ºÝºÝߣshows by User: TherapeuticGoodsAdministration / http://www.slideshare.net/images/logo.gif ºÝºÝߣshows by User: TherapeuticGoodsAdministration / Mon, 09 Sep 2019 12:04:07 GMT ºÝºÝߣShare feed for ºÝºÝߣshows by User: TherapeuticGoodsAdministration Pharmacovigilance and complementary medicines - Regulatory requirements /slideshow/pharmacovigilance-and-complementary-medicines-regulatory-requirements/170249801 02a05-clairelarter-pharmacovigilanceandcomplementarymedicines-arcs2019-190909120407
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance]]>
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance]]> Mon, 09 Sep 2019 12:04:07 GMT /slideshow/pharmacovigilance-and-complementary-medicines-regulatory-requirements/170249801 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Pharmacovigilance and complementary medicines - Regulatory requirements TherapeuticGoodsAdministration Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/02a05-clairelarter-pharmacovigilanceandcomplementarymedicines-arcs2019-190909120407-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Pharmacovigilance and complementary medicines - Regulatory requirements from TGA Australia
]]> 2269 0 https://cdn.slidesharecdn.com/ss_thumbnails/02a05-clairelarter-pharmacovigilanceandcomplementarymedicines-arcs2019-190909120407-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 The challenges of regulating direct to consumer digital medical devices /slideshow/the-challenges-of-regulating-direct-to-consumer-digital-medical-devices/170249110 03presentation-arcs-a06-thechallengesofregulatingdirecttoconsumerdigitalmedicaldevices-190909115859
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing]]>
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing]]> Mon, 09 Sep 2019 11:58:59 GMT /slideshow/the-challenges-of-regulating-direct-to-consumer-digital-medical-devices/170249110 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) The challenges of regulating direct to consumer digital medical devices TherapeuticGoodsAdministration Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/03presentation-arcs-a06-thechallengesofregulatingdirecttoconsumerdigitalmedicaldevices-190909115859-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
The challenges of regulating direct to consumer digital medical devices from TGA Australia
]]> 804 6 https://cdn.slidesharecdn.com/ss_thumbnails/03presentation-arcs-a06-thechallengesofregulatingdirecttoconsumerdigitalmedicaldevices-190909115859-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Updates from the Pharmacovigilance and Special Access Branch /slideshow/updates-from-the-pharmacovigilance-and-special-access-branch/170248235 04a07-grantpeggsarahmay-arcspresentation-psabupdate-consolidatedslidesarcs2019-janet-190909115229
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS) Q and A]]>
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS) Q and A]]> Mon, 09 Sep 2019 11:52:29 GMT /slideshow/updates-from-the-pharmacovigilance-and-special-access-branch/170248235 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Updates from the Pharmacovigilance and Special Access Branch TherapeuticGoodsAdministration Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS) Q and A <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/04a07-grantpeggsarahmay-arcspresentation-psabupdate-consolidatedslidesarcs2019-janet-190909115229-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS) Q and A
Updates from the Pharmacovigilance and Special Access Branch from TGA Australia
]]> 1180 5 https://cdn.slidesharecdn.com/ss_thumbnails/04a07-grantpeggsarahmay-arcspresentation-psabupdate-consolidatedslidesarcs2019-janet-190909115229-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Consumer Medicine Information - Improving the CMI template /slideshow/consumer-medicine-information-improving-the-cmi-template/170247557 05a17-grantpeggmitemplateimprovementproject-arcsconference2019-fran-190909114728
Presentation on the revised, improved CMI template, reduce complexity and improve readability and evidence-based changes]]>
Presentation on the revised, improved CMI template, reduce complexity and improve readability and evidence-based changes]]> Mon, 09 Sep 2019 11:47:28 GMT /slideshow/consumer-medicine-information-improving-the-cmi-template/170247557 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Consumer Medicine Information - Improving the CMI template TherapeuticGoodsAdministration Presentation on the revised, improved CMI template, reduce complexity and improve readability and evidence-based changes <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/05a17-grantpeggmitemplateimprovementproject-arcsconference2019-fran-190909114728-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on the revised, improved CMI template, reduce complexity and improve readability and evidence-based changes
Consumer Medicine Information - Improving the CMI template from TGA Australia
]]> 673 3 https://cdn.slidesharecdn.com/ss_thumbnails/05a17-grantpeggmitemplateimprovementproject-arcsconference2019-fran-190909114728-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Regulatory updates from the Complementary and OTC Medicines Branch - Listed medicines regulatory reforms /slideshow/regulatory-updates-from-the-complementary-and-otc-medicines-branch-listed-medicines-regulatory-reforms/170246843 06a19-michaelshum-comb-updatefromthecomplementaryandotcmedicinesbranch-arcs2019-fran-190909114138
