Current Training Courses Available

PharSafer®, through its sister company SaPhar, organises and delivers a variety of training courses throughout the year and the current list of available courses topics are detailed below. For further information on specific courses, to discuss a bespoke course or to book a place, then please contact PharSafer by telephone on: +44 (0) 1483 212155 or click here to email us.

Introductory

Global Pharmacovigilance and Global Institutions; Global Pharmacovigilance and Safety Standards; Adverse reaction reporting; Collecting Good Quality Safety Information; Pharmacovigilance and its Role in Other Departments; Pre-Clinical Animal and In vitro Studies; Clinical Drug Safety; Post Marketing Drug Safety; Medicines and Pregnancy; Causality Assessments in Pharmacovigilance; MedDRA – Introductory; An Introduction to Medical Device Reporting; the Case Narrative, Sources, Evaluation, Case Content, Role; the Blinded Study and Safety Reporting;

Intermediate

An introduction to Pharmacoepidemiology: Writing Safety Information into the Investigator Brochure; The EU Clinical Trials Directive: ICH E2D – Post marketing Safety; The Role of the Qualified Person for Pharmacovigilance; MedDRA Intermediate; Developing Company Core Safety Information – CIOMS III; PSURs

Advanced

Signal Detection; Quantitative Signal Detection: Independent Data Monitoring Boards; CIOMS VI; Due Diligence; Training for Drug Safety Reporting Duties; Audits and Expectations; Compliance and Drug Safety; Product Safety Reviews – Purpose & Function; Safety Reporting in Licensing agreements; Risk/Benefit Determinations; The Company Pharmacovigilance System; Risk Management & Risk Minimisation; Crisis Management within Drug Safety; The DDPS; PIPs;