Curriculum of Master of Science in Medicine with Industrial Specialisation Cand ... · Master of...

Curriculum of

Master of Science in Medicine with Industrial Specialisation

Cand. scient. med. i medicin med Industriel

specialisering

Faculties of Engineering, Science and Medicine Aalborg University

2010


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Preface In pursuance of Danish Law No. 403 of 28 May 2003 on universities, the following curriculum was established.

The curriculum defines the Master’s Degree programme within Medicine with Industrial Specialisation.

Within this programme, the recommended tracks are focused on one of the following areas:

Translational Medicine

Biomedicine

Medical Market Access The first semester of the Master’s Degree Programme has focus on scientific communication, and the programme offers a number of initiatives aiming at integration of students with various backgrounds. (International students starting on the first semester of the Master’s Degree Programme are to attend a course ensuring knowledge of problem-based learning organized in groups at the beginning of the programme.) Through the programme it is possible for the students to choose different study activities which can differentiate their educations. The opportunities comprise various projects, voluntary student activities, international exchange, trainee positions in Danish or foreign institutions or companies.

Table of Contents

Chapter 1 - Authorization of the Curriculum Chapter 2 - Admission, Designation, Duration and Competence Profile Chapter 3 - Contents of the Curriculum Chapter 4 - Commencement, Transition Rules and Revision Chapter 5 - Other Rules


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Contents

Chapter 1: Authorization of the Curriculum etc. ................................................................... 4

1.1 Legal Authorization ........................................................................................................ 4

1.2 Faculty Affiliation ............................................................................................................ 4

1.3 Study Board ................................................................................................................... 4

Chapter 2: Admission, Designation, Duration and Qualifications Profile .............................. 5

2.1 Admission ...................................................................................................................... 5

2.2 Designation of the Education in English and Danish (Latin) .......................................... 5

2.3 Specification of the Programme Stated in ECTS ........................................................... 5

2.4 Qualification Profile ........................................................................................................ 5

Chapter 3: Contents of the Curriculum................................................................................. 7

Chapter 4: Commencement, Transition Rules and Revision ............................................. 43

Chapter 5: Other Rules ...................................................................................................... 44

5.1 Rules on Written Assignments, Including the Master’s Thesis and Its Extent .............. 44

5.2 Credit Transfer ............................................................................................................. 44

5.3 Rules for Latest Completion of the Education .............................................................. 44

5.4 Examination and assessment Rules ............................................................................ 44

5.5 Dispensation ................................................................................................................ 44


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Chapter 1: Authorization of the Curriculum 1.1 Legal Authorization The Master of Science (MSc) programme in Medicine with Industrial Specialisation has been determined with reference to the ministerial order on Bachelor and Master Programmes at universities (No. 338 of 6 May, 2004) and with reference to the Framework Provisions of the Faculty for Engineering, Science and Medicine. 1.2 Faculty Affiliation The MSc programme Master of Science in Medicine with Industrial Specialisation belongs to the Faculties of Engineering, Science and Medicine, Aalborg University. 1.3 Study Board The MSc programme Master of Science in Medicine with Industrial Specialisation belongs to the Study Board for Medicine.


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Chapter 2: Admission, Designation, Duration and Qualifications Profile

2.1 Admission Admission to the MSc programme in Master of Science in Medicine with Industrial Specialisation requires a BSc degree in Medicine, Health Science or equivalent. Applicants with a BSc in Science in Medicine with Industrial Specialisation or with a BSc in Medicine will be admitted directly. All other applications will be considered individually by a committee appointed by the Study Board for Medicine. The Study Board for Medicine may require supplementary courses before start of the first semester, and it is therefore recommended to apply one year before start of the programme. 2.2 Designation of the Education in English and Danish (Latin) The MSc programme gives the right to the following academic title:

- Master of Science (MSc) in Medicine with Industrial Specialisation In Danish:

- Cand.scient.med. 2.3 Specification of the Programme Stated in ECTS The MSc Master of Science in Medicine with Industrial Specialisation programme is a 2-year full-time education, containing 120 ECTS points. 2.4 Qualification Profile The below qualification profile will appear from the diploma: An MSc has qualifications acquired through an education programme which has taken place in a research environment. The MSc will be able to hold positions requiring high qualifications. Further, the MSc has acquired qualifications for research (Ph.D. education). Compared to the BSc the MSc has an extended specialist knowledge and independence, which enable the MSc to independently use scientific theories and methods within both academic and commercial/professional contexts. Description of Qualifications Intellectual qualifications

Further to the qualifications described for the bachelor level, an MSc is to be able to:

Communicate professional problems to both specialists and non-professionals

Formulate and analyze scientific problems independently

Work systematically and critically by means of scientific methods

Continue his/her own development and specialisation of qualifications

Professional qualifications

Further to the qualifications described for the bachelor level, an MSc is to be able to:

Assess the expediency of various methods for analysis and professional problem solving

Demonstrate understanding of research work and on the basis of this enter into research work


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Demonstrate either o specialist understanding in continuation of the

previous degree, or o a wider perspective on the field of the previous

degree, or o new professional qualifications next to the

previous degree

Demonstrate knowledge of the implications of research work (research ethics)

Practical qualifications Further to the qualifications described for the bachelor level, an

MSc is to be able to:

Manage research work on the basis of scientific, theoretical and/or experimental methods

Independently make and give reasons for professionally related decisions, and if necessary, implement investigations, which procure a sufficient basis for decision

Occupational qualifications

After completion of the MSc programme, the student has achieved occupational qualifications, which ensure that the MSc can perform specialized and general business functions at the highest level within Medicine with Industrial Specialisation, both nationally and internationally. The occupational opportunities cover a wide field including research, development, consulting services and start of own business.


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Chapter 3: Contents of the Curriculum Projects and Courses The distribution of ECTS-points over the project and courses are given in the following table.

