#34: Fourteen Steps from Research to Development Day & Time:
June 23, 1:00PM - 4:30PMRoom Number:
Michael R. Hamrell, PhD,RAC
MORIAH Consultants, 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.
There are 14 steps from research to development (R to D) and initiation of phase 3 clinical studies; the majority of time committed to drug development occurs during this period. A discussion of the 14 critical steps from R to D will include identifying ways to streamline the process and interactions with FDA. Discussion of each of the 14 steps used to develop the optimal strategic plan will address the resources and various approaches to tailoring the plan to a sponsor’s specific product under development and obtaining FDA concurrence with the strategic plan. A smooth progression through the preclinical process into early clinical programs will be presented in this half day tutorial targeted to familiarize pivotal staff in startup companies with the required terminology and functions, pharmaceutical/biological companies that have yet to file INDs and those who want to improve their early development approach.
|#34: Fourteen Steps from Research to Development ||CME|
At the conclusion of this tutorial, participants should be able to:
• Identify ways to tailor the development, streamline the process, and interact with FDA
• Explain the specialties and resources needed to develop a product
• Design processes to guide your company smoothly through the progression of research and development. Target Audience:
This tutorial is designed for pivotal staff in start-up companies, pharmaceutical/biological companies that have yet to file INDs, and all personnel who want to broaden their knowledge of product development.