DIA 2017 is located at:
2301 South Martin Luther King Jr. Drive
This short course will cover common mistakes and solutions in the areas of drug development planning, regulatory agency interactions, and regulatory document writing. Practical advice for each of these areas will be presented, with an emphasis on learning from past examples that illustrate approaches to adopt or to avoid.
Who should attend?
At the conclusion of this course, participants should be able to:
- Identify ways to increase the efficiency and success of product development programs
- Describe key principles for successful regulatory interactions during drug development and marketing application preparation
- Discuss best practices in developing successful clinical trial designs, statistical analysis plans, and regulatory submission documents