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US Regulatory Affairs 2014
05-07 Nov 2014
Holiday Inn London Bloomsbury, United Kingdom
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US Regulatory Affairs 2014
Key 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.
Read more
Past Events
US Regulatory Affairs 2014 - 05-07 Nov 2014, Holiday Inn London Bloomsbury, United Kingdom
(47046)
US Regulatory Affairs 2026
Important
Please, check "US Regulatory Affairs" official website for possible changes, before making any traveling arrangements
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Law & Regulations
Health & Medicine:
Healthcare, Pharma
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