Regulatory Affairs Part I: The IND Phase and Part II: The NDA Phase

Venue: Sheraton Inner Harbor Hotel

Location: Baltimore, Maryland, United States

Event Date/Time: Nov 15, 2010 End Date/Time: Nov 18, 2010
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Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

What you will learn
• Overview of the drug development process
• The IND process
• Quality assurance in drug development (GXPs)
• FDA’s actions on the original IND and amendments
• Activities and submissions after the original IND
• Procedures for reporting adverse events (AEs)
• Overview and roles and responsibilities of FDA
• NDA in CTD format
• Regulatory compliance and FDA inspections
• Post-approval regulatory requirements for NDAs
• Regulatory requirements for prescription drug/biologics labeling
• Regulatory requirements for prescription drug/biologics advertising
• How to interact with the FDA

Learning Objectives:
At the conclusion of this course, participants should be able to:
• Apply the role of regulatory affairs and the impact on the drug development process
• Discuss the role of FDA and composition of FDA’s review teams
• Effectively plan and submit an IND
• Report adverse events accurately and correctly to the FDA
• Prepare NDA/BLA using the Common Technical Document format
• Define post-approval requirements
• Explain the regulatory requirements for prescription drug labeling and advertising/promotion
• Apply common meeting etiquette in dealing with the FDA during the IND/NDA phases

Target Audience:
• New regulatory affairs professionals
• Clinical researchers
• Quality professionals
• Biostatisticians
• Medical writers
• Basic researchers
• Business and marketing professionals

Event Code:


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