Webinars and Virtual Workshops 2 +...

2025 Hybrid Public Workshop: Artificial Intelligence in Drug and Biological Product Development Date: Tue, Oct. 7, 2025; 9 a.m. ET Be a part of a dynamic conversation as leading experts dive into the rapidly evolving role of AI in transforming drug and biological product development — spotlighting the evolving role of AI in advancing the safety, efficacy, and quality of drug and biological product development. Drawing on real-world breakthroughs since the first workshop in 2024, our speakers will address best practices, highlight cross-disciplinary collaborations, and reveal creative strategies to boost data quality, reduce bias, and enhance transparency and performance in AI models. Discover fresh opportunities for partnership and walk away with actionable steps to drive responsible, transformative uses of AI in clinical research and to support regulatory decisions. https://duke.zoom.us/meeting/register/B3i1Vb8RTb6Vwh3TMW1BXQ?utm_medium=email&utm_source=govdelivery#/registration Advancing Generic Drug Development: Translating Science to Approval 2025 Day 1: Tue, Oct. 7, 2025; 9 a.m. - 4 p.m. ET Day 2: Wed, Oct. 8, 2025; 9 a.m. - 3 p.m. ET Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in abbreviated new drug applications (ANDAs) alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues related to product-specific guidance development, as well as pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development. https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-translating-science-approval-2025-10072025?utm_medium=email&utm_source=govdelivery FDA Workshop: 10th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop Date: Wed, Oct. 8, 2025 - 1 - 3:30 p.m. ET The FDA Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD) program welcomes you to the Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) 10th annual workshop. Each year, the COA-CCT workshop provides a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the regulatory and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. This workshop will review the FDA guidance on core PROs, finalized in 2024, and discuss how these core outcomes have been used to describe patient experience using recent examples from oncology product labeling. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-workshop-10th-annual-clinical-outcome-assessment-cancer-clinical-trials-workshop-october-8-2025?utm_medium=email&utm_source=govdelivery FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes Date: Fri, Oct. 10, 2025; 9:30 a.m. - 5 p.m. ET The FDA Oncology Center of Excellence (OCE) and The Osteosarcoma Institute (OSI) have a shared interest in engaging with the osteosarcoma community to identify the major barriers to drug development for osteosarcoma and to discuss opportunities for collaboration to address these challenges. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fdathe-osteosarcoma-institute-osi-workshop-advancing-osteosarcoma-drug-development-connecting?utm_medium=email&utm_source=govdelivery Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends Day 1: Wed, Oct. 15, 2025; 8:30 a.m. - 5:10 p.m. ET Day 2: Thu, Oct. 16, 2025; 8:30 a.m. - 3:40 p.m. ET Artificial Intelligence (AI) is rapidly transforming drug development and regulatory processes across the pharmaceutical industry. This workshop explores cutting-edge applications of modeling and AI throughout the drug development lifecycle, with particular emphasis on complex generics. Through presentations, panel discussions, and interactive sessions, attendees will examine how AI is being integrated into regulatory frameworks to streamline workflows, accelerate development timelines, and advance quantitative medicine approaches. https://www.complexgenerics.org/education-training/modeling-and-artificial-intelligence-ai-in-generic-drugs-regulatory-insights-and-future-trends/?utm_medium=email&utm_source=govdelivery