How to Source, Vet, and Oversee Medical Product Development Contractors to Ensure Efficient, Timely, and High-quality Studies and Data for Regulatory Submissions

Event description

Presenters: Dr. Greg Gatto and Dr. Willie Salminen

This Webinar which will be presented by Greg Gatto and Willie Salminen who have extensive experience sourcing and vetting medical product development contractors. The seminar 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.

Seminar presented on July 20, 2022 to an invited audience.

This video is provided for educational purposes only.

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This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.