Bioequivalence and Biowaiver Studies Preparation & Review for Regulatory Personal

The course goal is to provide you with the right skills to handle properly, the pharmaceutical CTD bioequivalence and biowaiver studies preparation & review. It covers all the areas of knowledge that a regulatory person needs to understand how to review, understand and assess the content of the mentioned studies. Eventually, having the capabilities to discuss, reply and fill forms related to regulatory authorities’ questions and procedures. Training is based on many reference guidelines such as ICH, US FDA, and many more. In the training, participants will work with practical examples and application, of the concepts presented.  The course uses different ways of delivering knowledge like case studies,  exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable. You can find the course outline in the video above