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METHOD:PUBLISH
X-WR-CALNAME:SAHPRA
X-ORIGINAL-URL:https://www.sahpra.org.za
X-WR-CALDESC:Events for SAHPRA
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X-Robots-Tag:noindex
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BEGIN:VTIMEZONE
TZID:Africa/Johannesburg
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0200
TZNAME:SAST
DTSTART:20220101T000000
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END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20241108T090000
DTEND;TZID=Africa/Johannesburg:20241108T120000
DTSTAMP:20260419T211443
CREATED:20241028T090532Z
LAST-MODIFIED:20241111T102855Z
UID:17145-1731056400-1731067200@www.sahpra.org.za
SUMMARY:SAHPRA's Regulatory Technical Forum (RTF) Virtual Meeting
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted industry stakeholders at the Regulatory Technical Forum (RTF) Meeting. \nAreas discussed on the agenda included: \n\nEOI on model dossiers for training\nBAU applications and variations\nMedicines (Allopathic)\nVeterinary Medicines\nComplementary Medicines\nInspectorate and Regulatory Compliance\nMedical Devices & IVDs\nRadiation Control\nLegislation/ Guidelines for Comment/Implementation\nIT Upgrade\n\nPresentations \nHPA Updates \nMedical Devices and Radiation Control Updates \nDigitalisation Project Updates \n  \nRecording
URL:https://www.sahpra.org.za/event/sahpras-regulatory-technical-forum-rtf-virtual-meeting-november/
LOCATION:Virtual
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/png:https://www.sahpra.org.za/wp-content/uploads/2024/10/RTF-08Nov-web-email-banner.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240920T090000
DTEND;TZID=Africa/Johannesburg:20240920T110000
DTSTAMP:20260419T211443
CREATED:20240902T080908Z
LAST-MODIFIED:20240923T061718Z
UID:16878-1726822800-1726830000@www.sahpra.org.za
SUMMARY:Industry Workshop: Launch of the SAHPRA Engagement Portal
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted the launch of the SAHPRA Engagement Portal. \n\n\n\n\nThe expected outcomes: \n\nOverview\nAccount administration\nTraining\n\nWho attended? \n\nIndustry stakeholders\n\nPresentation \nDownload Presentation \nWatch Recording
URL:https://www.sahpra.org.za/event/industry-workshop-launch-of-the-sahpra-engagement-portal/
LOCATION:Virtual
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/png:https://www.sahpra.org.za/wp-content/uploads/2024/09/website-mailer-Industry-Workshop-eCTDs-Launch-of-the-Engagement-Portal-20Sept.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240918T130000
DTEND;TZID=Africa/Johannesburg:20240918T143000
DTSTAMP:20260419T211443
CREATED:20240912T091024Z
LAST-MODIFIED:20240918T160316Z
UID:16961-1726664400-1726669800@www.sahpra.org.za
SUMMARY:SADC Webinar: Substandard and Falsified health products: situational analysis and collaborations
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA)\, together with the SADC SF Group\, were excited to extend a special invitation to you for the SADC SF Group Webinar on Substandard and Falsified Health Products: situational analysis and collaborations. \nKey Highlights:\n\nBroader awareness and status of the fight against substandard and falsified medical products mainly within the SADC region and a glance of global work.\nThe dangers of using SF medical products and overall impact within these countries.\nInsights into general activities relating to prevention\, detection\, and response to SF medical products in the region and beyond.\n\nWho attended:\n\nHealth professionals\nSouth African public\nStakeholders from NRAs\nCivil society\nResearch institutions\nPublic health experts\nPolicy makers\n\nDownload Presentations: \n\nSADC Webinar – SF Situational Analysis – AUDA-NEPAD\nSADC Webinar – SF Situational Analysis -TMDA\nSADC Webinar – SF Situational Analysis -ZAMRA\n\nWatch Recording
URL:https://www.sahpra.org.za/event/sadc-webinar-substandard-and-falsified-health-products-situational-analysis-and-collaborations/
LOCATION:Virtual
CATEGORIES:Webinar,Workshop
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/09/mailer-website-SADC-Webinar-Substandard-and-Falsified-health-products-Situational-analysis-and-collaborations.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240913T090000
DTEND;TZID=Africa/Johannesburg:20240913T100000
DTSTAMP:20260419T211443
CREATED:20240829T133110Z
LAST-MODIFIED:20240917T093521Z
UID:16862-1726218000-1726221600@www.sahpra.org.za
SUMMARY:Industry Workshop: Specification 3.1 Processes
