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How to Source, Vet, and Oversee Medical Product Development Contractors to Ensure Efficient, Timely, and High-quality Studies and Data for Regulatory Submissions
This Webinar will provide practical advice for outsourcing medical product development studies at 3rd party laboratories (e.g., Contract Research Organizations [CROs]) and manufacturers (e.g., Contract Development and Manufacturing Organizations [CDMOs]). This will include highlighting the importance of vetting and selecting CROs and CDMOs, oversight of the work, and final reporting and wrapping-up projects. As a case example, the Webinar will focus on designing, contracting, monitoring, and reporting Investigational New Drug Application (IND)-enabling Good Laboratory Practice (GLP) nonclinical studies, which encompasses pivotal toxicology studies to support first-in-human clinical trials. However, the general concepts are applicable to all work that is outsourced to 3rd parties such as Clinical Studies and Chemistry, Manufacturing, and Controls (CMC) work and some examples of these activities will also be covered.

Jul 20, 2022 12:00 PM in Eastern Time (US and Canada)

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