Parimer Scientific的动态

The #SYNTHIA consortium is a robust collaboration of 32 esteemed partners, representing a diverse range of expertise from across Europe and beyond. Together, these expert organisations form a multidisciplinary community, leveraging their collective knowledge and resources to ensure the success and impact of the SYNTHIA project. #SYNTHIA_syntheticdata #PrecisionMedicine #PersonalizedMedicine #SyntheticData #DataGeneration #FutureOfMedicine #Datascience?#EUInnovation #HealthResearch?#publicprivatepartnership #SYNTHIA is supported by the Innovative Health Initiative (IHI) Joint Undertaking (IHI JU) under grant agreement No 101172872. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA - European Federation of Pharmaceutical Industries and Associations, EuropaBio - the European Association for Bioindustries, MedTech Europe, and Vaccines Europe and DNV. The UK consortium partner, The National Institute for Health and Care Excellence (NICE) is supported by UKRI Grant No 101172872. We are currently starting up - however would already you like to know more about the SYNTHIA work packages and tasks? Mail to: [email protected] or connect with Pieternella [Ellen] de Waal, SYNTHIA Lead communications.

?? Cyril Thouseau, Head of Device and Packaging Vaccine LCM Portfolio at Sanofi Global Device and Packaging Unit shared his thoughts on the latest advancements in the #PreFilledSyringes and #InjectableDrugDevices industry, ahead of the #PFS25 conference this January. See our interview with Cyril here ?? https://bit.ly/4hBpwaJ ?? " The evolution of drug device combination regulation continues to evolve with new guidelines (MDR in EU, Deep cold storage in NA, Specific guidelines in Brazil for PFS, Local Standards / Guideline in China). This situation is increasing the complexity to respect all the regulations. My intent at the event is to address the complexity of managing a portfolio of devices, given the overall evolution in various dimensions. Gathering all critical inputs to develop and maintain an ecosystem is challenging and motivating! " Join him and our 3-day tailored programme, through our #FREE tickets for pharma & biotech representatives, or through one of our final #SolutonProvider passes left. ?? See all speakers and sessions here: https://bit.ly/4hBN93c ?? Book your tickets here: https://bit.ly/3ZjhFpU ?? London, UK ?? 14 - 16 January, 2025 #PFSUK #PFSUK25 #CombinationDrugDelivery #ConnectedDevices #LargeVolumeDelivery #DigitalHealthTechnologies #DigitalHealth #MedicalDevices #DrugContainerDevelopment #Biocompatability

Are you a US or APAC #biotech focused solely on #FDA approval for your #raredisease therapy? ?? Expanding your strategy to include Europe could be the key to unlocking your therapy's global potential. Partner Rare's new 3-part article series, "Don't Sleep on the EU", reveals how the European regulatory pathway can accelerate your success: ?? EU as a Launchpad: Gain faster approvals & early investor confidence, especially for ultra-rare diseases. ?? The Global Ambition: Streamline #FDA and #EMA approvals with efficient dual-submission strategies. ?? Hurdles to Harmonization: Navigate #regulatory differences and leverage EU insights for US success. ?? Dive into our first article, "EU as a Launchpad: Think Global, Start European" to discover how a strategic EU focus can propel your therapy onto the global stage. https://lnkd.in/e2PZnDJ9 #pharma #globalstrategy #drugdevelopment #clinicaltrials #marketaccess

???The European Parliament?published?the Final Text of the European Health Data Space (EHDS)! The next steps include: ???Council's Approval ???Publication in the Official Journal (January 2025) ???Entry into Force (March 2025) The EHDS unlocks opportunities?for innovation, particularly for small and mid-sized pharmaceutical companies working on therapies for rare diseases. ??Under secure and trustworthy conditions, the EHDS will provide: researchers, innovators, and the pharmaceutical industry access to large, high-quality data sets. ??For rare diseases, the EHDS ensures interoperability via the European electronic health record exchange format?and establishes a unique single market?and common access point?for data. This is a game-changer in fostering cutting-edge research and development! ?? Access the complete text here:?https://lnkd.in/d9UGGpxf Now is the time to prepare for the EHDS implementation. Reach out to EUCOPE's team?to make the most of this transformative opportunity for the healthcare and pharmaceutical industries! #EHDS #HealthData #Innovation #RareDiseases #PharmaInnovation

