Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval Published 2021-09-02 Download video MP4 360p Download video MP4 720p Recommendations 55:07 Plain Language Summaries & Patient Engagement in Pediatrics 1:31:06 The FDA Drug Development Process: GLP, GMP and GCP Regulations 1:06:05 Regulatory Affairs 1:00:26 "Monoclonal Antibody Manufacturing: Transforming Our Most Important Biologics Manufacturing Process" 1:10:48 CMC - NDA requirements and Common Pitfalls of BLAs (14of15) REdI – May 29-30, 2019 1:04:00 Survival of the Fittest: Evolving Pharmacokinetic Modeling with Pirana 1:12:03 21 CFR, Parts 210 and 211 04:01 Small Molecule vs Biologics 36:49 WEBINAR: Overview of CMC Biotechnology Webinar - Dr Nadine Ritter 3:52:21 RPA UiPath Full Course | RPA UiPath Tutorial For Beginners | RPA Course | RPA Tutorial | Simplilearn 1:32:16 An Answer to Cancer? Using the immune system to fight cancer -- Longwood Seminar 59:23 First-In-Human (FIH) faster: The Power of Physiologically Based Pharmacokinetic (PBPK) Modeling 3:49:55 🔥Google Cloud InDepth Tutorial | Google Cloud Platform Tutorial 2022 | Cloud Computing | Simplilearn 29:42 CMC Considerations for CAR T Cell Product Development 8:09:40 Vaccines and Related Biological Products Advisory Committee – 9/17/2021 1:20:20 Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017 11:00 Interview: Medtronic - Regulatory Affairs Specialist 56:47 James Bradner: "Small molecule therapeutics" (11/24/2020) 2:52:21 Binding Site Predictions and Analysis & Theory, principles, methods of molecular docking Similar videos 8:03:06 FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Biologics Day 2 31:53 Getting to First-in-Human for Small Molecules and Biologics 56:24 CMC Considerations for Biotechnology Product Development: A Regulatory Perspective 11:41 The Regulatory Pathway & The Road to FDA Approval 02:47 Biosimilars: Approval Process 32:42 Biologics, biosimilars, and small molecules 44:00 Transforming Regulatory CMC – from divergence to convergence 24:48 FDA Perspectives on Biosimilar BLA-Manufacturing (28of33) Quality – Oct. 16-17, 2019 26:41 Small Molecule Case Studies (8of33) Quality – Oct. 16-17, 2019 7:31:34 FDA Regulatory Education for Industry (REdI) – Biologics Track 1:02:19 Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it. 1:02:22 Get there Faster - Therapeutics Development to CMC IND Submission 03:12 Biosimilars: Critical Quality Attributes 36:55 Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019 26:29 CMC Considerations for Developing an Effective mRNA/LNP Therapeutic 03:59 Training Snippet: What is special about biologics CMC? 19:08 Overview of FDA 351 vs 361 Classifications on Biologics and HCTPs 08:44 CMC Considerations For mRNA Manufacturing More results