Professional Certificate in Pharmacoepidemiology & Pharmacovigilance at London School of Hygiene & Tropical Medicine, University of London

About

Overview

Overview - Pharmacoepidemiology & Pharmacovigilance

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The global health challenge of maximising drug safety yet maintaining public confidence has become increasingly complex. Pharmaceutical companies are required to employ named members of staff responsible for pharmacovigilance. NGOs need to have confidence that the medicines and products that they provide to communities are both effective and safe. Health authorities grapple with the need to provide quality care whilst containing a burgeoning drug budget. Regulatory authorities must balance the potential benefits of new drugs with varying levels of suspicion of their potential harm.

This intensive modular course in pharmacoepidemiology and pharmacovigilance addresses the increasing need for well informed professionals to work in all areas related to the assessment of drug safety and risk-benefit of drug use. It is an introductory course and should meet the needs of a wide variety of individuals. The variety of backgrounds and the knowledge possessed by lecturers ensures that the course has a sound mixture of the theoretical and the practical issues surrounding drug safety.

Course delivery

The course is organised into the following three Blocks, with the teaching for each Block delivered synchronously online during the following weeks:

Block 1 (14 - 17 November 2022): Introduction to Pharmacoepidemiology
Block 2 (6 - 9 February 2023): Introduction to Pharmacovigilance
Block 3 (27 - 30 March 2023): Intermediate Pharmacoepidemiology & Pharmacovigilance

Students can sign up for one, two, or three Blocks. Students who would like to be assessed in order to obtain a Professional Certificate (30 credits) must attend all three Blocks in addition to preparing a project (submitted in May) and taking an exam (in June).

Each Block consists of approximately 27 hours of formal teaching and contact time (via online synchronous teaching/group work). The full assessed course leading to a Professional Certificate (three Blocks plus project and exam) comprises 300 total hours, which are spent as follows: ~80 hours formal teaching and contact time, ~120 hours self-directed study, and ~100 hours project work.

Already know the basics? Our Real-World Evidence in Pharmacoepidemiology short course (Block 4) provides hands-on experience analysing and overcoming common sources of error when using real-world data.

Who should apply for this course?

This introductory level course covers aspects of drug development, licensing, surveillance and policy, and is aimed at individuals who are working (or intending to work) on any of these aspects in the following sectors:

the pharmaceutical industry
NGOs
regulatory bodies
health services
health policy decision-making agencies

There are no formal prerequisites for this course, but some experience equivalent to the followed is required:

an undergraduate degree (e.g., bachelor) in a subject appropriate to the course (e.g., epidemiology, statistics, pharmacy, biological sciences, chemistry, physics, medicine, dentistry, etc.); or
in exceptional circumstances requiring pre-approval from the course organisers, at least 6 monthsâ€™ relevant work experience

As part of the application process, applicants are required to demonstrate how they meet the LSHTMâ€™s minimum English language requirements. This course requires Band B or above, or Band C with extensive recent experience in an English-speaking setting. For more information, please refer to the LSHTM English Language Requirement Policy.

If you do not satisfy the above requirements you may still be admitted at our discretion on the basis of your academic qualifications, work experience and references.

Up to 25 participants will be accepted for each Block.

Advice for EU nationals

Students from the EU are very welcome at LSHTM and we would strongly encourage applications from EU nationals to this course.

Beyond Brexit: Why is Europe so important to us

Course objectives

Course objectives - Pharmacoepidemiology & Pharmacovigilance

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Aims & Objectives

The aim of this well established training programme is to equip students with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance. By the end of the programme, students should be able to:

demonstrate an understanding of, and critically evaluate, issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs), the manner of which these are detected and monitored, and the related historic and legal frameworks
be familiar with and compare fundamental statistical, economic and epidemiological concepts and methods
gain an understanding of, and reflect upon, important pharmacoepidemiological concepts and methods and how these methods can be applied to specific drug issues and pharmaceutical risk management
assess and critically analyse the results of pharmacoepidemiological studies (other investigators'), including critical appraisal of the study question, study design, methods and conduct, statistical analyses and interpretation

Course Content

The curriculum will provide an introduction to epidemiology, statistics, pharmacoepidemiology and health economics. It will also cover the historical and legal background to pharmacovigilance and pharmacoepidemiology, and pharmacological basis of ADEs, addressing ADE issues at individual and population levels, and the application of pharmacoepidemiological principles and methods to practical drug issues.