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted the third industry workshop in a series of informative sessions around eCTD. This webinar focused on Specification 3.1 processes. \nThe processes covered included: \n\nBaselines-Iterative\nTOA\nSplitting the eCTD\nMultiple applications (replicas\, clones\, and duplicates)\nLine Extensions\nCancellations\nWithdrawals\n\n  \nPresentations \nDownload Presentation \n  \nWatch Recording
URL:https://www.sahpra.org.za/event/industry-workshop-specification-3-1-processes/
LOCATION:Virtual
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/png:https://www.sahpra.org.za/wp-content/uploads/2024/09/website-mailer-Industry-Workshop-eCTD-Specification-Processes-13Sept2024.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240828T190000
DTEND;TZID=Africa/Johannesburg:20240828T200000
DTSTAMP:20260419T211443
CREATED:20240820T134041Z
LAST-MODIFIED:20240829T063008Z
UID:16812-1724871600-1724875200@www.sahpra.org.za
SUMMARY:CCI Webinar Series | 3rd Module | Patient Safety - codeine’s place in pharmaceutical care
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) recently hosted the 3rd webinar in our Codeine Care Initiative (CCI) series\, focusing on Patient Safety – Codeine’s Place in Pharmaceutical Care.\n\n\n\n\n\n\n\n\n\n\nFollowing our first module\, which centred on holistic management for pain\, cough\, and colds\, and the second\, which highlighted the legislation surrounding codeine-containing medicines\, this third session delved into the crucial topic of patient safety. \nWhy Was This Webinar Important? \nParticipants had the opportunity to gain a deeper understanding of the vital role healthcare professionals play in supporting patients with responsible self-care. The session provided valuable guidance and advice on ensuring patient safety when dealing with codeine-containing medicines. \nWho attended? \n\nIndustry Stakeholders\nHealthcare Professionals\n\nThis webinar proved to be an essential platform for those invested in the safe and effective use of codeine in pharmaceutical care. \n\nPresentations \n\nDr Andrew Scheibe – Codeine Use & Harm Reduction\nDr Johann Kruger – CCI overview\n\nWatch Recording
URL:https://www.sahpra.org.za/event/cci-webinar-series-3rd-module-patient-safety-codeines-place-in-pharmaceutical-care/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/08/website-mailerCCI-Webinar-Series-_-Module-3-_-Patient-Safety-Codeines-place-in-pharmaceutical-care1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240822T090000
DTEND;TZID=Africa/Johannesburg:20240822T120000
DTSTAMP:20260419T211443
CREATED:20240807T073636Z
LAST-MODIFIED:20240822T133915Z
UID:16770-1724317200-1724328000@www.sahpra.org.za
SUMMARY:SAHPRA's Regulatory Technical Forum (RTF) Virtual Meeting
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted industry stakeholders at the Regulatory Technical Forum (RTF) Meeting. \nAreas discussed on the agenda included: \n\nComments on the newly established SAHPRA Regulatory Technical Forum\nEOI on model dossiers for training\nBAU applications and variations\nMedicines (Allopathic)\nVeterinary Medicines\nComplementary Medicines\nInspectorate and Regulatory Compliance\nMedical Devices & IDVs\nRadiation Control\nLegislation/ Guidelines for Comment/Implementation\nIT Upgrade\n\nPresentations:\n \n\nSAHPRA RTF New Registrations and Variations\nRTF Inspectorate update\nMedical Device Regulatory Roadmap\nICH Survey Results Presentation RTF meeting\n\nRecording:
URL:https://www.sahpra.org.za/event/sahpras-regulatory-technical-forum-rtf-virtual-meeting/
LOCATION:Virtual
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/08/RTF-22-August-web-banner.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240808T090000
DTEND;TZID=Africa/Johannesburg:20240808T100000
DTSTAMP:20260419T211443
CREATED:20240801T130620Z
LAST-MODIFIED:20240808T095544Z
UID:16755-1723107600-1723111200@www.sahpra.org.za
SUMMARY:Industry Workshop: eCTD’s Introduction of Specification 3.1
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted the second industry workshop in a series of informative workshops on eCTD. This webinar introduced you to Specification 3.1. \nThe discussion points were: \n\nChanges from Specification 3.0\nEnvelopes\nHeadings\nLifecycle maintenance\nValidations\nBaselines\nClosing sequences\n\nPresentation \nIntroduction to the ZA eCTD Specifications 3.1\n \nWatch Recording
URL:https://www.sahpra.org.za/event/industry-workshop-ectds-introduction-of-specification-3-1/
LOCATION:Hybrid [Venue: Innovation Hub]
