Regulatory Affairs for Biologics

Venue: Drug Information Association, Inc

Location: Horsham, Pennsylvania, United States

Event Date/Time: Apr 06, 2011 End Date/Time: Apr 07, 2011
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Description

Discuss proven strategies to achieve regulatory compliance for the development of biologics.

What you will learn
• Difference between traditional biologics and biotechnology products
• Regulatory needs and requirements for biologics
• Unique aspects in the development of specific biologics such as vaccines and gene therapy
• Differences in how CBER views product development compared to CDER



Learning Objectives:
At the conclusion of this course, participants should be able to:
• Discuss specific regulatory requirements for biologics regulated by CBER
• Define expectations of CBER and how they differ from those of CDER
• Identify the unique aspects in the development of specific biologics such as vaccines and gene therapy
• Assess unique characteristics of biologics and why development differs from small molecules.
• Compare the differences in regulatory needs and requirements for biologics compared to small molecules
• Evaluate the differences in how CBER view product development compared to CDER

Event Code:
11414

Venue

Enterprise Drive
Horsham
Pennsylvania
United States
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