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TGA presentation: ARCS Australian Pharmacovigilance Regulatory Requirements and Risk Management Plans Summit, 27 March 2019
- Pharmacovigilance inspections
- Periodic Safety Update Reports
- Adverse Event Management System and Electronic Data Interchange
- What's new in the 2019 RMP guidance update?
- Risk minimisation
- Risk Management Plan compliance monitoring
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.