Presentation on listed medicines regulatory reforms]]>
Presentation on listed medicines regulatory reforms]]> Mon, 09 Sep 2019 11:41:38 GMT /slideshow/regulatory-updates-from-the-complementary-and-otc-medicines-branch-listed-medicines-regulatory-reforms/170246843 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Regulatory updates from the Complementary and OTC Medicines Branch - Listed medicines regulatory reforms TherapeuticGoodsAdministration Presentation on listed medicines regulatory reforms <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/06a19-michaelshum-comb-updatefromthecomplementaryandotcmedicinesbranch-arcs2019-fran-190909114138-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on listed medicines regulatory reforms
Regulatory updates from the Complementary and OTC Medicines Branch - Listed medicines regulatory reforms from TGA Australia
]]> 737 1 https://cdn.slidesharecdn.com/ss_thumbnails/06a19-michaelshum-comb-updatefromthecomplementaryandotcmedicinesbranch-arcs2019-fran-190909114138-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Improved electronic submission methodologies - Challenges and future state /slideshow/improved-electronic-submission-methodologies-challenges-and-future-state/170245668 07a24-emmarichards-arcsaug2019presentationdraftelectronicsubmissionspresentationarcs2019-190909113438
Presentation on our greatest challenge, how current work helps us tackle this challenge and the future]]>
Presentation on our greatest challenge, how current work helps us tackle this challenge and the future]]> Mon, 09 Sep 2019 11:34:38 GMT /slideshow/improved-electronic-submission-methodologies-challenges-and-future-state/170245668 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Improved electronic submission methodologies - Challenges and future state TherapeuticGoodsAdministration Presentation on our greatest challenge, how current work helps us tackle this challenge and the future <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/07a24-emmarichards-arcsaug2019presentationdraftelectronicsubmissionspresentationarcs2019-190909113438-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on our greatest challenge, how current work helps us tackle this challenge and the future
Improved electronic submission methodologies - Challenges and future state from TGA Australia
]]> 370 0 https://cdn.slidesharecdn.com/ss_thumbnails/07a24-emmarichards-arcsaug2019presentationdraftelectronicsubmissionspresentationarcs2019-190909113438-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Regulation, ethics and reimbursement of novel biological therapies in Australia – an update /slideshow/regulation-ethics-and-reimbursement-of-novel-biological-therapies-in-australia-an-update/170244065 08a25-glennsmith-regulationethicsandreimbursementofnovelbiological-arcs2019-190909112533
Presentation introducing 'novel biologics/gene therapy products', regulatory pathways and guidelines]]>
Presentation introducing 'novel biologics/gene therapy products', regulatory pathways and guidelines]]> Mon, 09 Sep 2019 11:25:32 GMT /slideshow/regulation-ethics-and-reimbursement-of-novel-biological-therapies-in-australia-an-update/170244065 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Regulation, ethics and reimbursement of novel biological therapies in Australia – an update TherapeuticGoodsAdministration Presentation introducing 'novel biologics/gene therapy products', regulatory pathways and guidelines <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/08a25-glennsmith-regulationethicsandreimbursementofnovelbiological-arcs2019-190909112533-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation introducing &#39;novel biologics/gene therapy products&#39;, regulatory pathways and guidelines
Regulation, ethics and reimbursement of novel biological therapies in Australia – an update from TGA Australia
]]> 1056 3 https://cdn.slidesharecdn.com/ss_thumbnails/08a25-glennsmith-regulationethicsandreimbursementofnovelbiological-arcs2019-190909112533-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Updates to Good Manufacturing Practices - Recent, current and future changes /slideshow/updates-to-good-manufacturing-practices-recent-current-and-future-changes/170243281 09b03-mattdavis-updatestogoodmanufacturingpractices-arcs2019-190909112103
Presentation on updates to TGA guidance, adoption of PE009-14, changes in version 14 and future updates to the PIC/S GMPs]]>
Presentation on updates to TGA guidance, adoption of PE009-14, changes in version 14 and future updates to the PIC/S GMPs]]> Mon, 09 Sep 2019 11:21:02 GMT /slideshow/updates-to-good-manufacturing-practices-recent-current-and-future-changes/170243281 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Updates to Good Manufacturing Practices - Recent, current and future changes TherapeuticGoodsAdministration Presentation on updates to TGA guidance, adoption of PE009-14, changes in version 14 and future updates to the PIC/S GMPs <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/09b03-mattdavis-updatestogoodmanufacturingpractices-arcs2019-190909112103-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on updates to TGA guidance, adoption of PE009-14, changes in version 14 and future updates to the PIC/S GMPs
Updates to Good Manufacturing Practices - Recent, current and future changes from TGA Australia
]]> 627 2 https://cdn.slidesharecdn.com/ss_thumbnails/09b03-mattdavis-updatestogoodmanufacturingpractices-arcs2019-190909112103-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Good Clinical Practice Inspections - Consultation to introduce a pilot program of voluntary GCP inspections /slideshow/good-clinical-practice-inspections-consultation-to-introduce-a-pilot-program-of-voluntary-gcp-inspections/170242327 10b07-katherineclark-goodclinicalpracticepilotinspectionprogram-16x9arcs2019-190909111542
Presentation on the good clinical practice inspections consultation, feedback received and next steps]]>
Presentation on the good clinical practice inspections consultation, feedback received and next steps]]> Mon, 09 Sep 2019 11:15:42 GMT /slideshow/good-clinical-practice-inspections-consultation-to-introduce-a-pilot-program-of-voluntary-gcp-inspections/170242327 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Good Clinical Practice Inspections - Consultation to introduce a pilot program of voluntary GCP inspections TherapeuticGoodsAdministration Presentation on the good clinical practice inspections consultation, feedback received and next steps <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/10b07-katherineclark-goodclinicalpracticepilotinspectionprogram-16x9arcs2019-190909111542-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on the good clinical practice inspections consultation, feedback received and next steps
Good Clinical Practice Inspections - Consultation to introduce a pilot program of voluntary GCP inspections from TGA Australia
]]> 731 3 https://cdn.slidesharecdn.com/ss_thumbnails/10b07-katherineclark-goodclinicalpracticepilotinspectionprogram-16x9arcs2019-190909111542-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Manufacturing Investigational Medicinal Products - Legislative and GMP requirements /slideshow/manufacturing-investigational-medicinal-products-legislative-and-gmp-requirements/170241471 11b10-mattdavis-manufacturinginvestigationalmedicinalproducts-arcs2019-190909111027
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues]]>
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues]]> Mon, 09 Sep 2019 11:10:27 GMT /slideshow/manufacturing-investigational-medicinal-products-legislative-and-gmp-requirements/170241471 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Manufacturing Investigational Medicinal Products - Legislative and GMP requirements TherapeuticGoodsAdministration Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/11b10-mattdavis-manufacturinginvestigationalmedicinalproducts-arcs2019-190909111027-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Manufacturing Investigational Medicinal Products - Legislative and GMP requirements from TGA Australia
]]> 1042 4 https://cdn.slidesharecdn.com/ss_thumbnails/11b10-mattdavis-manufacturinginvestigationalmedicinalproducts-arcs2019-190909111027-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Update on regulatory reforms from the Scientific Evaluation Branch /slideshow/update-on-regulatory-reforms-from-the-scientific-evaluation-branch-170240312/170240312 12b11-jennyburnett-regulatoryreformsfromthescientificevaluationbranch-arcs2019-190909110409
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines ]]>
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines ]]> Mon, 09 Sep 2019 11:04:09 GMT /slideshow/update-on-regulatory-reforms-from-the-scientific-evaluation-branch-170240312/170240312 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Update on regulatory reforms from the Scientific Evaluation Branch TherapeuticGoodsAdministration Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/12b11-jennyburnett-regulatoryreformsfromthescientificevaluationbranch-arcs2019-190909110409-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation Branch from TGA Australia
]]> 368 0 https://cdn.slidesharecdn.com/ss_thumbnails/12b11-jennyburnett-regulatoryreformsfromthescientificevaluationbranch-arcs2019-190909110409-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Update on regulatory reforms from the Scientific Evaluation Branch /TherapeuticGoodsAdministration/update-on-regulatory-reforms-from-the-scientific-evaluation-branch 12b11-jennyburnett-regulatoryreformsfromthescientificevaluationbranch-arcs2019-190909105920
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines]]>
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines]]> Mon, 09 Sep 2019 10:59:20 GMT /TherapeuticGoodsAdministration/update-on-regulatory-reforms-from-the-scientific-evaluation-branch TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Update on regulatory reforms from the Scientific Evaluation Branch TherapeuticGoodsAdministration Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/12b11-jennyburnett-regulatoryreformsfromthescientificevaluationbranch-arcs2019-190909105920-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation Branch from TGA Australia
