RegOrbit

Post-Market Surveillance (PMS) for Medicinal Products

SOP for #CAPA Handling Procedure in pharmaceutical industry #GMP #interview #job

🚀Excited to share our latest #article on the transformative impact of #AI and #ML in #drug #manufacturing! 🚀 Together with my esteemed Sidley Austin LLP colleagues Josefine Liv Sommer Chris Fanelli, Michelle Gandolfo, and Julea Lipiz, we've explored how AI and machine learning are reshaping the #pharmaceutical landscape under Good Manufacturing Practices (#GMP). From enhancing operational efficiency and precision to ensuring #regulatory #compliance, the integration of these technologies is paving the way for safer and more effective medications. Key takeaways from our article include: Innovative #UseCases: From aseptic processing to advanced therapy medicinal products (#ATMPs), AI is driving innovation at every stage of drug manufacturing. #Compliance Mastery: Understanding and navigating the complexities of GMP while leveraging AI for operational excellence. Emerging #Standards: Keeping up with evolving regulations in the EU and U.S. to ensure AI-integrated processes meet all requirements. #DataIntegrity & #Security: Implementing #robust #datamanagementstrategies to mitigate risks and ensure #accuracy and #reliability. #Explainability & #Transparency: Investing in #explainable AI (#XAI) technologies to enhance #trust and understanding in AI applications. #Validation & #Testing: Developing comprehensive validation protocols to maintain consistency and compliance in AI systems. #Risk #Management: Proactively addressing new risks associated with AI to ensure reliable and fair outcomes. #Training & #Competence: Ensuring #personnel are adequately trained to oversee and manage AI-based applications effectively. AI is set to become the #new #standard in pharmaceutical manufacturing, promising safer and more effective medications. By proactively addressing challenges, we can harness the full potential of AI for innovation and improved patient health! Dive into the full article here: 👇

You may have seen the growth in AI/ML-based medical devices cleared by FDA. But that's backward looking, in that we are only learning after the fact about the clearances. I want to look forward. As a result, in this post I explore the information on clinicaltrials.gov showing studies done on AI/ML products being investigated for future clinical use. I was surprised by both the huge growth, and also the sheer diversity of clinical applications being evaluated.

Corrective Actions ctions vs Preventive Actions 🎯💯⬇️ Corrective Actions and Preventive Actions (CAPA) are two important components of quality management systems in the pharmaceutical industry. While both aim to improve processes and prevent future issues, there are key differences between the two. Corrective Actions are taken in response to an identified issue or nonconformity that has already occurred. These actions are implemented to address the root cause of the problem and prevent its recurrence. Corrective Actions are reactive in nature and focus on fixing the immediate issue at hand. On the other hand, Preventive Actions are proactive measures taken to identify and eliminate potential issues before they occur. These actions are aimed at preventing problems from happening in the first place by identifying and addressing potential risks and weaknesses in processes. Preventive Actions are forward-looking and focus on continuous improvement. In the pharmaceutical industry, both Corrective and Preventive Actions are crucial for ensuring product quality, compliance with regulations, and patient safety. Corrective Actions help to address issues that have already occurred, while Preventive Actions help to prevent future issues from arising. It is important for pharmaceutical companies to have robust CAPA processes in place to effectively manage quality issues and continuously improve their operations. By implementing both Corrective and Preventive Actions, pharmaceutical companies can enhance product quality, reduce the risk of non-compliance, and ultimately ensure the safety and efficacy of their products. #CAPA #PHARMA #GMP

AI and ML tools have the potential to expedite and enhance many regulatory functions, from writing and research to strategy and submissions. However, AI technology is evolving, and current AI solutions have limitations in fully automating complex regulatory tasks. Meredith Brown-Tuttle, FRAPS, RAC, and Jay H. Mashburn, PhD, RPh, review a selection of free AI tools and assess how they can be applied to support the creation of quality regulatory deliverables. Read the full Regulatory Focus article here: https://bit.ly/3wRuqhu

Deviation and #CAPA

📢 EMA's 2023 annual report now published! We are excited to share our 2023 annual report with you 🎉 This year’s report, with a fresh layout and new interactive features, provides an overview of EMA’s contributions to public and animal health in the EU. 👉 https://lnkd.in/dzjEEBpv 🔎 Check out the key highlights like: - The outcomes of the evaluation and monitoring of human and veterinary medicines; - The launch of the ‘Cancer Medicines Pathfinder’ initiative to expedite the development and approval of impactful cancer treatments; - The achievements in data-driven regulation; - The strengthened efforts towards transparency and communication. 📱 Dive into the report through: - An interactive digital version to navigate and interact with data on any device (including smartphones and tablets) or; - The traditional PDF version available for those who prefer a print-ready format. #EMA #AnnualReport #PublicHealth #AnimalHealth #CancerMedicines #DataDrivenRegulation #Transparency #Innovation #EUHealth #OneHealth

