The planning, preparing, and organising of clinical trials have become a highly complex task that includes important issues such as: the need to protect participants generate reliable data, perform trials efficiently within short timelines, fulfil quality requirements according to current legislation and inspection requirements, utilisation of new technology and conduct clinical trials within budget to ensure sustainable business. To protect patient safety and trial integrity, the pharmaceutical industry made strides to accelerate trial innovations such as digital tools and virtualization, with support from regulatory authorities. The increased complexity of medicines development and regulatory requirements require well-trained staff in industry, CROs and Regulatory Agencies. The 2022 SAHPRA guidelines on “Capacity Building and Transformation in Clinical Trials Research in South Africa” requires public or private clinical trial sites to offer training related to “Clinical Research and Regulatory Sciences”. PharmaTrain and the European Clinical Research Infrastructures Network (ECRIN) have developed an international standardised Clinical Investigator Certification (CLIC) Course syllabus as training platform for investigators, site staff as well as regulatory and other scientists. Fundisa African Academy of Medicines Development, together with Tiervlei Trial Centre, have successfully hosted CLIC courses in Cape Town and Johannesburg in line with the PharmaTrain syllabus since 2015.
Registration deadline: Thursday, 05 September 2024
REGISTRATION FEES:
R6 000 (Level 1 only)
R 12 000 (Level 1 and 2)
R 8 000 (Level 2 only)
Levels of training according to distinct responsibilities in the performance and evaluation of clinical trials:
CLIC LEVEL 1 + SA GCP 2020:
Core knowledge on ethics, quality data, preparation and conduct of clinical trials at
investigational sites. The target audience for this two-day programme includes sub/co-investigators, study nurses, and study coordinators. CLIC 1: 12 Clinical, 2 Ethics
CLIC LEVEL 2:
Knowledge in regulatory and managerial aspects, according to SA-GCP, international and national requirements. The target audience for this five-day programme includes principal and co-investigators, clinical trial managers, and site managers. CLIC 2: 15 Clinical, 4 Ethics
CPD ACCREDIDATION NUMBER: MDB015/1210/07/2024
Introduction of daily registrations for those who are not able to attend the full course: Daily Registration Rate: R2,400.00
Next to the date for each day, kindly include the following daily CPD points
09 Sep 2024 CLIC 1 (Day Registration CPD: 2 Ethical, 5 Clinical)
10 Sep 2024 CLIC 1 (Day Registration CPD: 7 Clinical)
11 Sep 2024 CLIC 2 (Day Registration CPD: 1 Ethical, 6 Clinical)
12 Sep 2024 CLIC 2 (Day Registration CPD: 1 Ethical, 5 Clinical)
13 Sep 2024 CLIC 2 (Day Registration CPD: 2 Ethical, 4 Clinical)
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