Immunogenicity of Biopharmaceuticals workshop

Osaka, Japan , Japan

The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil and the Ministry of Food and Drug...

Workshop – Pharmacovigilance Systems

Virtual

The SAHPRA Vigilance and Inspectorate units hosted a workshop on the Pharmacovigilance Systems' Guideline for Holders of Certificate (HCR). The workshop is scheduled for: Date: 30 August 2022 Time: 09h00 – 12h00 Registration link: https://bit.ly/pv-systems-workshop Event recording: 

Upcoming Workshop: QOS/QIS and Variation Validation Template

Virtual

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. Date: 22 May 2023 Time: 09:00 - 11:00 Watch Recording

Medical Devices Stakeholder engagement Industry Meeting

Virtual

A Consultative meeting with the industry to communicate updates, and improve the application process, as well as the overall services and relations. Date: 28 June 2023 Time: 9h00 to 12h30 Watch Recording

Webinar on Virtual Fee Regulation Workshop with Industry | Revised Fee Regulations

Virtual

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. Thu, Feb 22, 10:00 AM - 2:00 PM (CAT)   Download...

Webinar on Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact. Key Highlights: Understanding the basics of substandard and falsified medicines Identifying the dangers of consuming untested and unauthorised medicines Importance of reporting agencies/outlets...

Virtual Training Session | How to use the OTC Online Medicines Directory Toolkit

Virtual

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. By registering, you have an opportunity to: grasp and understand how you can...

Industry Workshop | Understanding SAHPRA’s Risk Management Plan Guidelines

Virtual

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). This workshop highlighted the importance of maintaining RMPs to ensure the safety of medicines, while also sharing requirements for compliance....