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Pharmacoepidemiology and Pharmacovigilance

Professional Development

Boost your expertise in the evaluation of medicines with distance-learning opportunities. Postgraduate Professional Development course in Pharmacoepidemiology and Pharmacovigilance.

This is an introductory course which should meet the needs of a wide variety of practitioners.

The course is aimed at personnel concerned with the safe use of medicines, particularly in developed countries, including those working (or intending to work) in: the pharmaceutical industry who are involved in drug development, licensing, and surveillance; regulatory bodies who are involved in licensing and surveillance; the health service who are involved in drug policy; and health policy decision-making agencies.

By the end of this course, you’ll be able to:

  • Evaluate issues surrounding the risks and benefits of drug use in humans, including the cause and effects of adverse drug effects.
  • Compare statistical, economic and epidemiological concepts and methods.
  • Reflect upon how pharmacoepidemiological methods can be applied to specific drug issues.
  • Analyse and appraise pharmacoepidemiological studies and their results.
  • Understand the cost-effectiveness assessment for new medicines.
  • Use your learning alongside your experience to produce an evaluative project.
Demography Health
Boost your expertise in the evaluation of medicines with distance-learning opportunities.

During this short course, you will explore the following themes:

Pharmacoepidemiology

Learn about the fundamentals of pharmacoepidemiology, its conduct, practical uses and limitations in determining the effects of medications in large groups of people. Discover more about the statistical basis underpinning pharmacoepidemiology, and gain the skills required to evaluate pharmacoepidemiology studies.

Individual sessions include:

  • Introduction to critical appraisal of trials
  • Selection and information bias
  • Essential statistics for epidemiology
  • Critical appraisal of case-control studies
  • Introduction to comparative effectiveness research
  • Electronic healthcare records in pharmacoepidemiology
  • Introduction to pharmacoepidemiology and applications in the pharmaceutical industry
  • Introduction to comparative effectiveness research

Pharmacovigilance

Discover the key elements of pharmacovigilance and its basis within drug regulation. You'll gain insight into risk management and how pharmacoepidemiology and pharmacovigilance unite when investigating the effects of medicines. Principles will be demonstrated largely within a European legal context, but we will consider how they apply more broadly throughout the world.

Individual sessions include:

  • Pharmacovigilance and spontaneous ADR reporting systems
  • Overview of pharmaceutical risk management
  • Vaccine risk management
  • Medications in pregnancy
  • Guidelines on pharmacoepidemiology and pharmacovigilance
  • Drug safety decision-making using a range of evidence
  • Post-marketing benefit-risk assessment.

Health economics

Discover the fundamental concepts involved in assessing the cost effectiveness of health technologies and methodologies used to assess the health related quality of life. Concepts will be illustrated using real world examples.

Individual sessions are as follows:

  • The role of pharmaceutical data in NICE’s appraisal of new and current health technologies
  • Assessing the health related quality of life
  • Case study: a health technology appraisal.

Project

The project allows you to demonstrate your global understanding of pharmacoepidemiology and pharmacovigilance by analysing a current drug safety issue.

You'll be given a number of study reports. You then evaluate the evidence, make decisions based on your assessment, and offer suggestions for future regulatory action and research.

Application deadline 30 September 2019
Registration deadline October 2019

The programme is offered online and is fully supported by a Virtual Learning Environment (VLE). You study at a time and pace that suits you (subject to certain deadlines), using the study materials provided and with support available from academic staff.

Study materials

Your materials are provided via a dedicated Virtual Learning Environment (VLE). These include:

  • Fully interactive self-directed sessions on each topic;
  • Audio and video case studies;
  • A compendium of resources, including relevant papers and reports.
  • Access to the University of London and LSHTM online library resources.

Online support

When you register, we will give you access to your Student Portal. You can then access your University of London email account and two other key resources:

  • The Virtual Learning Environment (VLE) enables access to course materials, resources, and forums to discuss course material and work collaboratively with others. Tutors are available to answer queries and promote discussion during the study year through the VLE.
  • The Online Library holds thousands of journal articles which you can access free of charge. A dedicated helpdesk is available if you have any difficulties in finding what you need.

Teaching staff provide written, personalised feedback and advice on assignments. You can also communicate with other distance learning students, and set up your own learning support groups.

Time commitment

This course requires 300 hours of learning:

  • Self-study / self-directed learning (working through course materials, general reading, online learning and engagement), 160 hours.
  • Assessment, review and revision, 40 hours.
  • Project, 100 hours.

