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Free University of Brussels (ULB), PHARMED

Drug Safety, Pharmacovigilance & Regulatory Affairs

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 - Basic concepts in pharmacoepidemiology, Eric Van Ganse (University of Lyon) - Pharmacovigilance in daily practice, Natalia Vlcek (Vigilex) - European organisation of pharmacovigilance, Marc Ceuppens (Tibotec) - Safety monitoring of biologics, Michel Daubresse (UCB Pharma) - Drug registration: European and international environment, Stéphane Callewaert (GSK Biologicals) - The EMA network, EU procedures and incentives for drug development, Irene Rager (EMA) - Paediatric Regulation, Daniel Brasseur (FAMHP) - Decentralised & Mutual Reconginition procedures & regulation of generics, Els Verschaeren (FAMHP) - Orphan medicinal products, André Lhoir (FAMHP) - Specific regulatory aspects of biologics, Alan Fauconnier (FAMHP) - Preparation of a new drug application, Anne Hepburn (4Clinics)

Outcomes

Understanding of: - General principles of medicines regulation at EU and global level - Role of national agencies and international bodies in medicines regulation - Classification of adverse events/adverse drug reactions - Safety reporting requirements

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