#55: Overview of Drug DevelopmentDay & Time:
June 23, 9:00AM - 5:00PMInstructor(s):
George H. D'Addamio, PhD
PharmConsult Inc., United StatesDescription:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 meeting registration by registering for two half day tutorials or one full day tutorial. Purchases must be made at the same time in order to receive the discount.
This tutorial will provide 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.
|#55: Overview of Drug Development||IACET|
At the conclusion of this tutorial, participants should be able to identify:
• 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
• Concepts and functions associated with ensuring overall study quality.Target Audience:
This tutorial is designed for professionals who work in the following areas: clinical research, project management, administrative support, quality assurance, regulatory affairs, manufacturing, medical writing, and business support.