization and Joint Clinical Assessment Successfully". 🗓 Date & Time: Oct. 17th, 13:00 CET 📢 Format: Online session 👉 Free registration: https://lnkd.in/ePKqFAZN Decebal Bora, Gabrielle Nayroles, Christelle Fasano, Susan Benjamin, Saku Torvinen, PhD, Linsen Du #Regulatory #MarketAccess

Book your seat! Last chance to register to this free webinar to learn how the Joint Clinical Assessment (JCA) will impact your Marketing Authorization Application (MAA) in Europe.

Learn how to optimize your trials with advice from global clinical research experts! Introducing Clinical Confidential, a new document series from MCRA’s Global Clinical Research Organization. In this series, we’ll reveal the interrelated requirements of clients developing novel healthcare technologies from a global perspective. Led by a team of industry experts and informed by the entire commercialization process, the series will help guide established companies and startups through the clinical trial labyrinth with the goal of maximizing the value of their healthcare innovations. #MCRA #clinicalresearch #medtech #medicaldevice #regulatory #machinelearning #FDAsubmission #digitalhealth Contact Us https://lnkd.in/egTEWYaV

Swissmedic publishes 2023 Annual Report! 🇨🇭📊 The Swissmedic Annual Report for 2023 details the agency's performance in the first year of its new 2023-2026 strategic plan. This plan prioritizes efficient regulatory oversight, expanding international cooperation, fostering trust through public communication, and supporting innovation in new areas of medicine. A significant accomplishment in 2023 was the creation of a dedicated Medical Devices Surveillance Sector, reflecting the growing importance of this field. Swissmedic achieved a top rating from the World Health Organization #WHO as a regulatory agency for therapeutic products, solidifying its position as a global leader. The report provides a wealth of data on Swissmedic's activities in 2023 including financial details, with the agency primarily funded by fees and supervisory levies. The report also details the agency's workload, highlighting the processing of over 12,000 applications for medicinal products and tackling over 6,000 cases of illegal imports. Find the e-paper report here 👉 https://lnkd.in/edNcv-bj Medical devices play a critical role in patient care. As a trusted partner, we provide support and expertise to manufacturers of #medicaldevices, assisting them in meeting #regulatory requirements and delivering safe, effective products. Contact us for hands-on guidance ☞ meetus@taoexcellence.ch #swissmedic #AnnualReport #healthcare #healthcareindustry #medtech #medtechindustry #publichealth #publicSafety #patientsafety #medicaldevicesafety #regulatoryaffairs #regulatorycompliance #Switzerland #Europe #EU

How are GLP-1s impacting your business? If you’re not clear, it’s time to cut through the noise with IQVIA MedTech, as our experts uncover the challenges and opportunities of GLP-1s – allowing you to plan with confidence for a successful MedTech future. Watch on-demand: https://lnkd.in/eiKuWdsJ #GLP1 Joanna Wills

CLIN-r+ are delighted to announce their participation at the SurgiTech 2024 summit on supporting innovation across the surgical pathway and are looking forward to seeing you there on FRIDAY!! Details on the Panel discussion 'Regulatory strategy to ensure your UK and EU market access.' so far…. Common mistakes in the MedTech sector can delay market entry and reduce company value. Our expert panel will explore these pitfalls, offering insights to keep you ahead. By avoiding these blunders, start-ups can maximise investments, speed up market entry, and enhance their valuation. Key discussions include: 👉Setting out with a clear roadmap. 👉What the EU and UK market offers and why the difficulty in producing a Technical Document for this jurisdiction can give you an international advantage and save costs in entering the USA, AU and another markets? 👉Designing a Clinical Development Plan to boost commercial results and company value. Whilst you're there, you are also welcome to make an appointment with us in advance to discuss your regulatory or clinical affairs needs to obtain your MDR CE mark. We are offering clients a free 40-minute consultation (at the event or virtually) to discuss your most pressing EU MDR Clinical Regulatory questions. BOOK NOW! https://loom.ly/-K2iFVc More details and tickets to the event can be found here: https://loom.ly/2a98ylE

Learn how to optimize your trials with advice from global clinical research experts. Introducing Clinical Confidential, a new document series from MCRA’s Global Clinical Research Organization. In this series, we’ll reveal the interrelated requirements of clients developing novel healthcare technologies from a global perspective. Led by a team of industry experts and informed by the entire commercialization process, the series will help guide established companies and startups through the clinical trial labyrinth with the goal of maximizing the value of their healthcare innovations.   Contact Us https://lnkd.in/eEXumAgX   #MCRA #clinicalresearch #medtech #medicaldevice #regulatory #machinelearning #FDAsubmission #digitalhealth

At #GlobalAccess2024, Ireland’s largest MedTech event, Rana Chalhoub, Regulatory Affairs Director at Mecomed, shared her expertise in a panel discussion on #InternationalHarmonization. The discussion emphasized the importance of aligning #regulatory frameworks across borders to streamline market access, reduce #compliance burdens, and ensure patient safety worldwide. It underscored how harmonization is crucial in enabling innovation, accelerating time-to-market for medical technologies, and building a more interconnected global #MedTech ecosystem.

The GHA - German Health Alliance "Regulatory Roundtable" is back on track. After a summer break, we went straight into the discussions on the topics of MDR / FDA and the Indian market access. The 19th edition of the event also showed once again that the problems of the MDR are still very present, especially for smaller Med-Tech companies.  The GHA - German Health Alliance offers its members this roundtable to generate a quick and uncomplicated exchange on the topic of regulatory affairs. See you at the 20th regulatory roundtable in October!   "SHAPING HEALTH FOR ALL" #germanhealthalliance #kimetec #medtech #germany

To all my connections in the Life Sciences industry: sometimes compliance in some EU countries may feel restrictive, but strict regulations mean higher standards. And higher standards are our chance to lead with transparency and integrity in Life Sciences (Pharma, Biotech, MedTech). Let's continue our journey to turn Compliance into Trust - together! 👇 #incompliancewetrust #gcoglobal #gcr #pharma #lifesciences #strategicmeetingsmanagement #stakeholderengagement #hcpengagement