Review how regulators address digital health tools and data in the context of drug development. Dialogue on evolving guidelines and compliance challenges with real-world cases. Pull real world literature examples from your OPR&D sources where appropriate.The goal of the talk is to try and stay up to date on what has been going on and what is the most relevant. You will know more now. This has been a short dive and all people on board were ready to dive!

Review how regulators address digital health tools and data in the context of drug development. Dialogue on evolving guidelines and compliance challenges with real-world cases. Pull real world literature examples from your OPR&D sources where appropriate. The goal of the talk is to try and stay up to date on what has been going on and what is the most relevant. You will know more now. This has been a short dive and all people on board were ready to dive!

Review how regulators address digital health tools and data in the context of drug development. Dialogue on evolving guidelines and compliance challenges with real-world cases. Pull real world literature examples from your OPR&amp;D sources where appropriate.The goal of the talk is to try and stay up to date on what has been going on and what is the most relevant. You will know more now. This has been a short dive and all people on board were ready to dive!

148 – Regulatory Considerations for Digital Health (S10E13)

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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148 – Regulatory Considerations for Digital Health (S10E13)

148 – Regulatory Considerations for Digital Health (S10E13)

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