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Eu2P

Principles of Pharmacovigilance

Practical Information

Commencing Date:
Anytime
Language:
English
Location:
World Wide (Distance Learning)


Teaching Methodology:
Distance Learning
Credits :
Short courses (CPD): 3 ECTS credits


European Fees:
3000 EUR
Scholarship Possibilities:
No

Course Contact

Eu2P Office

+ (33) 5 57 57 92 57

contact@eu2p.org


Website

Office Link

Eu2P

University Accreditation: Yes

PharmaTrain Centre

Description

Objectives To enable trainees to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-authorisation environment and the roles of various stakeholders within pharmacovigilance. Topics covered: Introduction to pharmacovigilance principles Safety evaluation during a products lifecycle Labelling and risk management

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