Semester Project Unit ECTS-points

Common courses

ECTS-points

Recommended track courses ECTS-points

Elective courses

ECTS-points

Total ECTS- points

1 15 8 7 0 30 2 17 2 8 3 30 3 30 0 0 0 30 4 30 0 0 0 30

In the following course lists, some courses are listed as mandatory for one or more of the recommended tracks. The students follow one of three recommended tracks during the master programme. Some courses are common for all recommended tracks, whereas others are recommended for one of the three tracks. In the second semester there are three ECTS elective courses for each individual student to choose from the courses offered. The third and fourth semesters consists of either one project pr. semester within the recommended track or one final project covering 60 ECTS project work. The individual student may elect optional courses at a maximum of 5ECTS during the third and fourth semester.


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3.0 Objectives for the recommended tracks

3.0.1 Objectives for recommended track “Translational medicine” Translational medicine is driven by the objective of improving clinical outcomes by efficiently moving results from basic science to clinical application. Upon completion of the master program the student will be able to

demonstrate a broad knowledge of basic and clinical sciences within medical research,

demonstrate understanding of disease processes and their pharmacological treatment,

demonstrate understanding of drug research related to pharmaceutical targeting, experimental methods and clinical trials,

formulate a hypotheses on a translational research problem,

design a pre-clinical / clinical study and apply appropriate experimental and clinical research methods to address scientific hypotheses,

identify relevant biomarkers

translate experimentally identified putative targets into clinical therapy,

translate experimental data into regulatory approval. 3.0.2 Objectives for recommended track “Biomedicine” Biomedicine focuses on the understanding of causes and treatment of disease at the molecular and cellular level. It builds upon the understanding of whole body functions. The students will learn how to perform hypothesis-driven experiments in order to understand human pathophysiology and to identify new targets for treatment. Therefore, a substantial part is devoted to experiments on mammalian cells or laboratory animals. Upon completion of the master program the student will be able to

demonstrate understanding of the molecular mechanisms of pathologies and disease processes,

demonstrate understanding of the cellular basis of human disease using in-vitro and in-vivo experimental conditions,

apply the knowledge of molecular and cellular tools for the study of disease,

combine theory and practice to identify biomarkers for diagnostics and therapy (personalized medicine),

understand and apply concepts necessary for tissue and organ replacement and regeneration.

3.0.3 Objectives for recommended track “Medical Market Access” Medical Market Access is driven by the objective to improve market access of industry within the biotechnological, pharmaceutical and medical devices markets. Upon completion of the master program the student will be able to

demonstrate knowledge of research design and methodology,

understand the economics of health and health care financing,

formulate hypotheses in relation to research problems related to market access,

demonstrate a broad knowledge of analyzing market potential of products,

demonstrate understanding of the economic evaluations of medical innovations,

assess market potential of medical products and develop marketing plans.

apply techniques for economic evaluations of health care-related issues

understand the methods and applications of health technology assessment.


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3.1 Project Theme for 1st and 2nd semester “Translational Medicine”

3.1.1 Recommended track “Translational Medicine” 1st Semester Title/Theme General principles of pharmacology and experimental methods in preclinical research / Generelle farmakologiske principper og eksperimentelle metoder i præklinisk forskning

Scope in ECTS 15 ECTS

Placement 1st semester

Prerequisites Bachelor of Science degree as described in section 2.1 of this Curriculum.

Objective The project broadens and deepens the student’s knowledge on general principles of pharmacology and the experimental methods in order to address scientific investigations in pharmacokinetics and pharmacodynamics.

Rationale Building on a Bachelor-level understanding of physiological principles and pathophysiological mechanisms and knowledge of some selected drugs the project provides for general principles of pharmacology and experimental methods that are essential for translational research and development.

Goals To understand and apply general principles of pharmacology:

Pharmacokinetics, drug delivery technology, pharmacodynamics, membrane transport and drug response, drug metabolism, pharmacogenetics

To describe and obtain experience in experimental methods: Research design and methodology, statistics and data handling, preclinical evaluation

To analyze results from phase one, phase two, phase three and phase four trials of pharmaceutical compounds.

Contents The project is a scientific project focusing on general principles of pharmacology and experimental methods in the field.

Form of Examination Internal individual oral examination

Assessment Individual grade according to the 7-scale

Assessment criteria See Framework Provisions


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3.1.2 Recommended track “Translational Medicine” 2nd Semester

Title/Theme Pharmacology and evaluation / Farmakologi og evaluering


Placement 2nd semester

Prerequisites First semester in track Translational Medicine

Objective Translation of general pharmacological principles and experimental knowledge in the context of clinical pharmacology and medicine.

Rationale Translational medicine is driven by the objective of improving clinical outcomes from basic experimental discoveries to the benefit of the patient. The projects translate experimental into clinical pharmacology by identifying relevant biomarkers.

Goals To understand and apply running concepts of clinical pharmacology in different disease areas

(e.g. Drugs affecting neuroeffector junction sites, cardiovascular functions, …) To consider rules of research governance and ethics To know and apply requirements of clinical evaluation:

Perspectives of translational medicine, commercial aspects and implications affecting clinical research and seeking approval, marketing interface

To analyze regulatory requirements of clinical trials

Contents The scientific project focuses on the translation of experimental knowledge into clinically relevant study design.

Form of Examination External individual oral examination




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3.2 Project Theme for 1st and 2nd Semester, “Biomedicine” 3.2.1 Recommended track “Biomedicine” 1st Semester

Title/Theme

Pathophysiology and diagnostics / Patofysiologi og diagnostik




Objective To introduce students to modern diagnostic methodology. To encourage students to formulate working hypothesis and teach the students how to test these hypotheses by analyzing disease processes using relevant methods.

Rationale The project is focused on the use of relevant methodology for analyzing the human biological system. This includes the pathogenesis and/or pathophysiology of diseases, regenerative medicine, immunology, medical microbiology and cancer.

Goals After the project period, the students are expected to be able to critically demonstrate an understanding at the theoretical and practical level on relevant methodology used for testing their hypotheses. The student must be able to describe the relevant biological system and apply this knowledge to experimental or theoretical experiments.

Contents Literature review. Hypothesis formulation. Practical work in laboratory. The project period is experimentally based and will attempt to allow the students to work in depth in the laboratory.





