Events

Insight into the role and expectations of committee members.

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

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

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.

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

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.

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

A presentation discussing the lessons learnt from the Actemra (tocilizumab) shortage.

TGA speaker opportunity at ARCS conference.

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

Guest speakers presented on their experiences in implementing UDI in healthcare.

Presentation on medical device regulations.

A webinar to provide an overview on the new Good Clinical Practice (GCP) Inspection Program guidance document.