Regulatory Affairs for Biologics

Date(s) And Time(s):
Mar 11 2010 8:30AM - Mar 12 2010 2:30PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Overview:

Learn Regulatory Requirements for Biologics
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

Contact Information:
For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183
Email Susan.Mazak@diahome.org