Masters Degrees (Pharmacoepidemiology)

The aim of the Eu2P Master in Pharmacovigilance and Pharmacoepidemiology is to respond to the growing need for well-trained professionals in pharmacovigilance and pharmacoepidemiology highlighted by industry, regulatory and academic bodies. There is a particular need for skilled people, trained in medicine risk-benefit assessment, risk management plan elaboration, risk minimization and risk communication.

Eu2P-trained professionals are qualified for new job profiles such as project managers, pharmacoepidemiological coordinators, risk-benefit analysts and people able to interact with statisticians and clinicians. Eu2P is designed for: non-specialists, graduate and postgraduate students in Health and Life Sciences, healthcare professionals, companies, regulatory agencies and academic institutions.

Program structure

The Eu2P Master offers six high level curricula track specializations to meet specific professional needs in: benefit assessment of medicine, medicine risk identification and quantification, medicine benefit-risk assessment, medicine and public health, medicine risk communication along with an “A la carte” track.

Year 1: 60 ECTS credits

Validation of mandatory basis modules for Pharmacovigilance and Pharmacoepidemiology (24 ECTS).

Completion of a tutored project (6 ECTS).

Validation of a research project (30 ECTS).

Year 2: 60 ECTS credits

Validation of theoretical content (ten modules, 30 ECTS):

Six mandatory theoretical modules.

• plus modules of the chosen track.
• plus choice of one or two complementary optional modules.

Validation of a research project (30 ECTS).

Strengths of this Master program

• 100% online, open to all professionals or students throughout the world. The Master may be completed at work or at home, you do not need to travel as even the examinations are online. 70% of our students are professionals and manage their Eu2P diploma while they work full or part-time, it’s up to you!
• The Eu2P European Master is built and recognized by all 24 academic, regulatory and industrial Eu2P partners. The courses are based on today’s job market and practices.
• Research projects may be performed in public or private environments.
• Increasing worldwide recognition for the Eu2P program as an excellent employment opportunity and also a way of improving regulatory sciences.

After this Master program?

Opportunities that involve collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications to ensure that drugs on the market are safe for patients and to identify new hazards associated with the medication.

Students are generally in either full or part-time employment and are likely to have a range of responsibilities, mostly in pharmacovigilance and medical information, monitoring safety data in either pre- or post-marketing studies or from spontaneous reports. Pharmacovigilance is an expanding area, primarily due to an increase in regulation and product withdraws based on safety concerns.

Following registration to Eu2P, students are invited to join the Alumni group via which they regularly receive job offers from all over the world.

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The aim of this MSc is to provide a postgraduate education in pharmacovigilance, including relevant techniques, the basis of adverse drug reactions, regulations and guidelines, handling safety issues including labelling and risk management and systems and processes. Teaching consists of lectures and workshop activities in small groups and takes into account real world situations. There are opportunities for sharing experiences and networking which contributes to the development of your knowledge and understanding of pharmacovigilance issues.

Flexible programme

This is a flexible programme designed to meet the needs of those in either full or part-time employment who are likely to have a spread of responsibilities. Students are able to complete the MSc course in under three years if able to attend all modules at the earliest opportunity. Alternatively, they can take up to five years, progressing at a slower pace.

Participants will normally be graduates and/or experienced personnel and usually will need to have held positions in drug safety for one to several years. The programme is run as a series of intensive short courses supplemented with substantial pre and post-course reading and set coursework. In addition, if you are studying for an MSc, you will undertake a research project that is normally carried out at your workplace but may be done at the University, or an institution with appropriate experience of pharmacovigilance or adverse drug reactions.

The programme has attracted students from European Union countries, Norway, Switzerland, Japan and the USA and its success has led to the organisation of an annual Pharmacovigilance Update day for those who have completed their studies.

Recruitment will take place at the beginning of each taught module and the programme offers the awards of a PgC, PgD or MSc. Students are typically able to obtain any one of the awards in a minimum of two years; however you have a maximum registration of up to five years in order to complete the course. This course has the option of being a diploma if you do not feel you can commit to the full MSc programme.

Why choose this course?

-The MSc/PgD/PgC in Pharmacovigilance is a programme developed by the School of Life and Medical Sciences and the Pharmaceutical Information and Pharmacovigilance Association (PIPA).
-In addition to offering this course, The University of Hertfordshire is also part of the Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, an online pan European e-learning/e-teaching MSc course.
-The programme includes eight taught modules, provided as intensive three-day workshops, and for the MSc award, a research project.
-It is taught mainly through teams of staff drawn from the professions appropriate to pharmacovigilance. This is a major feature of the programme, the majority of staff delivering the courses will be acknowledged experts.
-The aim is to provide a postgraduate education in pharmacovigilance, including relevant techniques, the basis of adverse drug reactions, regulations and guidelines, handling safety issues and the role of systems and processes.

