If you are interested in being an investigator on industry-sponsored trials...
On 5 April, two new regulations on medical devices were adopted by the EU namely EU2017/745 and EU2017/746. These replace the existing Directives for Medical Devices and In-Vitro Medical Devices, respectively i.e. 90/385/EEC and 93/42/EEC, 98/79/EC 2010/227/EU.
These regulations were published May 5, 2017 in the Official Journal of the European Union (OJEU) and 'entered into force' occurred on May 26, 2017.
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.
Apply now for 2017: UCT Scientific Computing Grant Application Call
UCT invites faculties to apply for prioritised pieces of medium size compute-related hardware and software (R50 000 to R500 000).
Herewith the dates for OPEN GCP Beginner and Refresher courses planned for February and March in Cape Town. Please register at least two weeks prior to the course dates.
The CRC's special MMED training calendar is now available!