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School of Life and Medical Sciences Title of Programme: MSc Pharmacovigilance and Pharmacoepidemiology Programme Code: HHMPVPE

Programme Specification This programme specification is relevant to students entering: 01 September 2015 Associate Dean of School (Academic Quality Assurance): Philomena Shaughnessy Signature

V1.9 /Master’s Programme Specification / July 2015 / AS © University of Hertfordshire 2014

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Programme Specification MSc Pharmacovigilance and

Pharmacoepidemiology This programme specification (PS) is designed for prospective students, enrolled students, academic staff and potential employers. It provides a concise summary of the main features of the programme and the intended learning outcomes that a typical student might reasonably be expected to achieve and demonstrate if he/she takes full advantage of the learning opportunities that are provided. More detailed information on the teaching, learning and assessment methods, learning outcomes and content for each module can be found in Definitive Module Documents (DMDs) and Module Guides.

Section 1 Awarding Institution/Body University of Hertfordshire Teaching Institution University Bordeaux, Segalen, France

Autonomous University of Barcelona represented by Catalan Institute of Pharmacology, Spain

Erasmus Medical Centre, Rotterdam, Netherlands

Utrecht University, Netherlands

University of Verona, Italy

University of Hertfordshire University/partner campuses University Bordeaux, Segalen, France

Autonomous University of Barcelona represented by Catalan Institute of Pharmacology, Spain

Erasmus Medical Centre, Rotterdam, Netherlands

Utrecht University, Netherlands

University of Verona, Italy

College Lane, University of Hertfordshire

Programme accredited by Not applicable Final Award MSc All Final Award titles Pharmacovigilance and Pharmacoepidemiology FHEQ level of award Language of Delivery type all languages that have been approved

7 English

A. Programme Rationale Pharmacovigilance is the detection, assessment and prevention of the adverse effects of medicines and pharmacoepidemiology is the study of medicine use and effects in the population. The University of Hertfordshire is a member of a consortium comprising the five other European universities indicated above, the European and French Medicines Agencies and 15 pharmaceutical companies which secured EU funding to develop a Pan-European Masters degree in Pharmacovigilance and Pharmacoepidemiology (termed ‘Eu2P’). The rationale of the programme is to deliver an e-learning masters course, jointly validated, taught and awarded by the principal European pharmacovigilance educational institutes and supported by the European Federation of Pharmaceutical Industries and Associations. The programme is designed to recruit both new graduates in health or life sciences and professionals working in the field of pharmacovigilance/pharmacoepidemiology. A key feature is that one half of the programme will consist of conducting a project in placement with a pharmaceutical company to enable the student to undertake a research project within the industry. Graduates of the programme will be equipped for employment in the pharmaceutical and health-related industries, related regulatory authorities and academic research.


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B. Educational Aims of the Programme The programme has been devised in accordance with the University's graduate attributes of programmes of study as set out in UPR TL03. Additionally this programme aims to: 1. engender a continuing and independent approach to learning, encouraging initiative and self-

discipline such that students will be able to comprehend, contribute to, and apply advances, in pharmacovigilance and pharmacoepidemiology;

2. build and improve on students’ cognitive skills, including the ability to think logically and independently; to be reflective and critical of scientific hypotheses; to analyse, synthesise and be creative;

3. provide not only specialist knowledge but also a perspective of broad intellectual, ethical and social contexts;

4. provide a flexible framework for the acquisition of a comprehensive understanding of pharmacovigilance and pharmacoepidemiology skills applicable to their own current and future research, advanced scholarship and professional practice;

5. develop an ability to apply the knowledge ( 3 above) and skills (4 above) to inform judgments and develop and advance ideas in the discipline.

C. Intended Learning Outcomes

The programme provides opportunities for students to develop and demonstrate knowledge and understanding, skills and other attributes in the following areas. The programme outcomes are referenced to the Frameworks for Higher Education Qualifications of UK Degree-Awarding Bodies (2014), and relate to the typical student. Additionally, the SEEC Credit Level Descriptors for Further and Higher Education 2010 have been used as a guiding framework for curriculum design.

Knowledge and Understanding of:

Teaching/learning methods & strategies

Assessment

A1-the main epidemiological and statistical principles, concepts and tools that are used in pharmacoepidemiology and pharmacovigilance practices and research

A2- the worldwide regulations and guidelines concerning pharmacovigilance

A3-the clinical, pharmacological and epidemiological principles underlying the prescribing of medicines and their effectiveness evaluation.

