We’re #hiring! #Accumulus is seeking a #ProductManager to: ➡ Drive product innovation ➡ Deliver value to users ➡ Assist in the execution of our roadmap If you have a passion for innovation and driving product excellence, apply today! https://lnkd.in/eSuXRpM4
Accumulus Synergy
Non-profit Organizations
Burlingame, CA 2,769 followers
Responsible Innovation. Next Generation Data & Information Exchange.
About us
Accumulus Synergy is a global, nonprofit industry association that is developing a transformative data exchange platform that aims to enable enhanced collaboration and efficiency between life sciences organizations and global health authorities, while also affording users the ability to extract dynamic, data-driven insights. Sponsored by leading biopharmaceutical companies, Accumulus Synergy was formed in 2020 to create innovative solutions that can reduce regulatory review times and transform global data exchange. The non-profit company is creating a first-of-its-kind cloud-based platform between life sciences organizations and and health authorities worldwide. The single-platform approach aims to improve speed, transparencies and efficiencies in the regulatory process by leveraging advanced technology and tools for data exchange. This will help reduce the cost of innovation and ultimately bring patients safe and effective medicines faster.
- Website
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https://www.accumulus.org/
External link for Accumulus Synergy
- Industry
- Non-profit Organizations
- Company size
- 51-200 employees
- Headquarters
- Burlingame, CA
- Type
- Nonprofit
- Founded
- 2020
Locations
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Primary
Burlingame, CA, US
Employees at Accumulus Synergy
Updates
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📆 One year ago, #Accumulus kicked off its quarterly #RegulatorForum. In the past year, the Forum grew to 12 participating national regulatory authorities (NRAs) with representation from the US, Japan, EU, UK, Switzerland, Canada, Brazil, Ireland, Israel, Africa, Saudi Arabia, and Singapore. We also have participants from CEPI (Coalition for Epidemic Preparedness Innovations), Bill & Melinda Gates Foundation, and the World Health Organization. Our fourth quarterly meeting was held yesterday and we are grateful for all who participate and contribute! 🤝 As we work to pave the way for the advancement of #regulatory interactions, the Regulator Forum is designed to capture NRA perspectives more consistently and efficiently. Topics such as product vision, security, operations, and governance are discussed on a quarterly basis to always keep participants up to date. ➡ If you are a Regulatory Authority interested in playing an important role in helping to shape #data and #informationexchange with #AccumulusSynergy, reach out today to get involved.
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Last month, Latin America’s national regulatory authorities of reference discussed progress on a two-year-old plan to strengthen regulatory capacities across the Americas. In particular, officials with the agencies of Chile, Mexico, Argentina, Colombia, Cuba, and Brazil discussed pathways to becoming #WHO-Listed Authorities (WLAs). WLA’s are an important instrument for #harmonization as they can help foster #regulatory #reliance. Read more in this #RAPS roundup: https://lnkd.in/gzfseEZc
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We’re #hiring! #Accumulus is seeking a talented and creative individual to join our team as an Instructional Designer. Be a part of something bigger than yourself. With every project you undertake, you’ll have the satisfaction of knowing that you are working towards accelerating therapies to patients around the world. Together, we can shape the future. Learn more here: https://lnkd.in/gQv5mj8F
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"#DIA's Global Annual Meeting recently concluded, leaving attendees with a wealth of insight into the future of healthcare. Tamei Elliott, DIA's Associate Director of Scientific Programs, and Radha Goolabsingh, DIA's Global Regulatory Strategy and Engagement Leader, spoke in an on-site interview immediately after the final session ended on the most compelling topics and thought-provoking ideas that emerged from the event's four intensive days." Read more here! https://lnkd.in/e4zGEdff
'Now Is the Time': At DIA 2024, Biopharmaceutical Industry Insists It's Ready for Convergence
DIA on LinkedIn
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Exciting news! #Accumulus is proud to have Dominique Lagrave as a contributing author of the newest eBook, “Achieving Excellence in Regulatory Information Management”. This eBook is a comprehensive guide that covers best practices in #RIM capabilities and functional interfaces. Dom's section is specifically focused on health authority collaboration and highlights Accumulus' innovative regulatory collaboration and information exchange platform. You can find the eBook on Amazon: https://lnkd.in/ex75fuGj
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#ICMRA just concluded two pilots focused on #collaboration among #regulators, with the aim of reducing regulatory burden and improving manufacturing capacity. ⏭ What's next? According to a newly released article by AgencyIQ, one next step could be to identify a cloud-based platform to allow regulators and industry to access computing resources without having to manage the information technology platform locally. 📰 The article states, "One example of such a system was recently test-driven by Roche: the #Accumulus #cloud platform. In February 2024, #Roche became the first company to submit a post-approval change to 48 global regulators at the same time." 🈁 Read more here: https://lnkd.in/ebF_nrXR
ICMRA gives early readout on collaborative assessment, hybrid inspection pilots
https://www.agencyiq.com
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So many great takeaways from #DIA2024 this year. Thank you, Patrick Crooks, for highlighting these key themes. What topics or insights are you still thinking about? Let's continue the conversation!
Healthcare Innovation | Life Sciences | Product Development | Business Operations | Tech, Policy, and Ethics
It was great to be back at #DIA2024 this year in San Diego! There were so many wonderful sessions and not enough time to attend them all. Below are takeaways I am still thinking about this week. Let me know what I missed! 🤝 Collaboration: Themes of globalization, international collaboration, and reliance permeated many sessions. Let's work together and move from pilots to standard practice. 🗣 Patient Voice: We know how important it is to incorporate the patient perspective into drug development. Let's ensure patient voices and narratives are consistently elevated and heard. 💻 AI, AI, AI: Buzzword fatigue has already set in, so it's important for innovators to clearly explain what goals we are working toward. While many AI tools are not new, there is a sense that we are just starting to scratch the surface of what is possible. A lot of interest in upskilling, training, and education. 📊 Clinical Trial Diversity: It's not a trend, it's better science. We've moved from the "why" to the "how." The FDA's updated diversity action plan guidance is eagerly awaited and should be coming soon. We can't lose sight of the ultimate goal, which is broader treatment access for underrepresented groups and health equity. 📚 Workforce: Many interesting discussions around the clinical research and regulatory workforces. How do we make these career paths ones that students proactively choose vs. "fall into?" More (and earlier) education, training, and awareness programs are needed. #healthcareinnovation #lifesciences #publichealth #clinicaltrials #healthcare
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Join IFPMA, June 27th, for a webinar on “Leveraging IDMP standards for harmonized product data management in the pharmaceutical industry” The session will explore how #IDMP helps frame product master data within R&D and Supply Chain management, by providing the first internationally standardized medicinal product model usable across various domains. Register now! https://lnkd.in/geX2yKz5 #IFPMA #AccumulusSynergy
Leveraging IDMP standards for harmonized product data management
events.zoom.us
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DIA: Pharma expert offers advice on #AI best practices for industry "Best practices for artificial intelligence in the #pharmaceutical industry don’t need to be built from scratch, and instead could be based on guidelines developed by government entities and #standards organizations." Read more about AI best practices from #DIA2024: https://lnkd.in/em7qVRNE #accumulussynergy #regulatory #innovation
DIA: Pharma expert offers advice on AI best practices for industry
raps.org