US Regulatory Affairs: A Comprehensive Review 2015

16-18 Nov 2015

Holiday Inn London - Kensington Forum, United Kingdom

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Key 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

Past Events

US Regulatory Affairs: A Comprehensive Review 2015 - 16-18 Nov 2015, Holiday Inn London - Kensington Forum, United Kingdom (52872)

US Regulatory Affairs: A Comprehensive Review 2026

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Government & Global Issues: Law & Regulations

Health & Medicine: Pharma

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