| ABOUT THE EVENT |

New drugs are beginning to make inroads against some of the most important and debilitating diseases threatening mankind. The need is still great in western countries, in which ageing populations face the onset of diseases of the central nervous system (e.g. Alzheimer’s disease, Parkinson’s disease and psychiatric diseases), the cardiovascular system (arterial disease with associated stroke and myocardial infarction) and cancer. Africa is further challenged with the still high incidence of HIV and related autoimmune diseases as well as carrier-mediated infectious diseases such as malaria. The hallmark of any new, successful medicine is the clinical proof of efficacy and proof of its safety with clinical use. Thus, drug safety and tolerability is a prerequisite for dealing with the current medical needs of the world, including those of Africa. Most of this work has not been conducted in Africa but times are changing and new infrastructure is being put into place to fill this void. It is time to bring drug safety into Africa for the benefit of the population. For the first time, an international conference will be held to bring together African experts with others across the world to discuss current approaches and challenges to drug safety testing.


Four main areas of drug safety will be addressed in this conference: safety pharmacology, toxicology, clinical drug safety and precision medicine. Each day will include two plenary lectures by international experts. The plenary lecturers will be asked to address newly developed methods and approaches to enhance the prediction of drug safety with their ultimate use in a diverse patient population. Of particular interest and a dedicated focus point for the plenary lectures will be the degree of translation between both in vitro and in vivo preclinical studies first to first-in-man clinical trials and to further, larger clinical trials. Within the preclinical area, the use of novel experimental approaches to better predict the clinical performance of new drugs will be a main theme. Which new models appear to offer the potential for enhancing the predictability of adverse events with clinical use of a new drug? Where should new investments be made to further improve on the current situation both from the preclinical as well as clinical perspective. This will have an impact on the data required in future for the demonstration of drug safety. The conference will provide a forum for regulators for new developments in drug safety testing.

| WHO SHOULD ATTEND |

Any individual in the academic or business environment with an interest in drug safety as a subject will benefit from this conference, specifically: Academia; Medicine and drug compound developers; Clinical and preclinical trial project managers; Regulatory agencies; Medical en pharmaceutical researchers; Geneticists and molecular biologists involved in drug development and therapeutic models; Heads of drug safety; Quality control & assurance managers; Compliance and regulatory affairs managers; Drug safety practitioners; Public health officers