Regulatory Affairs Part I: The IND Phase and Part II: The NDA Phase
Venue: Palomar Hotel
Location: Philadelphia,, Pennsylvania, United States
Event Date/Time: Nov 07, 2011 | End Date/Time: Nov 10, 2011 |
Description
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 postapproval 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:
11438