#52: Regulatory Affairs for Biologics

Jun 23 2013 9:00AM - Jun 23 2013 5:00PM | Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

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Learning Objectives

At the conclusion of this tutorial, 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.

Instructor(s)

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Carol H. Danielson, DrPH,MS

President
Regulatory Advantage, United States

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.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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