A4-the principles of PV from the development of the science to its place in pre and post-authorisation environment and the roles of various stake holders within PV

A5- the evaluation of the effects of medicines from epidemiological and public health points of view

Acquisition of knowledge and understanding is through a combination of e-studies, live interactive tutoring, e-exercises, e-quizzes and case studies. Throughout, the learner is encouraged to undertake independent study both to supplement and consolidate what is being taught/learnt and to broaden their individual knowledge and understanding of the subject. Throughout, the learner is encouraged to undertake independent study both to supplement and consolidate what is being taught/learnt and to broaden their individual knowledge and understanding of the subject.

Knowledge and understanding are assessed through a combination of unseen examinations, case studies, on-line workshops, written reports and oral presentations.

http://sitem.herts.ac.uk/secreg/upr/TL03.htm


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A6- the basic principles of medicines risk communication, its tools and its place in mitigating risks linked to the use of medicines

Intellectual skills - able to: Teaching/learning methods & strategies

Assessment

B1-Analyse and critically evaluate experimental, pharmaco-epidemiological data and adverse drug reactions

B2-analyse benefit-risk assessment methods (including pharmacoeconomics), the process of decision making and communication on medicines by different stakeholders

B3-To identify and quantify risks of medicine, interpret publications and results

B4- be able to draw upon elements of the regulatory environment to explain pharmacovigilance principles.

Intellectual skills are developed through case studies, e-learning tutorials and presentations and e-discussion groups. Throughout, the learner is encouraged to develop intellectual skills further by independent study. Throughout, the learner is encouraged to develop intellectual skills further by independent study

Intellectual skills are assessed through problem-solving exercises, case studies and written assignments.

Practical skills - able to: Teaching/learning methods & strategies

Assessment

C1-apply the main health indices used to describe mortality and morbidity of the population

C2-apply the methodology used in epidemiological studies and randomized clinical trials to assess the efficacy and effectiveness of medicine

C3-qualitatively and quantitatively analyse the utilization of medicines

C4-design studies and write protocols to quantify and analyse safety signals or risks

C5-to apply benefit-risk assessment methods in daily practice

Practical skills are developed through e-tutorials, e-based materials, on-line group discussions, data analysis and case studies.

Practical skills are assessed through the preparation of written protocols, design of PV and PE procedures and the analysis of data.

Transferable skills - able to: Teaching/learning methods & strategies

Assessment

D1-communicate written and oral scientific results.

D2-Present and support an

Transferable skills are developed through e-discussions, by undertaking the project within an

Transferable skills are assessed through written and oral reports, particularly


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D. Programme Structures, Features, Levels, Modules, and Credits The programme is offered in full-time (2 years) and part-time (4 years) modes, and leads to the award of MSc Pharmacovigilance and Pharmacoepidemiology. Entry is normally at first year Masters (7) with qualifications described in Section F. Entry may also be granted directly into the second year as indicated in Section 7. Intake is normally semester A (September). The Eu2P Programme Board may award Eu2P Certificates* to individuals taking single, or multiple modules, in recognition of successful completion of these modules. Entry to such modules will require the same qualifications as those specified for entry to the Masters programme. Programme Structure The programme structure and progression information below (Table 1a and 1b) is provided for the award. Any interim awards are identified in Table 1b. The Programme Learning Outcomes detailed above are developed and assessed through the constituent modules. Table 2 (in section 2) identifies where each learning outcome is assessed. The key features of the structure are: • Each year of the programme is composed of 60 ECTS credits. • All modules in the first year of the programme are mandatory. • There are six compulsory taught modules in the second year of the programme. A student chooses

additional modules to facilitate specialization in any one of five “Tracks”, indicated in Figure 1, giving a total of 10 modules (30 ECTS credits). Tracks 2 and 3 specify a further 3 modules (9 ECTS) whilst tracks 1, 4 and 5 specify a further 2 modules each (6 ECTS). The remaining credits comprise modules within other tracks; thus students taking Tracks 4 and 5 study one module outside the specialism Track whereas students taking Tracks 2, 6 or 7 study two modules outside the specialism Track.

• A student may take a broader programme designated “a la carte” in which the six compulsory modules (18 ECTS) are supplemented by four modules (12 ECTS) chosen from the remaining modules.

• All students undertake a Research Project in each year carrying 30 ECTS credits each. The projects are undertaken on a placement within a pharmaceutical company or research organization.

