Dmitri Serebrianik

How does DSCSA Impact 340B Drug Pricing Product? We share insights and highlight questions in our latest blog. #DSCSA https://lnkd.in/giyeq3Zt

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Ready to elevate your quality management system? Dive into our latest blog to explore the top features of #VeevaQMS and how they can transform your compliance and quality processes. From streamlined document management to enhanced collaboration tools, discover how Veeva QMS is setting the standard for modern quality systems.   Don’t miss the opportunity to boost your organization’s quality management!   Check out the full blog here: Please send your questions to [email protected]   #VeevaQMS #QualityManagement #Compliance #Innovation #TechTrends #BusinessExcellence

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Defining your monitoring strategy…… Thank you to Rachel Oakley of Regeneron for leading the session “Defining your monitoring strategy from your risk assessment” at the 2nd Annual ACDM: Association for Clinical Data Management Symposium on Risk-Based Quality Management. In this session, Rachel took the audience through the process of creating a fit-for-purpose monitoring strategy proportionate to the risks of the study, taking into account what has been identified as critical in the risk assessment. This presentation provided a detailed approach to selecting the right cross-functional monitoring strategy for a study. #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #edc #ACDM #RBQM #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #edc #ACDM #RBQM

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We'll be there! How about you? #TheTeamBehindYourTeam #VeevaSummit #LifeSciences #ClinicalData #ClinicalOperations #Quality #Regulatory #Safety #VaultPlatform

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Register now: https://loom.ly/V7hvN_g Join experts from AssistRx and MMIT (Managed Markets Insight & Technology) on Dec. 3 at 1 p.m. ET to discover the strategies life sciences organizations can use to alleviate copay program disruptions in 2025. During the webinar, we’ll detail how the perfect blend of tech and talent can help address recent payer activity, including new payer utilization management strategies and the changing copay accumulator and maximizer landscape. Can’t make it live? Request a recording when you sign up to view on your schedule. #InformedAccess #ImprovedOutcomes

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Karl-Heinz Loebel's latest article delves into the critical importance of both near and long-term strategies for managing medicinal product data. With the EMA's #PMS evolving, companies must prioritize data cleansing, resource allocation, and strategic planning to stay ahead. Learn how to navigate these challenges and prepare for the future of regulatory affairs: https://lnkd.in/dwTrDH4s #Pharmalex #RegulatoryAffairs #DataManagement

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It’s not uncommon for early-phase drug developers to operate lean and/or virtual teams, but a refined focus shouldn’t compromise compliance. Our GxP consultants bridge the gap to ensure your CDMOs adhere to #GMP, #GLP, and #GCP. Partner with us for #GxP audits and supplier selection expertise. #PaceGxP https://ow.ly/jZvT50SRE2R

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NSF’s team of experts discuss 4 traits that define truly exceptional pharmaceutical quality leaders. #nsfexperts #leadership Check out this article to uncover what the experts say: https://bit.ly/3y1cp0m

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Accelerate regulatory submissions and lifecycle variations through automation and effective global-to-local collaboration on core packages. Learn how: https://bit.ly/3UdapLc #RIM #regulatory #submissions #biopharma

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🎙️ New Episode Alert - QMM Program! 🚀 Check out the latest Veeva LearnGxP Podcast episode featuring Peter Alcocer, our regulatory surveillance expert! 🧑‍🔬 Dive into the Quality Management Maturity (QMM) program and learn how it can transform your quality management systems and mitigate drug shortages. Tune in to explore the evolution of QMM, the importance of a risk-based approach, and how fostering a strong quality culture benefits both patients and businesses. Don’t miss Peter’s invaluable insights on enhancing manufacturing processes and reducing risk. 🎧 Listen now, subscribe to our newsletter, and join our LinkedIn community for more expert insights and industry updates. Click here to listen: https://lnkd.in/eqaRjM5N #LearnGxP #QMM #QualityManagement #Pharma #Podcast #IndustryInsights

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Many #lifesciences organizations have separate training applications for GxP and non-GxP curricula. The same is true for asset management systems. With the vast advancements in enterprise cloud applications, this tradition is rightfully being questioned. In this White Paper, learn how Veeva Vault, can effectively help manage both, reduce cost and complexity and shorten time-to-market on such implementations. https://lnkd.in/gqFv9zcY

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Going to the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop this week? The Lotus Group will be there. Make sure to stop by Booth #18 and say hi to our teammates Lei Wang, Helena Fan, & Bill Emker. American Statistical Association - ASA #pharma #fda #statistics #statisticians #biostatisticians #biostatistics #datascience

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Download the results of our research report and learn how blending human regulatory expertise with innovative technology is driving the adoption of regulatory outsourcing in the biopharmaceutical industry. https://bit.ly/3LQYZI2 #regulatorysolutions #regulatorytech #outsourcing

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Are you ready for the upcoming changes in ICH E6 R3? This new guideline will emphasize the importance of #DataGovernance and #QualityManagement for #ClinicalTrials. At SDC, we have the expertise and experience to help you navigate these changes and ensure compliance and efficiency. Check out our latest blog post that summarizes key learnings from the recent #OCTEastCoast conference where Catherine Hall from Egnyte spoke about data quality and risk management. https://bit.ly/4dVbX4a

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As state boards continue to refine and expand their regulatory frameworks, the drug delivery industry must remain agile and proactive. By fostering collaboration with external partners, embracing innovation, and taking a leadership role in regulatory discussions, companies can not only navigate the current challenges but also seize new opportunities for growth and advancement.⁠ ⁠ The stakes have never been higher, but for those willing to adapt and evolve, the future of drug delivery holds immense potential. Read the full article featuring Jeff Cohen, Co-founder of AIVA, with the link in bio!⁠ ⁠ #theamericanivassociation #AIVA #ivhydration #wellnessindustry⁠ #intravenoustherapy

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Staying ahead in a complex regulatory environment is crucial. Our whitepaper on intelligent automation in regulatory information management offers a roadmap for success. Learn from industry leaders and transform your operations. Get your copy here: 👉 https://bit.ly/4dHGfXg 👈 #WeAreCGI #LifeSciences #CGIUS

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Catch up on our webinar with ICON plc today! You’ll gain insight into the basics of ADA assays, as well as their advantages. Watch today >>> https://hubs.ly/Q02KbTll0

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