https://www.tga.gov.au/ Presentations en 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-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-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/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/gmp-forum-2023 The TGA Good Manufacturing Practice Forum returned to Sydney on 21 March 2023. Tue, 21 Mar 23 12:00:00 +0000 Tue, 21 Mar 23 12:00:00 +0000 https://www.tga.gov.au/presentations/gmp-forum-2023 https://www.tga.gov.au/presentations/webinar-presentation-change-classification-mdma-and-psilocybin-enable-prescribing-authorised-psychiatrists This webinar will address the recent announcement by the TGA that medicines containing psilocybin and MDMA will be conditionally classified as Schedule 8 (controlled drug) in the Poisons Standard. Thu, 02 Mar 23 12:00:00 +0000 Thu, 02 Mar 23 12:00:00 +0000 https://www.tga.gov.au/presentations/webinar-presentation-change-classification-mdma-and-psilocybin-enable-prescribing-authorised-psychiatrists https://www.tga.gov.au/presentations/medicinal-cannabis-reforms-complying-therapeutic-goods-standard-medicinal-cannabis-tgo-93-order-2017 This webinar will explain labelling requirements for finished MCP in detail. Wed, 01 Feb 23 12:00:00 +0000 Wed, 01 Feb 23 12:00:00 +0000 https://www.tga.gov.au/presentations/medicinal-cannabis-reforms-complying-therapeutic-goods-standard-medicinal-cannabis-tgo-93-order-2017 https://www.tga.gov.au/presentations/medicinal-cannabis-fees-and-charges-information-session This webinar will guide you through the process of charging for regulatory activities, the medicinal cannabis funding model and the fees and charges structure and amounts proposed to commence on 1 July 2023. Tue, 20 Dec 22 12:00:00 +0000 Tue, 20 Dec 22 12:00:00 +0000 https://www.tga.gov.au/presentations/medicinal-cannabis-fees-and-charges-information-session https://www.tga.gov.au/presentations/webinar-presentation-eu-mdr-transition-consent-supply-and-market-notifications The final webinar in this series will explore the impact changes to the EU MDR will have on consent to supply and market notifications. Tue, 13 Dec 22 12:00:00 +0000 Tue, 13 Dec 22 12:00:00 +0000 https://www.tga.gov.au/presentations/webinar-presentation-eu-mdr-transition-consent-supply-and-market-notifications https://www.tga.gov.au/presentations/webinar-presentation-eu-mdr-transition-manufacturer-evidence-and-variations-artg This is the second in a series of three educational webinars outlining what regulatory actions are required as a result of changes under the EU MDR, with a focus on manufacturer evidence and variations to the ARTG. Wed, 07 Dec 22 12:00:00 +0000 Wed, 07 Dec 22 12:00:00 +0000 https://www.tga.gov.au/presentations/webinar-presentation-eu-mdr-transition-manufacturer-evidence-and-variations-artg https://www.tga.gov.au/presentations/webinar-presentation-introduction-new-formatting-and-structure-poisons-standard Presentation on the new formatting and structure of the Poisons Standard Wed, 07 Dec 22 12:00:00 +0000 Wed, 07 Dec 22 12:00:00 +0000 https://www.tga.gov.au/presentations/webinar-presentation-introduction-new-formatting-and-structure-poisons-standard https://www.tga.gov.au/presentations/webinar-presentation-eu-mdr-transition-overview-and-management-under-australian-regulatory-framework This is the first in a series of three educational webinars outlining what regulatory actions are required as a result of changes under the EU MDR. Tue, 06 Dec 22 12:00:00 +0000 Tue, 06 Dec 22 12:00:00 +0000 https://www.tga.gov.au/presentations/webinar-presentation-eu-mdr-transition-overview-and-management-under-australian-regulatory-framework https://www.tga.gov.au/presentations/webinar-presentation-computerised-systems-establishing-and-maintaining-data-integrity Presentation at the RACI Pharmaceutical Science Group (NSW) Seminar/Webinar, information for manufacturers of medicinal products on Computerised Systems - establishing and maintaining data integrity Tue, 25 Oct 22 12:00:00 +0000 Tue, 25 Oct 22 12:00:00 +0000 https://www.tga.gov.au/presentations/webinar-presentation-computerised-systems-establishing-and-maintaining-data-integrity https://www.tga.gov.au/presentations/webinar-presentation-viewing-and-responding-notifications-consent-non-compliance-dashboard This webinar will cover the process of submitting evidence of compliance with the EPs for devices in a consent application in a live demonstration. Thu, 20 Oct 22 12:00:00 +0000 Thu, 20 Oct 22 12:00:00 +0000 https://www.tga.gov.au/presentations/webinar-presentation-viewing-and-responding-notifications-consent-non-compliance-dashboard https://www.tga.gov.au/presentations/application-consent-import-supply-or-export-medical-device-non-compliant-essential-principles-eps This webinar will guide you through the process of applying for consent to import, supply or export a medical device non-compliant with the Essential Principles (EPs) Wed, 19 Oct 22 12:00:00 +0000 Wed, 19 Oct 22 12:00:00 +0000 https://www.tga.gov.au/presentations/application-consent-import-supply-or-export-medical-device-non-compliant-essential-principles-eps https://www.tga.gov.au/presentations/unique-device-identification-webinar-14-guest-speakers-zebra-technologies-will-present-uk-scan4safety-pilot Guest speakers from Zebra Technologies will share observations and learnings from the UK Scan4Safety pilot. Tue, 18 Oct 22 12:00:00 +0000 Tue, 18 Oct 22 12:00:00 +0000 https://www.tga.gov.au/presentations/unique-device-identification-webinar-14-guest-speakers-zebra-technologies-will-present-uk-scan4safety-pilot https://www.tga.gov.au/presentations/risks-intentional-self-poisoning-paracetamol-key-independent-expert-findings-and-consultation-possible-access-and-purchasing-controls A webinar on the key findings from the independent expert report on the risks of intentional self-poisoning with paracetamol and options for amending the Poisons Standard Fri, 16 Sep 22 12:00:00 +0000 Fri, 16 Sep 22 12:00:00 +0000 https://www.tga.gov.au/presentations/risks-intentional-self-poisoning-paracetamol-key-independent-expert-findings-and-consultation-possible-access-and-purchasing-controls https://www.tga.gov.au/presentations/unique-device-identification-webinar-12-qa-ausudid-sandpit-and-information-about-udi-consultation-paper-3 Information for manufacturers, sponsors and users of the UDI data on how to access the AusUDID Sandpit Tue, 16 Aug 22 12:00:00 +0000 Tue, 16 Aug 22 12:00:00 +0000 https://www.tga.gov.au/presentations/unique-device-identification-webinar-12-qa-ausudid-sandpit-and-information-about-udi-consultation-paper-3 https://www.tga.gov.au/resources/event/presentations/learn-about-transformed-new-tga-website To raise awareness and engage with potential website users about the TGA website redevelopment and release. Thu, 07 Jul 22 12:00:00 +0000 Thu, 07 Jul 22 12:00:00 +0000 https://www.tga.gov.au/resources/event/presentations/learn-about-transformed-new-tga-website https://www.tga.gov.au/resources/event/presentations/unique-device-identification-webinar-10-accessing-and-using-australian-udi-database-sandpit Information for manufacturers, sponsors and users of UDI data on how to access the AusUDID Sandpit. Tue, 21 Jun 22 12:00:00 +0000 Tue, 21 Jun 22 12:00:00 +0000 https://www.tga.gov.au/resources/event/presentations/unique-device-identification-webinar-10-accessing-and-using-australian-udi-database-sandpit https://www.tga.gov.au/presentations/presentation-significant-safety-issue-reporting Significant safety issue reporting - Changes to the Pharmacovigilance guidelines for sponsors. Wed, 25 May 22 12:00:00 +0000 Wed, 25 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-significant-safety-issue-reporting https://www.tga.gov.au/presentations/presentation-medicine-and-vaccine-adverse-events-reporting-and-data Improving healthcare with data collected from medicine and vaccine adverse event reporting. Wed, 25 May 22 12:00:00 +0000 Wed, 25 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-medicine-and-vaccine-adverse-events-reporting-and-data https://www.tga.gov.au/presentations/presentation-post-market-surveillance Post Market Surveillance - Considerations for medial device sponsors. Tue, 24 May 22 12:00:00 +0000 Tue, 24 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-post-market-surveillance https://www.tga.gov.au/presentations/presentation-real-world-evidence Real world evidence in the regulation of medical devices. Tue, 24 May 22 12:00:00 +0000 Tue, 24 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-real-world-evidence https://www.tga.gov.au/presentations/presentation-evolving-role-real-world-evidence-supporting-access-medicines The increasing availability of Real World Evidence presents opportunities to improve treatments and repurpose medicines. Tue, 24 May 22 12:00:00 +0000 Tue, 24 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-evolving-role-real-world-evidence-supporting-access-medicines https://www.tga.gov.au/presentations/presentation-updates-prescription-medicine-authorisation-branch A presentation on current activities, collaborations, and performance of the Prescription Medicine Authorisation Branch. Tue, 24 May 22 12:00:00 +0000 Tue, 24 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-updates-prescription-medicine-authorisation-branch https://www.tga.gov.au/resources/event/presentations/presentation-establishing-australian-unique-device-identification-udi-system Current progress in establishing the Australian Unique Device Identification (UDI) System. Mon, 23 May 22 12:00:00 +0000 Mon, 23 May 22 12:00:00 +0000 https://www.tga.gov.au/resources/event/presentations/presentation-establishing-australian-unique-device-identification-udi-system https://www.tga.gov.au/presentations/regulatory-updates-medical-devices-authorisation-branch Updates on regulatory framework and key activities from the TGA's Medical Devices Authorisation Branch. Mon, 23 May 22 12:00:00 +0000 Mon, 23 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/regulatory-updates-medical-devices-authorisation-branch https://www.tga.gov.au/resources/event/presentations/presentation-medicine-shortage-management-working-together-effective-management A presentation discussing the lessons learnt from the Actemra (tocilizumab) shortage. Mon, 23 May 22 12:00:00 +0000 Mon, 23 May 22 12:00:00 +0000 https://www.tga.gov.au/resources/event/presentations/presentation-medicine-shortage-management-working-together-effective-management https://www.tga.gov.au/presentations/presentation-regulatory-updates-tga Updates on current activities and focus areas for the Complementary and Over the Counter Medicines Branch. Mon, 23 May 22 12:00:00 +0000 Mon, 23 May 22 12:00:00 +0000 https://www.tga.gov.au/presentations/presentation-regulatory-updates-tga