Save the Date: I will be in Mumbai on 20th June, talking about “Regulatory Convergence: From Bridging Gaps Across Borders to Navigating Regulatory Changes in a Digital Era”. See you there. #CPhl #GPRS2024, #aiRegulation #Regulatoryconvergence #event #vaccines #biologicals

How to Accomplish #DrugPooling in Europe? ? We’re looking forward to participating in the GCSG 2024 European Knowledge Forum, happening next week from October 15-17. ? Join us for a co-facilitated workshop on: ? ???How to Accomplish Drug Pooling in Europe ? ????Date:?October 16, 2024 ???Time:?11:00 am - 12:00 pm And ????Date:?October 17, 2024 ???Time:?13:15 am - 14:15 pm ? This workshop will explore the advantages of supplying multiple clinical trials from a pooled inventory. We’ll address the challenges of pooling supplies in Europe and provide solutions to maximize pooling efficiency. ? Speakers:?Paula Figueiredo, Mattia Scarafoni, Abi Fakolujo, and Jan Pieter Kappelle ? Stop by our booth to connect, discuss your clinical trial needs, and explore how we can support your projects with a focus on sustainability. ? #Inceptua #ClinicalTrials #Sustainability #GCSG2024 #Pharma #Biotech #ClinicalSupply

?? Missed the live session? Watch the recording of the 3rd EGHRIN Seminar! On December 5th, global health experts came together to discuss "Unpacking the Global Health Side Effects of the EU’s Pharmaceutical Legislation Reform." This insightful seminar explored the impact of the EU's legislative changes on medicine accessibility, health equity, and global health policies, particularly for low- and middle-income countries. ?? Key Highlights: ? The global health implications of the EU’s reforms ? Challenges to equitable access to medicines ? Opportunities to align EU policies with global health objectives Featured Speakers: Astrid Berner-Rodoreda (Moderator) – Heidelberg Institute of Global Health Katrina Perehudoff – Law Centre for Health and Life, University of Amsterdam Carlos Durán Salinas – UMC Utrecht Fatima Suleman – WHO Collaborating Centre for Pharmaceutical Policy & Evidence-Based Practice ?? This discussion is a must-watch for professionals and policymakers working in health, global development, and pharmaceutical regulation. ?? Watch the recording here: https://lnkd.in/evMXVcEP Let’s continue the conversation—what are your thoughts on the EU's role in promoting global health equity? #GlobalHealth #HealthEquity #PharmaReform #EGHRIN #EUHealthPolicy

China has started appearing as the key player in the clinical trial landscape globally in terms of the growing number of global clinical trials initiated in the country. https://ow.ly/FiwV50Ukffp Janelle Hart, Managing Editor, Custom Content at Citeline, a Norstella company, sits down with Xu Hu and Jie (Dexter) Yan, senior APAC reporters at Citeline, to discuss key trends and ongoing barriers impacting drug development in China and the future Chinese pharma market. Click the link in this post for access to the full article. #ClinicalTrials #ChinaBiotech #APACPharma #BiotechTrends #PharmaceuticalResearch

New Amendments to the Human Research Act ?? ? Significant changes to the Human Research Act just came into effect this month, strengthening protections for research participants whilst enhancing regulatory frameworks for researchers. These amendments prioritise ethical standards, safety, and transparency, reflecting an ongoing commitment to responsible, impactful research. ? At Mercatus Bioscience, we’re dedicated to the highest standards in research practices, and we applaud this important update to regulations that affect us all. ? For an overview of the changes, visit https://lnkd.in/d-sqasmK? ? #HumanResearchAct #RegulatoryUpdates #ResearchEthics #MercatusBioscience #ClinicalResearch #LifeSciences #Pharma #Healthcare #HealthcareInnovation #IndustryInsights #RefrigerationEquipment