Regulatory Affairs Part I & II: The IND and NDA Phases

Venue: University of Southern California

Location: Irvine, California, United States

Event Date/Time: Mar 11, 2012 End Date/Time: Mar 14, 2012
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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.

Learning Objectives:

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

· Explain the importance of incorporating regulatory strategy into the drug development plan

• Recognize content and format requirements for IND/NDA in the Common Technical Document Format

• Plan and prepare an IND/NDA, and know the reporting requirements for IND/NDA amendments

• Identify FDA review processes for evaluating IND/NDAs

• Define NDA post-approval responsibilities and requirements

• Identify regulatory mechanisms to facilitate development of new therapies

• Report adverse events in accordance with current FDA regulations

• Apply formal meeting principles and practices when interacting with the FDA during the IND/NDA phase

• Outline the regulatory requirements for prescription drug labeling and advertising/promotion

Target Audience:

· Regulatory affairs professionals new to the IND/NDA processes

· Clinical development professionals

· Biostatisticians

· Basic researchers

· Quality and manufacturing professionals

· Medical writers

· Business and marketing professionals

· Clinical research academicians

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