Assessment

For the project, you submit a brief summary in February and the final report in May. This comprises 40% of your final mark. The unseen examination for this module, PCM100, is held in June. This makes up 60% of your final mark.

You can sit exams at an approved centre anywhere in the world (mainly Ministries of Education or the British Council). Each centre charges a fee for hosting exams.

More about exams.

What qualifications do you need?

You will normally hold the equivalent of a UK second class honours degree in a science, medical, statistical or related subject, as well as some experience in the area. However, previous experience will be taken into account in all cases (e.g. six months in a pharmaceutical company or drug regulatory authority in a scientific role).

Find equivalent qualifications where you live.

English Language requirements

You need a high standard of English to study this programme. You will meet our language requirements if you have achieved one of the following within the past three years:

  • IELTS: 7.0 overall, with 6.5 in the written test and 5.5 in listening, reading and speaking.
  • TOEFL iBT: 100 overall, with 24+ in writing, 23+ in speaking, 22+ in reading and 21+ in listening.
  • Pearson Test (Academic): 68 overall, with 62+ in writing and 59+ in listening, reading and speaking.
  • Cambridge Certificate of Advanced English: 185 overall, with 176+ in writing and 169+ in listening.

Alternatively, you may satisfy the language requirements if you have at least 18 months of education or work experience conducted in English.

If you don’t meet these requirements but believe you can meet the standard, we may still consider your application.

Computer requirements

We set minimum basic computer requirements because your study resources are accessed via the Student Portal and it is vital that you can access this regularly. For this degree, you will also need Adobe Flash Player to view video material and a media player (such as VLC) to play video files.

More about computer requirements.

The fee below applies if you begin during the 2018-2019 session. This may be increased by up to 5% per year.

Academic year

2018-2019

Fee

£ 4,730

Disclaimer: Currency conversion tool

Additional Costs

You will also need to budget for exam centre fees, which are paid directly to the venues where you sit your exams.

We accept most traditional payment methods, including debit/credit card, international money order, and Western Union.

How to pay your fees.

On 1 July 2017 a Goods and Services Tax (GST) [external website] was introduced in India which applies to online services. From 1 August 2019, the University will be required to add GST at the statutory rate of 18% to its programme fees for new and continuing students resident in India.

The course is aimed at professionals concerned with the safe use of medicines - particularly in developed countries - including those working (or intending to work) in the pharmaceutical industry (drug development, licensing, and surveillance); regulatory bodies (licensing and surveillance); the health service (drug policy); and health policy decision-making agencies.

What do employers think of our graduates?

In some countries, qualifications earned by distance and flexible learning may not be recognised by certain authorities or regulators for the purposes of public sector employment or further study. We advise you to explore the local recognition status before you register, even if you plan to receive support from a local teaching institution.

The London School of Hygiene & Tropical Medicine (LSHTM) has an international standing, with faculty that boasts unique multidisciplinary and international experience. It was crowned University of the Year in 2016 by Times Higher Education for its extraordinary response to the Ebola crisis.

Without the cost of moving to London, studying for your University of London degree anywhere in the world represents excellent value for money. However, there are additional sources of support depending on where you live and how you choose to study.

More on funding your study.

Can I get sponsored?

If you're employed, your employer may be willing to cover part/all of the programme fee if you can make a compelling case as to how this programme will boost your contribution to the workplace.

Our courses are ideal for employers because they get to retain you as an employee and benefit from your learning from the moment you begin.

How can I get sponsored by my employer?

Open days

The School holds regular open days in London. You can come and meet staff and students and receive a tour of the School.

Find the next open day.

You can choose to attend a week of lectures at the London School of Hygiene and Tropical Medicine in November, which are part of the face-to-face version of the Pharmacoepidemiology and Pharmacovigilance course held in London.

Receive face-to-face teaching in a classroom and meet lecturers and fellow students in person, plus follow traditional teaching/learning of the materials of the first Block.

(Please note: if you do not choose the blended learning option, you will not be disadvantaged. Materials taught during the blended learning week are available online to everyone enrolled in the Distance Learning programme.)

To participate, you should make a separate application for the four days of lectures in London (5-8 November 2018). If you need a visa, the deadline for adding this option will be earlier than indicated, i.e. the application deadlines will coincide with those for the face-to-face version of the course as specified on the LSHTM website.