July 1st SAHPRA Stakeholder Workshop Presentations and Documents

Dear SACRRA Members,

All paid up members with their log-ins and access to the Member's section of the website are able to view and download the following presentations that were shared with the leaders of Industry and all SAHPRA stakeholders as a Workshop that took place last week: 1st July.

Please note only paid-up members have access to the Member's section.

These documents will be under "Resources - SAHPRA".

  • Communications Channel document from the Clinical Trials Unit of SAHPRA, with Procedures for consultation and following up on Application with a 10 -point guideline procedure in the

  • Insurance and Indemnification procedures

  • SA - GCP: Summary of the changes in the new guidelines

  • CFT1 & CFF2 Application procedures

  • SAHPRA - Clinical Trials Unite update on Operations

  • Master Protocols Adaptive design studies Sub-type Studies.

  • Import and Export Permits of Biological materials Clinical Trials workshop

  • The National Principal Investigator

  • ITG updates - SACR A& IPASA updates

  • Vaccine Trials

  • SARS CoV2 Vaccines

  • Expedited Review of Studies - Pharma & SAHPRA

Thank you.


July 2021.