The planning, preparing, and organising of clinical trials has become a highly complicated task that includes some important issues like: the need to protect patients, generate reliable data, perform trials efficiently within short timelines, fulfil quality requirements according to current legislation and inspection requirements, and conduct clinical trials within budget to ensure sustainable business.
The increased complexity and regulatory requirements create a need for increasing levels of knowledge (Scientific, Methodological, Regulatory, & Organisational). In South Africa, investigators and site staff need to be trained according to international standards and recommendations.
The 2018 SAHPRA draft guidance on “Capacity Building and Transformation in Clinical Trials Research in South Africa” requires public or privateclinical trial sites to provide training, especially of previously disadvantaged personnel at all levels, that will enhance the full participation by such individuals in the trial conduct.
PharmaTrain and the European Clinical Research Infrastructures Network (ECRIN) joined forces to establish a European investigator training infrastructure, called Clinical Investigator Certification (CLIC). Fundisa Academy African Academy of Medicines Development together with Tiervlei Trial Centre, have successfully hosted CLIC course in Cape Town, since 2015.
Different levels of training are related to distinct responsibilities in the performance of clinical trials:
CLIC LEVEL 1 covers the core knowledge in the preparation and conduct of studies at investigational sites. This two-day option is aimed at: sub/co-investigators, study nurses, study coordinators.
CLIC LEVEL 2 covers the knowledge in regulatory and managerial aspects required of principal investigators (and clinical trial managers), according to ICH-GCP definitions and national legislation. This five-day option is aimed at: principle investigators, clinical trial managers, site managers.
DATE: 16 - 20 July 2018
VENUE: Zulu Nyala Country Manor, 270E Third Avenue, Chartwell, Gauteng
FACILITATORS: Prof Bernhard Rosenkranz, Dr Haylene Nell, Marzelle Haskins, Dr Essack Mitha, Farhaad Shaik, Dr Margaré du Toit, Savi Chetty Tulsee, Dr Mada Ferreira, Dr Kennedy Otwombe, Dr Qasim Bhorat, Heila Engelbrecht, Jacky Celliers, Prof Patrick Bouic and Merissa Govender
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Complete and submit your booking form by Friday, 06 July 2018.