Key Course Topics

Pharmacoepidemiology - you will learn about the fundamentals of pharmacoepidemiology, its conduct, practical uses and limitations in determining the effects of medications in large groups of people. The statistical basis underpinning pharmacoepidemiology will also be introduced, and you will integrate statistics and epidemiology to gain competence in critically appraising pharmacoepidemiology studies.

Pharmacovigilance - you will be introduced to the key elements of pharmacovigilance and its basis within drug regulation. Within the risk management elements of the course, you will gain insight into how pharmacoepidemiology and pharmacovigilance are combined in the investigation of the effects of medicines. Principles will largely be demonstrated within the European legislative context, whilst recognizing these general principles apply more broadly throughout the world.

Health economics - you will be introduced to the fundamental concepts involved in assessing the cost effectiveness of health technologies and methodologies used to assess the health related quality of life. Real-world examples will be used to illustrate concepts.

Teaching Methods

This is an online course. There is no face-to-face component of this course.

Teaching for each Block will be delivered primarily via online synchronous teaching during each teaching week. This will include pre-recorded lectures from subject matter experts. Students and tutors will then interact in live Q&A sessions and workshops during the teaching week where students have the opportunity to apply and discuss concepts introduced in the pre-recorded content. Workshops will address topics such as designing a pharmacoepidemiological study, critical appraisal of published papers, developing risk management plans and responding to a drug safety alert. In addition to the pre-recorded lectures, students will be provided with lists of helpful scientific papers, articles and other content to assist with learning.

For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), there will also be self-directed learning in between the online synchronous teaching weeks in the form of completing a project and practice exams.

The variety of backgrounds and the knowledge possessed by lecturers ensures that the course has a sound mixture of the theoretical and the practical issues surrounding drug safety. The teachers range from academic staff at the School, with expertise in areas such as pharmacology, epidemiology and statistics, to senior practitioners in the international pharmaceutical industry, regulatory authorities, and public health who have practical expertise in pharmacovigilance and pharmacoepidemiology.

Assessment

For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), the assessment consists of submission of a written project (worth 40% of the total grade) and a written examination (worth 60% of the total grade). You must be awarded a pass grade for both elements to be awarded the Professional Certificate.

All materials for the project will be provided, and each student will be supported by an academic adviser. Additionally two lectures on the chosen topic for the project will be included in the syllabus.

There is no formal assessment at the conclusion of each individual Block, but a Certificate of Attendance will be provided.

Testimonials

Testimonials - Pharmacoepidemiology & Pharmacovigilance

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The Course

Specific Lectures

(The EMEA and the EU risk management guideline)

( Multivariable analysis and propensity scores)

(Meta analysis of Randomized Trials)

(Critical appraisal of meta analysis

(Structured examination of a response to an ADR alert)

(Case only design and analysis)

Careers

Careers - Professional Certificate in Pharmacoepidemiology

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Graduates from this programme enter a diverse range of positions.

Below you will find just a few of the positions and organisations that our graduates from this course have entered:

Example job titles:: Attending Pharmacist
Clinical Trials Project Manager
Manager (Drug Safety and Public Health)
Pharmacist
Risk Management Manager
Scientific Assessor
Therapeutic Group Co-Ordinator
Associate Manager in Drug Safety
Consultant Physician
Medical Assessor
Example organisations:: Baxter
Canadian Forces
Department of Health
Gilead Sciences, Inc.
GSK (GlaxoSmithKline)
IDIS
Medicines and Healthcare Products Regulatory
Quintiles
University of Oxford
NHS
Medicines and Healthcare Products Regulatory Agency (MHRA)

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Quote

Want to read more about our graduate careers and destinations? Take a look at our infographics on our Graduate Careers & Destinations page.

