Regulatory Affairs for Biologics

Date(s) And Time(s):
Aug 17 2011 8:30AM - Aug 18 2011 2:30PM

Location:
Hyatt Regency Boston
One Avenue De Lafayette
Boston, MA 02111

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

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

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

Target Audience:
Professionals involved in:
• Regulatory affairs
• Quality assurance
• Project management

Event Code:
11431

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