The Drug Development Simulation is a unique learning experience based on the entire drug development process. Participants work in a real life multidisciplinary development team. They experience the 'regular' drug development process and they will be surprised by unexpected events, opportunities, threats and daily troubles. Before the start of the course, participants receive detailed information on two drug compounds as a result of the research process. One of these has to be brought to registration, the portal to the market. The simulation runs through the preclinical and clinical phases of development until dossier submission for the authorities. All required disciplines such as DMPK, pharmacology, toxicology, CMC, marketing, regulatory affaris and clinical sciences will be needed. Expert trainers and faculty members will guide the participants through each stage and will set up regular meetings with 'management' and 'regulatory authorities' where the team presents progress and reports on reaching milestones.
1. To understand the drug development process and the role of disciplines within this process 2. To experience the interfaces and interactions between the different disciplines 3. To learn about results of actions and decisions to be taken at crucial points in the development process 4. To learn to react on deviations and risks in the drug development environment