Postgraduate Professional Development Short Course (30 credits)
The global challenge of maximising drug safety yet maintaining public confidence has become increasingly complex. Health authorities are tasked to provide quality care while managing a growing drug budget. Regulatory authorities must balance the potential benefits of new drugs with the perception of their potential harm.
This Postgraduate Professional Development Short Course addresses the need for well-informed professionals to work in all areas related to the assessment of drug safety and the management of risks and benefits of medications, including vaccines.
This course is run in collaboration with University of London, and applications must be made via the University of London website.
This course aims to equip you with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance, and to apply these skills to a currently unresolved drug safety issue.
By the end of this course, you will be able to:
- Demonstrate an understanding 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 in which these are detected and monitored, and the related historic and legal frameworks
- Understand and critically compare fundamental statistical, economic and epidemiological concepts and methods
- Understand and critically reflect upon important pharmacoepidemiological concepts and methods and how these methods can be applied to specific drug issues
- Assess and critically analyse the results of pharmacoepidemiological studies, including critical appraisal of the study question, study design, methods and conduct, statistical analyses and interpretation
- Understand how new medicines are assessed for their cost-effectiveness as well as efficacy and safety, before being recommended for use
- Apply the techniques and approaches covered in the taught element of the course, plus your own experience, to evaluate issues presented to you in the format of a project, and where relevant, develop recommendations for the best option or options
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.
An integrating project will enable you to demonstrate your global understanding of pharmacoepidemiology and pharmacovigilance.
Who is it for?
This course is aimed at personnel involved in the safe use of medicines, particularly in developed countries. This includes 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.
Comprehensive 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
Students may choose to attend a week of lectures at LSHTM in November (dates for 2019 are 4-7 November), which are part of the face-to-face version of the Pharmacoepidemiology and Pharmacovigilance course held in London. Those wishing to do so must apply directly to LSHTM by completing the online application form for the face-to-face programme (an additional fee of £500 will apply).
Staff involved in the on-campus course at LSHTM will support this course between the beginning of November and the end of May. You’ll also be allocated a personal advisor who will advise on your project.
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 on the virtual learning environment.
The anticipated time required to complete the course is 300 study hours - roughly 100 of which will be dedicated to the project.
LSHTM is a highly respected world leader in this field. This course is established on-campus and is moderated annually by an exam board and an external examiner.
|Award||Certificate of Achievement in Pharmacoepidemiology and Pharmacovigilance (worth 30 credits at FHEQ Level 7).|
|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, registration lasts two years for those unable to complete within the first year.|
|Technical requirements||Regular access to an internet-ready device, plus the ability to download and view documents including spreadsheets and PDF files.|
|Assessment||Unseen examination (60%), plus one project (40%). You must be awarded a pass grade for both elements to complete the module.|
|Programme regulations||Download programme regulations (pdf)|
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 the LSHTM Qualifications for Entrance (PDF).
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.
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.
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:
- 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
- Parallel software, with Windows installed, if using a non- Windows based PC such as a Mac.
* Certain essential functionality may not be supported on all mobile devices.
Students will need to use a calculator.
A headset/microphone will be required to participate in ‘real-time’ online discussions.