US Regulatory Affairs 2014 is a course that covers topics such as:
- 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
US Regulatory Affairs 2014 is intended for industry auditors and regulatory authority inspectors.