The European Medicines Agency (EMA) have issued a guideline on GCP compliance in relation to the trial master file (TMF), and invites comments from stakeholders. The guideline was compiled by the Good Clinical Practice Inspectors Working Group and the deadline for comments is 11 July 2017.
The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline (published in November 2016).
Justin Malherbe, at law firm Norton Rose Fulbright South Africa writes that the long-awaited ‘Regulations relating to Medical Devices and in vitro diagnostic medical devices (IVDs)’ were published by the Minister of Health in the Government Gazette on 9 December 2016. These regulations are now in force.
A number of South African researchers use the REDCap (Research Electronic Data Capture) web application to manage their research data. So much so that the University of Witwatersrand (Wits) invited the REDCap creator, Professor Paul Harris, to South Africa to share his insights. Read the full story here.