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10421 Regulatory Affairs for Biologics
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Title:
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

Interest Area(s):
Regulatory Affairs,Quality Assurance/Quality Control,Project Management

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



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:
10421

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


If you have not received confirmation within 5 business days, please contact:
DIA
Tel. +1-215-442-6100
Fax +1-215-442-6199
Email
confirmationservices@diahome.org