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Free University of Brussels (ULB), PHARMED

Conduct of Clinical Trials

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 - Set-up of the study-Conduct of the study-Closure of the study, Marc de Longueville (UCB Pharma) - Study monitoring by CRAs, Dominique Verhoeven (PPD) - Outsourcing of clinical trials and contract management, Rachel Emerson (GSK Biologicals) - Management of the investigational product, Yves Geysels (Quintiles) - Patient adherence and persistence in trials and practice, Bernard Vrijens (Aardex) - Data interpretation and writing the study report, Marc de Longueville (UCB Pharma) - Clinical research and the art of scientific writing, Anne Hepburn (4Clinics) - Phase I studies: strategic importance and practical organisation, Pascal Ryckmans, Clarisse Lukuamusu and Isabelle Formesyn (Pfizer) - Specific aspects of the conduct of clinical trials involving biologics, Marc de Longueville (UCB Pharma) and Domonique Verhoeven (PPD) - Clinical trials in developing countries-challenges and opportunities, Eckart Schwarz (GSK) - Audits of clinical trials, Jan-Willem Van der Velden (Mesama)

Outcomes

Understanding of: - Key issues involved in the conduct of a clinical study including investigator and site recruitment and investigative site management - Collection, evaluation and reporting of adverse event data in clinical trials - Evaluation and interpretation of clinical trial results

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