The Biologicals Development Simulation is a unique learning experience covering the entire biologicals discovery and development process. Participants work in a real life multidisciplinary research and development team. They experience the 'regular' biologicals discovery and development process and they will be surprised by unexpected events, opportunities, threats and daily troubles. In three days a biological drug candidate is selected, a production process developed and a clinical program executed. All required disciplines such as molecular biology, CMC, bioanalysis, production, toxicology, regulatory affairs and clinical sciences will be needed to develop an effective and safe novel biological for patients with an unmet medical need. Expert trainers and faculty members will guide participants through each stage with advice 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 biologicals discovery and 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 process 4. To learn to react on deviations and risks in the biological discovery ad development environment
Immunology and allergic disorders