Developing an Efficient Relationship with FDA 2014

Topics

• Stages in drug development
• Organization of the FDA
• Logistics of regulatory meetings
• Important meetings with the FDA
• Outline of IND and NDA application
• Content of protocols and clinical reports

Who should Attend

• Project Managers
• Formulation Managers and Scientists
• Clinical Research Scientists (CRS) and Associates (CRA)
• Pharmacokineticists