UPCOMING EVENTS

SACRA regional meetings: To be advised, watch the SACRA site for announcements

3rd African Cochrane Indaba (bursaries available from Jan 2019), 25-26 March 2019 - Cape Town. Details

FUNDISA/Tiervlei Trials Centre Investigator (& site staff) certification course, 15-19 Mar 2019 - Cape Town. For details contact info@fundisa-academy.com

8th ARESA Seminar in health research ethics, 4-5 April 2019 - Cape Town. Details

2nd South African Forensic Toxicology Symposium, 12 April 2019 - Cape Town. register before 1st March. Contact bronwen.davies@uct.ac.za for more details.

ONE HEALTH Symposium: A focus on infectious Diseases in Africa, 27-28 May 2019 - Durban. Registration, travel & hospitality costs covered for accepted abstracts from young, early career African researchers. Details

 

PREVIOUS EVENTS BY THE SOUTH AFRICAN REGIONAL FACULTY

2017 Building teratovigilance in Africa  

        Introduction of GRN to nursing staff at hospitals, clinics and a nursing college in Mpumalanga Province

        GRN workshop held at Groote Schuur Hospital, Cape Town

        Seminar presented by the EQUATOR Network

2016 GRN network lunch

2015 2-day conference

2014 Clinical Trial Site Management

2013 Critical issues in conducting non-commercially sponsored clinical research in South Africa

 NEWS

 Date Released

 

Jan 2019

Interim relocation of SAHPRA to CSIR

Dec 2018

CT meeting & submission dates 2019

Nov 2018

Updated guide to the direct transmission of fees to SAHPRA

Nov 2018

SAHPRA Backlog clearance programme

Oct 2018

Disruption to SAHPRA due to protests

Sep 2018

Revised process for Section 21 applications and re-authorisations

Jul 2018

DOH Material transfer agreement of human biological materials for clinical trials

Jun 2018

6.27_CT_Six_monthly_progress_report_form_May_18_v2: new progress report pdf (word also available)

Jun 2018

SAHPRA 6.05_CTF1_May18_v3: new Clinical trial application form pdf (word also available)

Jun 2018

SAHPRA Guideline: Clinical trial participant time, inconvenience & expense (TIE) compensation model

Jun 2018

SAHPRA Guideline: Post-clinical trial acess (PTA) / continuted access

Feb 2018

SAHPRA Capacity building & transformation in clinical trials research in SA

Jan 2018

SAHPRA Clinical Trial Committe meeting & committee dates 2018

Jan 2018

Medical device workshop with industry

Jan 2018

New MCC Progress report documents published. See website for word document

Jan 2018

GHT South Africa team contributed to the NIH updating its South Africa information in ClinRegs

Oct 2017

More than 1300 people from 75 counties attended The Global Evidence Summit

Oct 2017

SAHPRA Board appointed details

Jun 2017

National one-click access to evidence-based Cochrane Reviews. This collaboration between Wiley and the SAMRC offers free access, through IP recognition, to the Cochrane Library throughout South Africa details

Jun 2017

Notice stating commencement date of June 1, 2017 for No. 72 of 2008: Medicines and Related Substances Act, 2008 here

Jun 2017

Post-marketing reporting of ADRs to human medicines in SA here

Apr 2017

Notification Studies: Phase IV here

Jan 2017

Medicines and Related Substances Act, Draft General Medicine Regulations here

Dec 2016

MCC Definitions of Clinical trial investigators here

Dec 2016

MCC regulations relating to Medical devices and in vitro diagnostic medical  devices here

Nov 2016

MCC Oversight and monitoring in clinical trials here

Oct 2016

MCC Emergency procedures for clinical trial sites here

Jun 2016

South Africa’s Regulatory Profile Updated here

Jun 2016

MRC/DFID African Research Leader Scheme 2016/17 here

May 2016

CTC guidance on MCC submissions  here

May 2016

MCC draft guideline on risk-based monitoring here