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/08/web-banner-eCTD-08August2024.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240807T190000
DTEND;TZID=Africa/Johannesburg:20240807T200000
DTSTAMP:20260419T211443
CREATED:20240730T090708Z
LAST-MODIFIED:20240807T185116Z
UID:16737-1723057200-1723060800@www.sahpra.org.za
SUMMARY:CCI Webinar Series: Module 2 | Legislative Review
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted the 2nd webinar in our Codeine Care Initiative (CCI) series. Our first module had focused on the holistic management of pain\, cough\, and colds. \n\n\n\n\nThis 2nd webinar focused on a review of legislation around codeine-containing medicines. \n\n\n\n\n  \nPresentations \n1. Requests for Information related to selling of Medicines \n2. Overview of Legislative Requirements \n3. Overview of Codeine Regulation \n  \nWatch Recoding:
URL:https://www.sahpra.org.za/event/cci-webinar-series-module-2-legislative-review/
LOCATION:Hybrid [Venue: Innovation Hub]
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/07/website-mailerCCI-Webinar-Series-Module-2-Legislative-Review.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240719T090000
DTEND;TZID=Africa/Johannesburg:20240719T220000
DTSTAMP:20260419T211444
CREATED:20240704T110000Z
LAST-MODIFIED:20240724T082929Z
UID:16608-1721379600-1721426400@www.sahpra.org.za
SUMMARY:Industry Webinar on SAHPRA’s eCTD Specification 3.0
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted an informative workshop on the upcoming eCTD Specification 3.1 and the launch of the new Application Submission Portal. This was the first of three workshops. \nPresentations\nDownload Presentation \nWatch Recording
URL:https://www.sahpra.org.za/event/industry-webinar-on-sahpras-ectd-specification-3-0/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/07/website-mailer-SAHPRAs-eCTD-Submissions-Portal.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240710T190000
DTEND;TZID=Africa/Johannesburg:20240710T200000
DTSTAMP:20260419T211444
CREATED:20240703T073041Z
LAST-MODIFIED:20240710T201046Z
UID:16594-1720638000-1720641600@www.sahpra.org.za
SUMMARY:CCI Webinar Series | Module 1 | Holistic Management for pain\, cough & colds
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) recently hosted the launch webinar for our Codeine Care Initiative (CCI) series. This inaugural webinar focused on the holistic management of pain\, cough\, and colds. \nWhat was covered: \n\nInsightful information on pain\, cold\, and cough management.\nAn engaging session where attendees had the opportunity to ask burning questions and engage with experts on the topic.\n\nWho attended: \n\n\n\nIndustry stakeholders\nHealthcare professionals\n\n\n\nDownload Presentations:\nHolistic Cough & Cold Management \nHolistic Pain Management \nWatch Recording:
URL:https://www.sahpra.org.za/event/cci-webinar-series-module-1-holistic-management-for-pain-cough-colds/
LOCATION:Hybrid [Venue: Innovation Hub]
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/07/website-banner-CCI-Webinar-Series-Module-1-V1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240628T090000
DTEND;TZID=Africa/Johannesburg:20240628T123000
DTSTAMP:20260419T211444
CREATED:20230629T093130Z
LAST-MODIFIED:20241105T071915Z
UID:14721-1719565200-1719577800@www.sahpra.org.za
SUMMARY:Medical Devices Stakeholder engagement Industry Meeting
DESCRIPTION:A Consultative meeting with the industry to communicate updates\, and improve the application process\, as well as the overall services and relations. \nDate: 28 June 2023\nTime: 9h00 to 12h30 \nWatch Recording
URL:https://www.sahpra.org.za/event/medical-devices-stakeholder-engagement-industry-meeting/
LOCATION:Virtual
CATEGORIES:Webinar,Workshop
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/06/Stakeholder-engagement1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240628T090000
DTEND;TZID=Africa/Johannesburg:20240628T103000
DTSTAMP:20260419T211444
CREATED:20240619T124528Z
LAST-MODIFIED:20240701T150013Z
UID:16540-1719565200-1719570600@www.sahpra.org.za
SUMMARY:Industry Workshop on FAQs and Common Deficiencies for APIMF Submission
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the FAQs & Common Deficiencies for APIMF [Active Pharmaceutical Ingredient Master File] Submission. \nThe workshop provided information to the Industry Stakeholders and APIMF holders on the SAHPRA’s current APIMF submission procedure. In addition\, it highlighted the information on the FAQ/common deficiencies evaluators encounter when assessing the API. \n  \nDownload Presentations \n\nAPIMF Submissions\nFAQs & Common Deficiencies for APIMF Submission Documents\nGMP Requirements for APIs\n\nWatch Recording
