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Learning by Simulation

Drug Development Simulation

Practical Information

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


Teaching Methodology:
Face-to-Face


European Fees:
3500 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 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.

Outcomes

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

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