Attending #BIOAsiaTaiwan2024? Rakuten Medical's Chief of Staff Louise Chang will present at BIO Asia–Taiwan in Taipei. Stop by Room 402A, 4F, TaiNEX at 12:00 PM, July 25 to learn more about our investigational #Alluminox™ platform.
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I'm really pleased to see this collaborative #DIA/ #RAPS conference on #combinationproducts in Europe happening in January. It has taken a lot of effort from a wonderful organizing committee to bring all the key stakeholders together, from the pharma and medical device industries (representing SME's as well as large companies), national regulatory agencies, EMA, notified bodies, and importantly, the European Commission, from both medicines and medical devices units. The two-day conference will look at the challenges and opportunities of all types of combination and combined products and offer possible ways forward to realize their full potential for the benefit of patients. Check out the agenda as more speaker names are added. Its great to see so many people who have experience from both the regulatory network and industry perspectives - it really does help to understand the challenges on "both sides of the fence"... Thanks to the committee and teams from both RAPS and DIA for all your efforts! 🙏 Looking forward to meeting up again and helping share the outcomes from the discussions 😊 Gert Bos, PhD, FRAPS Tim Chesworth Sabina Hoekstra-van den Bosch, PharmD FRAPS Theresa Jeary Amanda Matthews Thomas W. Møller Sophie Tabutin Anja Wiersma (married Knollema) PhD #combinedproducts #EUMDR #article117 #collaboration #pharmaceuticalindustry #medicaldevices #EMA #EC #NB
Next month, RAPS and DIA are teaming up to put on 2024 Combination Products in the EU, an event that will unite key stakeholders across the field to explore a coordinated drug and device approach to incentivise competitive innovation in Europe. Join us in Brussels on 30-31 January, where experts will exchange ideas via action-oriented working groups that stimulate ideation and innovation around designing solutions for pragmatic implementation. Get your ticket today to join us in Brussels: https://bit.ly/3v0mQ2A
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Looking forward to covering more industry/regulator dialogue on #combinationproducts, this time in the complex European context - with national medicines and medical devices competent authorities, notified bodies, EMA and European Commission all playing a part in the regulatory network.... #combinedproducts #EMA #EC #NB #MDR #Article117
Next month, RAPS and DIA are teaming up to put on 2024 Combination Products in the EU, an event that will unite key stakeholders across the field to explore a coordinated drug and device approach to incentivise competitive innovation in Europe. Join us in Brussels on 30-31 January, where experts will exchange ideas via action-oriented working groups that stimulate ideation and innovation around designing solutions for pragmatic implementation. Get your ticket today to join us in Brussels: https://bit.ly/3v0mQ2A
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Did you know that Singapore is home to quite a number of medical device manufacturing facilities? Products like PCR kits to Class III heart valve implants are being produced locally. Many thanks to Enci Mary Kan and Justin Phoon for swinging by NUS TTI to share about MedTech Catapult! While this national medtech initiative might be new, it is definitely run by an experienced team who are constantly building and strengthening the medtech ecosystem in Singapore. It is evident from all the questions and conversations that we are excited to see how we can work together to support the medtech start-ups! Andy Li Huang Yingying Shuwen Koh Baoyi Cai
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Did you know? 😮 The global market for Software as a Medical Device (#SaMD) is growing rapidly and, according to various forecasts, will be worth 86.5 billion US dollars by 2027. Japan has recognized the potential of SaMD and has taken steps to promote the development and commercialization of these innovative medical solutions. So the time is right for European #MedTech and #DigitalHealth companies to enter or expand into the Japanese market. 🇯🇵🤝🇪🇺 🤔 But how does market entry in Japan work? What current conditions need to be considered and what other trends besides SaMD are there in the Japanese life science sector? 😀 To share as much knowledge as possible with all interested parties, MAGIA2Market Alliance & KOBE Biomedical Innovation Cluster (#KBIC) invite you to a webinar on 𝗠𝗮𝗿𝗰𝗵 𝟮𝟳, 𝗳𝗿𝗼𝗺 𝟵:𝟬𝟬 𝘁𝗼 𝟭𝟬:𝟭𝟱. Sign up – it's free of charge ⏩ https://lnkd.in/dWQ_x8YR And the lineup is worth seeing! 🎯 Sarah Niemann, #LifeScienceNord: Overview of the #MAGIA/#FBRI Collaboration 🎯 Takako Yokochi, FBRI: Exploring the Kobe Biomedical Innovation Cluster 🎯 Tadanori YASUDA, FBRI: Understanding SaMD in Japan: Market, Regulation, and Reimbursement 🎯 Keiko Kobayashi, FBRI: Innovation in Bio-Pharma and Regenerative Medicine 🎯 U. D. Haul, Dürr Dental Japan K.K.: Case Study – Dürr Dental's Success in Japan 🎯 Daniel Gralki, EU-Japan Centre for Industrial Cooperation: Fostering EU-Japan Business Collaborations We are of course delighted that our MAGIA activities together with bioPmed - Piemonte Healthcare Cluster, BioWin - The Health Cluster of Wallonia, Lyonbiopôle Auvergne-Rhône-Alpes and our close friends in #Japan continue to bear fruit!
