introduction to Pharmacovigilance

Introduction to Pharmacovigilance

About

“Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.”

All medicines and vaccines undergo rigorous safety and efficacy testing in clinical trials before they are approved for use. However, these trials are usually carried out on a limited number of carefully selected people for a short period of time. Certain side effects may only become apparent when these products are used in a diverse population, including those with comorbidities, over a longer period of time.

The course will introduce all critical Pharmacovigilance processes and interfaces with other departments of the Pharma Industry.

There will be an introduction to safety case processing, where participants can see the practical and operational aspects.

This complex but interesting developing branch of science will be brought in a simple way through some examples and scenarios.

MODULE 1

History and Meaning of Pharmacovigilance
Introduction to associated legislation globally and the responsible Health Authorities
Drug development and Risk-benefit profile of a medicinal product
Key aspects of case processing

MODULE 2

Introduction to Pharmacovigilance critical processes
Interfaces with other departments in the Pharma industry
Interface with partners – in licensing, out-licensing, copartners
Vendors used in Pharmacovigilance activities

The training is aimed at people who have recently joined the pharmacovigilance department and want to see the multifaceted nature of the science, helping them to understand how the risk-benefit profile of a drug is done and to understand the process of drug development until it reaches the market.
Aspirants who wish to work in this field are welcome.

Prior experience is not necessary.
A science background is recommended.

Slides presentation, working groups to analyze the elements of a safety case.
Key pharmacovigilance term crossword.

Lecturers

Info

Ranjana Khanna

Global Director PV QA, BeiGene Switzerland GmbH

Ranjana has a Masters in Technology and a Post Graduate DIploma in Pharmacovigilance. She has been
working in this field since 2004, starting her career in Safety Case Processing in a CRO followed by working
in various Pharmaceutical companies. Since 2012, Ranjana has been responsible for Pharmacovigilance
Quality assurance which includes conducting all types of audits, leading HA Inspections, providing Training
and overseeing all QMS aspects. She has led teams globally, presented at several conferences and published articles on aspects of Pharmacovigilance QA.

Useful information
Registration Fee

Online Training – 2 modules

Module 1 | 17 September 2024 from 09:00 am to h. 01:00 pm CEST
Module 2 | 18 September 2024 from 09:00 am to h. 01:00 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 895,00* (until 27 August 2024)

Ordinary: € 1095,00*

Freelance – Individual – Academy – Public Administration**: € 590,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Printable Version

At the end of the training, you will be able to

Understand the importance of the science of Pharmacovigilance

Identify the minimum criteria for Safety case

Understand your role / your department interface with Pharmacovigilance

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

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introduction to Pharmacovigilance