How to apply

How to apply - Pharmacoepidemiology & Pharmacovigilance

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Applying for the course

Applications are now open for Block 2 & Block 3 only. Please choose the Block you would like to apply for, and the link will direct you through to the relevant online application form:

Full course (all Blocks including Exam and Project)
Applications closed
Block 1 (14 - 17 November 2022): Introduction to Pharmacoepidemiology
Applications closed
Block 2 (6 - 9 February 2023): Introduction to Pharmacovigilance
Application deadline 6 January 2023
Block 3 (23 - 30 March 2023): Intermediate Pharmacoepidemiology & Pharmacovigilance
Application deadline 27 February 2023

Please read LSHTM's Admissions policies prior to submitting your application.

The aim of this well established training programme is to equip students with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance. By the end of the programme, students should be able to:

demonstrate an understanding of, and critically evaluate, issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs), the manner of which these are detected and monitored, and the related historic and legal frameworks
be familiar with and compare fundamental statistical, economic and epidemiological concepts and methods
gain an understanding of, and reflect upon, important pharmacoepidemiological concepts and methods and how these methods can be applied to specific drug issues and pharmaceutical risk management
assess and critically analyse the results of pharmacoepidemiological studies (other investigators'), including critical appraisal of the study question, study design, methods and conduct, statistical analyses and interpretation

Course Content

The curriculum will provide an introduction to epidemiology, statistics, pharmacoepidemiology and health economics. It will also cover the historical and legal background to pharmacovigilance and pharmacoepidemiology, and pharmacological basis of ADEs, addressing ADE issues at individual and population levels, and the application of pharmacoepidemiological principles and methods to practical drug issues.

Key Course Topics

Pharmacoepidemiology - you will learn about the fundamentals of pharmacoepidemiology, its conduct, practical uses and limitations in determining the effects of medications in large groups of people. The statistical basis underpinning pharmacoepidemiology will also be introduced, and you will integrate statistics and epidemiology to gain competence in critically appraising pharmacoepidemiology studies.

Pharmacovigilance - you will be introduced to the key elements of pharmacovigilance and its basis within drug regulation. Within the risk management elements of the course, you will gain insight into how pharmacoepidemiology and pharmacovigilance are combined in the investigation of the effects of medicines. Principles will largely be demonstrated within the European legislative context, whilst recognizing these general principles apply more broadly throughout the world.

Health economics - you will be introduced to the fundamental concepts involved in assessing the cost effectiveness of health technologies and methodologies used to assess the health related quality of life. Real-world examples will be used to illustrate concepts.

Teaching Methods

This is an online course. There is no face-to-face component of this course.

Teaching for each Block will be delivered primarily via online synchronous teaching during each teaching week. This will include pre-recorded lectures from subject matter experts. Students and tutors will then interact in live Q&A sessions and workshops during the teaching week where students have the opportunity to apply and discuss concepts introduced in the pre-recorded content. Workshops will address topics such as designing a pharmacoepidemiological study, critical appraisal of published papers, developing risk management plans and responding to a drug safety alert. In addition to the pre-recorded lectures, students will be provided with lists of helpful scientific papers, articles and other content to assist with learning.

For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), there will also be self-directed learning in between the online synchronous teaching weeks in the form of completing a project and practice exams.

The variety of backgrounds and the knowledge possessed by lecturers ensures that the course has a sound mixture of the theoretical and the practical issues surrounding drug safety. The teachers range from academic staff at the School, with expertise in areas such as pharmacology, epidemiology and statistics, to senior practitioners in the international pharmaceutical industry, regulatory authorities, and public health who have practical expertise in pharmacovigilance and pharmacoepidemiology.

