US Regulatory Affairs 2014

Topics

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

Who should Attend

Industry auditors and regulatory authority inspectors.