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Meet with Olga Ivanova, our Business Development Director at BIO KOREA 2024! Let us discuss the latest technology trends and how they can support your clinical trial success. From regulatory strategies to our unique Accelerant methodology, we’ll give you insights on how you can conduct your clinical studies on a global scale. Grab this chance to learn how our Functional Services (FSP) can advance your trial implementation. We’re looking forward to meeting you! #clinicalresearch #clinicaltrials #BIOKOREA #BK2024 #바이오코리아
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The region of Southeast Asia (SEA) is a significant emerging market for industries, including medical technologies (MedTech) industries. As with many other industries, MedTech strongly relies on computer implementations as these provide numerous advantages. In part one of this two-part series of articles, Patent Engineer Martina Barbiero and Principal Nicholas Lakatos discuss if it is possible to meet patentable subject matter requirements in the key countries in SEA for computer implemented medical technologies. Read part one here: https://lnkd.in/gq-ih6vS In part two, we'll look at specific real-life examples of patent applications in the hub of SEA, Singapore, and draw comparisons to how the same technologies are treated in Australia with respect to patentable subject matter.
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Last week, during the 2nd International DCT Salon by DCT-I in China, John Reites, CEO, THREAD, had the opportunity to present on global trends in decentralized clinical trials to consider in 2024. During the webinar, he also shared case studies, providing examples of study designs aligning with the global trends that sponsors should be implementing in their clinical trials. We appreciate the opportunity to contribute to this conversation and eagerly anticipate the exploration of practical use cases for decentralized clinical trials as a key theme at DIA China next month. Learn More: https://bit.ly/4aP0ukh #DIAChina #DCTs #clinicalresearch #clinicaltrials
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Webinar: Developing your China medtech market entry strategy Western medtech firms can be hesitant to explore the China market. But, as the fourth-largest spender on medical devices, China should certainly not be overlooked. This session, hosted by regulatory affairs consultancy Cisema, will present practical insights into how to succeed in the Chinese market. Cisema CEO Hamish King will be presenting, alongside our Shanghai-based medtech business development specialist Olex Nykytyuk. They will cover: - Market dynamics and trends in Chinese medtech registrations - The pivotal role of regulatory and distributor partnerships - How to overcome challenges and establish successful collaborations - The minimum production steps to become a “Made in China” product to compete in public tenders - Market access channels and pricing strategies Hope you can join us - sign up here: https://lnkd.in/eq_8M6ah
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The region of Southeast Asia (SEA) is a significant emerging market for industries, including medical technologies (MedTech) industries. As with many other industries, MedTech strongly relies on computer implementations as these provide numerous advantages. In part two of this two-part series, Patent Engineer Martina Barbiero and Principal Nicholas Lakatos, look at specific real-life examples of patent applications in the hub of SAE, Singapore, and draw comparisons to how the same technologies are treated in Australia with respect to patentable subject matter. Read part two here: https://lnkd.in/gMu8UUjC Last week, we released part one in this two-part series that examined if it is possible to meet patentable subject matter requirements in the key countries in SEA for computer implemented medical technologies. Read part one here: https://lnkd.in/gq-ih6vS
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BIO KOREA 2024 has been an impeccable opportunity to share our experience and expertise, and set new milestones in the bio-health industry. Until next time, let’s aim for groundbreaking progress, keep the conversation going and foster new collaborations. Didn’t have the chance to meet us during the conference? Contact us to learn how our Accelerant methodology, regulatory strategies and Functional Services can bring success to your clinical trials! See you in Bio Korea 2025! #clinicalresearch #clinicaltrials #BIOKOREA #BK2024 #바이오코리아
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