Assessment

For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), the assessment consists of submission of a written project (worth 40% of the total grade) and a written examination (worth 60% of the total grade). You must be awarded a pass grade for both elements to be awarded the Professional Certificate.

All materials for the project will be provided, and each student will be supported by an academic adviser. Additionally two lectures on the chosen topic for the project will be included in the syllabus.

There is no formal assessment at the conclusion of each individual Block, but a Certificate of Attendance will be provided.

Requirements

English Program Requirements

English Language requirements

As part of the application process, applicants are required to demonstrate how they meet LSHTM's minimum English Language requirements. This is particularly important for applicants requiring a Student Visa, as the UK Home Office requires that every student from outside the UK and Republic of Ireland shows evidence of a minimum level of English language ability (called CEFR B2 level) in order to be granted a Student visa and study in the UK.

Additionally, LSHTM asks for English language proficiency levels that are necessary for our academic programmes, which is slightly higher than the Common European Framework for languages (CEFR) B2 level.

English language requirements policy (pdf)

Accepted English language tests

The academic English language requirements for each of LSHTM’s programmes are categorised into one of three profiles:

Band A (highest requirement)
Band B (mid-range/’standard’ requirement)
Band C (lowest requirement)

Please refer to the appropriate Programme Specification for the English language requirement Band of your preferred programme.

IELTS (Academic)
Pearson PTE Academic

These tests are only valid for entry for 2 years. As a result the qualification must have been completed no more than 2 years prior to enrolment.

LSHTM requires the following minimum proficiency test scores. Please refer to the appropriate Programme Specification for the Band of your preferred programme.

	Band A	Band B	Band C
IELTS (Academic)	7.5 overall with 7.0 in each component	7.0 overall with 6.5 in each component	6.5 overall with 6.0 in each component
Pearson PTE Academic	80 overall with 80 in each component	76 overall with 76 in each component	59 overall with 59 in each component

Majority English-speaking countries

Last updated: 26 October 2022

The UK Government recognises the following countries as majority English-speaking countries:

Antigua and Barbuda
Australia
The Bahamas
Barbados
Belize
Dominica
Grenada
Guyana
Ireland
Jamaica
Malta
New Zealand
St Kitts and Nevis
St Lucia
St Vincent and the Grenadines
Trinidad and Tobago
United Kingdom
United States of America

These countries have been classified as majority English-speaking countries by the UK Government. Further information on Student Visa requirements, including Knowledge of English, can be found on the government website. In the interest of compliance, LSHTM is not able to consider other countries as majority English-speaking countries.

If you are a national of one of these countries, you are not required to submit evidence of English language proficiency.

If you have undertaken a full degree in one of the above countries, you will not be required to submit further evidence of your English Language if the degree certificate is successfully verified with the issuing body on receipt. Any applicant found to have submitted fraudulent documentation will have their application withdrawn.

Canadian nationals are also exempt from English Language requirements but non-Canadian nationals who have studied in Canada are required to meet standard English Language requirements due to Home Office policy.

Conditions

If you request to defer your entry to LSHTM, we may ask you to re-take your test if your original offer was based on a test which will be out of date at the point of registration. Our English language programme requirements and other accepted tests provide details of how long your qualification is deemed valid.

All test scores are verified with the issuing body on receipt. Any applicant found to have submitted a fraudulent score will have their application withdrawn.

LSHTM reserves the right to change minimum English Language requirements during an application cycle in-line with any compliance guidance released by the Home Office. In the event of a change in Home Office policy which affects entry requirements, the University will notify affected applicants in writing.

Exemptions

Applicants who are a national of a majority English-speaking country or who have successfully completed an appropriate academic qualification (at least equivalent to a UK Bachelor's degree), which was taught in a majority English speaking country from the UKVI approved country list automatically meet our English Language requirements.

UKVI’s approved country list

*Please note, Canadian nationals are exempt from English Language requirements but non-Canadian nationals who have studied in Canada are required to meet LSHTM’s standard English Language requirements due to Home Office regulations.