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3.2.2 Recommended track “Biomedicine”, 2nd Semester

Title/Theme Personalized medicine / Personlig medicin



Prerequisites First semester of the track "Biomedicine".

Objective To enable the students to expand their knowledge on diagnostic methodology. To encourage students to formulate working hypothesis and teach the students how to test these hypotheses using relevant methods in order to obtain control of a disease process.

Rationale The project will focus on modern topics in biomedical research such as regenerative medicine, immuno- and stemcell therapies as well as molecular approaches.

Goals After the project period, the students are expected to be able to critically demonstrate an understanding at the theoretical and practical level on relevant methodology used for testing their hypotheses. They must be able to apply theoretical knowledge relevant to the biological system of interest and design a proper experimental study. The students must be able to compare and choose relevant experimental methods.

Contents The project is focused on exploring and understanding the human biological system. Possible topics are: Mammalian cell growth and transformation, disease models using laboratory animals, transformation of brain endothelial cells with therapeutic cDNAs using different drug carriers, molecular analysis of gene expression and protein secretion from transgenic brain endothelium, siRNA induced downregulation of disease causative gene expression in a given cell line, overexpression of therapeutic peptides/proteins in vitro. The project period is experimentally based and will attempt to allow the students to work in depth in the laboratory.





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3.3 Project Theme for 1st and 2nd semester, “Medical Market Access”

3.3.1 Recommended track “Medical Market Access” 1st Semester Title/Theme Market analysis and new products business cases / Markedsanalyse og marketing




Objective The project broadens and deepens the students’ knowledge of theories and methods within marketing and marketing planning within the health care sector.

Rationale A basic understanding of the health care delivery systems provides a framework for subsequent courses. Further, the understanding of marketing and marketing management in theory and practice is the foundation for the track. Finally, the ability to apply analytical techniques and implement marketing activities in the medical sectors is fundamental competencies for the fulfilment of job requirements in the market oriented parts of the medical industry.

Goals This theme is designed to acquaint students with the various components of the health care system including the financing and how demand and supply is influenced by market orientation within the public sector and the medical industry. The students will after this theme be able develop, design, and implement marketing programs, processes, and activities. The students should be able to recognize and compare the breadth and interdependencies of today’s marketing environment. The students should be able to apply the analytical procedure to be followed when designing

questionnaires for survey or experimental research.

Contents The first part of the theme includes the components of the health care system across the continuum of care, the internal and external forces affecting the health care environment, factors influencing the use of health care services, and the unique characteristics that set health care apart from other service industries. The next part of the theme focuses on the basics of marketing and marketing management, including internal marketing, integrated marketing, relationship marketing and performance marketing Finally, the third part of the theme provides techniques for the evaluation of marketing decisions and the development of goal-oriented marketing strategies and market research including presentation of the stages in the marketing research process from the definition of a research problem to the presentation of research results.





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3.3.2 Recommended track “Medical Market Access” 2nd Semester

Title/Theme Economic evaluations and technology assessments / Sundhedsøkonomi og teknologivurdering




Objective To broaden and deepen the students’ knowledge of theories and methods within health economics and health technology assessment

Rationale A basic understanding of the methods of health economics and health technology assessment provides a framework for subsequent courses. The understanding of economics of health and medical care in theory and practice is the foundation for the track. The ability to understand and apply the techniques of health economic assessment and health technology are fundamental competencies for the fulfilment of job requirements in the market oriented parts of the medical industry.

Goals To describe topics in market oriented medical care. To understand and apply the methods for the health economic evaluation To understand and apply the methods for the health technology assessment of alternative health technologies. To understand and apply theories of evidence based marketing.

Contents The first part of the theme includes a general overview of the economics of health and medical care, and cover the medical and nonmedical determinants of health; markets for health care services and health insurance, analyses of key players in the health care sector, and different health care systems. The next part of the theme focus on the methods for the economic evaluation of health technologies (i.e. cost-effectiveness analyses, cost-utility analyses, cost-benefit analyses) that are increasingly used for reimbursement and pricing decisions in health care markets. Finally the third part of the theme explores some of the more advanced interdisciplinary tools for assessing medical products. It provide the students with an understanding of the basic tools for health technology assessment as a means for political, administrative and clinical decision-making in national and international health care systems.





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3.5 Project Themes for 3rd and 4th Semester (valid for all recommended tracks) The student can decide to use the 3rd and 4th semesters to carry out a final project, or he/she can use the 3rd semester as an alternative semester and the 4th semester to carry out the final project. 3.5.1 Project Theme for 3rd and 4th Semesters as a Two-Semester Master’s Thesis

Title/Theme Final project / Kandidatspeciale


Placement 3rd and 4th semester in the master program in Medicine with Industrial Specialisation

Prerequisites Successful conclusion of the first two semesters. Exemptions can be given only by decision of the Study Board.

Objective The final project is meant to further develop scientific skills within the chosen track and to display the student's ability to perform scientific / practical work.

Rationale The final project is the last element of the Master education, and thereby an opportunity to integrate and to deepen previously acquired knowledge and skills.

Goals Within the field of the track, to obtain experience in identification and analysis of realistic and complex problems, to apply and critically evaluate general scientific methods to solve specific problems. To synthesize the results of a scientific project to new levels of scientific understanding.

Contents The project is based on an integration of scientific skills as obtained within the track through the previous semesters. The project typically includes the design of a study with subsequent acquisition of data, processing of results, and discussion.


Assessment Individual grade according to the 7-scale.

Assessment Criteria See Framework Provisions.


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3.5.2 Theme for Alternative 3rd Semester

Title/Theme Medicine with Industrial Specialisation / Medicin med Industriel Specialisering

Scope in ECTS 30

Placement 3rd semester in the master program in Medicine with Industrial Specialisation

Prerequisites Active participation in the first two semesters.

Objective To give the student experience in applying scientific and/or industrial methods or performing scientific experiments related to Medicine with Industrial Specialisation at a University Department or in a company in Denmark or abroad.

