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From Concept to Medicine - A Comprehensive Drug Development JourneyAuthor: Jim Mitchell
Welcome to a Complete Drug Development Journey!Have you ever wondered how groundbreaking medicines go from a scientists vision to life-saving treatments in hospitals and pharmacies worldwide? The journey of drug development is an intricate, high-stakes adventurefilled 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 beginsexploring 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 testingwhat 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 productionhow pharmaceutical companies tackle formulation, stability, and distribution challenges. Market Access & Commercialization: The economics of drug developmentpricing, 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! Language: en Genres: Chemistry, Courses, Education, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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106 – Deep Dive into Regulatory Affairs (S8E1)
Episode 1
Sunday, 4 May, 2025
This episode introduces the complex world of regulatory affairs within the pharmaceutical industry. We explore the essential framework governing drug development, highlighting key agencies like the FDA (US), EMA (Europe), and the ICH (International Council for Harmonization). The discussion delves into the roles of regulatory affairs professionals, their impact on the drug development process, and how they ensure safety, consistency, and overall compliance. We also touch upon Title 21 of the Code of Federal Regulations, specifically part 312, regarding IND (Investigational New Drug) applications.We'll examine why these professionals are crucial for navigating the intricate maze of regulations and guidelines. The main goal is to clarify legal authority, define what actions are permitted by regulatory authorities, and to highlight the significance of their work in bringing safe and effective medications to patients. We will also tease apart future trends in the field, acknowledging the constantly shifting regulatory landscape.