𝗥𝗲𝗽𝗼𝗿𝘁: 𝗧𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵 – 𝗧𝗵𝗲 𝗘𝗺𝗲𝗿𝗴𝗶𝗻𝗴 𝗟𝗮𝗻𝗱𝘀𝗰𝗮𝗽𝗲 𝗼𝗳 𝗔𝘂𝗴𝗺𝗲𝗻𝘁𝗲𝗱 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 𝗶𝗻 𝗛𝗲𝗮𝗹𝘁𝗵 𝗖𝗮𝗿𝗲 I'm thrilled to share this report: "𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵: 𝗧𝗵𝗲 𝗘𝗺𝗲𝗿𝗴𝗶𝗻𝗴 𝗟𝗮𝗻𝗱𝘀𝗰𝗮𝗽𝗲 𝗼𝗳 𝗔𝘂𝗴𝗺𝗲𝗻𝘁𝗲𝗱 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 𝗶𝗻 𝗛𝗲𝗮𝗹𝘁𝗵 𝗖𝗮𝗿𝗲." This report delves into the transformative potential of augmented intelligence (AI) in medicine and offers practical insights for physicians considering or currently using AI-based tools for clinical and administrative purposes. 🔍 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗥𝗲𝗽𝗼𝗿𝘁: 1️⃣ 𝗛𝗶𝘀𝘁𝗼𝗿𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘁𝗲𝘅𝘁: AI has been a part of medicine since the mid-20th century, with its role significantly expanding in fields like radiology, cardiology, and neurology. 2️⃣ 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝗺𝗲𝗻𝘁𝘀: Recent innovations in deep learning and foundation models are unlocking new use cases in healthcare, from cancer prognoses to predicting adverse clinical events. 3️⃣ 𝗣𝗵𝘆𝘀𝗶𝗰𝗶𝗮𝗻 𝗣𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝘀: While 65% of surveyed physicians see definite or some advantage in using AI, 70% express concerns about potential biases, privacy risks, and liability issues. 4️⃣ 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝘁𝘆-𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝗨𝘀𝗲 𝗖𝗮𝘀𝗲𝘀: Each medical specialty leverages AI differently, from emergency medicine's vitals monitoring to family medicine's focus on personalized patient education and medication adherence. 5️⃣ 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝘃𝗲 𝗦𝘂𝗽𝗽𝗼𝗿𝘁: 56% of surveyed physicians identify administrative burden reduction through automation as AI's biggest opportunity. The American Medical Association (AMA) champions the term "𝗮𝘂𝗴𝗺𝗲𝗻𝘁𝗲𝗱 𝗶𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲" to emphasize AI's role in supporting—not replacing—human decision-making. 💡 𝗪𝗵𝗮𝘁'𝘀 𝗡𝗲𝘅𝘁? The AMA is committed to ensuring AI benefits all healthcare stakeholders equitably. Their goals include: ▪ Developing ethical AI principles ▪Advocating for appropriate state and federal policies ▪Collaborating with health and tech leaders ▪Promoting AI training in medical education ▪Providing actionable resources for physicians This report is a must-read for any physician interested in the potential of AI in healthcare. A/C: Annie Fox Jared Augenstein Stacy Lloyd Shannon Curtis Matthew Reid Ami Bhatt, MD, Michael D Abramoff Mark Sendak, Daphne Koller, John Halamka, M.D., M.S., Tom Lawry, Peter Lee, Abel Kho, Srinivas Sridhara, PhD MHS, Ed Lee, MD, MPH, Harlan Krumholz, Atul Butte, Ivy Lee, Allen M. McMillen, Steven Waldren, Lidia Moura, MD, PhD, MPH, FAAN, Peter Campbell, Scott Haber, MPA, Suresh Srinivasan, Ami Bhatt, MD, Jon Handler, MD, Nathaniel DeNicola, MD, MSHP, Bibb Allen Jr., MD, FACR, Matthew Hanna, Chris Carr #HealthcareInnovation #AugmentedIntelligence #AIinMedicine # #AMA 

Today, FDA issued a draft guidance that outlines how a well-understood and reproducible technology in an FDA-approved drug or biological product may be eligible for a platform technology designation: https://lnkd.in/egqRQuiv