Event Date/Time: Jun 24, 2012 End Date/Time: Jun 24, 2012
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This course will provide an introduction to the drug development process under US Food and Drug Administration (FDA) and International Conference on Harmonisation (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
The 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

Who Should Attend
Clinical researchers
Project managers
Administrative support staff
Quality assurance experts
Regulatory affairs experts
Clinical study authors
Medical writers
Business support staff

Learning Objectives Participants who attended this event should be able to:

Recognize the process of discovering and developing new pharmaceutical products
Describe the activities associated with conducting clinical research and reporting the results and responsibilities of various departments in accomplishing these activities
Discuss institutional review, informed consent, and financial disclosure
Explain the concepts and functions associated with ensuring overall quality of studies
Describe the organization of the FDA, their authority, and interactions with sponsor companies

George H. D'Addamio, PhD
PharmConsult Inc., United States


1101 Arch Street
United States