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TGA presentations given at the 2014 ARCS Scientific Congress, 10-11 September 2014
10 September 2014
Sessions
- What's in a name - biosimilars?
- Microbiology data requirements for submissions for registration of sterile products
- Prescription medicine registration process - Industry and TGA expectations
- General dossier requirements for OTC medicines
- Electronic submission requirements for prescription medicines - AU eCTD update
- Understanding the Advisory Committee on Prescription Medicines (ACPM) and the Pharmaceutical Subcommittee (PSC)
- An update on risk management plans - an evaluator's perspective
- Risk management plans - proposed changes
- Reducing GMP clearance timelines
- OTC Business Process Review - achievements and opportunities
- Medicine Shortages Information Initiative
- TGA Medicine Labelling Review
- International regulatory cooperation: more important than ever
Disclaimer
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.