Sponsor or Organizer: Drug Information Association (DIA)

Description: 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. This course will focus on drug and biologic products; the regulatory process for devices or multi-sourced (generic) products will not be addressed.

Dates: 10/23/2006

Location: Amsterdam, Amsterdam, Netherlands