Drug Information Association, Inc. , Horsham PA
Apr 12 2010
Proven Tips to Identify and Develop Pharmaceutical Products From Discovery Through Marketing Application Participate in interactive discussions on how to develop drugs and biologics under FDA and ICH Guidelines while proactively overcoming any drug development challenges.
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
• The 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
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