Academic entry requirements

LSHTM's minimum entry requirements for each of its degrees are listed below. Applicants who do not meet the minimum entry requirement for the programme of their choice but who have relevant professional experience may still be eligible for admission.

Master's programmes (intensive)

In order to be admitted to an LSHTM master's degree programme, an applicant must:

hold either a first degree at Second Class Honours (2:2) standard in a relevant discipline, or a degree in medicine recognised by the UK General Medical Council (GMC) for the purposes of practising medicine in the UK, or another degree of equivalent standard awarded by an overseas institution recognised by UK ENIC or the GMC).

or

hold a professional qualification appropriate to the programme of study to be followed obtained by written examinations and judged by LSHTM to be equivalent to a Second Class Honours (2:2) degree or above.

or

have relevant professional experience or training which is judged by LSHTM to be equivalent to a Second Class Honours (2:2) degree or above.

and

satisfy any additional requirements where prescribed for admission to a specific programme.

If you have not previously studied in the UK, you can check our guide to international equivalent qualifications for our master's degrees.

Some degree programmes may have a higher entry requirement than specified above. Please be sure to check the individual programme for any additional entry requirements.

MPhil and PhD

Academic requirements

The normal minimum entrance qualification for registration at the School on a MPhil/PhD programme is evidence of an aptitude for research and at least one of the following:

a master’s degree in a subject appropriate to the course of study to be followed (recommended)
a qualification appropriate to the course of study to be followed, in medicine, dentistry or veterinary studies
an Upper Second Class Honours (2:1) degree from a UK university, or an overseas qualification of an equivalent standard, in a relevant subject.

English language requirements

If English is not your first language, you will need to meet these requirements: Band B.

DrPH

Academic requirements

The normal minimum entrance qualification for registration at the School on a Doctoral programme is evidence of an aptitude for research and at least one of the following:

a master’s degree in a subject appropriate to the course of study to be followed (recommended)
a qualification appropriate to the course of study to be followed, in medicine, dentistry or veterinary studies
an Upper Second Class Honours (2:1) degree from a UK university, or an overseas qualification of an equivalent standard, in a relevant subject.

Applicants for the DrPH study are also required to have a minimum of two year's appropriate experience.

English language requirements

If English is not your first language, you will need to meet these requirements: Band B.

Essential digital skills

Digital skills and using computers are an everyday part of modern life – and you'll need both during your time at LSHTM.

You'll need to be able to use standard software (such as Word), a web browser and email. You'll also need to be able to type at a reasonable speed in order to perform to the best of your ability during any online assessments – for reference, the average person types around 40 words per minute – there are a number of free typing speed tests available online.

It'll benefit your studies if you know how to:

use digital technologies to find, evaluate and create information
communicate effectively with online technologies
select the correct tools to complete online and offline tasks
perform tasks efficiently in a variety of digital environments

Whatever you're studying you'll need to know how to work with digital technologies, stay safe online and build a positive online presence.

Reasonable adjustments and support are available for students who have additional accessibility or learning needs, and LSHTM recognises the use of voice to text or alternative software being available for those students with disabilities.

Career

Aims & Objectives

The aim of this well established training programme is to equip students with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance. By the end of the programme, students should be able to:

demonstrate an understanding of, and critically evaluate, issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs), the manner of which these are detected and monitored, and the related historic and legal frameworks
be familiar with and compare fundamental statistical, economic and epidemiological concepts and methods
gain an understanding of, and reflect upon, important pharmacoepidemiological concepts and methods and how these methods can be applied to specific drug issues and pharmaceutical risk management
assess and critically analyse the results of pharmacoepidemiological studies (other investigators'), including critical appraisal of the study question, study design, methods and conduct, statistical analyses and interpretation

Course Content

The curriculum will provide an introduction to epidemiology, statistics, pharmacoepidemiology and health economics. It will also cover the historical and legal background to pharmacovigilance and pharmacoepidemiology, and pharmacological basis of ADEs, addressing ADE issues at individual and population levels, and the application of pharmacoepidemiological principles and methods to practical drug issues.