URL:https://www.sahpra.org.za/event/industry-workshop-on-faqs-and-common-deficiencies-for-apimf-submission/
LOCATION:Hybrid [Venue: Innovation Hub]
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/06/website-emailer-APIMF-Webinar.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240614T083000
DTEND;TZID=Africa/Johannesburg:20240614T103000
DTSTAMP:20260419T211444
CREATED:20240528T125209Z
LAST-MODIFIED:20240722T095011Z
UID:16409-1718353800-1718361000@www.sahpra.org.za
SUMMARY:SAHPRA’s Hybrid Stakeholder Engagement Meeting
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted a Hybrid Stakeholder Engagement Meeting. The meeting was held in person and via our virtual platform. \n  \nAreas of discussion on the agenda included: \n\nSAHPRA’s strategy to support local manufacturing of vaccines as per African Union Agenda 2063\nFeedback on the B-BBEE Draft Policy\n\nDownload Presentations \n\nSAHPRA Responses to comments received on the draft B-BBEE Policy \nSAHPRA Draft Policy on Prioritisation of Local Manufacturers \n  \nWatch Recording
URL:https://www.sahpra.org.za/event/sahpras-hybrid-stakeholder-engagement-meeting/
LOCATION:Hybrid [Venue: Innovation Hub]
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/05/website-banner-SAHPRAs-Hybrid-Stakeholder-Engagement-Meeting-v2.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240516T090000
DTEND;TZID=Africa/Johannesburg:20240516T120000
DTSTAMP:20260419T211444
CREATED:20240423T050051Z
LAST-MODIFIED:20240528T130639Z
UID:16249-1715850000-1715860800@www.sahpra.org.za
SUMMARY:SAHPRA’s Regulatory Technical Forum (RTF) Inaugural Meeting
DESCRIPTION:South African Health Products Regulatory Authority (SAHPRA) hosted the Inaugural Meeting of the Regulatory Technical Forum (RTF). \nAreas of discussion on the agenda included: \n\nVeterinary Medicines\nComplementary Medicines\nPharmacovigilance\nMedical Devices and IVDs\nAllopathic Medicines\nRadiation Control\nLegislation/Guidelines for Comment or Implementation\n\nDate: 16 May 2024\nTime: 09:00 – 12:00 \nDownload Presentations: \n\n\nRTF Inspectorate update\nHarmonisation initiatives in veterinary medicines regulation\n\nWatch Recording Below:
URL:https://www.sahpra.org.za/event/sahpras-regulatory-technical-forum-rtf-inaugural-meeting/
LOCATION:Virtual
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/04/banner-SAHPRA-Regulatory-Technical-Forum-RTF-Inaugural-Meeting-.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240419T130000
DTEND;TZID=Africa/Johannesburg:20240419T140000
DTSTAMP:20260419T211444
CREATED:20240417T095133Z
LAST-MODIFIED:20240419T163954Z
UID:16204-1713531600-1713535200@www.sahpra.org.za
SUMMARY:3rd Session | Updates on Regulatory Information Management System (RIMS) Roll-Out
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted the 3rdsession of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates. \nWatch Recording:
URL:https://www.sahpra.org.za/event/3rd-session-updates-on-regulatory-information-management-system-rims-roll-out/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/04/email-banner-3rd-Session-_-Updates-on-Regulatory-Information-Management-System-RIMS-Roll-Out-copy.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240419T100000
DTEND;TZID=Africa/Johannesburg:20240419T130000
DTSTAMP:20260419T211444
CREATED:20240410T134856Z
LAST-MODIFIED:20240419T123411Z
UID:16155-1713520800-1713531600@www.sahpra.org.za
SUMMARY:SAHPRA’s Medical Devices’ Registration Update – Upcoming Feasibility Study
DESCRIPTION:The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an awareness session on this unit’s medical device registration update on the upcoming voluntary feasibility study. \nDate: 19 April 2024\nTime: 10:00 to 13:00 \n\nDownload Presentation \nDownload Feasibility Study \nWatch Recording:
URL:https://www.sahpra.org.za/event/sahpras-medical-devices-registration-update-upcoming-feasibility-study/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/04/facebook-SAHPRAs-Medical-Devices-Registration-Update-–-Upcoming-Feasibility-Study.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240412T090000
DTEND;TZID=Africa/Johannesburg:20240412T103000
DTSTAMP:20260419T211444
CREATED:20240404T183945Z
LAST-MODIFIED:20240412T095431Z
UID:16125-1712912400-1712917800@www.sahpra.org.za
SUMMARY:2nd Session | Updates on Regulatory Information Management System (RIMS) Roll-Out
