CCRM Nordic’s Post

ICYMI: Big changes are happening with the EU Joint Clinical Assessment (JCA) process, poised to transform the field. Dive into the #JCA insights as our experts dissect challenges and opportunities. Hosted by Cencora and PharmaLex, watch the on-demand webinar for a roadmap to navigate the new European product launch landscape: https://ow.ly/7IMM50PMZrL

📢 NoBoCap project offering C-level program on MDR/IVDR implementation   🇪🇺 Are you seeking insights into navigating the European regulatory landscape for medtech products? Sign up for NoBoCap Project’s free program on #MDR / #IVDR implementation and resource and budget allocation, adapted for C-level management. 🗓 The program kicks off on 17 May with a half-day seminar. It continues weekly with one-hour webinars and culminates in a second half-day seminar. The in-person seminars are in #Ghent. 👨💼 Marketing medtech products in Europe's highly regulated landscape 💻 Investments need to bridge Europe’s “regulatory valley of death” 💻 Selecting a Notified Body for your medtech product 💻 Developing quality management systems and documentation 💻 Start-up case study on investing at the right time 👩💼 Exchange experiences on challenges, successes and progress 𝗠𝗼𝗿𝗲 𝗶𝗻𝗳𝗼 & 𝗿𝗲𝗴𝗶𝘀𝘁𝗲𝗿! 👉🏾 https://lnkd.in/dpZHWTg2

Register now to secure your spot! https://lnkd.in/gTjdm-_G Fostering trust between sponsors and Contract Research Organizations (CROs) is crucial for successful clinical trial execution. Join us for an insightful webinar that delves into the transformative power of Risk-Based Quality Management (RBQM) in bridging this trust gap. Webinar Highlights: The Challenges Uncovered in Hundreds of Projects: Gain insights from our extensive experience across numerous projects, highlighting common hurdles and obstacles that hinder effective collaboration and trust. Regulatory Authorities’ Expectations: Understand what regulatory authorities demand and how meeting these expectations can solidify the sponsor-CRO relationship. RBQM: Concept, Challenges, and Benefits: Learn what RBQM is, explore its inherent challenges, and discover how this approach can be a game-changer in ensuring quality and reliability in clinical trials. The Role of Technology: Discover how cutting-edge technology is revolutionizing RBQM implementation, making processes smoother, more efficient, and ultimately more trustworthy. Join us to explore how RBQM can be the cornerstone of trust and efficiency in your clinical trials. This webinar is a must-attend for sponsors, CROs, and anyone involved in clinical research. Sponsors and CROs Only #RBQM #trust #efficiency #clinicaltrials

ICYMI: Big changes are happening with the EU Joint Clinical Assessment (JCA) process, poised to transform the field. Dive into the #JCA insights as our experts dissect challenges and opportunities. Hosted by Cencora and PharmaLex, watch the on-demand webinar for a roadmap to navigate the new European product launch landscape: https://ow.ly/bGVZ50PMZrM

Are you a clinical trial specialist, thought leader, curious listener, or critical thinker? 🧠 Register for RBQMLive to discover RBQM’s global transformation, understand the ICH E6 (R3) and E8 guidance updates, hear from leading clinical trial and RBQM experts, and more! Get details on this free, virtual event here: https://bit.ly/44qDvIR #rbqm #clinicalresearch #clinicaltrials

Hey LinkedIn, Are you heading to the #SCOPESummit this year? Me too! TRI are on a mission to revolutionize the operationalization of #RBQM for sponsors and CROs. We're bringing to the table a fresh, new approach. Think less complexity, more clarity. Think less spreadsheets, more innovation. Think making RBQM simple for all clinical trials. Drop me an IM, or drop by booth #215 while you’re there to hear all about it. TRI - The RBQM Experts #clinicalresearch #clinicaltrial #clinicaloperations #clinicaldatamanagement #clinicaldata #centralizedmonitoring 

