HOTLINE 24/7/365 UK: +44 (0) 1483 212150

Current Training Courses Available

saphar_page_logoPharSafer®, 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;

PharSafer® Tweets

#GAMP #21cfrpart11 #clinicaltrials #clinicaloperations #ICH #trainingdevelopment #training

Read on Twitter...

⬇ Follow PharSafer®: t.co/O7kJmLB5tq ⬇ Follow R.A.P.T.A.R®: t.co/Y6FZm2knkC #regulatorycompliance… t.co/DEfZqFVe2v

Read on Twitter...

These courses cover a variety of areas including Pharmacoepidemiology, Safety Information, Post Marketing Safety, M… t.co/kxCeXZxhM8

Read on Twitter...