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted the 2nd session of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates. \nThe session was recorded and published on the SAHPRA website. \nA similar Update session will be held once the eSubmission specifications and guidelines are ready – which tentatively will be held in July 2024. \nWe want this webinar to be interactive and engaging – so be sure to ask questions during the session through the chat interface. \nDownload Presentation \nWatch Recording
URL:https://www.sahpra.org.za/event/2nd-session-updates-on-regulatory-information-management-system-rims-roll-out/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/04/banner-2nd-Session-_-Updates-on-Regulatory-Information-Management-System-RIMS-Roll-Out.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240411T090000
DTEND;TZID=Africa/Johannesburg:20240411T120000
DTSTAMP:20260419T211444
CREATED:20240404T183024Z
LAST-MODIFIED:20240411T133359Z
UID:16121-1712826000-1712836800@www.sahpra.org.za
SUMMARY:Industry Workshop | Understanding SAHPRA’s Risk Management Plan Guidelines
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the Authority’s requirements when submitting Risk Management Plans (RMPs). \nThis workshop highlighted the importance of maintaining RMPs to ensure the safety of medicines\, while also sharing requirements for compliance. \nDate: 11 April 2024\nTime: 09:00 to 12:00 \nDownload Presentation \nWatch recording:
URL:https://www.sahpra.org.za/event/industry-workshop-understanding-sahpras-risk-management-plan-guidelines/
LOCATION:Virtual
CATEGORIES:Webinar,Workshop
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/04/web-banner-Understanding-your-RMP-requirements-final.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240325T100000
DTEND;TZID=Africa/Johannesburg:20240325T130000
DTSTAMP:20260419T211444
CREATED:20240319T065754Z
LAST-MODIFIED:20240325T131231Z
UID:16006-1711360800-1711371600@www.sahpra.org.za
SUMMARY:Virtual Meeting | Conformity Assessment Bodies Meeting
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA)\, in collaboration with the South African National Accreditation System (SANAS)\, hosted a Conformity Assessment Bodies (CABs) Virtual Meeting. \nWhat was discussed? \n\nExtension of scope of practice to include technical dossier review\nSANAS Accreditation process\nSAHPRA requirements and future process\n\nWho attended? \n\nLocal and International CABs\n\nMeeting Details \n\nDate: 25 March 2024\nTime: 10:00 – 13:00\n\n\nVirtual Meeting Presentations:\nSAHPRA approval process for CABs\nProposed Product Registration Feasibility Studies Model And Proposal For Cabs Support\nSANAS Accreditation Process\nCriteria For Certification Body Accreditation in the Scope of Product\, Process and Service Certification \nVirtual Meeting Recording:
URL:https://www.sahpra.org.za/event/virtual-meeting-conformity-assessment-bodies-meeting/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/03/twittter-mailer-Conformity-Assessment-Bodies-Meeting.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240314T110000
DTEND;TZID=Africa/Johannesburg:20240314T130000
DTSTAMP:20260419T211444
CREATED:20240313T085239Z
LAST-MODIFIED:20240315T083113Z
UID:15968-1710414000-1710421200@www.sahpra.org.za
SUMMARY:Industry Webinar | Updates on Regulatory Information Management (RIMS) Roll-Out
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) is hosting an Industry webinar for updates on the Regulatory Information Management System (RIMS) roll-out. \nWhat to expect? \n\nSAHPRA will start with cut-over activities during the course of March 2024 and the implementation process on 02 April 2024. We have modernised the eCTD Guideline and have introduced a new flexible management structure to allow SAHPRA to add new submission types more easily in future and also manage the validation of submissions a lot easier.\nAs part of the RIMS implementation\, all eCTD applications (New applications\, Renewal Applications and Variation applications – Type Ia\, Ib and II) will be managed in the docuBridge environment and will be subject to the eCTD guidelines and requirements accordingly. From April to 30 June 2024\, there is an interim requirement for a simple XML file to be included along with the eCTD dossier once loaded onto sFTP. We will go through the XML file requirements and duly share a “How-To” document and the simple template on the new Electronic Submissions Landing page.\nSAHPRA will also take the attendees through the roadmap for activities planned with the specific milestones for April 2024\, July 2024 and October 2024.\nWe will have a high-level discussion around the custom-developed Portal and also discuss the process we will be running to invite a limited number of Industry users to participate in the Focus Group testing\, along with internal users in May 2024\, June 2024 and September 2024 for the Portal Phase I test and feedback discussions.\n\nWho should attend? \nIt is quite important for the Industry users who will be preparing the submissions for Orthodox medicines and Biological medicines to attend this session to be apprised of the specifications guideline updates and linked changes and also where to find the relevant documents of matrix links. \nA similar Update session will be held once the eSubmission specifications and guidelines are ready – which tentatively will be held in July 2024. \nWe want this webinar to be interactive and engaging – so be sure to ask questions during the session through the chat interface. \n————————————————————————————————————————————————————————————————————————————- \nPlease note that we are unable to provide the video recording due the global outage of MS Office 365 that affected the recording of the Teams Meeting. However\, please have a look at the presentation from our COO\, Christelna Reynecke on the South African eCTD 3.0 Launch – 14 March 2024. \nDownload Presentation
URL:https://www.sahpra.org.za/event/industry-webinar-updates-on-regulatory-information-management-rims-roll-out/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/03/mailer-Industry-Webinar-_-Updates-on-Regulatory-Information-Management-System-RIMS-Roll-Out.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240307T100000
DTEND;TZID=Africa/Johannesburg:20240307T113000
DTSTAMP:20260419T211444
CREATED:20240307T090227Z
LAST-MODIFIED:20240307T102730Z
UID:15914-1709805600-1709811000@www.sahpra.org.za
SUMMARY:Virtual Training Session | How to use the OTC Online Medicines Directory Toolkit
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA)\, in conjunction with the Selfcare Association of South Africa\, hosted a virtual training session on How to use the OTC Online Medicines Directory Toolkit. \nBy registering\, you have an opportunity to: \n\ngrasp and understand how you can apply key visuals to your Over-The-Counter products.\nlearn how to activate the OTC Online Medicines Directory across your websites\, social media or point-of-sale materials.\n\nDownload Presentation \n  \nWatch Recording:\n \n 
URL:https://www.sahpra.org.za/event/virtual-training-session-how-to-use-the-otc-online-medicines-directory-toolkit/
LOCATION:Virtual
CATEGORIES:Webinar,Workshop
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/03/save-the-date-banner-email-Training-Session-How-to-use-the-OTC-Online-Medicines-Directory-Toolkit.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240228T150000
DTEND;TZID=Africa/Johannesburg:20240228T163000
DTSTAMP:20260419T211444
CREATED:20240219T132658Z
LAST-MODIFIED:20240301T095949Z
UID:15840-1709132400-1709137800@www.sahpra.org.za
SUMMARY:Webinar on Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact. \nKey Highlights: \n\nUnderstanding the basics of substandard and falsified medicines\nIdentifying the dangers of consuming untested and unauthorised medicines\nImportance of reporting agencies/outlets to curb the circulation of these medicines\n\nExpect to hear from continental experts from the Food and Drug Authority Ghana (FDA Ghana)\, the National Agency for Food and Drugs Administration and Control (NAFDAC)\, Medicines Control Authority of Zimbabwe (MCAZ) to name a few. \nOur webinar will be facilitated by seasoned journalist\, Zikhona Tshona. \nEvent Details: \n\nTopic: Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact\nDate: Wednesday\, 28 February 2024\nTime: 15:00 – 16:30 (SAST)\n\n  \nPresentations:\nCIPC – Counterfeit Medicines – Awareness of Substandard and Falsified Medications in South Africa\nSAPS – Counterfeiting operations\nBoMRA – Post Market Surveillance\nFDA Ghana – Enforcement Directorate\nMCAZ – How Zimbabwe is affected by SFs and approach to Prevention\, Detection and Response\nNAFDAC – Perspectives from NAFDAC \n  \nWatch Recording:
URL:https://www.sahpra.org.za/event/webinar-on-awareness-of-substandard-falsified-medications-in-south-africa-understanding-impact/
LOCATION:Virtual
CATEGORIES:Webinar,Workshop
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/02/twitter-Webinar-on-Awareness-of-Substandard-and-Falsified-Medications-in-South-Africa-Understanding-Impact.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240222T100000
DTEND;TZID=Africa/Johannesburg:20240222T140000
DTSTAMP:20260419T211444
CREATED:20240215T112941Z
