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

Venue: Hilton Boston Back Bay

Location: Boston, Massachusetts, United States

Event Date/Time: Aug 13, 2012 End Date/Time: Aug 15, 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 (IND)/new drug applications (NDA) 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 organization relative to the development of pharmaceuticals and biologics in the US. Learn the processes characteristic of pharmaceuticals and biologic product discovery, development, and commercialization in the United States.

What You Will Learn
•Fundamentals of the IND and processes
•Meetings and other interactions with FDA
•Historical perspectives of pharmaceuticals and biologic regulation
•Key legislative milestones and impact on medical 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/NDA processes
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
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 INDs/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

Karen K. Church, RAC
Vice President, Regulatory Affairs
Ocera Therapeutics Inc., United States
Drusilla L. Scott, PhD,RAC
Vice President, Regulatory Affairs
Cempra Pharmaceuticals, United States