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 presented by Fundisa African Academy of Medicines Development and Pharmacometrics Africa will provide insight into the use of modelling and simulations, adaptive trial designs and real-world effectiveness studies by local and international experts with hands-on experience. By meeting with fellow local clinical trial researchers, the workshop offers a unique networking opportunity for drug, medical device and biotech companies, clinical trial professionals such as project managers, CRAs, medical writers, statisticians, and regulatory affairs professionals.
Outline Agenda:
Modeling and Simulations
Modelling the dynamics and control of infectious diseases: the example of tuberculosis (Florian Marx)
Pharmacokinetic and pharmacodynamic modelling (Leon Aarons)
Novel clinical trial designs for optimizing parameter estimation in malaria disease-drug models (Joel S. Owen)
Project presentations (Various)
Clinical Trial Designs
Improving efficiency and quality in clinical trials in global health research: Adaptive trial designs and master protocols (Jay Park)
Real world evidence studies (Various)
Investigator experience: Role in trial design, conduct, analysis and reporting (Helmuth Reuter)
Novel clinical trial designs: Regulatory expectations
Project presentations (Various)
Global health working group for the UK MRC hubs for trial methodology research (Elizabeth Allen)
Call for Abstracts
Delegates are welcome to submit abstracts for poster presentation; selected abstracts will be invited for additional oral presentation (10 minutes). Submissions must be sent by email to info@fundisa-academy.com. All abstracts must be prepared according to the template provided in the attached document.
Registration
To register for this workshop, please visit this link.
The deadline for registrations is 18 February 2019.
For enquiries, please contact info@fundisa-academy.com
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