Pharmacovigilance in Clinical Trials

 

Pharmacovigilance in Clinical Trials

Clinical Research Related Courses

Patient safety is crucial within clinical research; but what is done with this safety reports and serious adverse event documents? Get the answers in this one-day training on pharmacovigilance?

dates
location
language
19 Apr 2012 Brussels English
1 000,00 €
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

This foundational one day course on the essential aspects of pharmacovigilance (clinical safety) is designed for everyone involved in clinical research activities. This course provides key definitions based on the European Community legislation as well as on consensus forums such as ICH and the CIOMS Working Groups. Practical examples and workshops are intended to illustrate these definitions and introduce the skills needed to perform clinical safety reporting and tasks successfully.

Who should attend?

Project Managers, Clinical Research Associates (CRAs) & Clinical Research Assistants (CTAs)  responsible for clinical operations, drug safety / pharmacovigilance personnel, investigators, representatives of organizations including academia running clinical trials and medical managers from
the pharmaceutical industry.

Trainers
  • Clinical safety data monitoring and processing: legal basis, rationale
  • Definitions of terms and examples
  • Sources of safety reports
  • Documentation and processing of clinical safety data: tools – from paper to electronic capture, risk of non-compliance
  • Evaluation of reports and coding
  • Annual safety reports, PSURs
  • Quality systems in clinical safety: audits and inspections
  • Safety databases and electronic reporting: signal detection & risk management introduction
  • Be familiar with the current regulatory aspects guiding clinical safety / pharmacovigilance
  • Identify key definitions and vocabulary used in clinical safety in the EU
  • Recognize important aspects in evaluating adverse events
  • Identify main characteristics of adverse events
  • Recognize and identify the roles and clinical safety responsibilities of their own specific organization or company
Workshops
  • Case studies
  • Practical Examples