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TGA presentations: 2019 ARCS Annual Conference, 6-8 August 2019
Presentations given by the TGA at the 2019 ARCS Annual Conference, Sydney, 6-8 August 2019
Presentations
- Updates from the Prescription Medicine Authorisation Branch
- The Prescription Medicine Authorisation Branch updates
- The patient will see you now! A regulator, policy maker and patient perspective
- Pharmacovigilance and complementary medicines - Regulatory requirements
- The challenges of regulating direct to consumer digital medical devices
- Updates from the Pharmacovigilance and Special Access Branch
- Consumer Medicine Information - Improving the CMI template
- Regulatory updates from the Complementary and OTC Medicines Branch - Listed medicines regulatory reforms
- Improved electronic submission methodologies - Challenges and future state
- Regulation, ethics and reimbursement of novel biological therapies in Australia - an update
- Updates to Good Manufacturing Practices - Recent, current and future changes
- Good Clinical Practice inspections - Consultation to introduce a pilot program of voluntary GCP inspections
- Manufacturing investigational medicinal products - Legislative and GMP requirements
- Update on regulatory reforms from the Scientific Evaluation Branch
- Reporting of Medicine Shortages
- Regulatory updates from the TGA Medical Devices Branch
- Regulatory updates from the TGA Medical Devices Branch - Part 2
- SME Assist - Help to navigate the regulatory maze
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.