Regulatory Affairs Training Course: Part I and II

Venue: Massachusetts College of Pharmacy

Location: Boston, Massachusetts, United States

Event Date/Time: Aug 06, 2007 End Date/Time: Aug 09, 2007
Report as Spam

Description

This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA.

KEY TOPICS
•Overview of FDA.
•Regulatory requirements for drug development and approval.
•Post approval and marketing Regulatory requirements and processes
•Overview of the CTD format.

Venue

179 Longwood Ave
Boston
Massachusetts
United States
MORE INFO ON THIS VENUE

Types