• 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

This course is designed for those who are new, changing areas or roles in the pharmaceutical industry.   Also professionals who work in the area of:

• Clinical Research
• Project Management
• Administrative Support
• Quality Assurance
• Regulatory Affairs
• Manufacturing
• Medical Writing
• Business Support

At the conclusion of this activity, participants 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