TGA presentations: 2023 ARCS Annual Conference

6 June

• Regulatory update from the Complementary and Over-the-Counter Medicines Branch

• Appealing TGA Decisions and Navigating Section 60 Reviews for Devices and Medicines

• Impact of European IVD Regulations in Australia

• Regulation of cell and gene therapies in Australia

• Recall reforms

• New substance applications to vary the permissible ingredients determination

• Streamlining the development of prescription medicines: Peptides to biosimilars to GMOs

• Learnings and best practices for compliance with 'patient-matched' devices

• Good Manufacturing Practice compliance signals

• Systematic literature reviews for OTC and complementary medicines

• Emerging medical device technologies and use of real-world data

7 June

• An update on clinical evidence guidelines for medical devices

• Hot topics in prescription medicines

• Regulatory update from the Medical Devices Authorisation Branch

• Lapses in conformity assessment

• Reclassification of some medical devices

• Update from the Prescription Medicines Authorisation Branch

• Medicine labelling: Update on the implementation of TGO91 / 92

• Update from the Pharmacovigilance Branch

• Sharing adverse event data for medicines and vaccines

• Updates on clinical trial inspections and the CTA scheme

• Regulatory update from the Medical Devices Surveillance Branch

• Transitioning from provisional to full approval