Free University of Brussels (ULB), PHARMED

Description

Courses - Non-clinical safety evaluation, René Verloes (Tibotec) - In vitro and in vivo mutagenicity studies, Véronique Thybaud (Sanofi-Aventis) - Safety evaluation of anticancer drugs, biotechnology products and gene therapy agents, Philippe Detilleux (Sanofi-Aventis) - Cardiac safety assessment in drug development, Koen Van Rossem (Stiefel Laboratories) - Toxicogenomics and in silico evaluation of toxicity, Stéphane Dhalluin (UCB Pharma) - Drug design: influence of stereochemistry on biological activity and metabolism, François Dufrasne (ULB) - Drug formulation, Jonathan Goole (ULB) - Accelerating the move to clinical trials, Luc Tritsmans (J & J) - How to choose the dose for first in human administration, Luc Van Bortel (RUG) - New concepts at the boundary between preclinical and clinical research: phase 0, microdosing and exploratory trials, Jan de Hoon (KUL) - From pharmaceutical development to pharmaceutical manufacturing, Michel Deleers (Oncobel)

Outcomes

Understanding of: - Molecular and cellular basis of toxic reactions - Steps in the pharmaceutical development of a drug substance and final drug product - Early exploratory development in man

Covered Areas

Scientific Areas

- Chemistry - Production technologies

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