Day 1 at #RAPSConvergence, Montreal - Pre-Conference Session (Coffee Beak) Recap by MedTech Leading Voice ☕☕☕ MLV captured insights from speakers and attendees during a coffee break, discussing key takeaways from two notable sessions: 1️⃣ US Regulatory Essentials for Devices and IVDs Speaker Etienne Nichols from Greenlight Guru was keen to share his thoughts: "So the biggest thing: QSR is moving to QMSR... I recommend reading that regulation. Go one step beyond, read the preamble... And for design controls, there's always a question, why are regulations so vague? It’s kind of like FDA will never put up a 45 miles per hour road sign... You interpret the regulations and apply them to your company specifically as they apply to your device." Attendee and recent grad Blessing Uko offered a fresh and earnest viewpoint: "My hope is to go into the industry as a regulatory affairs specialist... For me, the biggest takeaway would be understanding how to manage conversations and communications with the FDA on regulatory submissions. How do you communicate with the executive team in making sure that they understand feedback coming from the agency?" 2️⃣ PRRC - A New EU Requirement Speaker Alexey Shiryaev, MD PhD from DNV Product Assurance AS, enlightened us with EU perspectives: "The key takeaway is to describe in the quality management system the tasks clearly, responsibilities of the PRRC... Also, ensure that if you are an SME, and you have the outsourced PRRC function, it also clearly describes the connections and the functions within the PRRC." Attendees Beth Casier and Eddyth Florentino shared their perspectives: "The speakers have been very informative," said Beth. "I think they're going to be very helpful in refining our procedure for PRRC." Eddyth echoed her sentiment, saying, "Knowing that we have the proper methods to document that we have actually adequately fulfilled our role." This afternoon we are looking forward to more insider takes from Bassil Akra, Marta Carnielli, Tom Patten, and more attendees into these deep into essential regulatory topics! Stay tuned throughout the conference for more insights as we navigate through this incredible #MedTech journey at RAPS Convergence! #RAPS #RegulatoryAffairs #MedTech #MedicalDevices #IVDs #PRRC #Networking #Learning #Innovation #MLV Ryan Connors, Denise Fulton, Martin King, André Dias, Chelsea Patterson, Francesco B.

At the WorldEPA Congress last month and through my recent webinars, I had the privilege to share and discuss my most recent perspectives on the dynamic landscape of market access and innovative contracting. This exchange of ideas fuels my work, particularly with Verpora in creating resources like the Global Innovative Contracting Factbook, Q1 2024 edition. This isn't just another publication; it's our commitment to bringing clarity and actionable insights into the complex realms of contracting and pricing. I've personally seen the difference the right information can make in strategic decision-making. The latest Factbook aims to provide that edge, packed with in-depth analysis and perspectives you won't find elsewhere. What critical knowledge would give you more confidence in your strategies, or help you align global teams with shared insight? You're welcome to drop me a message, or catch me at AMCP 2024 New Orleans later this month, to discuss how I can support your goals and help navigate the evolving contracting landscape together. Best, Omar #MarketAccess #InnovativeContracting #Pharma

#PMS Info Day - Snippets I would like to express my gratitude to Isabel Chícharo, Marcos Fernández Gómez, Veronica Lipucci Di Paola, Kristiina Puusaari Sheahan, and all the other EMA colleagues for their invaluable information shared during #PMS Info Day. 📢Key snippets of the webinar. 🔄 Data is already in the PMS database, nevertheless, access to it is still unavailable. By the end of May, users will be able to access and read their data either through PMS API or PMS UI. 💡 EMA advised to verify any changes in name and presentation for split #CAPs. 🔍 #EU IG updates for PMS - New releases for Chapter 1 Registration Requirements, Chapter 5 Data access to medicinal products for human use will be available in Mid-May2024 on EMA website and New PUI registration guide will be available on PLM portal. Chapter 3 Process for data enrichment in PMS API/UI and Chapter 4 data quality assurance will be available by Q4 2024. 🚀Actions for #MAH Holders: For countries where the Marketing Authorization (MA) number is assigned at the product level, #EMA recommended initiating the submission of all authorized and valid pack sizes through #xEVMPD. This involves submitting all pack sizes for the union list of critical medicines (first focus) by February 2025, and submitting pack size structured data (Value and Unit of Presentation) before December 2025 for National Authorization Procedures (NAPs), manufacturers & manufacturing business operations for NAPs impacted by the union critical medicines list by December 2025 💡 It was emphasized to map manufacturers to the Organization Management Service (#OMS) and manufacturing operations to terms in the Reference Member State (#RMS) list. 🗓️ Key milestones for the industry to watch out for. Contact us if you need support / further information. #Genpact #SPOR #IDMP #eAF hashtag #PMS #XEVMPD #ProductManagementService #RIMS

Within the #medtech sector , identifying key skills and emerging industry trends are critical to the success of the sector . Lorraine Kirk is representing Bellurgan Precision Engineering to help communicate these requirements and keep our #medtech industry strong. #Skillsgap #Upskilling #Medtechskillnet #AdvancedManufacturing #TechnicalTraining #RegulatoryTraining #ManagementTraining #Funding #Skills #SkillsDevelopment