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Learning by Simulation

Biologicals Development Simulation

Practical Information

Commencing Date:
tba
Language:
English
Location:
St. Michielsgestel Netherlands


Teaching Methodology:
Face-to-Face


European Fees:
3000 EUR
Scholarship Possibilities:
No

Course Contact

Nicole van Straten

+31 6 29024947

nicole@learningbysimulation.com


Website

Learning by Simulation

University Accreditation: No

Individual Course

Description

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.

Outcomes

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

Covered Areas

Scientific Areas

Immunology and allergic disorders

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered