The academic year 2021/22 will be the last year that new applicants can register for this distance learning course. We would like to alert you to our new online intensive course in Pharmacoepidemiology & Pharmacovigilance, which will commence in December 2021 and replace this distance learning course going forward.
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 distance learning 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.
This course is run in collaboration with University of London, and applications must be made via the University of London website.
Course 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
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.
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
- at least 6 months’ relevant work experience; and
- applicants should have a good command of English.
Learning materials
Your materials are provided via a dedicated virtual learning environment. 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
Assessment and academic credits
The assessment consists of submission of a written project and a written examination. All materials for the project will be provided, and each student will be supported by an academic adviser.
Students who complete the course will be awarded a Certificate of Achievement in Pharmacoepidemiology and Pharmacovigilance (worth 30 credits at FHEQ Level 7).
Time commitment
The anticipated time required to complete the course is 300 study hours - roughly 100 of which will be dedicated to the project. Students may complete the course over one or two academic years.
Networking opportunities
Though much of the work is by self-directed learning, you are encouraged to take part in module-specific discussions and real-time tutorials available in the virtual learning environment.
Award
Certificate of Achievement in Pharmacoepidemiology and Pharmacovigilance (worth 30 credits at FHEQ Level 7). Credits may be considered for recognition of prior learning in a Master's level qualification. Level 7 refers to a level of education equivalent to a UK Master's degree.
Duration
It is expected that most students will study from the beginning of November to the June exam and complete the course in one year. However, students may also complete the course over two academic years.
Technical requirements
Regular access to an internet-ready device, plus the ability to download and view documents including spreadsheets and PDF files.
Assessment
Examination (worth 60% of total grade) and Project (worth 40% of total grade). You must be awarded a pass grade for both elements to be awarded the Certificate of Achievement.
Programme regulations
Programme regulations (pdf)
Academic Requirements
You will meet the academic entrance requirement if you hold:
- an undergraduate degree (e.g. bachelor) which is considered at least comparable to a UK second class honours degree, from an institution acceptable to the University, in a subject appropriate to the course (e.g. biological sciences, chemistry, physics, medicine, dentistry, pharmacy or statistics);
and
- at least 6 months’ relevant work experience (e.g. working in a pharmaceutical company or drug regulatory authority in a scientific role)
Please note we accept qualifications from around the world. For further guidance please see University of London's qualifications for entrance.
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.
Language Requirements
It is essential that you have an adequate command of the English Language to carry out your studies. The following may be considered as acceptable evidence of English language proficiency:
- substantial education (minimum of eighteen months) conducted and assessed in English, or
- substantial work experience (minimum of eighteen months) conducted in English.
If you do not meet one of the above requirements then you will be required to have passed one of the following within the past three years:
- Cambridge Certificate of Advanced English when a minimum overall score of 185 is achieved, with at least 176 in Writing and 169 in Listening. If taken prior to January 2015 then you must achieve a minimum overall score of grade B.
- (IELTS) International English Language Testing System when an overall score of at least 7.0 is achieved with a minimum of 6.5 in the Written sub-test and a minimum of 5.5 in Listening, Reading and Speaking.
- Pearson Test of English (Academic) overall score of 68 or above, with a minimum of 62 in Writing and a minimum of 59 in Listening, Reading and Speaking.
- (TOEFL) iBT Test of English as a Foreign Language overall score of 100 or above with at least 24 in Writing, 23 in Speaking, 22 in Reading and 21 in Listening.
Where an applicant does not meet the required English language level but believes they can demonstrate the required level for admission the University may, at its discretion, consider the application.
Computer Requirements
You must have regular access to a computer (or mobile device*) with an internet connection to use the University of London website and the Student Portal. These are where your programme’s study resources are located.
Through the Student Portal you can register as a student, enter exams and use your programme’s Virtual Learning Environment (VLE). The VLE provides you with electronic learning materials, access to the University of London Online Library, networking opportunities, and other resources.
To get the most from your studies, your computer should have at least the following minimum specification:
- A web browser (the latest version of Firefox, Chrome or Internet Explorer). This must accept cookies and have JavaScript enabled.
- Screen resolution of 1024 x 768 or greater.
- Sufficient bandwidth to download documents of at least 2-5 MB, and the following applications installed:
- Microsoft Word and Excel software
- Adobe, or other PDF reader
- Zoom software for live interactive sessions
* Certain essential functionality may not be supported on all mobile devices.
Additional requirements
Students will need to use a calculator.
A headset/microphone will be required to participate in ‘real-time’ online discussions.