* Eu2P certificate is used to denote modules studied at 3 or 6 ECTs points - no postgrad award from UPR AS11 is awarded

extended argument D3-demonstrate the ability to

carry out a defined task, solve it in a set period of time and adequately report the results of this work in a written report and in an oral presentation

D4-demonstrate skills in searching medical and scientific literature

D5-manage information

internship with support from the project tutor and experience gained in an industrial situation Throughout, the learner is encouraged to develop transferable skills by maintaining a record of evidence and completing a personal development plan. Throughout, the learner is encouraged to develop transferable skills by maintaining a record of evidence and completing a personal development plan.

the project report.


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Table 1a Outline Programme Structure

Mode of study Full Time Entry point Semester A


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Compulsory Modules Module Title

Modu

le C

od

e

Cre

dit P

oin

ts

Lang

uag

e o

f

Deliv

ery

% E

xam

ination

% C

ours

ew

ork

% P

ractica

l

Sem

este

rs

Basics in epidemiology applied to PV and PE

D1M1 3 English 0 100 0 A

Basics in statistics applied to PV and PE


Tools to do research applied to PV and PE


Basics in clinical pharmacology D2M1 3 English 0 100 0 A

Principles of pharmacovigilance D3M1 7LFS1020

3 English 0 100 0 A

Basics in pharmacoepidemiology D6M1 3 English 0 100 0 A

Basics in communication applied to D7M1 3 English 0 100 0 A

PV and PE Tutored project D1M4 6 English 0 100 0 B Research Project 1 30 English 0 100 0 B

Year 2

Clinical and pharmacological principles of PV and PE


Pharmacovigilance Regulations D3M2 7LFS1021

3 English 0 100 0 A

Principles of recognizing adverse events and safety signals


Introduction to benefit risk assessment and pharmacoeconomics in decision making


Drug utilization studies: introduction and quantitative methods


Needs and objectives in communication risk and benefit-risk related to medicines

D7M2 3 English 0 100 0 B

Research Project 2 30 English 0 100 0 A

Optional Modules Module Title

Modu

le C

od

e

Cre

dit P

oin

ts

Lang

uag

e o

f

Deliv

ery

% E

xam

ination

% C

ours

ew

ork

% P

ractica

l

Sem

este

rs

Methods in clinical research, PE and the assessment of efficacy of medicines


Critical appraisal of clinical trials: Evidence-based medicine and its uncertainties


PV regulatory processes D3M3 LFS1022

3 English 0 100 0 A

Substantiation of risks 1 D4M2a 3 English 0 100 0 A

Substantiation of risks 2 D4M2b 3 English 0 100 0 A

Identifying susceptibility to adverse drug reactions


Principles of pharmacoeconomics and valuation of health states



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Methods for quantitative benefit-risk assessment of medicines


Application of quantitative benefit-risk assessment in decision making on medicines


Drug utilization studies: qualitative methods


The public health impact of adverse drug reactions


Challenges in medicines: risk communication


Case studies D7M4 3 English 0 100 0 A

The award of a MSc in Pharmacovigilance and Pharmacoepidemiology requires 240 credits (120 ECTS credits). Table 1b Final and interim awards available The programme provides the following final and interim awards:

Award Minimum requirements Available at end of (normally):

Masters Pharmacovigilance and Pharmacoepidemiology

180 credit points including at least 150 at level 7 3 Semesters

Masters awards can be made "with Distinction" or "with Commendation" where criteria, as described in the Eu2P Masters Regulations and the Eu2P Master Regulations for trainees, are met.

E. Support for students and their learning Students are supported by;

An academic advisor (belonging to a University partner) to support the student in the choice and execution of the project(s).

A Research Project Director belonging to the host organization at which the project is carried out. A full description of the support given is described in the ‘Eu2P Masters Regulation’.

A residential induction programme termed “Freshers’ week”.

Access to the Eu2P e-learning platform

Support in the use of the Eu2P e-learning platform from lecturers, facilitators, administrative staff and a technical support team

Academic support from lecturers and facilitators

Representation on the Eu2P Education Board

Studynet access – a versatile on-line intranet learning environment giving access to UH electronic journals and books and full access to learning resources of other Eu2P universities.

Eu2P central office in the University of Bordeaux

Supporting documentation summarising the Eu2P regulations entitled “Eu2P Master Trainee Regulations: The Master Trainee’s code of rights and obligations.

