Course
US Regulatory Affairs
| Location: | Radisson Blu Acron Hotel, Prague, Czech Republic |
|---|---|
| Date: | 18.10.2010 |
| End Date: | 21.10.2010 |
Description
This course is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, drug metabolism), clinical research, quality assurance 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. DIA Europe 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.Contact
DIA in Europe
http://www.diahome.org/
Tatjana.Topalovic@diaeurope.org