European-Canadian Centre for Innovation and Research (ECCIR)’s Post

Brisa Advisors at FIME 2024: Connecting Innovations to the Brazilian Medical Device Market We are excited to announce that Brisa Advisors will be present at FIME 2024, the largest medical device trade show in the Americas, taking place from June 19 to 21 in Miami, USA. This event is a unique opportunity to explore the latest innovations in medical technology and discuss the newest trends in the departament. FIME brings together healthcare professionals, manufacturers, distributors, and regulators from around the world, providing a conducive environment for networking and knowledge exchange. As experts in market access and regulatory compliance with ANVISA, Brisa Advisors is committed to helping companies navigate the Brazilian market safely as your Sales Partner, ensuring the competitive effectiveness of your products. If you wish to market your products in Brazil through a strong, competitive, and highly reliable structure, schedule a conversation with our CEO, Marcelo Brisolla, and explore the best strategies Brisa Advisors can offer to expand your business in the region. During FIME, our team will be available to discuss how we can support your company in entering this market, from selecting the best sales channels, obtaining regulatory approvals, to effective commercialization. Schedule a meeting ( https://lnkd.in/dmePASFP ) at the trade show and discover how we can collaborate to accelerate the entry of your medical devices into the Brazilian market. We look forward to seeing you at FIME 2024! Click to learn more about FIME on our blog. https://lnkd.in/dpnquqJV #FIME #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices

Welcome to Week 40 of 52 Weeks of WOW: Word of the Week Wednesdays Word of the Week: ATTENDEE REGISTRATION Attendee Registration: The pivotal process through which individuals sign up to participate in a conference, typically requiring the submission of personal and professional details. Why is this important? Attendee registration serves as the gateway to the conference, enabling organizers to manage logistics, allocate resources, and tailor the event experience to the needs and preferences of registered attendees. What does the planner need to do? Develop user-friendly registration platforms, establish clear registration policies and procedures, and provide prompt and responsive support to registrants to ensure a seamless registration experience. How can planners apply it? By implementing efficient and accessible registration systems, planners can streamline the registration process, maximize attendee engagement, and gather valuable data to inform event planning and management. Key takeaway: Attendee registration is the first step towards a successful conference experience, laying the groundwork for attendee engagement, networking, and knowledge exchange within the conference community. #52WeeksofWOW #MEDiC #MEDiCseries #pharma #biotech #medicalmeetings #mmp #eventsindustry #meetingsandevents #eventprofs #medcomms #medicalcommunications

Exciting News from Accorto Regulatory Solutions! We are thrilled to announce our participation in four major events over the next few weeks: 📍 San Diego, CA - BIO24 This week, our team is in sunny San Diego attending the BIO International Convention, one of the most significant biotech events of the year. Anders Horn and Jasmine Birlew, MS are looking forward to engaging with industry leaders, exploring innovative technologies, and sharing their expertise in regulatory solutions. 📍 Dubai, UAE - Global Vape Forum Next up, our Chief Science Officer Vincent Angelico will be taking the stage not once, but twice at the Global Vape Forum in Dubai from June 14-16. This is an incredible opportunity to discuss the latest trends, regulations, and scientific advancements in the nicotine industry. Don't miss our sessions! 📍 Miami, FL - FIME & Next Generation Nicotine Finally, we'll be heading to Miami for not one, but two exciting events! Anders Horn and Kristina Haysmer will be attending FIME, one of America's leading medical device tradeshows. Join us as we connect with professionals from around the globe, showcase our regulatory solutions, and explore groundbreaking medical technologies. Simultaneously, Vincent Angelico will be across town at Next Generation Nicotine Delivery where he will be in discussions with industry partners and stakeholders on challenges in the industry and the evolving regulatory landscape. We can't wait to connect with you at these events! If you're attending any of these, please reach out and let's schedule a time to meet. See you there! 🌐🤝 #AccortoRegulatorySolutions #BIO24 #GlobalVapeForum #FIME #Biotech #VapingIndustry #MedicalDevices #RegulatoryExcellence #Innovation #Networking

