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US Regulatory Affairs: A Comprehensive Review 2015
16-18 Nov 2015
Holiday Inn London - Kensington Forum, United Kingdom
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Description
US Regulatory Affairs: A Comprehensive Review 2015
is a course that covers topics such as:
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)
Important
Please, check "US Regulatory Affairs: A Comprehensive Review" official website for possible changes, before making any traveling arrangements
Event Categories
Government & Global Issues:
Law & Regulations
Health & Medicine:
Pharma
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