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Understanding best practices is critical as you design a clinical program and regulatory strategy for a drug or biologic product. Identifying and obtaining the data actually needed for a product development program is key to the success of the program. Thinking ahead to the marketing application helps a sponsor avoid many of the common mistakes that are made in designing individual clinical trials and overall drug development programs. Even though it may be years before an NDA/BLA/MAA submission, the marketing application is the goal of each development program and should be kept in view throughout the program to avoid pitfalls and delays in submission and product approval.

This tutorial will cover common mistakes and solutions in the areas of drug development planning, clinical study design, statistical analysis 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 and case studies that illustrate approaches to adopt or to avoid.