Regulatory Affairs for Biologics

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr... Course

Date(s) And Time(s):
Apr 6 2011 8:30AM - Apr 7 2011 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

Event Code:
11414

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