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#42: Regulatory Affairs for Biologics

Tutorial name:
#42: Regulatory Affairs for Biologics

Day & Time:
June 24, 9:00AM - 5:00PM

Room Number:

Maximize your learning while attending the DIA 2012 Annual Meeting! Receive $100 off of your DIA 2012 meeting registration by registering for two half day tutorials (#20-34) or one full day tutorial (#40-48). Purchases must be made at the same time in order to receive the discount.

Participants in this tutorial will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and gene therapy, and the different ways that CBER and CDER view product development.

Learning Objective(s):
• Discuss product jurisdiction and how it affects the review of biologic products

• Identify the unique aspects of biologics and how their development compares to that of small molecules

• Describe the unique CMC compliance reporting aspects of biologics

• Discuss the regulatory mechanisms available to speed biologics development

• Explain the current regulatory, global, and public opinion trends that have the potential to impact biologics

Target Audience:
This tutorial is designed for professionals involved in regulatory affairs, quality assurance, and project management.

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