https://www.tga.gov.au/ Workshops en https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-76-7-december-2023 Advisory Committee on Medical Devices (ACMD) meeting Thu, 07 Dec 23 12:00:00 +0000 Thu, 07 Dec 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-76-7-december-2023 https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-42-30-november-1-december-2023 Advisory Committee on Medicines (ACM) meeting Thu, 30 Nov 23 12:00:00 +0000 Thu, 30 Nov 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-42-30-november-1-december-2023 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-46-29-november-2023 Advisory Committee on Vaccines (ACV) meeting Wed, 29 Nov 23 12:00:00 +0000 Wed, 29 Nov 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-46-29-november-2023 https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare We will provide an update on the Australian UDI implementation and a guest speaker will present on the real-world benefits of the UDI adoption in the US healthcare system. Tue, 21 Nov 23 12:00:00 +0000 Tue, 21 Nov 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare https://www.tga.gov.au/resources/event/committee-meetings/acb-meeting-21-10-november-2023 Advisory Committee on Biologicals (ACB) meeting Fri, 10 Nov 23 12:00:00 +0000 Fri, 10 Nov 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acb-meeting-21-10-november-2023 https://www.tga.gov.au/resources/event/committee-meetings/accm-meeting-33-9-november-2023 Advisory Committee on Complementary Medicines (ACCM) meeting Thu, 09 Nov 23 12:00:00 +0000 Thu, 09 Nov 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/accm-meeting-33-9-november-2023 https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-75-12-october-2023 Advisory Committee on Medical Devices (ACMD) meeting Thu, 12 Oct 23 12:00:00 +0000 Thu, 12 Oct 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-75-12-october-2023 https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-41-5-6-october-2023 Advisory Committee on Medicines (ACM) meeting Thu, 05 Oct 23 12:00:00 +0000 Thu, 05 Oct 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-41-5-6-october-2023 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-45-4-october-2023 Advisory Committee on Vaccines (ACV) meeting Wed, 04 Oct 23 12:00:00 +0000 Wed, 04 Oct 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-45-4-october-2023 https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-18-project-checkpoint-what-we-know-and-what-you-can-do-get-involved Update on what we know so far, next 6 - month plan and what you can do to get involved. Tue, 19 Sep 23 12:00:00 +0000 Tue, 19 Sep 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-18-project-checkpoint-what-we-know-and-what-you-can-do-get-involved https://www.tga.gov.au/resources/event/webinars/new-medical-devices-vigilance-program-information-session-medical-device-sponsors-australia Learn about the new Medical Device Vigilance Program that we will be piloting, and volunteer to participate. Thu, 14 Sep 23 12:00:00 +0000 Thu, 14 Sep 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/new-medical-devices-vigilance-program-information-session-medical-device-sponsors-australia https://www.tga.gov.au/resources/event/committee-meetings/acb-meeting-20-1-september-2023 Advisory Committee on Biologicals (ACB) meeting Fri, 01 Sep 23 12:00:00 +0000 Fri, 01 Sep 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acb-meeting-20-1-september-2023 https://www.tga.gov.au/resources/event/webinars/updated-reporting-requirements-safety-issues-understanding-changes-pv-guidelines-webinar-2 Webinar to understand recent changes to safety issue reporting requirements as outlined in the Pharmacovigilance responsibilities of medicine sponsors guidance. Mon, 14 Aug 23 12:00:00 +0000 Mon, 14 Aug 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/updated-reporting-requirements-safety-issues-understanding-changes-pv-guidelines-webinar-2 https://www.tga.gov.au/resources/event/webinars/updated-reporting-requirements-safety-issues-understanding-changes-pv-guidelines-webinar-1 Attend this webinar to understand recent changes to safety issue reporting requirements as outlined in the Pharmacovigilance responsibilities of medicine sponsors guidance. Thu, 10 Aug 23 12:00:00 +0000 Thu, 10 Aug 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/updated-reporting-requirements-safety-issues-understanding-changes-pv-guidelines-webinar-1 https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-74-10-august-2023 Advisory Committee on Medical Devices (ACMD) meeting Thu, 10 Aug 23 12:00:00 +0000 Thu, 10 Aug 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-74-10-august-2023 https://www.tga.gov.au/resources/event/webinars/insights-tga-good-clinical-practice-gcp-inspection-program-session-two Register to hear insights from our Good Clinical Practice Inspection Program. Wed, 09 Aug 23 12:00:00 +0000 Wed, 09 Aug 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/insights-tga-good-clinical-practice-gcp-inspection-program-session-two https://www.tga.gov.au/resources/event/webinars/insights-tga-good-clinical-practice-gcp-inspection-program-session-one This presentation provides an update on the GCP Inspection Program implemented in 2022. Mon, 07 Aug 23 12:00:00 +0000 Mon, 07 Aug 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/insights-tga-good-clinical-practice-gcp-inspection-program-session-one https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-40-3-4-august-2023 Advisory Committee on Medicines (ACM) meeting Thu, 03 Aug 23 12:00:00 +0000 Thu, 03 Aug 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-40-3-4-august-2023 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-44-2-august-2023 Advisory Committee on Vaccines (ACV) meeting Wed, 02 Aug 23 12:00:00 +0000 Wed, 02 Aug 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-44-2-august-2023 https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-17-discussion-recent-udi-workshop-feedback-and-demonstration-ausudid-pre-production UDI 17, 18 July 2023 Australian UDI update, workshop summary and AusUDID Pre-Production demonstration Tue, 18 Jul 23 12:00:00 +0000 Tue, 18 Jul 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-17-discussion-recent-udi-workshop-feedback-and-demonstration-ausudid-pre-production https://www.tga.gov.au/resources/event/committee-meetings/accm-meeting-32-13-july-2023 Advisory Committee on Complementary Medicines (ACCM) meeting Thu, 13 Jul 23 12:00:00 +0000 Thu, 13 Jul 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/accm-meeting-32-13-july-2023 https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-73-8-june-2023 Advisory Committee on Medical Devices (ACMD) meeting Thu, 08 Jun 23 12:00:00 +0000 Thu, 08 Jun 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acmd-meeting-73-8-june-2023 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-43-7-june-2023 Advisory Committee on Vaccines (ACV) meeting Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acv-meeting-43-7-june-2023 https://www.tga.gov.au/presentations/presentation-medicine-labelling-update-implementation-tgo91-92 Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-medicine-labelling-update-implementation-tgo91-92 https://www.tga.gov.au/presentations/presentation-updates-clinical-trial-inspections-and-cta-scheme Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-updates-clinical-trial-inspections-and-cta-scheme https://www.tga.gov.au/presentations/presentation-reclassification-some-medical-devices Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-reclassification-some-medical-devices https://www.tga.gov.au/presentations/presentation-sharing-adverse-event-data-medicines-and-vaccines Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-sharing-adverse-event-data-medicines-and-vaccines https://www.tga.gov.au/presentations/presentation-regulatory-update-medical-devices-authorisation-branch Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-regulatory-update-medical-devices-authorisation-branch https://www.tga.gov.au/presentations/presentation-regulatory-update-medical-devices-surveillance-branch Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-regulatory-update-medical-devices-surveillance-branch https://www.tga.gov.au/presentations/prescription-update-prescription-medicines-authorisation-branch Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/prescription-update-prescription-medicines-authorisation-branch https://www.tga.gov.au/presentations/presentation-update-clinical-evidence-guidelines-medical-devices Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-update-clinical-evidence-guidelines-medical-devices https://www.tga.gov.au/presentations/presentation-update-pharmacovigilance-branch Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-update-pharmacovigilance-branch https://www.tga.gov.au/presentations/presentation-lapses-conformity-assessment Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-lapses-conformity-assessment https://www.tga.gov.au/presentations/presentation-transitioning-provisional-full-approval Presented at the 2023 ARCS Annual Conference Wed, 07 Jun 23 12:00:00 +0000 Wed, 07 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-transitioning-provisional-full-approval https://www.tga.gov.au/presentations/presentation-impact-european-ivd-regulations-australia Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-impact-european-ivd-regulations-australia https://www.tga.gov.au/presentations/presentation-emerging-medical-device-technologies-and-use-real-world-data Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-emerging-medical-device-technologies-and-use-real-world-data https://www.tga.gov.au/presentations/presentation-new-substance-applications-vary-permissible-ingredients-determination Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-new-substance-applications-vary-permissible-ingredients-determination https://www.tga.gov.au/presentations/presentation-hot-topics-prescription-medicines Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-hot-topics-prescription-medicines https://www.tga.gov.au/presentations/presentation-regulatory-update-complementary-and-over-counter-medicines-branch Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-regulatory-update-complementary-and-over-counter-medicines-branch https://www.tga.gov.au/presentations/presentation-good-manufacturing-practice-compliance-signals Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-good-manufacturing-practice-compliance-signals https://www.tga.gov.au/presentations/presentation-regulation-cell-and-gene-therapies-australia Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-regulation-cell-and-gene-therapies-australia https://www.tga.gov.au/presentations/tga-presentations-2023-arcs-annual-conference Presentations given by the TGA at the 2023 ARCS Annual Conference, 6-8 June 2023. Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/tga-presentations-2023-arcs-annual-conference https://www.tga.gov.au/presentations/presentation-streamlining-development-prescription-medicines-peptides-biosimilars-gmos Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-streamlining-development-prescription-medicines-peptides-biosimilars-gmos https://www.tga.gov.au/presentations/presentation-appealing-tga-decisions-and-navigating-section-60-reviews-devices-and-medicines Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-appealing-tga-decisions-and-navigating-section-60-reviews-devices-and-medicines https://www.tga.gov.au/presentations/presentation-systematic-literature-reviews-otc-and-complementary-medicines Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-systematic-literature-reviews-otc-and-complementary-medicines https://www.tga.gov.au/presentations/presentation-recall-reforms Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-recall-reforms https://www.tga.gov.au/presentations/presentation-learnings-and-best-practices-compliance-patient-matched-devices Presented at the 2023 ARCS Annual Conference Tue, 06 Jun 23 12:00:00 +0000 Tue, 06 Jun 23 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-learnings-and-best-practices-compliance-patient-matched-devices https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-39-1-2-june-2023 Advisory Committee on Medicines (ACM) meeting Thu, 01 Jun 23 12:00:00 +0000 Thu, 01 Jun 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acm-meeting-39-1-2-june-2023 https://www.tga.gov.au/resources/event/committee-meetings/acb-meeting-19-26-may-2023 Advisory Committee on Biologicals (ACB) meeting Fri, 26 May 23 12:00:00 +0000 Fri, 26 May 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/acb-meeting-19-26-may-2023 https://www.tga.gov.au/resources/event/committee-meetings/accm-meeting-31-20-april-2023 Advisory Committee on Complementary Medicines (ACCM) meeting Thu, 20 Apr 23 12:00:00 +0000 Thu, 20 Apr 23 12:00:00 +0000 https://www.tga.gov.au/resources/event/committee-meetings/accm-meeting-31-20-april-2023