Key Course Topics

Pharmacoepidemiology - you will learn about the fundamentals of pharmacoepidemiology, its conduct, practical uses and limitations in determining the effects of medications in large groups of people. The statistical basis underpinning pharmacoepidemiology will also be introduced, and you will integrate statistics and epidemiology to gain competence in critically appraising pharmacoepidemiology studies.

Pharmacovigilance - you will be introduced to the key elements of pharmacovigilance and its basis within drug regulation. Within the risk management elements of the course, you will gain insight into how pharmacoepidemiology and pharmacovigilance are combined in the investigation of the effects of medicines. Principles will largely be demonstrated within the European legislative context, whilst recognizing these general principles apply more broadly throughout the world.

Health economics - you will be introduced to the fundamental concepts involved in assessing the cost effectiveness of health technologies and methodologies used to assess the health related quality of life. Real-world examples will be used to illustrate concepts.

Teaching Methods

This is an online course. There is no face-to-face component of this course.

Teaching for each Block will be delivered primarily via online synchronous teaching during each teaching week. This will include pre-recorded lectures from subject matter experts. Students and tutors will then interact in live Q&A sessions and workshops during the teaching week where students have the opportunity to apply and discuss concepts introduced in the pre-recorded content. Workshops will address topics such as designing a pharmacoepidemiological study, critical appraisal of published papers, developing risk management plans and responding to a drug safety alert. In addition to the pre-recorded lectures, students will be provided with lists of helpful scientific papers, articles and other content to assist with learning.

For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), there will also be self-directed learning in between the online synchronous teaching weeks in the form of completing a project and practice exams.

The variety of backgrounds and the knowledge possessed by lecturers ensures that the course has a sound mixture of the theoretical and the practical issues surrounding drug safety. The teachers range from academic staff at the School, with expertise in areas such as pharmacology, epidemiology and statistics, to senior practitioners in the international pharmaceutical industry, regulatory authorities, and public health who have practical expertise in pharmacovigilance and pharmacoepidemiology.

Assessment

For students who take the full assessed course leading to a Professional Certificate (three Blocks plus project and exam), the assessment consists of submission of a written project (worth 40% of the total grade) and a written examination (worth 60% of the total grade). You must be awarded a pass grade for both elements to be awarded the Professional Certificate.

All materials for the project will be provided, and each student will be supported by an academic adviser. Additionally two lectures on the chosen topic for the project will be included in the syllabus.

There is no formal assessment at the conclusion of each individual Block, but a Certificate of Attendance will be provided.

Fee Information

Tuition Fee

GBP 0

How to Apply

Applying for CPD and short courses

All of our short courses can be applied for online. Details on how to apply including fees and payment deadline can be found the page of the course you are interested in. A link to the online application form will be found on the tab of the chosen course. For a full details of what is on offer, please visit our short courses section.

Please also read our Continuing Professional Development (CPD) and short courses admissions policy before applying for a course.

Applying for London-based modules

Details on how to apply including fees and payment deadline can be found on the London-based module section of the website. Applicants for individual modules should complete the MSc module application form and email it to shortcourses@lshtm.ac.uk.

Please note that the School gives priority to the needs of students registering for masters and research degrees, and so places on any module may be limited.

Applying for distance learning modules

Applications should be made online to the University of London international programmes. Applicants should go to the relevant programme webpage and click on the corresponding ‘Apply online’ tab. Please see below for the list of available modules per programme and to apply:

Clinical Trials modules
Demography & Health modules
Epidemiology modules
Global Health Policy modules
Infectious Diseases modules
Public Health modules

Further information on the application process for the distance learning programmes can be found on the University of London website.

Professional Certificate in Pharmacoepidemiology & Pharmacovigilance

London School of Hygiene & Tropical Medicine, University of London

London School of Hygiene & Tropical Medicine, University of London

Key Facts

Start & Deadlines