Regulatory Affairs Part II: The NDA Phase
Venue: Drug Information Association, Inc
Location: Horsham, Pennsylvania, United States
Event Date/Time: Oct 17, 2011 | End Date/Time: Oct 19, 2011 |
Description
What you will learn
• 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:
• Prepare NDA/BLA using the Common Technical Document format
• Define FDA 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
• Biostatisticians
• Quality professionals
• Medical writers
• Basic researchers
• Business and marketing professionals
Event Code:
11435