Events

Advisory Committee on Medicines (ACM) meeting

The 35th meeting of the Advisory Committee on Vaccines (ACV), August 2022.

Information for manufacturers, sponsors and users of UDI data on how to access the AusUDID Sandpit

To raise awareness and engage with potential website users about the TGA website redevelopment and release.

The 34th meeting of the Advisory Committee on Vaccines (ACV), July 2022.

Information for manufacturers, sponsors and users of UDI data on how to access the AusUDID Sandpit.

The 31st joint meeting of the Advisory Committees on Medicines Scheduling and Chemicals Scheduling (Joint ACMS-ACCS #31), June 2022.

The 38th meeting of the Advisory Committee on Medicines Scheduling (ACMS #38), June 2022.

The 34th meeting of the Advisory Committee on Chemicals Scheduling (ACCS #34), June 2022.

Advisory Committee on Medical Devices (ACMD) meeting

Advisory Committee on Medicines (ACM) meeting

Significant safety issue reporting - Changes to the Pharmacovigilance guidelines for sponsors.

Improving healthcare with data collected from medicine and vaccine adverse event reporting.

Real world evidence in the regulation of medical devices.

A presentation on current activities, collaborations, and performance of the Prescription Medicine Authorisation Branch.

The increasing availability of Real World Evidence presents opportunities to improve treatments and repurpose medicines.

Post Market Surveillance - Considerations for medical device sponsors.

Updates on regulatory framework and key activities from the TGA's Medical Devices Authorisation Branch.

Updates on regulatory pathways for gene therapy products in Australia.

Updates on key activities for the TGA's Manufacturing Quality Branch.

Updates on current activities and focus areas for the Complementary and Over the Counter Medicines Branch.

Lessons learnt from COVID-19 to improve future vaccine development.

Current progress in establishing the Australian Unique Device Identification (UDI) System.

Current considerations for regulating the design and development of software based medical devices.

Patient-Matched Medical Devices (PMMDs) - key regulatory considerations.