]]> 150 0 https://cdn.slidesharecdn.com/ss_thumbnails/12b11-jennyburnett-regulatoryreformsfromthescientificevaluationbranch-arcs2019-190909105920-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Reporting of Medicine Shortages /slideshow/reporting-of-medicine-shortages/170238246 13b18-annanhan-arcspresentation-august2019-reportingmedicineshortages-annanhan-finalarcs2019-190909105134
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework]]>
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework]]> Mon, 09 Sep 2019 10:51:34 GMT /slideshow/reporting-of-medicine-shortages/170238246 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Reporting of Medicine Shortages TherapeuticGoodsAdministration Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/13b18-annanhan-arcspresentation-august2019-reportingmedicineshortages-annanhan-finalarcs2019-190909105134-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Reporting of Medicine Shortages from TGA Australia
]]> 364 0 https://cdn.slidesharecdn.com/ss_thumbnails/13b18-annanhan-arcspresentation-august2019-reportingmedicineshortages-annanhan-finalarcs2019-190909105134-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Regulatory updates from the TGA Medical Devices Branch - Part 1 /slideshow/regulatory-updates-from-the-tga-medical-devices-branch-part-1/170237408 14b19-part1-mimichu-gourlay-regulatoryupdatesfromthetgamedicaldevicesbranch-arcs2019-190909104444
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring]]>
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring]]> Mon, 09 Sep 2019 10:44:44 GMT /slideshow/regulatory-updates-from-the-tga-medical-devices-branch-part-1/170237408 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Regulatory updates from the TGA Medical Devices Branch - Part 1 TherapeuticGoodsAdministration Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/14b19-part1-mimichu-gourlay-regulatoryupdatesfromthetgamedicaldevicesbranch-arcs2019-190909104444-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Regulatory updates from the TGA Medical Devices Branch - Part 1 from TGA Australia
]]> 400 1 https://cdn.slidesharecdn.com/ss_thumbnails/14b19-part1-mimichu-gourlay-regulatoryupdatesfromthetgamedicaldevicesbranch-arcs2019-190909104444-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Regulatory updates from the TGA Medical Devices Branch - Part 2 /slideshow/regulatory-updates-from-the-tga-medical-devices-branch-part-2/170228827 15b19part2elizabethmcgrathwed1445pyrmonttheatreelizabethmcgratharcs2019-190909095047
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs ]]>
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs ]]> Mon, 09 Sep 2019 09:50:47 GMT /slideshow/regulatory-updates-from-the-tga-medical-devices-branch-part-2/170228827 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Regulatory updates from the TGA Medical Devices Branch - Part 2 TherapeuticGoodsAdministration Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/15b19part2elizabethmcgrathwed1445pyrmonttheatreelizabethmcgratharcs2019-190909095047-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
Regulatory updates from the TGA Medical Devices Branch - Part 2 from TGA Australia
]]> 460 4 https://cdn.slidesharecdn.com/ss_thumbnails/15b19part2elizabethmcgrathwed1445pyrmonttheatreelizabethmcgratharcs2019-190909095047-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 SME Assist: Help to navigate the regulatory maze /slideshow/sme-assist-help-to-navigate-the-regulatory-maze/170224034 16c14-avirebera-smeassistpresentation-arcs2019-190909092006
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help]]>
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help]]> Mon, 09 Sep 2019 09:20:05 GMT /slideshow/sme-assist-help-to-navigate-the-regulatory-maze/170224034 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) SME Assist: Help to navigate the regulatory maze TherapeuticGoodsAdministration Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/16c14-avirebera-smeassistpresentation-arcs2019-190909092006-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
SME Assist: Help to navigate the regulatory maze from TGA Australia
]]> 300 1 https://cdn.slidesharecdn.com/ss_thumbnails/16c14-avirebera-smeassistpresentation-arcs2019-190909092006-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an overview, 12 June 2019 /slideshow/tga-webinar-the-good-manufacturing-practice-gmp-clearance-framework-an-overview-12-june-2019/166455558 tga-presentation-the-good-manufacturing-practice-clearance-framework-an-overview-190826061631
Introduction to the GMP clearance process, why it exists and future directions]]>
Introduction to the GMP clearance process, why it exists and future directions]]> Mon, 26 Aug 2019 06:16:30 GMT /slideshow/tga-webinar-the-good-manufacturing-practice-gmp-clearance-framework-an-overview-12-june-2019/166455558 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an overview, 12 June 2019 TherapeuticGoodsAdministration Introduction to the GMP clearance process, why it exists and future directions <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/tga-presentation-the-good-manufacturing-practice-clearance-framework-an-overview-190826061631-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Introduction to the GMP clearance process, why it exists and future directions