Rationale With this semester the student will be able to broaden his or her experience in Medicine with Industrial Specialisation in order to strengthen the specific topics as chosen within the respective tracks.

Goals To deepen or to broaden the student’s repertoire of scientific theories, methods, instrumentation and marketing skills. Within the field of the track, to obtain experience in identification and analysis of realistic and complex problems. To apply and critically evaluate general scientific methods to solve specific problems. To synthesize the results of a scientific project to new levels of scientific understanding.

Contents The student can choose to carry out a semester project or to replace the semester project with activities such as courses, self-study, laboratory assignments, field trips and / or study groups within the recommended track. The activities have to be documented through written reports, articles, mini-projects and/or course exams. Typically, the project will include the design of a study with data acquisition, and interpretation of results and a discussion.


Assessment Individual grade according to the 7-scale.



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3.6.2 Project Theme for 4th Semester as a One-Semester Master’s Thesis

Title/Theme Master’s Thesis/ Kandidatspeciale


Placement 4th semester in the master program in Medicine with Industrial Specialisation

Prerequisites Successful conclusion of the first three semesters. Exemptions can be given only by decision of the Study Board.

Objective The final project is meant to further develop scientific skills within the track and to display the student's ability to perform scientific work.

Rationale The final project is the last element of a scientific education, and thereby an opportunity to integrate and to deepen previously acquired knowledge and skills.

Goals To deepen or to broaden the student’s repertoire of scientific theories, methods, instrumentation and marketing skills. Within the field of the track, to obtain experience in identification and analysis of realistic and complex problems. To apply and critically evaluate general scientific methods to solve specific problems. To synthesize the results of a scientific project to new levels of scientific understanding.

Contents The project is based on an integration of scientific skills as obtained within the track through the previous semesters. The project typically includes the design of a study with subsequent acquisition of data, processing of results, and discussion.


Assessment External individual grade according to the 7-scale.



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3.6 Course Descriptions for 1st and 2nd Semesters Elective courses are chosen from Tables II and III, in addition to the mandatory course(s), to fulfil the requirements as laid down in Table I above. The mandatory courses are marked as TM, BM or MA to indicate for which tracks they are mandatory. TABLE II - 1st semester course list

Course ID

Course Title ECTS-Points

Mandatory

1-1 Advanced Principles of Pharmacology incl. toxicology / Videregående principper i Farmakologi inkl. toksikologi

3 TM BM MA

1-2 Research design and methodology / Forskningsmetoder og planlægning

3 TM BM MA

1-3 Evidence based marketing strategies /Evidensbaserede marketingstrategier

2 TM BM MA

1-4 Drugs affecting renal, cardiovascular, gastrointestinal and endocrinological functions / Farmaka med nefrogen, cardiovaskulær, gastrointestinal og endokrinologisk virkning

3 TM

1-5 Drugs acting on the central nervous system / Farmaka med virkning på centralnervesystemet

2 TM

1-6 Preclinical evaluation / Præklinisk evaluering 2 TM 1-7 Genomics and proteomics in diagnostics and

disease / Genom og proteom metoder i diagnostik og sygdom

3 BM

1-8 Methods in cellular diagnostics and biomedicine / Diagnostiske metoder i cellebiologi og biomedicin

2 BM

1-9 Molecular pathogenesis / Molekylær patogenese 2 BM 1-10 Principles of marketing and marketing

management / Marketingprincipper og marketing management

3 MA

1-11 The economics of health and health care / Sundhedsøkonomi

4 MA


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TABLE III - 2nd semester course list

Course ID

Course Title ECTS-Points

Mandatory

2-1 Research Governance and Ethics / Forskningsstyring og Etik

2 TM BM MA

2-2 Perspectives of translational medicine - clinical trials / Perspektiver af translationel medicin - kliniske forsøg

3 TM

2-3 Regulatory requirements and commercial aspects

affecting clinical research / Regulatoriske krav og kommercielle aspekter af klinisk forskning

3 TM

2-4 Clinical research: marketing interface / Klinisk forskning: Marketing

2 TM

2-5 Regenerative medicine / Regenerativ medicin 3 BM 2-6 Immuno and stem cell therapies / Immun- og

stamcelleterapier 3 BM

2-7 Molecular therapies / Molekylærterapier 2 BM 2-8 Economics of health technologies and technology

assessment / Sundhedsteknologier og teknologivurdering i økonomisk perspektiv

3 MA

2-9 Marketing Research / Markedsanalyse 3 MA 2-10 Non-experimental research design and analysis /

Metoder i forskningsdesign og markedsforskning 2 MA


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Title 1-1 Advanced Principles of Pharmacology incl. toxicology / Videregående principper i Farmakologi inkl. toksikologi

Workload 3 ECTS

Semester 1

Prerequisites Bachelor education

Purpose The purpose of this course is to transform knowledge of general pharmacology into skills of pharmacology.

Rationale During the bachelor, students are taught specific pharmacodynamics in relation to diseases with less emphasis on skills, i.e. actual computations of drug doses, halflife, volumes of distribution etc, as well as toxic effects of drugs. This is a requirement for further studies of clinical trials and forms the basis of this course.

Objective Understand and apply principles of pharmacokinetics Understand and apply principles of pharmacodynamics Analyze the effects of drugs on different organs in the body Understand the effects of toxic compound

Contents Pharmacokinetics Drug delivery technology Pharmacodynamics Membrane transport and drug response Drug metabolism Pharmacogenetics

Principles of toxicology

Treatment of poisoning

Heavy metals and heavy metal antagonists

Organisation Lectures and exercises

Examination

Internal written or oral examination according to the existing frame work provisions and the existing guidelines from the Study Board

Assessment Passed/failed

Criteria See Framework Provisions.


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Title 1-2 Research design and methodology / Forskningsmetoder og planlægning

Workload 3 ECTS

Semester 1

Prerequisites BSc in Medicine or equivalent

Purpose To provide an advanced treatment of statistical analysis in biomedical science connected to research methodology

Rationale Basic statistics provide a set of simplified tools for hypothesis development and hypothesis testing. Nature or society, however, often does not follow mathematically well-defined distributions or provide easily quantifiable data. Thus more advanced statistical methods are needed. A more advanced knowledge of statistics also provides for a better understanding of pitfalls and biases in published research and a better foundation for proper research design .

