GCP and GCLP Training – Namibia
University of Namibia, from 18 to 20 June 2018, delivered short courses in Basic GCP with ICH E6 (R2) material; and Basic GCLP training course. Course Instructors: Ms. Siza Mphele and Dr. Sumen Govender. Trainees included research staff working in clinical trials, and lab personnel involved in handling clinical research materials. Competency assessment for GCP was carried out post training to ensure on-the-job application of training. Certificates of competency for CPD points were issued to all trainees that met the assessment threshold. Certificates of attendance were issued to all GCLP trainees. The GCP and GCLP was attended by 38 participants.
UNAM recently indicated that the ICH GCP and GCLP training provided capacity for UNAM to identify the need to strengthen Ethics and Regulatory capacities.
“The GCP and GCLP training have given us capacity to identify that a lot need to be done NEC and NRA.”
Dr Jacob Sheehama, 2018
Subsequently, UNAM intends to respond to the EDCTP call: Ethics and regulatory capacities (22 Nov 2018).
• 75% strongly agree that the GCP course is a good basis for learning about conducting a clinical trial, managing a trial, ICH-GCP.
• All attendees reported to now have a better understanding of ICH GCP
• 50% understand their investigator responsibilities
• 75% have a better understanding of conducting clinical trials and preparing for monitoring visits
• 50% have a better understanding of safety reporting
• All attendees reported that they will apply ICH GCP in their day-to- day job
• Participants feedback is that the GCLP training led to increased confidence in applying GCLP principles
• Assessment indicate that most laboratory participants may have had limited exposure to GCLP concepts, hence faced many challenges in meeting GCLP standards for clinical trials.