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Free University of Brussels (ULB), PHARMED

Clinical Development of Medicines

Practical Information

Commencing Date:
tba
Language:
English
Location:
Brussels Belgium


Teaching Methodology:
Face-to-Face
Credits :
ECTS


European Fees:
1000 EUR
Scholarship Possibilities:
Yes

Course Contact

Free University of Brussels (ULB), PHARMED

University Accreditation: Yes

Centre of Excellence

Description

Courses - Study designs, Marie-Paule Derde (DICE) - Reminder of basic statistical notions, Viviane de Maertelaer (ULB) - Statistical aspects in the planning of clinical trials, Viviane de Maertelaer (ULB) - Good Clinical Practice, Monique Podoor (Pharmakon) - The role of ethics committees, André Herchuelz (ULB) - Differences in the ethics committee review process between EU member states, Ingrid Klingmann (EFGCP) - Clinical trials in Europe: the regulatory framework and the role of the national competent authority, Anne Lenaers (FAMHP) - Pharmacokinetics: basic concepts and applications, Roger Verbeeck (UCL) - Specificities of the clinical development plan of biologics, Marc de Longueville and Isabelle Campine (UCB Pharma) - Vaccines development: from preclinical to clinical studies (Arnaud Marchant,IMI)

Outcomes

Understanding of: - Clinical trial design - Legal and ethical provisions for protection of clinical trial subjects - Principles and application of statistics in clinical trials - Principles and practical applications of pharmacokinetics

Covered Areas

Scientific Areas

- PK/PD modelling

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