Recap and reflection over the regulatory affairs, post-marketing surveillance and pharmacovigilance season. Looping back around on the key points and concerns with a forward looking attitude toward future directions and trending.
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24:31
119 – Emerging Trends in Regulatory Science (S8E14)
This episode explores the innovations that are transforming regulatory science, including adaptive pathways, AI-driven analytics, and real-time monitoring. We discuss how these technologies are accelerating drug approvals, enhancing safety assessments, and streamlining compliance processes. The conversation highlights the shift towards a more flexible, data-driven, and patient-centered approach to drug regulation.Recent literature and real-world case studies are used to illustrate the advancements shaping the future of regulatory oversight. The episode also touches on the challenges of integrating these new technologies and the evolving role of regulatory agencies in a rapidly changing landscape.
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8:41
118 – Digital Tools in Surveillance (S8E13)
This episode explores how digital technologies and data analytics are transforming pharmacovigilance and post-market surveillance. We discuss the use of mobile apps, wearables, AI-driven analytics, and big data integration in detecting adverse events and improving patient safety.The conversation highlights real-world applications, such as the FDA's Sentinel Initiative, AI signal detection, and real-time patient monitoring tools. Case studies are used to illustrate the impact and challenges of these technologies. The episode emphasizes the potential of digital tools to enhance the efficiency and effectiveness of drug safety monitoring while also acknowledging the ethical considerations and the need for human oversight.
This episode examines how patient registries support long-term safety and outcome studies in the pharmaceutical industry. We discuss the design, data collection, and analytical methods used in these registries. The conversation highlights their role in tracking rare adverse events, assessing treatment effectiveness over time, and understanding disease progression.Real-world examples from chronic disease registries, post-market drug monitoring programs, and biologics safety studies are used to illustrate the key benefits and lessons learned. The episode emphasizes the importance of high-quality data, patient engagement, and adaptability in ensuring the success of these long-term studies.
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15:36
116 – Real-World Evidence Impact (S8E11)
This episode delves into the increasing importance of real-world evidence (RWE) in informing post-approval drug safety and effectiveness assessments. We discuss key data sources, including electronic health records (EHRs), insurance claims data, patient registries, and even social media. Analytical platforms, such as AI-driven signal detection and machine learning models, are explored.The conversation highlights how RWE influences regulatory decisions, label updates, and the development of risk mitigation strategies. Real-world case studies from post-market surveillance programs are used to illustrate the practical impact of RWE. The episode also touches on the ethical considerations and challenges associated with using RWE, such as data privacy and ensuring the accuracy and reliability of algorithms.
Over From Concept to Medicine - A Comprehensive Drug Development Journey
Welcome to a Complete Drug Development Journey!Have you ever wondered how groundbreaking medicines go from a scientist’s vision to life-saving treatments in hospitals and pharmacies worldwide? The journey of drug development is an intricate, high-stakes adventure—filled with scientific breakthroughs, regulatory twists, and the relentless pursuit of innovation.In this podcast, we take you behind the scenes of pharmaceutical research and development, unraveling the complex and fascinating process that transforms a promising compound into a fully approved, market-ready medicine. Each episode is a deep dive into the critical stages of drug development, including:🔬 Drug Discovery: Where innovation begins—exploring cutting-edge research, target identification, and the quest for the next medical breakthrough.🧪 Preclinical Testing: Investigating safety, efficacy, and mechanisms of action before a drug ever reaches human trials.👩⚕️ Clinical Trials: The rigorous, high-stakes world of human testing—what works, what fails, and what it takes to get to the finish line.📜 Regulatory Approval: Understanding the intricate web of global regulatory agencies, FDA submissions, and the make-or-break moments for new drugs.🏭 Manufacturing & Scale-Up: From lab to large-scale production—how pharmaceutical companies tackle formulation, stability, and distribution challenges.💰 Market Access & Commercialization: The economics of drug development—pricing, market dynamics, and the delicate balance between innovation and accessibility.Whether you're a scientist, industry professional, investor, or simply fascinated by the inner workings of the pharmaceutical world, this podcast brings you expert insights, real-world case studies, and in-depth discussions on the past, present, and future of drug development.Join us as we demystify the science, strategy, and business behind the medicines that change lives. Subscribe now and be part of the journey!04/28/25 - Public Beta for early access to the cGXP regulatory training module is open now here: https://firstpenguinproductions.notion.site/From-Concept-to-Medicine-A-Complete-Drug-Development-Journey-with-cGXP-Guidance-and-Training-Mod-1c1fcd6a5f5880e9b689f1f8c5b5fc09
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