Master’s Thesis Help-Comparison of EU and UAE Pharmacovigilance System

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Master’s Thesis Help-Comparison of EU and UAE Pharmacovigilance System

Structure of the Master Thesis

 

Contains all essential thoughts which lead to the comprehension of the subject • Declarations resulting from current literature, current investigations, statistics, etc. • After the description of the problem research question is stated – Sub question (s) can be derived from the global question • Methodology has to be defined • At the end of the introduction follows the content structure • Definition of terms is recommended

 

Methodology

  • Description of the methodology – Which method is used for answering the research question? • Empirical work is welcome, but not obligatory • Methodology (with reference to literature) has to be described in detail – literature research or empirical work • First possible methodical approaches are discussed and evaluated critically • In continuation it is decided which method is suitable for the work. – decision has to be constituted in detail

Literature comparison/Theoretical part

  • Describes the state-of-the-art and similar problems which already have been treated and published • Informs the reader, e.g. about solutions concerning parts of the problem • It is not enough to summarise similar works – look at those parts of these works which are important for your work, and discuss them with reference to your work • You should only deal with questions which deliver a contribution to answer the research question – no information concerning the problem in general

 

Empirical part

  • includes a detailed description of the utilized methodology as well as the requested empirical inquiries and evaluations • Primary data must be collected and evaluated • experience during the procedure and the problem solving should be described • usually consists of several subchapters

 

Conclusion

  • Contains a summary of the initial situation (incl. problem formulation and scientific question), theoretical and empirical part and the results – To which new knowledge did you come? – To which conclusions did you come? – Is there possibly another way to solve the problem? • It should be shown that research question has been answered • Recommendations for further work or research as well as future perspectives should be stated – What should happen in the future? – Managerial implications…

 

Research question

  • Scientific works often are meant to fail because their scope is too vague (e.g.: “Quality Mgt”, “Pharma Mgt”, “Marketing and Sales in Pharmaceutical”) • Its purpose is to provide the rationale for the study • To formulate the question is a task on its own. • Good questions are formulated by means of “w-question” (What?, • how?, why?) • Bad questions can be recognized by: – Incorrect presumptions – Imprecision ( no answer possible) – Contradiction (the question is self-contradictory) – Pseudo-question (Statement case) – Persuasive, tendentious questions • The right choice of the research question helps to justify the choice of a particular method and the literature review

 

Example Research Question

“…. The following research question shall be seen as guideline for formulating the thesis: What measures have international organizations adopted, to assist countries with a probability of an Ebola outbreak??

The purpose of this research is, to identify which measures have been and will be taken to assist countries with a probability of an Ebola outbreak and to anticipate and counteract successfully against the impacts.

Structure of the thesis

  • Is determined by its research question • Every chapter has to have relevance for answering research question
  • Introduction – provides the rationale for the study – contains the nature, scope and intention of research and – the method of investigation – sets the scene of what is to follow • Main body – contains the analysis/discussion of the research question, hypothesis and interpretation of data • Conclusion – contains final results and findings, recommendations – should identify how the results may be applied and indicate perspectives for further research

General Structure

  • One section title has to have at least 2 sub-sections – If a section (e.g. 3.) needs to have a sub-section (e.g. 3.1) you are also going to have at least one other sub-section (e.g. 3.2.)
  • The sub-sections should not be a mere repetition of the section title

Formatting, Layout

Layout

  1. Front page 2. Abstract (one page) 3. Table of content 4. Introduction with – Problem definition (description of the problem area ) – Research question – Aim of the work – Methodology 5. Main part: Development of the problem and State of the Art and optionally an empirical research 6. Conclusion List of literature List of illustrations (optional) List of tables (optional) Appendix (optional)

Contents

Formal indications

  • Length of the Master Thesis: 11.500 – 13.500 words (50 – 60 pages) • Margins – Upper margin: 3 cm; Lower margin: 3 cm; Left margin: 3 cm; Right margin: 2 cm • Format: DIN A-4 • Font size: 12 pt, Arial, • Line spacing: 1,5 pt • Paging: Each page has to be numbered consecutively. The front page, the declaration, the abstract, Index of literature, the Index of figures, Index of tables and the Appendix are not to be numbered. • Page layout: only write on the front side of each page – each chapter starts with a new page – for subchapters do not start a new page

Appendix

  • Should be placed at the end • Contains those documents that could help to better understand the work, but which would be disruptive for the reading • Typical documents – more extensive interpretations – supplementary tables or figures – Questionnaires – interview transcripts, etc.

Abstract

  • Should give an overview about the problem, the scientific (research) question, the aim of the work, the methodology and the • 0,5 page, max. 1 page • Following questions should be answered: – Which problem is being treated? – Research question – Methodology: How should the problem be solved? What are the essential considerations? – What are the results or the perceptions? • Abbreviations should be avoided in the abstract

Example Abstract Risk Management in der Pharmakovigilanz – Patient Reporting

Direct patient reporting of Adverse Drug Reactions (ADRs) is one way of actively including patients as crucial stakeholders to the risk management process of pharmacovigilance (PV). The aim of this paper is to examine opportunities and challenges of patient reporting systems in PV by investigating the UK Yellow Card Scheme, the Netherlands Pharmacovigilance Centre Lareb and the Danish Health and Medicines Authority. A comparative literature analysis was performed to identify and evaluate studies and publications of existing systems. The results showed that all three organisations consider the information received from patient reports to be a valuable addition to health care professional reports. Patients report different ADRs, ADRs at different frequencies and for different drugs. Through their individual perspective they provide greater insight to the effects ADRs may have on their quality of life. As patient reports account for approximately 13% – 31% of ADR reports, they help to decrease high underreporting rates in PV and contribute to signal detection of possible safety concerns. Challenges lie in establishing patient reporting systems, managing efficient data handling, improving communication between involved stakeholders and working with the organizations’ limited resources. Active involvement of patients in ADR reporting systems is generally welcomed as a step towards patient empowerment.

Style Form

Writing style of a scholarly paper/Master thesis

  • Follow the guidelines! • Technical, formal, serious and impersonal • Tense in third person • No informal tone or colloquialisms • Personal positions must be supported by the research literature • APA publication manual
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