An exceptional event with an expanding lineup of top-tier speakers in the field. It's the talk of the industry right now. Yet, ISoP continues to stay ahead of the curve, consistently offering forward-thinking content that predicts the future of pharmacovigilance.
Join us at the 8th ISoP Seminar – Intelligent Automation in Pharmacovigilance! 📅 5-6 Dec 2024 | Boston-Cambridge, MA Explore cutting-edge innovations in drug safety and automation! Registration Now Open: https://lnkd.in/e7MNKYuK
Join our live webinar 📢 'Safety at the Center: The Synergistic Role of Drug Safety in Clinical Trial Operations' on April 23, 2024, at 11:00 AM EDT. Learn how drug safety and pharmacovigilance are pivotal for patient safety and product success through effective collaboration and leadership. Key Takeaways: - Role of a Drug Safety Lead - Signs of ineffective trial dynamics - Best practices for collaboration and communication Register now or sign up for on-demand access. https://lnkd.in/e5DTdRbR #DrugSafety #ClinicalTrials #Webinar #inSeptionGroup
CEO@iVigee, Director@Institute of Pharmacovigilance, ISoP Lead for Global Pharmacovigilance Professional Certification (GPPC)
As AI-generated content becomes more prevalent, truth can feel elusive. In pharmacovigilance, this raises critical questions: How do we validate ICSRs and signals in a world rife with misinformation and deepfakes? Our systems must evolve to ensure we maintain accuracy and trust in drug safety. Register here: https://lnkd.in/gS_NsTJ2 #WorldDrugSafety
Check out my blog post on How Regulatory Intelligence and Pharmacovigilance are Shaped by Trends in Regulatory Insights via Databases! https://wix.to/Ia1RV3A #newblogpost
One of our clients in their ongoing process of expansion in Global clinical trials used multiple CROs and consequently had to confront the challenge of accrual of safety data of the same Investigational medicinal product lying in different data bases. Read to find out how AWINSA consolidated the data in a centralized safety data base to provide robust clinical safety and Pharmacovigilance services. #GlobalPV #drugsafety #safetydatabase #AWINSA
One of our clients in their ongoing process of expansion in Global clinical trials used multiple CROs and consequently had to confront the challenge of accrual of safety data of the same Investigational medicinal product lying in different data bases. Read to find out how AWINSA consolidated the data in a centralized safety data base to provide robust clinical safety and Pharmacovigilance services. #GlobalPV #drugsafety #safetydatabase #Awinsa
Traditional case intake and data entry processes have long been plagued by challenges, impacting business operations significantly. Delays and inaccuracies in these processes can not only jeopardize patient safety but also lead to regulatory penalties. However, the integration of advanced PV solutions like Salvus, leveraging GenAI, promises to revolutionize the case intake process. To learn more about the hurdles faced in traditional case intake, the repercussions on business efficiency, and the revolutionary potential of GenAI in PV, check out the insightful article at the following link: https://lnkd.in/gCE43Dsi Stay informed and stay ahead in the evolving landscape of healthcare and pharmacovigilance. #Pharmacovigilance #GenAI #HealthcareInnovation
Quality & Compliance Consulting - Pharma, Biotech & MedDev - Certified Compliance Officer & Business Manager *Creating a SMART Life Science Community*
Transitioning from a #GCP-focused clinical development stage to a #GVP-driven #PostMarket stage is a challenge that hinges on strategic decisions around the operating model for pharmacovigilance activities. Thanks Stefan Brüning for this great visualisation. Find out what the differences are 👇 #Pharmacovigilance #DrugSafety #Clinical #Pharma
Life Sciences | Automation & AI | Pharmacovigilance & Patient safety | Project & Change Management
↔️ 𝗘𝘅𝗽𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗳𝗼𝗰𝘂𝘀 ↔️ Transitioning from a GCP-focused clinical development stage to a GVP-driven post-marketing stage is a challenge that hinges on strategic decisions around the operating model for pharmacovigilance activities. This transition requires not only a shift towards comprehensive safety monitoring but also a critical evaluation of how to structure the post-marketing surveillance operations to ensure efficiency, compliance, and scalability. The most notable shift is the expansion of the drug safety horizon from what it was in the distinct clinical setting. The post-marketing PV system expands beyond the R&D barrier well into other fields like commercial activities. 𝘏𝘦𝘳𝘦 𝘢𝘳𝘦 𝘴𝘰𝘮𝘦 𝘦𝘹𝘢𝘮𝘱𝘭𝘦𝘴, 𝘩𝘰𝘸 𝘵𝘩𝘦 𝘧𝘰𝘤𝘶𝘴 𝘤𝘩𝘢𝘯𝘨𝘦𝘴 𝘥𝘶𝘳𝘪𝘯𝘨 𝘵𝘩𝘪𝘴 𝘵𝘳𝘢𝘯𝘴𝘪𝘵𝘪𝘰𝘯. ⏬ 𝘾𝙝𝙚𝙘𝙠 𝙩𝙝𝙚 𝙘𝙤𝙢𝙢𝙚𝙣𝙩𝙨 𝙨𝙚𝙘𝙩𝙞𝙤𝙣 𝙛𝙤𝙧 𝙢𝙤𝙧𝙚 𝙞𝙣𝙛𝙤𝙧𝙢𝙖𝙩𝙞𝙤𝙣! ⏬
Truveta offers regulatory and audit capabilities to support customers in real-world evidence submissions to the FDA and other global regulatory authorities. RWE can clearly demonstrate real-life clinical performance, so we've invested in establishing: ✅rigorous standards of data quality and provenance, 📃workflow support for regulatory submissions, and 🔎audit-ready processes and controls to support life science orgs in meeting the most stringent regulatory requirements. Learn more: https://tr.vet/3Rx4qiG #RWE #RealWorldEvidence #RegulatoryGrade #RegulatorySubmission #FDA #FoodAndDrugAdministration #DataQuality #RealWorldData #RWD #HEOR #ClinicalTrials #LifeSciences #RegGrade
Check out these six core considerations for safety reporting in clinical trials! Thanks PPD!
Delve into the complex and evolving world of safety reporting in #clinicaltrials, and uncover regulatory and ethics challenges that sponsors face. Learn 6️⃣ core considerations to help you navigate the terrain of #pharmacovigilance and gain a deeper understanding of the pivotal role played by safety reporting in #clinicalresearch. » https://bit.ly/41cdi0q
Check out my blog post on Revolutionizing Pharmacovigilance: Crypta's Data-driven Approach! https://wix.to/bNZhBul #newblogpost
