The South African Health Products Regulatory Authority (SAHPRA) hosted the launch of the SAHPRA Engagement Portal. The expected outcomes: Overview Account administration Training Who attended? Industry stakeholders Presentation Download Presentation Watch Recording ...
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. The processes covered included: Baselines-Iterative TOA Splitting the eCTD Multiple applications (replicas, clones, and duplicates) Line Extensions Cancellations ...
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. The discussion points were: Changes from Specification 3.0 Envelopes Headings Lifecycle maintenance Validations Baselines Closing sequences Presentation Introduction to the...
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. Watch Recording: ...
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. The session was recorded and published on the SAHPRA website. A similar Update session will be held once the eSubmission specifications and guidelines...
The South African Health Products Regulatory Authority (SAHPRA) is hosting an Industry webinar for updates on the Regulatory Information Management System (RIMS) roll-out. What to expect? SAHPRA will start with cut-over activities during the course of March 2024 and the implementation process on 02 April 2024. We...