A careers service at the University of Hertfordshire

An equal opportunities officer F. Entry requirements The minimum admission criteria for entry to the first year of the Eu2P Master are:


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For all applicants: Bachelors’ degree (180 ECTS credits / 3 years) or equivalent in Health or Life sciences

A personal letter of motivation to participate in the Eu2P Master.

Applicants whose native language is not English, the candidates should provide one of the following English certificates with min. score: IELTS: 6.5 (with no score below 6) Paper‐based TOEFL: 580 Computer‐based TOEFL: 237 Internet‐based TOEFL: 92 Certificate of Advanced English: B/C Certificate of Proficiency in English: B/C

For applicants working in an English environment, a certificate from employer or manager.

Additional selection criteria for direct entry into the second year of the programme: Master year 1 level

(240 ECTS credits / 4 years) or equivalent in Health or Life sciences or

For professionals (i.e. in relevant employment): Bachelors’ degree (180 ECTS credits/3 years) or equivalent, and three years relevant professional experience.

For all applicants:

A personal letter of motivation to participate in the Eu2P Master including wishes on a research project topic.

Evidence of appropriate English language skills The programme is subject to the University's Principles, Policies, Regulations and Procedures for the Admission of Students to Undergraduate and Taught Postgraduate Programmes and will take account of University policy and guidelines for assessing accredited prior certificated learning (APCL) and accredited prior experiential learning (APEL).


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Section 2 Programme management Relevant QAA subject benchmarking statements None Date of validation/last periodic review June 11 Date of production/ last revision of PS May 2011 Relevant intakes Level 7 entering September 2011 FROM GRADUATING Administrative School School of Life and Medical Sciences

The programme is managed by; The Eu2P Education Board, the membership of which includes:

Permanent members: - One member from each of Academic Partners to be chosen among the domains directors,

Modules coordinators or Eu2P teaching teams members, - The representatives of Associated Members that are domain co-directors, - One representative of an Academic Partner dedicated to quality aspects, - One representative of an Associated Member dedicated to quality aspects, - One representative of an Academic Partner dedicated to communication aspects, - One representative of an Associated Member dedicated to communication aspects, - One representative of an Academic Partner dedicated to e-learning aspects, - One representative of an Associated Member dedicated to e-learning aspects.

Additional members:

Representatives of Eu2P trainees will be invited to the Education Board meetings when the agenda of the Education Board requires such attendance. Such representatives will be elected by their fellow trainees during the freshers’ week on the following basis:

Two representatives of the trainees enrolled in the first year of the Master- Two representatives of the trainees enrolled in the second year of the programme

The Eu2P Administrative Committee, the membership of which includes: one member of each Eu2P partner’s administrative staff to serve as the local administrative contact person for the Eu2P central office.

Domain Directors responsible for the academic coherence of each Domain of modules

Module Coordinators responsible for the day-to-day operation of modules.

Eu2P Central Office The responsibilities of the central office shall include but not be limited to responsibility for all operational activities relating to: - Course catalogue & calendar database - Trainee application & database - Trainer services - Trainee services - Fees (collection, redistribution) and grants (files and payment) - Research projects & mobility - Quality procedures - Communication activities - Qualification procedures - Organise any face-to-face assessments according to module calendar and team needs. These

assessments can either take place on-line (via Adobe connect videoconference) or physically in a central place (e.g., Eu2P university) or place near the student. Students will be expected to follow the examination rules set out by the Academic Partner to which the Module coordinator belongs.

Programme-specific assessment regulations


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The programme is compliant with the University's academic regulations (UPR AS11, UPR AS12 or UPR AS13, UPR AS14) with the exception of those listed below, which have been specifically approved by the University:

“Eu2P Master Trainee Regulations: The Master Trainee’s code of rights and obligations”

“Eu2P Certificate Trainee regulations: The Certificate Trainee’s code of rights and obligations”

Other sources of information

Eu2P Standard Operating Procedures (SOPs)

Definitive Module Documents

Module Guides

Student Handbook

University of Hertfordshire Course website: http://www.herts.ac.uk/courses/

QAA Benchmark Statement website: http://www.qaa.ac.uk/academicinfrastructure/benchmark/default.asp

Frameworks for Higher Education Qualifications of UK Degree-Awarding Bodies (2014)

The Frameworks for Higher Education Qualifications of UK Degree-Awarding Bodies

SEEC Credit Level Descriptors for Further and Higher Education 2010: http://www.seec.org.uk/academic-credit/seec-credit-level-descriptors-2010

External Quality Review report website: http://www.qaa.ac.uk/reviews/reports/instReports.asp?ukprn=10007147

