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University of Basel - European Center of Pharmaceutical Medicine (ECPM)

Drug Safety and Pharmacovigilance: E-Learning

Practical Information

Commencing Date:
Anytime
Language:
English
Location:
Basel Switzerland


Teaching Methodology:
Distance Learning
Duration:
1 Year(s)
Credits :
en Short courses (CPD): 1 ECTS


Non European Fees:
650 CHF
Scholarship Possibilities:
No

Course Contact

Annette Mollet

+41 61 267 19 52

annette.mollet@unibas.ch


Website

Office Link

University of Basel - European Center of Pharmaceutical Medicine (ECPM)

University Accreditation: Yes

Centre of Excellence

Description

This e-learning course provides an understanding of the safety-related aspects within the drug development process. These range from early preclinical testing, risk/benefit assessment up to clinical adverse event signal detection and monitoring.

Outcomes

At the end of the course, the participants should be able to describe:

  • The role of drug safety in the successful development and usage of a medicine to the benefit of patients
  • Which safety-related questions need to be answered in early and late drug development
  • Tools, techniques, and methodologies used in drug safety evaluation
  • What frequent pitfalls related to drug safety considerations occur and why they can lead to discontinuation of drugs in development, label changes or even withdrawal of drugs from the market after launch
  • How changes in safety assessment could become part of a new drug development paradigm

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