« Back to Listing

#42: Regulatory Affairs for Biologics

Tutorial name:
#42: Regulatory Affairs for Biologics

Day & Time:
June 15, 9:00AM - 5:00PM (Pacific Standard Time)

Room Number:

Maximize your learning while attending the DIA 2014 50th Annual Meeting! Receive $100 off of your DIA 2014 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.

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 cellular therapy, and the different ways that CBER and CDER view product development.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• Identify the unique aspects of the development of biologics;
• Explain the regulatory mechanisms available to speed biologics development;
• Discuss 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.