Professional or Statutory Regulatory Body information: <insert URL>

UNISTATS website: http://www.unistats.com/

University of Hertfordshire Academic Quality Office website: (StudyNet Staff Department Lists Academic Quality Office)

Structure & Assessment Regulations - Undergraduate & Taught Postgraduate Programmes, UPR AS14:

http://sitem.herts.ac.uk/secreg/upr/AS14.htm

Learning and Teaching Policy and Graduate Attributes, UPR TL03: http://sitem.herts.ac.uk/secreg/upr/TL03.htm

Admissions - Undergraduate & Taught Postgraduate Students, UPR SA03: http://sitem.herts.ac.uk/secreg/upr/SA03.htm

Academic Quality, UPR AS17: http://sitem.herts.ac.uk/secreg/upr/AS17.htm

Index of UPRs for students: http://sitem.herts.ac.uk/secreg/upr_azlist_info.htm

Information on Programme and Module External Examiners http://www.studynet1.herts.ac.uk/ptl/common/studentcentre.nsf/Teaching+Documents/184A221E5EECA6B780257A5C00250BA9?OpenDocument

Other information relevant to the programme

University policies relevant to the Programme The University undertakes to use all reasonable endeavours to deliver, assess and administer this programme in accordance with this Programme Specification. At the same time it is recognised that it is






http://www.herts.ac.uk/courses/

http://www.qaa.ac.uk/academicinfrastructure/benchmark/default.asp

http://www.qaa.ac.uk/publications/information-and-guidance/publication?PubID=2843#.VT8b6ZNH50F

http://www.seec.org.uk/academic-credit/seec-credit-level-descriptors-2010

http://www.qaa.ac.uk/reviews/reports/instReports.asp?ukprn=10007147

http://www.unistats.com/


http://sitem.herts.ac.uk/secreg/upr/TL03.htm

http://sitem.herts.ac.uk/secreg/upr/SA03.htm


http://sitem.herts.ac.uk/secreg/upr_azlist_info.htm

http://www.studynet1.herts.ac.uk/ptl/common/studentcentre.nsf/Teaching+Documents/184A221E5EECA6B780257A5C00250BA9?OpenDocument

http://www.studynet1.herts.ac.uk/ptl/common/studentcentre.nsf/Teaching+Documents/184A221E5EECA6B780257A5C00250BA9?OpenDocument


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in the nature of academic developments that changes, for example to the structure, curriculum, and assessment of a programme may be necessary in order to ensure that the programme remains up to date, in response to issues raised as a result of on-going monitoring and evaluation, and/or in order to conform to new regulatory requirements imposed by this institution, by professional or statutory bodies, or by national or governmental bodies. The programme operates within the guidelines and policies relating to equal opportunities and environmental issues which may be agreed from time to time by the Board of Governors and/or the Academic Board of the University. Where the programme is offered in collaboration with another institution these policies and guidelines will normally be those of the partner institution. The programme operates in accordance with the University's Regulations Governing Studies Involving the Use of Human Subjects (UPR RE01) agreed from time to time by the Academic Board of the University. However, where the programme is offered in collaboration with another institution (for example through a franchise arrangement for all or part of the programme) then specific approval must be obtained from the University for the operation of the programme within ethical guidelines prepared by the partner institution. The partner institution will be responsible for all insurance liability in connection with the observance of ethical guidelines.

Signed ………… ………… Date…22 October 2015…

Philomena Shaughnessy Associate Dean of School (Academic Quality Assurance)

If you would like this information in an alternative format please contact: Student Administrator

http://sitem.herts.ac.uk/secreg/upr/RE01.htm

Eu2p MSc Pharmacovigilance and Pharmacoepidemiology

Table 2: Development of Programme Learning Outcomes in the Constituent Modules This map identifies where the programme learning outcomes are assessed in the constituent modules. It provides (i) an aid to academic staff in understanding how individual modules contribute to the programme aims (ii) a checklist for quality control purposes and (iii) a means to help students monitor their own learning, personal and professional development as the programme progresses.

