Date(s) And Time(s):
Mar 19 2012 8:30AM - Mar 20 2012 2:30PM

Location:
DIA
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

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

Overview:

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

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Learning Objectives:

At the conclusion of this activity, participants should be able to:

· Discuss product jurisdiction and how it affects the review of biologic products

· Identify the unique aspects of biologics and how their development compares to that of small molecules

· Describe the unique CMC compliance reporting aspects of biologics

· Discuss the regulatory mechanisms available to speed biologics development

· Explain the current regulatory, global, and public opinion trends that have the potential to impact biologics

Target Audience:

Professionals involved in:

Regulatory affairs
Quality assurance
Project management

Event Code:
12433

Contact Information:

For registration questions, please contact Elizabeth Espich at +1-215-293-5802 or Elizabeth.espich@diahome.org
For agenda details, please contact Susan Berkelbach at +1-215-442-6183 or Susan.Berkelbach@diahome.org