🔈 Last week I had the pleasure to attend as a member of Amadix to the third edition of Team PRRC annual summit in Malaga.💡As important take home messages, we can highlight: 🔹The PRRC should not only ensure compliance with the MDR/IVDR, but also with all legislation applicable to medical devices, such as the new IA Act. 🔹Work must be done on the implementation of the IA Act in combination with the IVDR/MDR. 🔹In audits, Notified Bodies (NBs) or Competent Authorities expect that the intervention and action of the PRRC in critical regulatory activities will be reflected in the Quality System documentation. 🔹SMEs are facing difficulties in the transition to IVDR in relation to the associated costs and lack of experience with NBs, especially for IVD SMEs. 🔹Manufacturers need more specification from NBs on what they expect to receive to demonstrate compliance with requirements. This can be achieved through structured dialogues with NBs. 🔹Concern is expressed about the innovation blockade in Europe and the lack of a dedicated pathway for innovative products, such as the Breakthrough Device Program at the FDA. 🔹In Switzerland, they are working towards recognition of FDA approval to ensure, among other things, that the Swedish population has access to innovative medical devices. 🔹UK will update its medical device regulation more closely resembling the IVDR/MDR. I would like to thank AseBio - Asociación Española de Bioempresas for giving me the opportunity to attend, and TEAM-PRRC for organising the event which has allowed us to learn more about the key role that PRRC plays within a company, as well as creating an ideal environment for the exchange of experiences and knowledge between the actors in this sector, being very valuable. #TeamPRRC #IVDR #Compliance

💫 Congress Season Is Here 💫 Today’s S stands for… STANDS! 💫 💡 Did you know… If the ONLY support a company provides at a third party congress is a stand, they will NOT be liable for other aspects of a congress, IF certain criteria are met: ⚫ The exhibition must be a formal part of a genuine & independent scientific/ medical meeting.  ⚫ The meeting must not be wholly/ mainly social/ sporting.  ⚫ The £ for the space must cover the genuine costs and not towards unacceptable activities. ⚫ It's preferable for other companies to also be exhibiting.  ⚫ It should be made clear to attendees that the pharma company had only paid for a stand.  ⚫ The venue must be appropriate and compliant. ⚫ The company must have NO other involvement in the meeting. Ref: Case AUTH/2561/11/12 #abpicode #clarity #compliance #confidence #pharma #congress

🔵 The #HealthWorld2024 begins in two days❗ 🔷 The American-Hellenic Chamber of Commerce is pleased to launch the 23rd HealthWorld Conference, scheduled for Monday, September 23 and Tuesday, September 24, 2024, at the Athenaeum InterContinental Hotel in Athens. 💬 The conference will cover a range of vital topics, including:   🔹  Challenges ahead for the Healthcare Systems and the macro healthcare environment: Are we ready? 🔹Challenges for early access to pharmaceutical innovation, medical devices, and diagnostics along with ways to support them through regulatory requirements and safety standards 🔹Creating sustainable funding strategies amid healthcare budget challenges 🔹Scientific and technological innovations in advancing healthcare delivery 🔹Need for a framework agreement for a sustainable healthcare system 🔹Towards value based medicine and evaluation 🔹The vital role of AI in securing patient safety 🔹Pharmaceutical policy in changing sociopolitical environment 🔹The value of innovation for economic growth and development. ✍ Register: https://lnkd.in/dXFDXdqG 🔗 More information: https://lnkd.in/dxxGw77G #AmChamGR #HealthWorld2024 #AmChamGRPharmaceuticalCommittee

Join Oximio (Formerly SMO Group) for their upcoming webinar where they discuss how the Importer of Record (IoR) plays an essential role in the clinical supply chain, helping products arrive at their intended destination on schedule. However, the area is rife with complexities as regulations vary in different regions and countries. Any documentation errors can have serious consequences for products, clinical trials, and patients. When it comes to IoR, it is crucial not to try and go it alone – even if you think you have everything covered on paper. Ensuring smooth passage requires specialist knowledge and experience. In this webinar, we hear from clinical supply chain solutions provider, Oximio, on the best practices and how to identify the main pain points. Throughout the course of the discussion, we will learn why complexities don’t necessarily have to mean delays. They will also cover real-world examples of common mistakes in IoR and how to avoid them to prevent delays to your clinical shipments. Key learnings: 👉 Understanding the role of IoR 👉 How to ensure compliance with requirements 👉 The importance of partnerships across borders 👉Dos and Donts 👉 Challenges + examples Speakers - 🗣 Zayheda Khan - Chief Commercial Officer 🗣 Mark Woolf - Chief Strategy and Development Officer 📅 25th September 2024 🕑 3pm London / 10am New York 👉 Click here to register for free - https://lnkd.in/dMBaQUgN #clinicaltrials #clinicalsupply #IoR #importerofrecord #clinicalservices #clinicaltrialsupply #clinicaltrialservices #pharma