Programme Learning Outcomes (as identified in section 1 and the following page)

Module Title Module Code A1 A2 A3 A4 A6 B1 B2 B3 B4 C1 C2 C3 C4 C5 D1 D2 D3 D4 D5

Year 1

Basics in epidemiology applied to PV and PE D1M1

Basics in statistics applied to PV and PE D1M2

Tools to do research applied to PV and PE D1M3

Basics in clinical pharmacology D2M1

Principles of pharmacovigilance* D3M1

Basics in pharmacoepidemiology D6M1

Basics in communication applied to PV and PE D7M1

Tutored project

Research project 1

Clinical and pharmacological principles of PV and

PE

D2M2

PV regulations D3M2

Principles of recognizing adverse events and

safety signals

D4M1

Introduction to benefit risk assessment and

pharmacoeconomics in decision making

D5M1

Drug utilization studies: introduction and

quantitative methods

D6M2

Needs and objectives in communication risk and

benefit-risk related to medicines

D7M2

Le

ve

l 7

Practical SkillsKnowledge &

Understanding

A5

Year 2

Transferable

Skills

Intellectual

Skills


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Programme Learning Outcomes (as identified in section 1 and the following page)

Module Title Module Code A1 A2 A3 A4 A5 A6 B1 B2 B3 B4 C1 C2 C3 C4 C5 D1 D2 D3 D4 D5

Optional

Methods in clinical research, PE and the

assessment of efficacy of medicines

D2M3

Critical appraisal of clinical trials: Evidence-based

medicine and its uncertainties

D2M4

PV regulatory processes D3M3

Substantiation of risks 1 D4M2a

Substantiation of risks 2 D4M2b

Identifying susceptibility to adverse drug reactions D4M3

Principles of pharmacoeconomics and valuation of

health states

D5M2

Methods for quantitative benefit-risk assessment

of medicines

D5M3

Application of quantitative benefit-risk assessment

in decision making on medicines

D5M4

Drug utilization studies: qualitative methods D6M3

The public health impact of adverse drug reactions D6M4

Transferable

Skills

Le

ve

l 7

Knowledge &

Understanding

Intellectu

al Skills Practical Skills

Key: Learning Outcome which is assessed as part of the module


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Table 3: Grading equivalents for Eu2P Academic Partners

Eu2P grades translation

Université Bordeaux Segalen

University of Hertfordshire

Universiteit Utrecht

Erasmus Universitair Medisch Centrum Rotterdam

Universitat Autònoma de Barcelona

Università di Verona

A+ Excellent 16,0 - 20 80 - 100 8,5 - 10 8,5 - 10 8,0 - 10 29 - 30 lode

A Very Good

14,0 – 15,9 70 - 79 7,5 - 8,4 7,5 - 8,4 7,0- 7,9 27 - 28

B Good 12,0 – 13,9 60 - 69 7,0 - 7,4 7,0 - 7,4 5,6 - 6,9 23 - 26

C Pass 10,0 – 11,9 50 - 59 5,5 - 6,9 5,5 - 6,9 5,0 - 5,5 18 - 22

F Fail 0 - 9,9 0 - 49 0 - 5,4 0 - 5,4 0 - 4, 9 0 - 17


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Key to Programme Learning Outcomes

Knowledge and Understanding eg Practical Skills

A1.-the main epidemiological and statistical principles, concepts and tools that are used in pharmacoepidemiology and pharmacovigilance practices and research

C1. apply the main health indices used to describe mortality and morbidity of

the population

A2. the worldwide regulations and guidelines concerning pharmacovigilance C2. apply the methodology used in epidemiological studies and randomized

clinical trials to assess the efficacy and effectiveness of medicine

A3. the clinical, pharmacological and epidemiological principles underlying the prescribing of medicines and their effectiveness evaluation.

C3. qualitatively and quantitatively analyse the utilization of medicines

A4. the principles of PV from the development of the science to its place in pre and post-authorisation environment and the roles of various stake holders within PV

C4. design studies and write protocols to quantify and analyse safety signals

or risks

A5. the evaluation of the effects of medicines from epidemiological and public health points of view

C5. apply benefit-risk assessment methods in daily practice

A6. the principles of medicines risk communication, its tools and its place in mitigating risks linked to the use of medicines

Intellectual Skills eg Transferable Skills

B1. discuss and analyse the need to solve therapeutic uncertainties through clinical research

D1. communicate written and oral scientific results

B2. analyse benefit-risk assessment methods (including pharmacoeconomics), the process of decision making and communication on medicines by different stakeholders

D2 present and support an extended argument

B3. To identify and quantify risks of medicine, interpret publications and results D3. demonstrate the ability to carry out a defined task, solve it in a set period

of time and adequately report the results of this work in a written report and in an oral presentation

D4. demonstrate skills in searching medical and scientific literature

D5. manage information