Event Date/Time: Oct 15, 2007
End Date/Time: Oct 18, 2007
This course is specifically designed for persons with a background in preclinical research (e.g., pharmacology, toxicology, and 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.
Workshops are utilized in the course to augment the lectures. During such workshops, participants will work in teams on case studies and will present the results to other participants.
This course will focus on drug and biologic products; the regulatory process for devices or multi-sourced (generic) products will not be addressed.