Professional Accreditations

PIPA (Pharmaceutical Information and Pharmacovigilance Association)

Careers

Potential candidates will normally be in either full or part-time employment and are likely to have a spread of responsibilities, mostly in pharmacovigilance and medical information, monitoring safety data in either pre- and post-marketing studies or from spontaneous reports. They will be graduates and/or experienced personnel and usually will have held positions in drug safety for one to several years. Some applicants may have doctorates and may be medically qualified. Following successful completion of the course the knowledge gained should enable the post-graduates to make a greater contribution to the pharmacovigilance industry.

Teaching methods

Taught modules normally consist of approximately 24 hours class contact. In addition, about 120 hours will be needed to complete the pre and post-course activities. The actual amount of time spent will depend upon your existing knowledge and ability. All modules are free-standing. Satisfactory completion of four modules is compulsory for the PgCert; all eight modules are required for the PgDip and MSc. Coursework will contribute significantly to assessment and may comprise some or all of the following: summaries of pre-course reading, written reports of class discussions, essays, performances in seminars, poster presentations, problem solving or data interpretation exercise, short projects and case studies. Unseen written examinations will feature in some courses; they may be used to examine understanding of pre-course reading material. Attendance at the taught component and satisfactory completion of both coursework and examinations (where present), with a minimum mark of 50% in each element, is normally required to pass each module.

Structure

Year 1
Optional
-Adverse Drug Reactions by Major Body Systems I
-Adverse Drug Reactions by Major Body Systems II
-Drug Safety in Clinical Trials
-Labelling and Risk Management
-Management of Pharmacovigilance Data
-Pharmacoepidemiology
-Pharmacovigilance Regulations and Guidelines
-Principles of Pharmacovigilance

Year 2
Optional
-Adverse Drug Reactions by Major Body Systems I
-Adverse Drug Reactions by Major Body Systems II
-Drug Safety in Clinical Trials
-Labelling and Risk Management
-Management of Pharmacovigilance Data
-Pharmacoepidemiology
-Pharmacovigilance Regulations and Guidelines
-Principles of Pharmacovigilance

Year 3
Optional
-Adverse Drug Reactions by Major Body Systems I
-Adverse Drug Reactions by Major Body Systems II
-Drug Safety in Clinical Trials
-Labelling and Risk Management
-Management of Pharmacovigilance Data
-Pharmacoepidemiology
-Pharmacovigilance Regulations and Guidelines
-Principles of Pharmacovigilance
-Project, Pharmacovigilance

Year 4
Optional
-Adverse Drug Reactions by Major Body Systems I
-Adverse Drug Reactions by Major Body Systems II
-Drug Safety in Clinical Trials
-Labelling and Risk Management
-Management of Pharmacovigilance Data
-Pharmacoepidemiology
-Pharmacovigilance Regulations and Guidelines
-Principles of Pharmacovigilance
-Project, Pharmacovigilance

Year 5
Optional
-Adverse Drug Reactions by Major Body Systems I
-Adverse Drug Reactions by Major Body Systems II
-Drug Safety in Clinical Trials
-Labelling and Risk Management
-Management of Pharmacovigilance Data
-Pharmacoepidemiology
-Pharmacovigilance Regulations and Guidelines
-Principles of Pharmacovigilance
-Project, Pharmacovigilance

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How does a disease develop in a patient or model system? Which substances can influence this process? How is effective medication designed and tested? Can you cure diseases with stem cells?

You study the causes and pathophysiology of diseases and intervention with drugs. The programme is interdisciplinary covering the whole range of drug development disciplines. From basic drug target discovery to molecular modeling of targets. And from synthesis andanalysis, pharmacology, toxicology and biopharmacy to clinical pharmacoepidemiology and post marketing surveillance.

The main feature of the programme are research projects in which you will learn about conducting research by actually doing it. You will independently perform experiments and go through the whole process of conducting science developing skills such as studying scientific literature, formulating hypotheses, designing and performing experiments, and interpreting and presenting your results. The programme therefore is a good preparation for a PhD programme or for independent practice of science in a future job.

You can either choose to design your programme tailored to your individual research interest or choose a specialisation. Available specialisations:Toxicology and Drug Disposition, with focus on adverse drug reactions and toxicokinetics of drugs, or Pharmacoepidemiology which studies intended and unintended effects of drugs in daily life.

Why in Groningen?

- Groningen drug research is among the best in the world
- Unique interdisciplinary cooperation between clinical, preclinical and pharmaceutical research fields
- Specialisations: Toxicology and Drug Disposition | Pharmacoepidemiology

Job perspectives

When you have finished the Master's programme in Medical Pharmaceutical Sciences you have multiple career options. You are optimally prepared to start a research career but you can also choose for a position that links science to business and policy.

