Innovative drug development methods and tools are developed and used by pharmaceutical industry, clinical research organisations, public/private partnerships, and academic researchers to decrease cost and time to market and to increase the probability of success of pharmaceuticals R&D. Novel clinical trial methodologies based on stringent scientific criteria have gained acceptance for successful regulatory approval. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established formal advice procedures for qualification of such methodologies, in consultation with the scientific community.
This workshop was presented by Fundisa African Academy of Medicines Development and Pharmacometrics Africa to provide insights into the use of modelling and simulation, adaptive trial designs and real-world effectiveness studies by local and international experts with hands-on experience. Over 50 delegates from academia, industry, regulatory agencies and ethics committees attended this interactive forum of presentations and discussions.
Agenda and Links to Presentations:
Meeting Host and Opening Remarks: Bernd Rosenkranz
Modeling and Simulation (Chair: Phumla Sinxadi)
Pharmacokinetic and pharmacodynamic modelling (Leon Aarons)
South African clinical trials database - an update (Duduzile Nwandwe & Lindi Mathebula)
Clinical Trial Designs (Chair: Colin Pillai)
Real World Data and Evidence in Clinical Trial Design (Natasha Pillai)
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