Join Oximio (Formerly SMO Group) for their upcoming webinar where they discuss how the Importer of Record (IoR) plays an essential role in the clinical supply chain, helping products arrive at their intended destination on schedule. However, the area is rife with complexities as regulations vary in different regions and countries. Any documentation errors can have serious consequences for products, clinical trials, and patients. When it comes to IoR, it is crucial not to try and go it alone – even if you think you have everything covered on paper. Ensuring smooth passage requires specialist knowledge and experience. In this webinar, we hear from clinical supply chain solutions provider, Oximio, on the best practices and how to identify the main pain points. Throughout the course of the discussion, we will learn why complexities don’t necessarily have to mean delays. They will also cover real-world examples of common mistakes in IoR and how to avoid them to prevent delays to your clinical shipments. Key learnings: 👉 Understanding the role of IoR 👉 How to ensure compliance with requirements 👉 The importance of partnerships across borders 👉Dos and Donts 👉 Challenges + examples Speakers - 🗣 Zayheda Khan - Chief Commercial Officer 🗣 Mark Woolf - Chief Strategy and Development Officer 📅 25th September 2024 🕑 3pm London / 10am New York 👉 Click here to register for free - https://lnkd.in/dMBaQUgN #clinicaltrials #clinicalsupply #IoR #importerofrecord #clinicalservices #clinicaltrialsupply #clinicaltrialservices #pharma

🚀 Sneak Peek Alert! IVY Diagnostics is about to unveil its latest technological marvel at the Cosmofarma Exhibition the A1c Go Point-of-Care Glycated Hemoglobin Analyzer! A1c Go is more than just a diagnostic tool; it's a reliable companion for delivering quality care quickly and efficiently. Here's what makes it so special: 🔍 Advanced Technique: It employs affinity chromatography with boronates, ensuring accurate and stable analyses. 🤖 Automatic Operation: Complete in a single step, making analysis quick and seamless. ⏱️ Fast Results: Get precise results in just minutes, enabling timely care. 🚫 No Liquid Pathway: With this feature, there are no issues of carryover, and maintenance is kept to a minimum. 🔄 Minimal Interference: Hb variants have minimal impact on results, ensuring maximum accuracy. 💼 Suitable for Any Setting: Usable in hospital labs, medical clinics, and more, making primary care timely and accessible. With A1c Go, diagnosing and monitoring glycated hemoglobin becomes easier than ever, allowing medical professionals to focus on their patients' health. Learn more at the IVY Diagnostics booth 29 STAND A 24 at the Cosmofarma fair! #A1cGo #IVYDiagnostics #Cosmofarma #farmacia #farmacy #lab #primarycare #rapiddiagnostics

👉 Join us at the 23rd #HealthWorld2024 ❗ 🟦 The American-Hellenic Chamber of Commerce is pleased to announce the 23rd HealthWorld Conference, scheduled for Monday, September 23 and Tuesday, September 24, 2024, at the Athenaeum InterContinental Hotel in Athens. 💬 The conference will cover a range of vital topics, including:   🔹  Challenges ahead for the Healthcare Systems and the macro healthcare environment: Are we ready? 🔹Challenges for early access to pharmaceutical innovation, medical devices, and diagnostics along with ways to support them through regulatory requirements and safety standards 🔹Creating sustainable funding strategies amid healthcare budget challenges 🔹Scientific and technological innovations in advancing healthcare delivery 🔹Need for a framework agreement for a sustainable healthcare system 🔹Towards value based medicine and evaluation 🔹The vital role of AI in securing patient safety 🔹Pharmaceutical policy in changing sociopolitical environment 🔹The value of innovation for economic growth and development. 🔗 More information: https://lnkd.in/dxxGw77G #AmChamGR #HealthWorld2024 #AmChamGRPharmaceuticalCommittee