Part I – The IND Phase
Part II - The NDA in CTD Format

This course is specifically designed for persons with a background in preclinical research (e.g., pharmacology, toxicology, drug metabolism), clinical research , or academia and who have novice to intermediate experience in Regulatory Affairs, who need an enhanced knowledge of the US regulatory procedures. This course will also be beneficial to and enhance understanding of persons who are in Clinical Research, Data Processing, Biostatistics, Basic Research, Project Management, and Marketing, etc. The DIA also welcomes attendance by regulatory agency staff members. Attendees will need to have some knowledge of the ICH and in particular the Common Technical Document (CTD). Participants will gain a better understanding of the regulation of investigational new drugs and biologics, of the basics of submission of applications seeking marketing approval for a product, and post-marketing regulatory requirements.

Registration required:

Yes

Free:

No