Explore the European Medicines Agency (EMA) and the ways this group works with international bodies to regulate clinical trials. This podcast episode discusses the ICH harmonization, and how this integrates with global standards, while taking into account the regional differences.Explore ICH's E6R3 draft guideline and ICH's Q series which provides guidance on how to achieve consistent quality in pharmaceutical manufacturing globally. It also covers what regulators in the European Union use. This podcast explores how they navigate differing regulations and how it affects the creation of multinational clinical studies.

Explore the European Medicines Agency (EMA) and the ways this group works with international bodies to regulate clinical trials. This podcast episode discusses the ICH harmonization, and how this integrates with global standards, while taking into account the regional differences. Explore ICH's E6R3 draft guideline and ICH's Q series which provides guidance on how to achieve consistent quality in pharmaceutical manufacturing globally. It also covers what regulators in the European Union use. This podcast explores how they navigate differing regulations and how it affects the creation of multinational clinical studies.

52 - European and International Regulatory Perspectives (S21E3)

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 &amp; Scale-Up: From lab to large-scale production—how pharmaceutical companies tackle formulation, stability, and distribution challenges.💰 Market Access &amp; 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!Access the Notion Template for cGXP Training Modules here: <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.notion.so/marketplace/templates/cgxp-guidance-and-training-module">https://www.notion.so/marketplace/templates/cgxp-guidance-and-training-module</a>***Information in this podcast series is for education only and not meant to construe medical advice. For that, please consult your health care professional.***

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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! Access the Notion Template for cGXP Training Modules here: https://www.notion.so/marketplace/templates/cgxp-guidance-and-training-module ***Information in this podcast series is for education only and not meant to construe medical advice. For that, please consult your health care professional.***

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 &amp; Scale-Up: From lab to large-scale production—how pharmaceutical companies tackle formulation, stability, and distribution challenges.💰 Market Access &amp; 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!Access the Notion Template for cGXP Training Modules here: <a href="https://www.notion.so/marketplace/templates/cgxp-guidance-and-training-module" rel="noopener noreferrer">https://www.notion.so/marketplace/templates/cgxp-guidance-and-training-module</a>***Information in this podcast series is for education only and not meant to construe medical advice. For that, please consult your health care professional.***

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52 - European and International Regulatory Perspectives (S21E3)

52 - European and International Regulatory Perspectives (S21E3)

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