Rymedi’s Post

I'm thrilled to announce that I'll be presenting at the 2nd Annual European Medical Device Biocompatibility Conference on September 18th & 19th, 2024, at the NH Munich Airport Hotel, Germany. I'll talk about Biological Equivalence under the EU MDR, and in particular about the implications of terms such as "same" or "similar" in the Regulation, trying to shed some light on this tricky topic.   Looking forward to sharing insights and connecting with industry peers. See you in Munich!   #MedicalDevices #Biocompatibility #EUMDR #RegulatoryCompliance #MedicalDeviceSafety #Conference2024 #TTLifesciencesEvent #TTEUBIO24

Ahead of the AusMedtech 2024 conference in Adelaide next week, we're highlighting a compelling two-part series authored by Patent Engineer Martina Barbiero and Principal Nicholas Lakatos on the significance of the Southeast Asia (SEA) region as an emerging market for industries, including medical technologies (MedTech) industries. In part one, Martina and Nicholas 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, Martina and Nicholas 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. Read part one here: https://lnkd.in/gMu8UUjC

Do all digital therapeutics companies have to take the pharma partnership route to guarantee commercial success? What are pharma players looking for in a DTx partner? And have either partners worked out what the most robust business model is for commercialising DTx together with drugs? These are just a few questions I'll be asking my panel of esteemed speakers (comprising Marko Kuisma Shahram Sharif Gregoire Guillet Ashutosh Malhotra) at LSX World Congress next Monday, April 29th. We'll be deconstructing past and existing partnerships our panellists have had with DTx companies and pick out what works and what doesn't. Of course, it takes two to tango so this is opportunity for DTx companies to share with the panel their experience with pharma. If you can't make the panel but attending the meeting, do come and connect/re-connect with me over coffee and several pastries (hopefully they will be proper man-sized buns and not made for Lilliputians). #LSXWorld https://lnkd.in/dBFexViz #digitaltherapeutics #digitalanddrugs #digitalhealth #pharmapartnerships #strategy #healthtech Informa Connect

Accelerating toward profitability - Oncopeptides publishes the 2023 Annual Report “2023 was a year when we set ourselves up for success in Europe. We built the foundation in Germany where we now have a full team in place and have secured a price that reflects our scientific innovation. This was a critical achievement to ensure a reference price point for the rest of Europe where we during the year worked intensively to progress market access,” says Sofia Heigis ♦️, CEO of Oncopeptides. “Commercializing a new drug doesn’t happen overnight, but I am fully convinced that we are on the right track and that we slowly but surely have started to gain speed.” The Annual Report for 2023 is available in Swedish at Oncopeptides’ web site under financial reports, where an unofficial translation in English also can be found: https://lnkd.in/dmSmsEDu

✨ Excited to Share! ✨ I am thrilled to announce that I have received a certification to attend the 30th Congress of the FAPA 2024 in Seoul, South Korea! 🎉 Even more exciting is the opportunity to present my research as the first author of our paper, titled- Transforming to Automated Drug Delivery and Management System in Community Pharmacy in HCI principles. #FAPA2024 #FirstAuthor #ResearchPresentation #PharmaceuticalInnovation #HumanComputerInteraction #ProudMoment

Pure Global is Heading to CMEF Shenzhen 2024! 🚀 From October 12th to 15th, the China International Medical Equipment Fair (CMEF and ICMD) will gather innovators and thought leaders across the medtech world—and guess what? Pure Global will be there! While we won’t have a booth this year, our Pure Global China team will be attending, ready to connect and discuss how we can support your regulatory and compliance journey. Whether it's navigating complex global markets, ensuring your products meet the highest safety standards, or accelerating time to market, we’re excited to share our expertise. Let’s make the most of this opportunity to engage and grow! If you're attending, drop us a message or look out for the Pure Global team on the ground. We’d love to connect. #CMEF2024 #PureGlobal #MedicalDevices #MedTech #RegulatoryAffairs #ChinaMedTech #Compliance #GlobalMarkets #Shenzhen

Meet my colleagues at the #SCOPESummit: Mike Keens, Robert McGrath, Sunny Hoffman, MS, MPH, RBP(ABSA) and Michele Baptista. Let's talk about accelerating your next study timelines (IRB and IBC). #clinicalresearch #research

So happy to be going to #SCOPESummit again next month! Let's chat IRB and IBC. You have more than two choices! And if you don't want to talk IRB/IBC, I'll take Instapot recipes. #clinicaltrials #celltherapy #letsbefriends

Our very own, Austin Collins, will be presenting at the SOCRA 17th Annual Device Research & Regulatory conference this week! He gave us a sneak peek into his presentation, "Introduction to Statistics in Medical Device Research 🎯" earlier this week. We are excited to see him share his expertise and passion with the industry. If you're attending the conference, make sure to say hi to Austin and ask him about his bird shirt! 🐦 Good luck, Austin - we're so proud to have you representing the Biomedical Statistical Consulting LLC team! #socra #clinicaltrials #regulatory #statistics #pigeonshirt #biomedicalstatisticalconsulting #medicaldevice #professionaldevelopment #conferences

𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐟𝐢𝐜 𝐞𝐯𝐞𝐧𝐭: "𝐁𝐀𝐂𝐊 𝐓𝐎 𝐁𝐀𝐒𝐈𝐂: 𝐀𝐏𝐓𝐓 𝐈𝐍𝐃𝐈𝐂𝐀𝐓𝐈𝐎𝐍𝐒, 𝐋𝐈𝐌𝐈𝐓𝐀𝐓𝐈𝐎𝐍𝐒, 𝐏𝐑𝐄𝐀𝐍𝐀𝐋𝐘𝐓𝐈𝐂 𝐏𝐈𝐓𝐅𝐀𝐋𝐋𝐒 𝐀𝐍𝐃 𝐌𝐈𝐗𝐈𝐍𝐆 𝐒𝐓𝐔𝐃𝐘 𝐄𝐒𝐒𝐄𝐍𝐓𝐈𝐀𝐋𝐒” Proud to be one of the leaders in coagulation testing, Stago, a partner of Medigroup Vietnam, will organize a virtual webinar to deliver scientific information regarding aPTT, one of the essential basic coagulation assays. The objective focuses on aPTT’s principle, indications, interpretation, pitfalls and laboratory approach on how to address challenges to ensure comprehensive and nuanced assessment of a patient’s coagulation profile. ⏰ 𝗘𝘃𝗲𝗻𝘁 𝗱𝗮𝘁𝗲: Tuesday, 18/06/2024, 20:00-21:00 ➡️ 𝗙𝗼𝗿 𝗼𝗻𝗹𝗶𝗻𝗲 𝗿𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/dW7KuWf #Webinar #MediGroup #Stago #aPTT #Coagulation