LAST-MODIFIED:20240222T114841Z
UID:15822-1708596000-1708610400@www.sahpra.org.za
SUMMARY:Webinar on Virtual Fee Regulation Workshop with Industry | Revised Fee Regulations
DESCRIPTION:South African Health Products Regulatory Authority (SAHPRA) hosted a virtual workshop in the Virtual Fee Regulation Workshop with Industry. The workshop addressed the responses to public comments and proposed changes to the Revised Fee Regulations. \n\nThu\, Feb 22\, 10:00 AM – 2:00 PM (CAT)\n  \nDownload Presentation \n  \nWatch Recording
URL:https://www.sahpra.org.za/event/webinar-on-virtual-fee-regulation-workshop-with-industry-revised-fee-regulations/
LOCATION:Virtual
CATEGORIES:Webinar,Workshop
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2024/02/facebook-banner-Virtual-Fee-Regulation-Workshop-with-Industry-_-Revised-Fee-Regulations.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20231114T090000
DTEND;TZID=Africa/Johannesburg:20231116T180000
DTSTAMP:20260419T211444
CREATED:20231113T094948Z
LAST-MODIFIED:20231113T180835Z
UID:15275-1699952400-1700157600@www.sahpra.org.za
SUMMARY:Good Regulatory Practices and Technical Competencies
DESCRIPTION:This workshop will provide an exchange of information and capacity building between the South African Health Products Regulatory Authority\, SAPHRA and partner reference NRAs including the WHO\, USFDA\, TGA\, HSA\, ANVISA\, covering the core international references for medical device regulatory. The workshop objective is to support and advance to strengthen the soft infrastructure of medical device regulatory framework to incorporate global lessons learned from the COVID-19 pandemic\, to better prepare for future health emergencies\, to prevent the implementation of unnecessary regulatory barriers to medical technologies\, to improve general MD NRA public administration and general public health. \n  \nDate: 14 November 2023\nTime: 9:00 – 17:30 Pretoria\, South Africa (2:00 am – 10:30 ET)\nPlatform: Hybrid (In-person: Southern Sun Pretoria Hotel\, Cnr. Steve Biko and\, Pretorius St\, Arcadia\, Pretoria\, 0083). Please register here for virtual or in-person participation. \n\nRegister for hybrid event here.
URL:https://www.sahpra.org.za/event/good-regulatory-practices-and-technical-competencies/
LOCATION:Hybrid [Venue: Innovation Hub]
CATEGORIES:Hybrid meeting
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/11/event-banner.jpeg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20231106T180000
DTEND;TZID=Africa/Johannesburg:20231106T193000
DTSTAMP:20260419T211444
CREATED:20231106T162207Z
LAST-MODIFIED:20260209T131036Z
UID:15237-1699293600-1699299000@www.sahpra.org.za
SUMMARY:Webinar | Importance of Reporting Adverse Events to SAHPRA | #MedSafetyWeek
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) is commemorating the #MedSafetyWeek2023 campaign\, in collaboration with South African Pharmacy Council (SAPC)\, by hosting a webinar focused on the Importance of Reporting Adverse Events. \nThe #MedSafetyWeek is an international social media campaign organised every year by the Uppsala Monitoring Centre (UMC) to raise awareness of adverse events and national reporting systems. \nYou have an opportunity to learn and engage with SAHPRA and SAPC colleagues on key safety and reporting issues. \nWhat you will learn about: \n\nReporting side effects\nSide effects experienced at health facilities\nRole of pharmacies and patient safety\n\nDate: 06 November 2023\nTime: 18:00 \n\nPresentations:\nJHB Health District\nExpanded Program On Immunisation In South Africa \n  \nWebinar recording:
URL:https://www.sahpra.org.za/event/webinar-importance-of-reporting-adverse-events-to-sahpra-medsafetyweek/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/11/mailer-banner-Importance-of-Reporting-Adverse-Events-to-SAHPRA.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20231025T100000
DTEND;TZID=Africa/Johannesburg:20231025T113000
DTSTAMP:20260419T211444
CREATED:20231106T120041Z
LAST-MODIFIED:20231124T073157Z
UID:15232-1698228000-1698233400@www.sahpra.org.za
SUMMARY:Radiation Control’s Regulatory Compliance Webinar
DESCRIPTION:The Radiation Control (RadCon) Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an informational webinar to increase awareness and understanding of radiation control regulatory processes. \nYou have an opportunity to learn and engage with SAHPRA colleagues on key regulatory compliance processes within the RadCon unit. \nWhat you will learn about: \n\nRegulatory processes\nUnderstanding the licensing process\nRole of sub-units within RadCon\nDiagnostic and inspection process\n\n  \nPresentations:\nSAHPRA Compliance Requirement\nRADIATION CONTROL REGULATORY COMPLIANCE \nWebinar Recording:
