US Regulatory Affairs: A Comprehensive Review 2015

Topics

• Overview of the FDA
• Regulation of drugs and biologics: The basics
• The IND - A general introduction
• Regulatory requirements for drug development and approval
• IND Amendments and maintenance
• The IND - In detail
• Submitting the NDA in CTD format – What’s unique to FDA
• Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
• Interactions with FDA
• Post-approval regulatory requirements for NDAs
• Regulatory compliance and FDA Inspections: What to expect after submitting the NDA
• US regulatory requirements for advertising and labelling
• Navigating the FDA on the internet