#35: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions and Regulatory Document WritingDay & Time:
June 23, 1:00PM - 4:30PMInstructor(s):
Elaine B. Taylor,
Associate Director, Regulatory Strategy, Consulting, and Submissions
INC Research, United States
Director, Regulatory and Scientific Affairs
CTI Clinical Trial and Consulting Services, United StatesDescription:Maximize your learning while attending the DIA 2013 49th Annual Meeting! Receive $100 off of your DIA 2013 meeting registration by registering for two half day tutorials or one full day tutorial. Purchases must be made at the same time in order to receive the discount.
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 that illustrate approaches to adopt or to avoid.
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At the conclusion of this tutorial, 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.
This tutorial is designed for those in regulatory affairs and submissions, and medical writing professionals.