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Events

• Today, with live webcast! September 11-12, 2019: 2019 FDA Science Forum (Silver Spring, MD) - Agenda available. Don't miss the Oubreak! track.
• September 18, 2019: Implementing FDA’s Predictive Toxicology Roadmap: An Update of FDA Activities public workshop (Silver Spring, MD and webcast) Register by September 16, 2019.
• New! September 18-19, 2019: Workshop on Standards for NGS Detection of Viral Adventitious Agents in Biologics and Biomanufacturing (Gaithersburg, MD) - This National Institute of Standards and Technology (NIST) workshop, co-organized with FDA, will focus on the development of different types of standards for supporting standardization of Next Generation Sequencing (NGS) for detection of adventitious viruses in biologics (including viral vaccines, gene therapies, and biotherapeutics). Register by today September 11, 2019.
• September 25-26, 2019: 2019 Complex Generic Drug Product Development Workshop (College Park, MD and webcast) - FDA will link GDUFA science and research on complex products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science, hosted by CDER Small Business & Industry Assistance.
• October 3, 2019: Developing Real-World Data and Evidence to Support Regulatory Decision-Making (Washington, DC) - Through extensive engagement with the stakeholder community, FDA published a framework (PDF) for the Agency’s RWE Program in December 2018. This conference will bring together leading experts to discuss questions about and topics addressed in the framework, as well as emerging topics in the development of real-world data and evidence.
• October 9, 2019: Vaccines and Related Biological Products Advisory Committee (Silver Spring, MD and webcast) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season.
• October 16-17, 2019: Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium (College Park, MD and webcast) - FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency.
• November 8, 2019: Vaccines and Related Biological Products Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will discuss and make recommendations on the development of chikungunya vaccines.
• New! November 12-14, 2019: Regulatory Education for Industry (REdI): Clinical Investigator Training Course (College Park, MD) This course provides an intermediate-level study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers. Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products. Registration is now open.