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10574 Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing
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 Continuing Education 
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Title:
Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing

Date(s) And Time(s):
Aug 11 2010 8:45AM - Aug 13 2010 3:00PM

Location:
University of Pretoria
Pretoria
0002 South Africa

Interest Area(s):
Clinical Research,Medical Writing,Clinical Safety/Pharmacovigilance,Medical Communications,Regulatory Affairs

Overview:

This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.

 

Key Topics

  • Legal basis for safety reporting including a historical perspective
  • Basic definitions and tools
  • Data collection and processing in post marketing phase
  • Medical evaluation
  • Safety reporting requirements in pre-marketed phase
  • A workshop and practical exercises
  • Safety reporting requirements in the post marketing phase
  • An introduction to risk communication
  • Inspections in pharmacovigilance
  • Introduction to risk management, epidemiological methods for signal detection and risk assessment

 



Learning Objectives:

At the conclusion of this course, the participants should be able to:

  • Identify the history, the principles and regulatory framework for clinical safety/pharmacovigilance
  • Discuss the basic definitions of terms used in day-to-day work
  • Recognise EU, US and international safety surveillance regulatory requirements
  • Describe the criteria and elements of expedited and periodic reporting of drug safety from Phase I studies to post-marketing
  • Demonstrate an awareness of risk management and pharmacoepidemiology




Target Audience:


Individuals with limited experience in the clinical safety/pharmacovigilance area. Those from the pharmaceutical industry, academia, regulatory authorities. Medical writers, marketing personnel, and those who need an overview of clinical safety and may interact with members of those departments.

To register for the training course, please fill in the registration form which is included in the programme. To download the programme, please click on ‘View PDF’.



Event Code:
10574

Contact Information:
DIA Europe

ELISABETHENANLAGE 25, POSTFACH

4002 BASEL

SWITZERLAND

 

TEL.:+41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG