Your introduction to drug safety (pharmacovigilance)2019-10-07T11:02:04+00:00

Project Description

Your introduction to drug safety (pharmacovigilance)

A DSRU and Royal Pharmaceutical Society collaborative event

Course overview

Venue: Royal Pharmaceutical Society, 66-68 East Smithfield, London E1W 1AW

Date: Monday 18 Nov 2019

This collaborative event with the Royal Pharmaceutical Society is designed to explore why pharmacovigilance is important, how adverse drug reactions are reported and the role of a pharmacist in drug safety. The course will benefit staff interested in working in pharmacovigilance departments and will be of interest to a broad range of staff in pharmacy, the pharmaceutical industry, regulatory authorities and academia.

Monitoring drug safety is very important to public health. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. In order to work in pharmacovigilance, it is essential to have a good working knowledge of the principles of drug safety, its regulations and proactive strategies for risk management and risk minimisation.

*Please note that the course dates and programme may be subject to change.

Who should attend?

Those with little or no knowledge of drug safety (pharmacovigilance), who wish to gain an understanding of the background and the methods used to reduce risks to patients.


Aims of course

  • To provide you with a historical perspective of pharmacovigilance
  • To ensure an understanding of basic terminology and provide definitions of key concepts
  • To explain the role of pharmacists in drug safety
  • To provide an overview of how adverse drug reactions are reported
  • To introduce delegates to current key regulatory requirements
  • To explain the methods in place to minimise the risks associated with drugs

Learning Outcomes

On successful completion of this course delegates should be able to:

  • Explain key drug safety definitions
  • Demonstrate a good understanding of pharmacovigilance regulations
  • Explain the process for reporting suspected adverse drug reactions
  • Explain some of the methods that are in place to minimise the risks to patients

Key Topics

Programmed features:

  • What is pharmacovigilance?
  • Pharmacovigilance for pharmacists
  • Regulatory aspects of pharmacovigilance
  • Reporting adverse drug reactions
  • Pharmacogenomics
  • Methods of risk minimisation

Course Leader blog

“We are delighted to be joining forces with the Royal Pharmaceutical Society to provide this course to introduce pharmacovigilance to pharmacists. Pharmacovigilance is defined by the European Medicines Agency as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.”

Monitoring safety and pharmacovigilance are key activities during the lifecycle of a medicine, both at the pre-marketing stage and once it is licensed for use in humans. No medicine is without risk of adverse effects and the science of drug safety involves assessing and optimising the risk-benefit balance for each medicine.

This course will detail the key role that pharmacists have to play in pharmacovigilance and will explain why it is important to report adverse drug reactions and methods for doing so. Presentations will be complemented by interactive sessions.

Routine risk minimisation measures are required for each drug and include the SmPC, PIL, packet size and the legal state. For products where these are considered insufficient, additional risk minimisation measures will be required in order to optimise the risk/benefit balance and maintain patient safety in everyday use of the drug. Community pharmacists are frequently involved in additional risk minimisation measures usually at the point at which a medicine is dispensed. For example, pharmacists may be asked to keep a log to indicate whether they have provided a patient card to the patient with their medicine (in addition to the PIL) and explained its use. The patient card may list serious potential side effects and actions to be taken in the event of occurrence.

This blog aims to provide you with a glimpse of the course. We do hope that you will be able to join us!”

Professor Saad Shakir MB ChB LRCP&S FRCP FFPM MRCGP, Director, DSRU and Course Leader


RPS Member: £195.00

Non-Member: £395.00

Non-GphC Registrant: £395.00

Registration fees include: 

  • Access to all sessions;
  • Delegate pack on arrival;
  • Printed and electronic event resources;
  • Refreshments and lunch;
  • Certificate of attendance.

Download Course Programme

Click here to download the programme


Booking options

Visit the Royal Pharmaceutical Society website to book your place

“The courses gave me a really good insight into what pharmacovigilance is about. Not only from the conference speakers and course lecturers, but from the other participants who are from all across the industry and have different perspectives on things and different approaches”

DSRU course delegate 2019

“Excellent content and presentations. Very well put together. Enjoyed the practical aspects with workshops”

DSRU course delegate 2019

“Very informative and comprehensive course with good interactive sessions. Good, qualified speakers covered relevant topics in detailed manner.”

DSRU course delegate 2019

Course Leader 

Professor Saad Shakir MB ChB, LRCP&S FRCP FISPE MRCGP – Director, Drug Safety Research Unit 

Saad Shakir is a pharmacoepidemiologist and drug safety physician.  He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit in Southampton.

The DSRU is an academic unit associated with the University of Portsmouth.  At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations.  He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.  Saad serves as a Chairman or member of Safety Advisory Boards and Data Safety Management Committees.  He is an author of many book chapters and publications in scientific journals on pharmacovigilance, pharmacoepidemiology and risk management and is a member of the editorial boards for the journals Drug Safety and Pharmacoepidemiology and Drug Safety.

Saad Shakir has led and co-ordinated many post graduate educational and training programmes including the MSc programme in Pharmacovigilance at the DSRU.  He supervises post graduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London; a Fellow of the Faculty of Pharmaceutical Medicine; a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the UK.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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