Regulatory Affairs Part I: The IND Phase

Venue: DIA

Location: Horsham, Pennsylvania, United States

Event Date/Time: Sep 12, 2012 End Date/Time: Sep 14, 2012
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Learn about US Food and Drug Administration (FDA) regulations and expectations for the content, submission, and review of investigational new drugs (INDs) and the importance of regulatory strategy. 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. Learn about FDA history, regulations, roles and responsibilities, and organizations relative to the development of pharmaceuticals and biologics in the United States. Learn the processes characteristic of pharmaceuticals and biologic product discovery, development, and commercialization in the United States.

What You Will Learn
The fundamentals of IND products
Meetings and other interactions with FDA
Historical perspectives of pharmaceutical and biologic regulation
Key legislative milestones and impact on product development
Overview of the organization, roles, and responsibilities of FDA
Key regulatory definitions
Three stages of new pharmaceuticals 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

Who Should Attend
Regulatory affairs professionals new to the IND process
Clinical development professionals
Basic researchers
Quality and manufacturing professionals
Medical writers
Business and marketing professionals
Clinical research academicians

Learning Objectives
Participants who complete this course 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

Elliott T Berger, PhD,MS
Senior Vice President, Regulatory Affairs
BioCryst Pharmaceuticals, Inc., United States


Enterprise Drive Suite 200
United States