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tga-australia documents
Health & Medicine
The world of Regulatory convergence: an Australian reflection
Health & Medicine
Regulation of software as medical devices
Health & Medicine
Module 3 requirements for Biologics (peptide/protein medicines)
Health & Medicine
Balancing post-market monitoring with pre-market requirements
Health & Medicine
Stem cells now and in the future: regulation in Australia
Health & Medicine
Presentation: TGA business services improvements: From eBS to TBS
Health & Medicine
Pharmacovigilance forum
Health & Medicine
TGA Business Services improvements
Health & Medicine
Literature based submissions (LBS)... the options and lessons
Health & Medicine
eCTD in Australia and Experience in the Pilot Programme
Health & Medicine
The Australian Specific Annex document
Health & Medicine
Clinical trials - TGA role
Health & Medicine
Regulatory and legal implications of food-like presentations
Health & Medicine
Introduction to changes to the TGA's Clinical Trial Notification (CTN) process
Health & Medicine
The regulation of IVD medical devices
Health & Medicine
Extrapolation of indications for biosimilars
Health & Medicine
A detailed look at impurities in medicines
Health & Medicine
Risk minimisation activities associated with risk management plans
Health & Medicine
Annual Charge Exemption (ACE) roadshow presentation - June 2015
Health & Medicine
Presentation: Release for supply, packaging - in house and contract
Health & Medicine
TGOs versus Pharmacopoeias: Do I have a choice?
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