Date(s) And Time(s):
Apr 11 2012 8:30AM - Apr 13 2012 12:15PM

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

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

Overview:

Learn about FDA regulations and expectations for the content, submission, and review of INDs and the importance of regulatory strategy.

What you will learn

· The fundamentals of the Investigational New Drug Products

o Preparation

o Content

o Strategy

· 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

• Identify FDA review processes for evaluating INDs

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

• 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 phase

Target Audience:

· Regulatory affairs professionals new to the IND process

· Clinical development professionals

· Biostatisticians

· Basic Researchers

· Quality and manufacturing professionals

· Medical writers

· Business and marketing professionals

· Clinical research academicians

Event Code:
12429

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