Good Pharmacovigilance Practice Workshop

Register online

Live interactive and instructor led

Overview

An effective and efficient pharmacovigilance system is essential to protect the wellbeing of patients, to meet regulatory requirements and to protect the commercial interests of organizations which market medicinal products or sponsor clinical trials.

The aim of this course is to facilitate the delegates contribution to improving the efficiency and effectiveness of the pharmacovigilance system. It will promote a clear understanding of the regulatory requirements and explore best practice in discharging legal and commercial responsibilities for marketing medicinal products for human use.

Featured Topics

• Introductions, overview of the course. What do we need to know to succeed? Pharmacovigilance planning.
• The Regulatory Framework
• Assessing and Processing Adverse Events
• Collection, collation and evaluation of individual case safety reports. Quality management of the process.
• Data Management in Pharmacovigilance
• Using IT to support the PV process
• Information Management
• Practical exploration of event assessment, processing, follow-up and documentation.
• Pharmacovigilance and the Interventional Clinical Trial
• Information flow and the responsibilities of the sponsor
• Roles and Responsibilities of the Qualified Person for
• What is a signal? Regulatory requirements.
• How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection.

Learning Objectives

Upon completion of this course, participants should be able to:

• Appreciate the wide scope of company responsibilities
• Develop confidence in handling quality issues within the pharmacovigilance system
• Discuss and develop ideas
• Solve specific problems

Who Should Attend

Professionals working in the area of:

• Qualified Persons responsible for Pharmacovigilance
• Pharmacovigilance Scientists
• Auditors
• Regulatory Affairs Professionals
• Medical Assessors
• Marketing Managers
• Statisticians
• Information Scientists

Certificate of Attendance and Course Material

• All participants will receive a certificate of attendance upon completion of the course.
• The participants will be receiving specially prepared course manual.