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an overview, 12 June 2019 from TGA Australia
]]> 1668 5 https://cdn.slidesharecdn.com/ss_thumbnails/tga-presentation-the-good-manufacturing-practice-clearance-framework-an-overview-190826061631-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Presentation: Updates from the Pharmacovigilance and Special Access Branch /slideshow/presentation-updates-from-the-pharmacovigilance-and-special-access-branch/165479564 a07-grantpeggsarahmay-arcspresentation-psabupdate-consolidatedslidesarcs2019-janet-190822022726
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.]]>
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.]]> Thu, 22 Aug 2019 02:27:26 GMT /slideshow/presentation-updates-from-the-pharmacovigilance-and-special-access-branch/165479564 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Presentation: Updates from the Pharmacovigilance and Special Access Branch TherapeuticGoodsAdministration This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/a07-grantpeggsarahmay-arcspresentation-psabupdate-consolidatedslidesarcs2019-janet-190822022726-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Presentation: Updates from the Pharmacovigilance and Special Access Branch from TGA Australia
]]> 476 9 https://cdn.slidesharecdn.com/ss_thumbnails/a07-grantpeggsarahmay-arcspresentation-psabupdate-consolidatedslidesarcs2019-janet-190822022726-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Presentation: The challenges of regulating direct to consumer digital medical devices /slideshow/presentation-the-challenges-of-regulating-direct-to-consumer-digital-medical-devices/165285391 presentation-the-challenges-of-regulating-direct-to-consumer-digital-medical-devices-190820235005
The challenges of regulating direct to consumer digital medical devices]]>
The challenges of regulating direct to consumer digital medical devices]]> Tue, 20 Aug 2019 23:50:05 GMT /slideshow/presentation-the-challenges-of-regulating-direct-to-consumer-digital-medical-devices/165285391 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) Presentation: The challenges of regulating direct to consumer digital medical devices TherapeuticGoodsAdministration The challenges of regulating direct to consumer digital medical devices <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/presentation-the-challenges-of-regulating-direct-to-consumer-digital-medical-devices-190820235005-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The challenges of regulating direct to consumer digital medical devices
Presentation: The challenges of regulating direct to consumer digital medical devices from TGA Australia
]]> 321 6 https://cdn.slidesharecdn.com/ss_thumbnails/presentation-the-challenges-of-regulating-direct-to-consumer-digital-medical-devices-190820235005-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018 /slideshow/tga-presentation-therapeutic-goods-advertising-code-no-2-2018/161147655 tga-presentation-therapeutic-goods-advertising-code-2-190805052203
This presentation covers the Therapeutic Goods Advertising Code (No. 2) 2018]]>
This presentation covers the Therapeutic Goods Advertising Code (No. 2) 2018]]> Mon, 05 Aug 2019 05:22:03 GMT /slideshow/tga-presentation-therapeutic-goods-advertising-code-no-2-2018/161147655 TherapeuticGoodsAdministration@slideshare.net(TherapeuticGoodsAdministration) TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018 TherapeuticGoodsAdministration This presentation covers the Therapeutic Goods Advertising Code (No. 2) 2018 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/tga-presentation-therapeutic-goods-advertising-code-2-190805052203-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This presentation covers the Therapeutic Goods Advertising Code (No. 2) 2018
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018 from TGA Australia
]]> 912 13 https://cdn.slidesharecdn.com/ss_thumbnails/tga-presentation-therapeutic-goods-advertising-code-2-190805052203-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://cdn.slidesharecdn.com/profile-photo-TherapeuticGoodsAdministration-48x48.jpg?cb=1568108980 www.tga.gov.au https://cdn.slidesharecdn.com/ss_thumbnails/02a05-clairelarter-pharmacovigilanceandcomplementarymedicines-arcs2019-190909120407-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/pharmacovigilance-and-complementary-medicines-regulatory-requirements/170249801 Pharmacovigilance and ... https://cdn.slidesharecdn.com/ss_thumbnails/03presentation-arcs-a06-thechallengesofregulatingdirecttoconsumerdigitalmedicaldevices-190909115859-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/the-challenges-of-regulating-direct-to-consumer-digital-medical-devices/170249110 The challenges of regu... https://cdn.slidesharecdn.com/ss_thumbnails/04a07-grantpeggsarahmay-arcspresentation-psabupdate-consolidatedslidesarcs2019-janet-190909115229-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/updates-from-the-pharmacovigilance-and-special-access-branch/170248235 Updates from the Pharm...