University of Southern California , Irvine, CA, USA
Mar 11 2012 8:00AM - Mar 14 2012 4:45PM
Learn about FDA regulations and expectations for the content, submission, and review of IND/NDAs and the importance of regulatory strategy.
What you will Learn
- Fundamentals of the Investigational New Drug and New Drug Application Processes
- Meetings and other interactions with FDA
This blended learning opportunity features two archived online courses focusing on fundamental concepts followed by a training course consisting of interactive lectures and hands-on workshops.
Archived Online Course Component
Introduction to Regulation of Drugs and Biologics in the United States
Learn about FDA history, regulations, roles and responsibilities and organization relative to the development of drugs and biologics in the US.
What you will learn
· Historical perspectives of drug and biologic regulation
· Key legislative milestones and impact on product development
· Overview of the organization, roles and responsibilities of FDA
· Key regulatory definitions
Overview of the Development Process for New Drugs and Biologics
Learn the processes characteristic of drug and biologic product discovery, development and commercialization in the US.
What you will learn
· Three Stages: Discovery, Development and Commercialization of New Drugs and Biologics
· Overview of Chemistry Manufacturing and Controls processes
· Highlights of Nonclinical studies
· Description and definition of Clinical Phases of study
· Expectations after the approval of new products
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.