Objectives To understand and choose the correct statistical analysis To understand and apply non-parametric statistical analyses Understand the concept of metaanalysis To use computer based statistical analyses

Contents Developing a hypothesis Laboratory research methodology Clinical research methodology Bias in research methodologies

Review basic concepts in statistics Non-parametric analysis Parametric analysis Determining difference Meta-analysis Introduction to computer-based analysis Introduction to statistical software packages Problems and pitfalls Additional methods of analysis


Examination





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Title 1-3 Evidence based marketing strategies / Evidensbaserede marketingstrategier

Workload 2 ECTS

Semester 1

Prerequisites Bachelor education

Purpose The purpose of this course is to introduce basic concepts of marketing strategies in a health related perspective.

Rationale Marketing strategies are important to understand the commercial background for health economics.

Objectives Describe basic principles of marketing strategies Understand how evidence is gathered and used Apply basic principles of health technology assesment Apply general knowledge of evidence based marketing in formulating strategies specific to pharmaceuticals Understand decision making in organizations

Contents Evidence based health economics Health technology assessment Introduction to marketing strategies The market for pharmaceuticals New medicine, strategies for marketing Approval


Examination





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Title 1-4 Drugs affecting renal, cardiovascular, gastrointestinal and endocrinological functions / Farmaka med nefrogen, cardiovaskulær, gastrointestinal og endokrinologisk virkning

Workload 3 ECTS

Semester 1

Prerequisites A bachelor in medicine or similar

Purpose To provide an advanced understanding of drugs affecting renal, cardiovascular, gastrointestinal and endocrinological functions.

Rationale An advanced understanding of drugs affecting renal, cardiovascular, gastrointestinal and endocrinological functions is necessary for working in clinical trials of these classes of drugs.

Objectives Analyze how renal diseases are best treated pharmacologically Analyze how Cardiovascular diseases are best treated pharmacologically Analyze how Gastrointestinal diseases are best treated pharmacologically Analyze how Endocrinological diseases are best treated pharmacologically

Contents Diuretics Vasopressin and other agents affecting the renal conservation of water Renin and angiotensin Treatment of myocardial ischemia Therapy of hypertension Pharmacotherapy of congestive heart failure Antiarrhythmic drugs Drug therapy for hypercholesterolemia and dyslipidemia Pharmacotherapy of gastric acidity, peptid ulcers, and gastroesophageal reflux disease Treatment of disorders of bowel motility and water flux Antiemetics Agents used in biliary and pancreatic disease Pharmacotherapy of inflammatory bowel disease Chemotherapy of parasitic infections Chemotherapy of microbial diseases Antifungal agents Antiviral agents Antiretroviral agents and treatment of HIV infection Chemotherapy of neoplastic diseases Hematopoietic agents: growth factors, minerals, and vitamins Blood coagulation and anticoagulant, thrombolytic, and antiplatelet drugs


Examination Internal written or oral examination according to the existing frame work provisions and the existing guidelines from the Study Board




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Title 1-5 Drugs acting on the central nervous system / Farmaka med virkning på centralnervesystemet

Workload 2 ECTS

Semester 1


Purpose

To provide an advanced understanding of drugs affecting the central nervous system. Rationale An advanced understanding of drugs affecting the central nervous system is necessary for working in clinical trials of these classes of drugs.

Objectives Understand how sedatives are used pharmacologically. Apply pharmacokinetics in drug dosing Compare different types of analgesics and other drugs acting on the central nervous system with respect to efficacy, dose-response Understand the problem of addiction.

Contents Neurotransmission and the CNS General and local anesthetics Therapeutic gases: oxygen, carbon dioxide, nitric oxide, and helium Hypnotics and sedatives Drug therapy of depression and anxiety disorders Pharmacotherapy of psychosis and mania Pharmacotherapy of epilepsies Treatment of CNS degenerative disorders Opioid analgesics Ethanol Drug addiction and abuse Histamine, bradykinin, and their antagonists Lipid-derived autacoids: eicosanoids and platelet-activating factor Analgesic-antipyretic and anti-inflammatory agents Pharmacotherapy of gout Pharmacotherapy of asthma Hormones and hormonal antagonists Pituitary hormones and their hypothalamic releasing factors Thyroid and antithyroid drugs Estrogens and progestins Androgens Adrenocorticotropic hormone Neurotransmission: The autonomic and somatic motor nervous systems Muscarinic receptor agonists and antagonists Anticholinesterase agents Agents acting at the neuromuscular junction and autonomic ganglia Adrenergic agonists and antagonists 5-Hydroxytryptamine: Receptor agonists and antagonists



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Title 1-6 Preclinical evaluation / Præklinisk evaluering

Workload 2 ECTS

Semester 1

Prerequisites A bachelor in medicine or equivalent

Purpose To introduce the students to concepts in pre-clinical evaluations

Rationale Before clinical testing of drugs is carried out in human trial, preclinical evaluations are necessary to screen for toxic or carcinogenous effects of new drugs.

Objectives Describe topics in preclinical evaluation Analyze ethical considerations in animal testing Apply basic models and systems in drug testing Evaluate toxic effects of new drugs on animals

Contents Introduction to preclinical studies Use of model systems - animals Use of model systems - in vitro systems Use of model systems - computer generated Toxicology Interface with clinical protocol






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Title 1-7 Genomics and proteomics in diagnostics and disease / Genom og proteom metoder i diagnostik og sygdom

Workload 3 ECTS

Semester 1

Prerequisites BSc in Medicine or similar education

Purpose 0To introduce students to modern concepts in genomics, molecular biology and proteomics and relevant methodology for diagnosing and investigating disease states.

Rationale In modern medicine, the ability to classify diseases and their levels of progression is critical for proper treatment. The advances in molecular biomarker discovery are crucial for accurate diagnostics and employs methods in molecular biology, cell biology and bioinformatics.

