FDA’s Digital Transformation | The Future of Technology & How To Prepare Published 2021-11-16 Download video MP4 360p Download video MP4 720p Recommendations 04:25 The Promises and Pitfalls of Gene Therapy for Rare Diseases: Gene Therapy Case Study–IND Submission 32:56 Simcyp-R Package 15:38 Introduction (1/9) FDA MyStudies Mobile App System – May 9, 2019 28:23 FDA Product Regulations Part 1 of 7 03:04 First digital pill approved by FDA 50:19 Impact on the PK of CYP Substrates with Increasing IL-6 after Administration of the TCB, Glofitamab 23:45 Key considerations for simulating oligonucleotides in the Simcyp Simulator 31:00 Introduction to Simcyp’s Endogenous Biomarker Module 39:03 The FDA Digital Health Center of Excellence and the Advancement of Digital Health Technology 59:31 Understanding FDA: Essentials for Briefing Books in Pre-IND, Pre-NDA, and Pre-BLA Meetings 17:08 SimRFlow 28:51 Simcyp Workflow Features 2:39:27 Day 1 Welcome, Opening Remarks, Overview, Keynote Speeches, Session1 Talks, Panel Discussion 47:10 PBPK Modelling of Prominent Oral Contraceptive Agents and Applications in DDI 09:25 Certara Talks - Rare Disease Day 2024 Regulatory Landscape 06:16 Certara Talks - Rare Disease Day 2024 Clinical Pharmacology 1:55:25 Day 1, Session 2 Talks, Panel Discussion 53:57 IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR 04:59 Certara Talks - JPM Biotech Showcase 2024 Recap 09:31 Certara Talks - ASCPT 2024 Similar videos 52:30 Keynote Presentation: Modernizing Drug Development Through Digital Transformation 1:48:54 2022 FDA Virtual Digital Transformation Symposium – Day 2 Afternoon Session 1:35:18 The Future of Digital Health: Exploring the Digital Transformation of Healthcare 1:03:57 Digital Transformation – Has the Pharma Industry’s ‘Digital Moment’ Arrived? 02:20 Here's how companies are bringing digital transformation through app development 24:35 The Future of Digital Transformation in Process Safety. 02:34 How AI Could Change the Future of Medicine 20:45 Merck’s Digital Transformation: The Journey to a Connected Healthcare Experience 21:46 2023 Quality Trends: How Digital Transformation is Advancing Quality Management 4:02:20 Data and Technology in the New Era of Smarter Food Safety 46:43 Creating your Digital Lab of the Future: Blueprint for Next-Generation Laboratories 07:48 Why Does Digital Transformation Require More Than Technology? 15:24 The FDA's Bakul Patel - Software as a Medical Device | Exponential Medicine 58:47 FDA's Oversight of Digital Health Products and Medical Software 54:07 DRF 23: The Challenge of Digital Transformation for CV Care 52:35 People and Their Data: Leveraging the Digital Transformation for a New Era of Knowledge Generation 47:35 FDA Lecture: Digital Health 06:56 Pandemic & Digital Transformation More results