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X-ORIGINAL-URL:https://www.sahpra.org.za
X-WR-CALDESC:Events for SAHPRA
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TZID:Africa/Johannesburg
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DTSTART:20230101T000000
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BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240307T100000
DTEND;TZID=Africa/Johannesburg:20240307T113000
DTSTAMP:20260429T074646
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
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BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240314T110000
DTEND;TZID=Africa/Johannesburg:20240314T130000
DTSTAMP:20260429T074646
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
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BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20240325T100000
DTEND;TZID=Africa/Johannesburg:20240325T130000
DTSTAMP:20260429T074646
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
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