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University of Aveiro

Drug Safety and Pharmacovigilance

Practical Information

Commencing Date:
tba
Language:
Portuguese
Location:
Lisbon Portugal


Teaching Methodology:
Blended Learning


European Fees:
300 EUR
Scholarship Possibilities:
No

Course Contact

Bruno Gago

(+351) 234 247 247

bmgago@ua.pt


Website

Office Link

University of Aveiro

University Accreditation: Yes

Centre of Excellence

Description

This is a 3-day stand-alone short course. It consists in a series of learning events, namely lectures, seminars, presentations, discussion panels and case studies. Pre-course distance-learning activities will also be available for the interested participants.

Outcomes

On successful completion of this Module the student should be able to: Explain the role of Pharmacovigilance in monitoring of drugs in non-clinical & clinical research and in the marketplace. Appraise common nomenclature associated with pharmacovigilance (including AE & ADR, Listedness, Expectedness, etc). Demonstrate the sources of safety data: methods for collection, analysis, interpretation and reporting drug safety data, including electronic safety data reporting. Evaluate the assessment of causality. Analyse the application of signal generation and handling of drug safety data in pre-marketing (clinical trial) and post-marketing (pharmacovigilance) contexts, including automated methods. Explain the principles of pharmacoepidemiology and examine the different types of pharmacoepidemiological studies used in evaluating drug safety including the choice of the most appropriate study design. Describe pharmacovigilance aspects of medicines regulation throughout the life-cycle of a medicine. Critically appraise the principles of risk-benefit analysis and management using qualitative and quantitative approaches. Evaluate the background and purposes of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Describe the role of the EU Qualified Person in PharmacoVigilance (QPPV). Describe major routes for reporting and communication of pharmacovigilance data. Evaluate the aetiology, mechanisms and pathology of major classes of adverse drug reactions and interactions.

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