This workshop provides an overview of the drug development process including GLP, GCP, and GMP processes.
It is ideal for early stage investigators from varied disciplines and new industry professionals with a need to develop an understanding of the drug development process.
The workshop will review the steps that lead up to the clinical trial process.
It will discuss the phases of clinical development that are part of the IND (the actual human trials that are conducted to demonstrate safety and efficacy to allow the regulatory authorities reason to approve the investigational drug for marketing).
The NDA process will then be reviewed with insight into possible post-NDA activities that may be requested. The included workbook is a great tool for reference purposes.
Note: This workshop takes place over two Zoom sessions. You must attend both:
Wednesday, April 26, 8:30 a.m. to 11:30 a.m.
Wednesday, May 3, 8:30 a.m. to 11:30 a.m.
Wednesday, April 26 at 8:30am to 11:30amVirtual Event