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Presentations given by the TGA at the 2022 ARCS Annual Conference, Sydney, 23-25 May 2022.
Presentations
- Regulation of cell and gene therapies in Australia
- Regulatory updates from the Medical Devices Authorisation Branch
- What's happening at the TGA's Manufacturing Quality Branch
- Regulatory updates from the TGA
- Regulatory aspects of vaccine development
- Establishing the Australian Unique Device Identification (UDI) system for medical devices: A regulator and industry perspective
- Software-based Medical Devices (SbMDs) - Current considerations of the regulatory mindset in the design and development of software products
- Regulation of personalised medical devices (including 3D - printed devices)
- Medicine Shortage Management - working together for effective management
- Real World Evidence in the Regulatory Context for Medical Devices
- Updates from the Prescription Medicine Authorisation Branch
- Post Market Surveillance
- The Evolving role of Real World Evidence in Supporting access to medicines
- Significant Safety Issue Reporting - Changes to the Pharmacovigilance Guidelines for sponsors
- Medicine and vaccine adverse events reporting and data