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Eu2P

Principles of Identifying and Recognizing Adverse Events and Safety Signals

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 students to develop an understanding of current practice in identifying adverse drug reactions and safety signals To be able to classify events, identify signals and understand the follow-up procedure Topics covered: Definition of adverse drug reactions - type of ADRs Detection and recognition of adverse events in clinical trials Adverse event coding principles and differences Spontaneous reporting databases Principles of signal detection on electronic health care databases Risk management plans

Covered Areas

Scientific Areas

Information 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