Guidelines


Assignments, Examination and Master Thesis

1    Types of assignment
There are a variety of approaches that test different aspects of the learning experience. The following paragraphs described some of these different approaches. The course provider will select one or more approach that is appropriate to each module.

  • Critical review
    Students are asked to undertake a critical review of a published paper, which covers a topic from the module. For example, if dealing with a clinical trial, the critical appraisal should include study objectives, design, and description of primary endpoint, power calculation, subject disposition, analysis, discussion and conclusion and the relevance of the paper for clinical practice at local / national level. Commentary pieces on drug development or regulation or drug safety issues may also be included here and the student asked to comment on the validity of the argument and the relevance for pharmaceutical medicine etc.

  • Research and discussion
    Students are asked to present an analysis of a topic covered in the module and to discuss the impact of this on the process / practice of pharmaceutical medicine / industry/regulation etc. They will be expected to undertake a literature search on the topic and to provide arguments, backed up by relevant references, for their opinions.
    Examples of this type of assignment include an evaluation of a therapeutic area (e.g. a specific orphan disease) or an analysis of new R & D tools (e.g. genotyping).

  • Discussion on general pharmaceutical industry issues
    Students are asked to review and comment on a recent activity relating to one or more pharmaceutical companies/pharmaceutical industry in general. Examples would include review of research pipelines based on published data (comparison between companies), the future of R & D in general, impact of recent regulatory changes / voluntary codes of practice on the industry at local and international level, etc.

  • Data Analysis
    Students should be expected to be able to analyse datasets, particularly relating to studies from each section of the R & D programme and from drug safety issues. In this type of assignment, students will be presented with a set of data and asked to describe what the data are telling them and how it will inform the future development / continued usage of the product and e.g. how it will contribute to / change the content of the target product profile.

  • General public health issues
    It is reasonable to expect students to have a general understanding of public health issues as they might affect the pharmaceutical industry, especially if they might impact on health technology assessments. Questions involving such concerns are a good way of testing the broad understanding of students about the overall environment within which the pharmaceutical industry operates.

    A pool of Assignments is attached in Appendix 8.8 to help course providers to implement them.

2    Integrated examination
An examination covering all parts of the syllabus forms a summative assessment of the knowledge-base required for certification as a specialist in pharmaceutical medicine/Medicines Development. In addition, for those not eligible for registration as a specialist, success in this examination provides a stand-alone demonstration of the level of knowledge achieved.

It is emphasised that this is a postgraduate examination that is unlikely to be appropriate to any who do not have a relevant degree and minimum of two years of experience in the pharmaceutical industry/CRO/regulatory authority. Any candidate without a relevant degree is advised to have at least five years such experience at the time of sitting the examination. Candidates should have attended one of the Europe-wide education and training programmes on integrated drug development / pharmaceutical medicine compliant with the PharmaTrain curriculum and / or attained an equivalent level of knowledge through workplace-based training and experience, private study, and other courses.

The examination will comprise three methods of assessment including a multiple choice question paper and at least one other format of written assessment e.g., short answer questions and/or essay. For students who have completed one of the PharmaTrain programmes, satisfactory completion of the assignments at the end of each module could constitute the second written assessment. The examination may include an oral component. The integrated examination will adhere to the principles summarised in Section 6.3 (?). Details are summarized in Appendix 8.9

3    Master dissertation/thesis
The term dissertation or thesis refers to the same endeavour, which is to present evidence that demonstrates that the student has grasped the essential elements of planning, researching, writing-up, and presenting the results and conclusions of a project that they have undertaken. This would normally be the end product of an MMD/MSc course and in most institutions a degree would not be awarded without this.
It is important to recognise that this is not a PhD research project and the much more extensive PhD thesis; it is essential to help the students understand what is expected of them.

Essential elements are:
  • Planning. The student should be able to demonstrate that they have thought through what they are planning to do. This is often achieved by writing an abstract and presenting this to their supervisor for the project. It should define the research question that they are asking and how they are going to approach obtaining the data and analysing them.
  • Research. This will vary widely in nature and could consist of a study that the student is doing as part of their normal work. In this case it will be necessary for them to demonstrate what their role was in the project such that they had influence over the way the study was conceived and executed. They will need agreement from their employer to use the research study for the purpose of dissertation. An alternative could be a literature-based project. In this case it is of particular importance to ensure that the research question is carefully framed and is not simply an extended essay.
  • Writing-up. This is the end-product of the project and will be the basis on which the examiners will determine if the student merits a pass. It will also be the document that is filed in the institution’s archives. Writing-up will include a statement about the research question, the way the research was undertaken, how the data were analysed and what the results and conclusions were.
  • Where appropriate, write one or two papers based on the research that can be published in peer-reviewed journals.

Management of the project
Management of the project should rest entirely with the institution at which the student is registered. This will include the appointment of supervisors, the resources made available to the student and the style and presentation of the project. Some institutions will insist on an oral discussion/examination of the project and others will only ask for this under defined circumstances.

Learning outcomes
At the end of the project the student should be able to:
  • Define a simple research question
  • Create a plan to answer the question
  • Carry out the necessary investigations / research
  • Analyse the data that have been generated
  • Write up the project in a logical and readable way.

Assessment of the dissertation
As with all assessments, the dissertation should be marked independently by two examiners who will focus on the ability of the student to analyse, synthesise and evaluate the topic. An oral defence may be required. An external expert in the field may be approached for comment and an external examiner will moderate the marks.
The examiners will make one of the following recommendations, as appropriate:
  • that the thesis/dissertation is of pass standard
  • that the thesis/dissertation is of pass standard, subject to specified minor corrections
  • that the thesis/dissertation be failed but that the student be permitted to submit a revised dissertation by a specified date
  • that the dissertation be failed

Specified corrections should be completed within a defined time frame and verified by one of the examiners.