Provides an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development.


WHAT YOU WILL LEARN
· How the pharmaceutical industry identifies new products and brings them to market
· Contributions of key groups within the company and how they interact
· FDA and regulation of the industry
· Basics of filing a New Drug Application (NDA)
· Ethical considerations in conducting clinical research
· Institutional review, informed consent, and financial disclosure
· Concepts and functions associated with ensuring overall study quality



Event Code:
11421