Pharmacometrics Africa: Online Learning Portal

Current Status: Self-paced
Course Language: English

This online course is part of a set of training activities offered by Pharmacometrics Africa to support the development of pharmacometric competency and expertise in Africa and low and middle income countries.

Pharmacometrics is the science of developing and applying mathematical and statistical models to characterize, understand and predict a drug’s pharmacokinetics, pharmacodynamics and biomaker-outcome behavior. By using pharmacometrics, researchers can model the characteristics of new drugs to simulate and predict their behavior, which can then enable more efficient development of new drugs and to improve use of existing drugs.

The course comprises twelve lessons which cover key aspects of clinical pharmacology and mathematical modelling that underpin the principles of pharmacometrics.

Welcome to this Applied Pharmacometrics Training Program – Africa course!

Following the success of the pilot course, we present herewith this fellowship that will provide scientists with with training in pharmacometrics and model-based analyses. The program is an effort to increase the application of model-based drug development in Africa. Participation in this programme will  provide opportunities to integrate work and education to gain in-depth knowledge of the subject matter. It will also facilitate development of an international contact network. 

The entire program is overseen and conducted by academic, pharma and product development partners, with a small secretariat taking responsible for administration. Innovative and modern methods of learning will be applied, including on-line self-study, group-work, case studies and research. The structured virtual learning curriculum and real-life research datasets exposes fellows to how model-based analyses are applied in drug development. Fellows will present their own data analyses for review and feedback.

Welcome to this Applied Pharmacometrics Training Program – Africa course!

Following the success of the pilot course, we present herewith this fellowship that will provide scientists with with training in pharmacometrics and model-based analyses. The program is an effort to increase the application of model-based drug development in Africa. Participation in this programme will  provide opportunities to integrate work and education to gain in-depth knowledge of the subject matter. It will also facilitate development of an international contact network. 

The entire program is overseen and conducted by academic, pharma and product development partners, with a small secretariat taking responsible for administration. Innovative and modern methods of learning will be applied, including on-line self-study, group-work, case studies and research. The structured virtual learning curriculum and real-life research datasets exposes fellows to how model-based analyses are applied in drug development. Fellows will present their own data analyses for review and feedback.

Adequate clinical trial design and conduct are the basis for patient protection and data integrity in support of a marketing authorization application. This Short Course addresses clinical data in regulatory dossiers obtained in clinical trials or other means. This practical course helps participants address the regulatory and clinical challenges when assessing the clinical sections in regulatory dossiers. The course reviews the regulatory environment and regulations applied in the participants’ own country as appropriate, for example by cross comparisons between home countries of the participants and benchmarking against the general principles applicable everywhere.

This Short Course forms part of a structured education and training programme for professionals working for government health product regulatory agencies in Africa. Participation in this programme will not only provide opportunities to integrate work and education and gain in-depth knowledge of the subject matter, and development of an international contact network.

The overall aim of the broader programme is to provide a comprehensive knowledge and understanding of the regulatory rules and requirements applicable to the regulatory review of medicines, medical devices and diagnostics, and the competence to apply them in the work practice.

Innovative and modern methods of learning will be applied, including on-line self-study, group-work, case studies and research. The programme will also explore practical ways of working and interacting with colleagues in industry, regulatory agencies and patients.

Current Status: Self-paced
Course Language: English

This online course is part of a set of training activities offered by Pharmacometrics Africa to support the development of pharmacometric competency and expertise in Africa and low and middle income countries.

Pharmacometrics is the science of developing and applying mathematical and statistical models to characterize, understand and predict a drug’s pharmacokinetics, pharmacodynamics and biomaker-outcome behavior. By using pharmacometrics, researchers can model the characteristics of new drugs to simulate and predict their behavior, which can then enable more efficient development of new drugs and to improve use of existing drugs.

The course comprises twelve lessons which cover key aspects of clinical pharmacology and mathematical modelling that underpin the principles of pharmacometrics.

Ce cours en ligne fait partie d'un ensemble d'activités de formation proposées par Pharmacometrics Africa pour soutenir le développement des compétences et de l'expertise en pharmacométrie en Afrique et dans les pays à revenu faible et intermédiaire.

La pharmacométrie est la science qui consiste à développer et à appliquer des modèles mathématiques et statistiques pour caractériser, comprendre et prédire la pharmacocinétique, la pharmacodynamique et le comportement des biomarqueurs et des résultats d'un médicament. En utilisant la pharmacométrie, les chercheurs peuvent modéliser les caractéristiques des nouveaux médicaments pour simuler et prédire leur comportement, ce qui peut permettre un développement plus efficace de nouveaux médicaments et améliorer l'utilisation des médicaments existants.

Le cours comprend dix leçons qui couvrent les aspects clés de la pharmacologie clinique et de la modélisation mathématique qui sous-tendent les principes de la pharmacométrie.

Les participants étudient eux-mêmes chaque leçon pendant une semaine, puis participent à un tutorat en direct à la fin de la semaine, au cours duquel un membre du corps enseignant discute du matériel de la semaine et des exercices qui ont été assignés.

Adequate clinical trial design and conduct are the basis for patient protection and data integrity in support of a marketing authorization application. This Short Course addresses clinical data in regulatory dossiers obtained in clinical trials or other means. This practical course helps participants address the regulatory and clinical challenges when assessing the clinical sections in regulatory dossiers. The course reviews the regulatory environment and regulations applied in the participants’ own country as appropriate, for example by cross comparisons between home countries of the participants and benchmarking against the general principles applicable everywhere.

This Short Course forms part of a structured education and training programme for professionals working for government health product regulatory agencies in Africa. Participation in this programme will not only provide opportunities to integrate work and education and gain in-depth knowledge of the subject matter, and development of an international contact network.

The overall aim of the broader programme is to provide a comprehensive knowledge and understanding of the regulatory rules and requirements applicable to the regulatory review of medicines, medical devices and diagnostics, and the competence to apply them in the work practice.

Innovative and modern methods of learning will be applied, including on-line self-study, group-work, case studies and research. The programme will also explore practical ways of working and interacting with colleagues in industry, regulatory agencies and patients.