Objectives After this course the students should have a more advanced understanding of molecular biology and protein chemistry related to disease and on methodologies used in diagnostics. They must be able to apply this knowledge in molecular bioinformatics. The students should be able to combine knowledge in molecular biology, protein chemistry and bioinformatics with previously learned knowledge in pathophysiology to obtain a deeper understanding of human disease processes.

Contents Gene organization

Genome organization

Epigenetic basis of gene regulation

PCR and microarrays

Methods in cloning

Basic protein chemistry

Protein purification

Proteomics and mass spectrometry

Molecular bioinformatics o Pair wise alignments, SW, Blast

o Multiple alignment and phylogenetics

o Databases

o PCR primer construction based on databases

o Microarray analysis and systems biology

Organisation The forms of teaching will be determined and described in connection with the planning of the semester. The description will account for the forms of teaching and may be accompanied by an elaboration of the roles of the participants.


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Title 1-8 Methods in cellular diagnostics and biomedicine / Diagnostiske metoder i cellebiologi og biomedicin

Workload 2 ECTS

Semester 1


Purpose To introduce students to modern diagnostic methods. To understand and analyze disease process and relevant methodology for diagnosing and investigating disease states.

Rationale In modern medicine, the ability to classify diseases and their levels of progression is critical for proper treatment. The advances in molecular biomarker discovery are crucial for accurate diagnostics and employs methods in molecular biology, cell biology and bioinformatics.

Objectives After the course, the students are expected to: i) Demonstrate understanding of the concepts, theories and methods of advanced cell biology, and immunological based detection methods. ii) Apply their knowledge of such methods in the analysis of pathophysiological relevant processes.

Contents

Mammalian cell and tissue culture.

o Biology of cultured cells, cell transformation and recombinant production, cell culture kinetics and organotypic cell cultures.

Microbiology.

o FISH, Rep-PCR, RFLP analysis, microarrays, biochemical assays and culture.

Immunocytology and histology.

o Flowcytometry, ELISA, Western-blot, tissue sectioning and staining, histochemistry.

Imaging techniques.

o Conventional and confocal microscopy, fluorescence imaging.

Organization Lectures and exercises.





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Title 1-9 Molecular pathogenesis / Molekylær patogenese

Workload 2 ECTS

Semester 1


Purpose To obtain an in-depth understanding of disease development in principally all organs of the body.

Rationale Understanding the basis of disease development is a prerequisite for formulating hypothesis that can be tested in the laboratory. The students will learn the often stepwise progression at the molecular level that often takes place as part of the pathogenesis of many diseases.

Objectives (must be adjusted to the workload) After the course, the students are expected to:

Explain the principles of disease classification.

Formulate current hypotheses underlying the causes of several diseases

Identify common pathological changes of organs.

Explain the effects of aging on normal body functions.

Contents The course spans the following topics General pathophysiological processes:

The cellular biology of aging and genetic disorders

Oxidative stress, inflammation, infection and immunity

Cancer pathogenesis Organ releated pathophysiology:

The brain: Neurology and psychiatry

The immune system: Immune pathogenesis

Cancer carcinogenesis and cancer growth

Organisation The forms of teaching will be determined and described in connection with the planning of the semester. The description will account for the forms of teaching and may be accompanied by an elaboration of the roles of the participants.





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Title 1-10 Principles of marketing and marketing management / Marketingprincipper og marketing management

Workload 3 ECTS

Semester 1

Prerequisites A relevant bachelor degree

Purpose To provide the students with the necessary skills to be able to participate in the development, design, and implementation of marketing programs, processes, and activities.

Rationale The understanding of marketing and marketing management in theory and practice is the foundation for the track. Further, this important competences the students should master to fulfil jobs in the market oriented part of the medical industry.

Objectives The students will after this course understand the basics of marketing and marketing management. Further, they will be able to participate in the development, design, and implementation of marketing programs, processes, and activities. Finally, the students should be able to recognize the breadth and interdependencies of today’s marketing environment.

Contents The course is based on four key dimensions:

Internal marketing – ensuring everyone in the organization embraces appropriate marketing principles, especially senior management

Integrated marketing – ensuring that multiple means of creating, delivering, and communicating value are employed and combined in the best way.

Relationship marketing – having rich, multi-faceted relationships with customers, channel members, and other marketing partners.

Performance marketing – understanding returns to the business from marketing activities and programs, as well as addressing broader concerns and their legal, ethical, social, and environmental effects.






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Title 1-11 The economics of health and health care / Sundhedsøkonomi

Workload 4 ECTS

Semester 1


Purpose To understand the basic health economic tools and concepts and its value in analyses of health and health care.

Rationale Most nations have experienced rapid increases in health care spending over the last decades, and health economics has emerged as a distinct specialty within economics.

Objectives To give the students an introduction to the field of health economics, and a firm understanding of the relevance of health economics, and economic methods.

Contents This course presents a general overview of the economics of health and medical care. Using the analytic approaches developed in the course various policy problems and proposals for reform are addressed. The course will cover the medical and nonmedical determinants of health; markets for health care services and health insurance; and proposed reforms of medical care. The primary objectives of this course are

To introduce application of basic microeconomic concepts and tools to resource allocation and policy problems facing health-sector decision makers internationally.

To cover the application of demand concepts to health care-seeking behaviour and their implications for marketing and for the design of insurance programs,

To uses basic concepts of cost and production theory to examine problems in efficiency measurement and issues of market structure.






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Title 2-1 Research Governance and Ethics / Forskningsstyring og Etik

Workload 2 ECTS

Semester 2


Purpose To introduce ethical concepts

Rationale Participation in clinical trial, animal testing and experiments require an understanding of ethical concepts involved as well as the role of involved parties and underlying regulations.

