SaPhar Ltd is the sister training Company to PharSafer® and conducts Pharmacovigilance training globally for clients in Pharmacovigilance.

SaPhar Ltd began in 2002 also and has conducted pharmacovigilance training at all levels (Introductory; Intermediate and Advanced) around the world.

Training can and does take many different forms and SaPhar is totally flexible in its approaches to this vital aspect of interactive and understandable Pharmacovigilance training

We can train all staff internally too on essential safety reporting from receptionists to sales representatives; customer services etc… to ensure that all Company personnel know how to report any adverse events that they receive.  We also perform competency testing as well to ensure that staff have understood all of the training.

We also work with other Training Companies in the support of Pharmacovigilance training and have conducted training on-site; via webinars; interactive e-learning programmes.

Examples of the topics covered in such training are provided below:

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;