URL:https://www.sahpra.org.za/event/radiation-controls-regulatory-compliance-webinar/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/11/radiation-Controls-Regulatory-Compliance-Webinar-mail-banner.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20230726T100000
DTEND;TZID=Africa/Johannesburg:20230726T113000
DTSTAMP:20260419T211444
CREATED:20230721T095512Z
LAST-MODIFIED:20230727T132401Z
UID:14826-1690365600-1690371000@www.sahpra.org.za
SUMMARY:Webinar on Demystifying Hepatitis
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted an exciting conversation on Demystifying Hepatitis to bring more awareness to World Hepatitis Day\, celebrated annually on 28 July. \nWe have invited panellists from various sectors to share their knowledge\, experience\, and expertise to begin this important conversation focusing on the: \n\nUnderstanding the basics of hepatitis\nHow to identify symptoms\nPrevention of hepatitis\n\nDate: 26 July 2023\nTime: 10:00 \nPresentations:\nUnderstanding Hepatitis B and C and the 2030 elimination targets\nHepatitis B infection status among South Africans attending public health facilities over a five-year period: 2015 to 2019 \nRecording below:
URL:https://www.sahpra.org.za/event/webinar-on-demystifying-hepatitis/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/07/Demystifying-Hepatitis-_-World-Hepatitis-Day-mailer-banner.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20230522T090000
DTEND;TZID=Africa/Johannesburg:20230522T110000
DTSTAMP:20260419T211444
CREATED:20230518T133822Z
LAST-MODIFIED:20240422T080006Z
UID:14535-1684746000-1684753200@www.sahpra.org.za
SUMMARY:Upcoming Workshop: QOS/QIS and Variation Validation Template
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted a workshop to share useful information on populating the QOS and QIS as a replacement for the SCoRe document\, as well as information on the Variations Validation template. \nDate: 22 May 2023\nTime: 09:00 – 11:00 \nWatch Recording
URL:https://www.sahpra.org.za/event/upcoming-workshop-qos-qis-and-variation-validation-template/
LOCATION:Virtual
CATEGORIES:Workshop
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/05/QOS-QIS-and-Variation-Validation-Template-Workshop.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20230425T100000
DTEND;TZID=Africa/Johannesburg:20230425T113000
DTSTAMP:20260419T211444
CREATED:20230420T072125Z
LAST-MODIFIED:20230426T085235Z
UID:14442-1682416800-1682422200@www.sahpra.org.za
SUMMARY:Webinar on Unpacking Malaria on World Malaria Day
DESCRIPTION:The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar to increase awareness and understanding of malaria this World Malaria Day. \nThe purpose was for the public to learn and engage with experts on malaria. \nWe had invited panellists from various sectors to share their knowledge to continue this important conversation focusing on the: \n\nBasics of malaria\nApproved health products to combat malaria\nMalaria prevention and control\nDrug resistance surveillance\n\n  \nWatch recording below\n \n  \nDate: 25 April 2023\nTime: 10:00\nRegister NOW: bit.ly/3KTF8Ho
URL:https://www.sahpra.org.za/event/webinar-on-unpacking-malaria-on-world-malaria-day/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/04/Webinar-Unpacking-Malaria-website-banner.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20230224T100000
DTEND;TZID=Africa/Johannesburg:20230224T120000
DTSTAMP:20260419T211444
CREATED:20230224T111503Z
LAST-MODIFIED:20230224T111503Z
UID:13905-1677232800-1677240000@www.sahpra.org.za
SUMMARY:Webinar on Radiation Control Engagement with Inspection Bodies
DESCRIPTION:The Radiation Control Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an engagement with Inspection Bodies.\n\nWe have invited several Inspection Bodies to share their knowledge\, experience\, and expertise to begin this conversation focusing on the:\n\nAccreditation process by the South African National Accreditation System (SANAS)\nApproval process by SAHPRA\nConditions and scope of the Approved Inspection Authorities (AIA)\nImproving the workflow of electronic submissions\nImproving the quality of QC reports\n\nRecording below:
URL:https://www.sahpra.org.za/event/webinar-on-radiation-control-engagement-with-inspection-bodies/
LOCATION:Virtual
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2023/02/RADCON-Inspection-Bodies-Webinar-email-banner.jpg
END:VEVENT
END:VCALENDAR