Objective Describe ethical concepts of medicine and research Understand principles of good clinical practice (GCP) Understand principles of good manufacturing practice (GMP)

Contents Overview of research governance Research ethics Gaining ethical approval Good clinical practice, GCP Good manufacturing practice Consumers in research Communication of research to participants

Organisation Lecture and PBL exercise





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Title 2-2 Perspectives of translational medicine - clinical trials / Perspektiver af translationel medicin - kliniske forsøg

Workload 3 ECTS

Semester 2

Prerequisites 1st semester TM

Purpose To introduce the concept of translational medicine – how medicine moves from the laboratory to human testing

Rationale Before introducing topics of clinical trials, the students must understand problems of efficiently translating medical and pharmacological research into usable drugs.

Objectives Describe the different phases of clinical research: phase 1, phase 2, phase 3 and phase 4 trials Apply statistic skills to research practice Analyze case studies in real world situations

Contents Moving into humans - Translational medicine Identify relevant biomarkers Academic vs. commercial trials Phase I trials Phase II trials Phase III trials Case-study through the phases (case report form, CRF) Integrating statistics with research practice






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Title 2-3 Regulatory requirements and commercial aspects affecting clinical research / Regulatoriske krav og kommercielle aspekter af klinisk forskning

Workload 3 ECTS

Semester 2


Purpose To provide an overview of regulatory affairs in clinical trials.

Rationale Before students can analyze the results of clinical trials, they must gain an understanding of current regulations regarding clinical trials

Objective Describe the legal framework of translational medicine Describe the regulatory process Understand the role of the end user Analyze case studies of clinical trials

Contents The legal framework behind translational medicine The regulatory process The role of key global agencies for regulation Role of end-users Case-studies of regulatory process






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Title 2-4 Clinical research: marketing interface / Klinisk forskning: Marketing

Workload 2 ECTS

Semester 2


Purpose To provide an overview of problems associated with introduction of new drugs

Rationale The students should understand how pharmacological research is translated into public perception of new drugs.

Objectives Understand the difference between phase1-3 and phase 4 trials Provide an advanced understanding of requirements and regulations in phase 4 trials Analyze the impact of public opinion on clinical research and marketing

Contents Role of phase IV trials Reporting and monitoring adverse reactions Integrating scientists with non-scientists Role of engaging opinion leaders Role of sponsoring/involvement at conferences






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Title 2-5 Regenerative medicine / Regenerativ medicin

Workload 3 ECTS

Semester 2


Purpose To give the students a broad knowledge of the procedures to engineer human tissues and organs

Rationale In personalized medicine, several innovative procedures where tissues and organs are developed ex vivo are currently being tested in pre-clinical and clinical settings.

Objectives The students will acquire understanding of the challenges that tissue and organ engineering faces. The students should gain an advanced understanding of growth of tissue and organs in vitro, such as connective tissue, bone, vessels, nerve tissue, and pancreas. The students should be able to combine knowledge of pathologies and how application of these biological “spare parts” in regenerative medicine can be applied to solve pathological problems. The students should analyze ethical problems and considerations with respect to these modern methods.

Contents

1. Intro+cell fate, ECM+cells 2. Biomaterials and biocompatibility 3. Tailoring biomaterials 4. Oxygen and differentiation 5. Ion channels and differentiation 6. Somatic stem cells 7. Pluripotent stem cells 8. Cartilage 9. Bone 10. Skin+cornea 11. Muscle 12. Kidney+bladder

Organisation The form(s) of teaching will be determined and described in connection with the planning of the semester. The description will account for the form(s) of teaching and may be accompanied by an elaboration of the roles of the participants.





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Title 2-6 Immuno and stem cell therapies / Immun- og stamcelleterapier

Workload 3 ECTS

Semester 2


Purpose To introduce the students to the immunologically based therapeutic strategies that are increasingly being used in the treatment of human disease. Stem cell based therapies are used to regenerate new tissue in pathological disorders.

Rationale The immune system is highly specific and represents a very potent force of healing or destruction in human health. Gradually, we are learning to exploit and control the forces of the immune system. In the coming years this will result in new, efficient and physiologically attractive therapeutic modalities.

Objectives After the course, the students are expected to:

Understand of the basic concepts of immunotherapy. Be able to give examples of the main forms of immunotherapy in use today Understand basic concepts of stem cell differentiation and proliferation Give examples of and compare current stem cell treatments

Contents a. Elements of advanced immunology

b. Antibody-, cytokine- and cell-based immunotherapies

c. Advanced topics in vaccination

d. Immune modulation

e. Basic molecular-biological mechanisms that control proliferation of the cells,

f. Proliferation and induced differentiation

g. Interaction between extra-cellular matrix and cell surface, cell adhesion, cell migration and cell response to stress.

h. Therapeutic uses of stem cells

Organisation modules consisting of lectures alternating with work with study problems.





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Title 2-7 Molecular therapies / Molekylærterapier

Workload 2 ECTS

Semester 2

Prerequisites 1st semester course “Proteomics and Genomics in Diagnostics and Disease”

Purpose To introduce the students to the knowledge and principles of modern molecular pharmacology.

Rationale Several newly identified targets of disease calls for therapy that cannot be performed using classical pharmacological drug formulation and treatment. Topics like gene therapy enabling transgene expression or inhibition, enhanced drug delivery, and targeted therapy calls for new principles of treatment.

Objectives Train students to understand, apply, and develop the knowledge from within the field. After the course students should be able to compare and analyze different methods in disease therapy.

Contents The course spans the following topics

Viral and non-viral gene therapy

Modern peptide and protein therapeutics

Therapies based on nucleic acids with the focus on short RNAs and homologous recombination.

Molecular conjugation techniques

Micelle and liposomal formulation

Polymer drug carriers

Self-assembling materials

Biodegradable drug carriers

Organisation The form(s) of teaching will be determined and described in connection with the planning of the semester. The description will account for the form(s) of teaching and may be accompanied by an elaboration of the roles of the participants.





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Title 2-8 Economics of health technologies and technology assessment / Sundhedsteknologier og teknologivurdering i økonomisk perspektiv

Workload 3 ECTS

Semester 2

Prerequisites First semester of the track "Medical Market Access".

Purpose To deepen and broaden the students knowledge of methods for the economic evaluation of health technologies with a focus on marketing medical products. To understand the methods and applications of health technology assessment for medical market access

Rationale Health economic assessments (i.e. cost-effectiveness analyses, cost-utility analyses, cost-benefit analyses) are increasingly used for reimbursement and pricing decisions in health care markets. Health technology assessment is an anchored tool in most countries for decisions of whether or not to adopt new medical products in national/regional health care systems

Objectives To understand and apply the methods for the health economic evaluation of alternative health technologies. To provide knowledge and understanding of the different paradigms and methods used in health technology assessments, and the conditions for affecting political decision-making through evidence of effectiveness and cost-effectiveness.

Contents Students will learn the basic theoretical and methodological skills necessary to conduct economic assessments of relative therapeutic value, patient reported outcomes, health care budget impact, and cost-effectiveness (cost-benefit) for drugs and other technologies in health care. The weight is placed on applied methods and techniques to value costs and benefits of alternative products. Central topics are the most common economic evaluation methods, measurement of costs, utility and willingness to pay, uncertainty and sensitivity analyses, and time horizon and discounting. Furthermore, the course will cover issues such as how to measure costs and health outcomes in clinical trials, and the construction of decision analytic models. Exploration of some of the more advanced interdisciplinary tools for assessing medical products. It builds on the underlying theories of social decision-making in cost-benefit analyses and evidence based management for evaluating the social consequences of medical products. The course will cover the definition and scope of health technology assessment, and provide the students with an understanding of the basic tools for health technology assessment. A special focus is the application of technology assessments (and economic evaluations) as a means for political, administrative and clinical decision-making in national and international health care systems. The students will learn how to make different types of health technology assessment including mini-HTA.






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Title 2-9 Marketing Research / Markedsanalyse

Workload 3 ECTS

Semester 2


Purpose The students will after this course be able to apply the analytical procedure to be followed when conducting marketing research. This includes especially designing questionnaires for surveys and non-experimental research.

Rationale It is fundamental in marketing research to be able to cope with the technical challenges to plan, gather, analyze and interpret information. The students must learn to be aware of the challenges faced by the array of decision-makers that trust sound marketing research. Further, the students need to master the relevant techniques applied in marketing research.

Objectives The students will learn to evaluate marketing decisions and the development of goal-oriented marketing strategies, e.g. in order to increase profits or customer lifetime value. Further, the students should be able to understand how marketing decisions are dependent on the quantification of the causal relationship between marketing metrics and their drivers. Finally, the students should, as the main objective of the course, be able to design marketing research projects, conduct relevant fieldwork, analyze data, identify relationships, draw decision relevant conclusions and report results.

Contents Market research describes the function that links the organization to its market through the gathering of information. It is a systematic process and this course will outline the elements that comprise this process. Particular emphasis will be placed on practical applications. The course will provide a comprehensive overview of the stages in the marketing research process from the definition of a research problem to the presentation of research results. The course will focus on how various stakeholders have a role in health care decisions and how the information needs are addressed from a marketing perspective.






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Title 2-101 Non-experimental research design and analysis / Metoder i forskningsdesign og markedsforskning

Workload 2 ECTS

Semester 2


Purpose To give the students the necessary statistical techniques to analyze causal structures based on non-experimental data.

Rationale Within the area of social and behavioral sciences the concepts studies are of a more vague nature than in natural sciences. This is also the case within marketing research, thus the knowledge of additional statistical techniques are required for the track in Medical Market Access. Further the techniques addressed in this course are relevant in outcome research and more generally in health technology assessments.

Objectives The students should after this course be able to develop models based on Structural Equation Modeling (SEM), design survey instruments and analyze questionnaire and survey data using these statistical techniques. Further, the students should be able to use relevant statistical software.

0Contents The first part of the course lays the basis for structural equation modeling by covering scale construction, the concepts of reliability and validity along the lines of classical test theory and the component analysis and exploratory factor analysis. In the second part of the course the students will learn simple SEM models with manifest variables as well as more complicated ones involving latent variables. Further the students will learn how to build models based on several samples from different populations as well as handling incomplete and in other ways problematic data. As part of this course the students will also be introduced to conjoint analysis to evaluate consumer preference where products are composed of combinations of attributes.






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Chapter 4: Commencement, Transition Rules and Revision

The curriculum has been adopted by the Study Board for Medicine, approved by the Dean of the Faculty of Engineering, Science and Medicine and will become effective as of 01 September 2009.

According to the Curriculum and the quality control manual for the Faculty of Engineering, Science and Medicine at Aalborg University, the curriculum has to be revised 5 years at the latest after the commencement.


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Chapter 5: Other Rules 5.1 Rules on Written Assignments, Including the Master’s Thesis and Its Extent

All written assignments (no matter in which language they have been made) will be assessed with regard to the spelling and wording. The basis of the assessment of the linguistic performance is orthographic and grammatical correctness as well as stylistic skills. The written performance will always be an independent dimension of the overall assessment. However, no assignment will be passed on the linguistic performance alone, just like an assignment will normally not be failed due to a poor linguistic performance. The above is valid unless otherwise stated in connection with the specific exam. The Master’s Thesis is to include an abstract in a foreign language (fx English, French, Spanish or German according to the approval of the Study Board). If the project is written in a foreign language (fx English, French, Spanish or German), the abstract can be written in Danish after approval by the Study Board. The abstract is to be minimum 1 and maximum 2 pages (the length of the abstract is not included in the minimum/maximum number of pages established pr. student). The abstract will be included in the overall assessment of the project. The abstract is included in the overall assessment of the project. 5.2 Credit Transfer Students with other education elements from another master’s degree may gain credit transfer/access after the Study Board’s evaluation of the application. 5.3 Rules for Latest Completion of the Education The master’s degree programme is to be completed 4 years (exclusive of leave of absence periods) after the commencement. 5.4 Examination and assessment Rules The Examination and assessment rules appear from the Examination and assessment regulations of the faculty, which can be found via the web site of the S Study Board. 5.5 Dispensation In special cases The Study Board for Medicine may grant an exemption from the parts of the Curriculum which have not been stipulated by laws or regulations. The dispensation regarding Examination and assessment is valid for the next exam.

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