Researcher (usually as a PhD) in a variety of organisations:
- Universities
- Academic and general hospitals
- Pharmaceutical, biomedical industries and food industries

Positions linking medical pharmaceutical sciences to a business or policy strategy in:
- Governmental and semi-governmental institutions such as the Medicines Evaluation Board or the Ministry of Health and Welfare
- Societal and patient organisations

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Why this course?

This new and unique course enables pharmacists (registered with the General Pharmaceutical Council) to come together in a small peer-group learning environment to develop as advanced clinical practitioners. The course is flexible with a choice of classes that look at specific practice and personal development needs.

The course is designed to produce highly skilled practitioners who can improve patient care by driving forward innovation in all areas of pharmacy practice through delivery of the Scottish Government’s Vision and Action Plan: Prescription for Excellence

The Independent Prescribing (IP) qualification is included within the course as an optional 30-credit module; practitioners who have already completed the IP qualification will receive 30 credits for prior learning and the requirements for each award will be reduced by 30 credits.

See the website https://www.strath.ac.uk/courses/postgraduatetaught/advancedclinicalpharmacypractice/

You’ll study

This course consists of a series of optional classes.
Successful completion of 60 credits from any combination of classes leads to the award of a Postgraduate Certificate.
The award of a Postgraduate Diploma requires 120 credits. The MSc requires 180 credits, which includes a project and class in research skills.

Our facilities & staff

The Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS)is recognised as one of the foremost departments of its kind in the UK. It's a leading research centre in the search for new and improved medicines. You'll benefit from the advanced facilities of a new £36 million building.

Our postgraduate community comes from all corners of the globe and benefits from the support and guidance of the Institute’s Graduate School as well as from close, long-standing industrial and NHS links.

Research in SIPBS is focused on “New Medicines, Better Medicines, Better Use of Medicines”. In the 2014 Research Excellence Framework, SIPBS submitted in the Allied Health unit of assessment and was ranked fourth on research power in the UK and first in Scotland.

The teaching and research interests of the Institute cover many aspects of pharmacy and biomedical sciences. There's particular emphasis on:
- fundamental bioscience to develop new targets and translational opportunities
- drug discovery to translate basic science into target validation
- advanced pharmaceutical manufacturing and industrial biotechnology
- pharmacoepidemiology and pharmacy practice research for better pharmaceutical care and medicines use

Learning & teaching

The course places a strong emphasis on student-centred learning delivered through a blended learning approach. There's a combination of e-learning materials, small group tutorials and workshops led by experienced staff, student presentations and work-based practice activities. Class material is available through online learning tools which can be accessed at any time.

The Strathclyde Institute of Pharmacy and Biomedical Sciences has a well-established relationship with NHS Scotland and a number of leading clinicians have visiting or honorary appointments. The course team combines both academic and clinical expertise to deliver classes that provide both the scientific knowledge and practical skills that are necessary to achieve the changes required to improve patient care.

Together we undertake collaborative research focused on the “Better Use of Medicines” through the study of real-world clinical data (pharmacoepidemiology) and the design and testing of novel healthcare intervention models in clinical practice settings (practice research).

Assessment

Assessment is through both written assignments and practical observation/examinations and submission of a manuscript (MSc students only).

Careers

The course prepares you to develop and grow your clinical career to prepare you for senior clinical leadership appointments in variable healthcare settings. For example:
- appointments as principal clinical pharmacist
- clinical pharmacy lead within a managed healthcare in hospital or primary care
- clinical pharmacist independent prescriber within a speciality with your own clinical caseload

Find information on Scholarships here http://www.strath.ac.uk/search/scholarships/

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Epidemiology

The Master's in Epidemiology focuses on biomedical research, examining the distribution of health and the spread of disease in both human and veterinary medicine.

In the Master's in Epidemiology you acquire extensive knowledge and practical skills in epidemiologic research design and implementation, quantitative analysis and its application to human or veterinary medicine and public health. The knowledge and skills gained form a solid basis for health research and disease control programmes, including applications in developing countries.

This two year research programme comprises such core theoretical courses as 'Study Design' and 'Modern Methods in Data Analysis.' You choose from five specializations: Clinical Epidemiology, Veterinary Epidemiology, Epidemiology of Infectious Diseases, Pharmacoepidemiology or Environmental & Occupational Epidemiology. You undertake a practical research project (which may be completed at an external company or research institute), that results in a publishable scientific paper. A final Master's thesis based on a literature review of a relevant topic completes the programme. Graduates may go on to a PhD programme, or a position as an epidemiologist in various settings. This programme is also offered in a 1.5 year post graduate format.

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This course is open to registered pharmacists with at least two years’ post-registration experience in a clinical, patient-facing role.

Upon successful completion of the 40 credit module, you will be awarded the Practice Certificate in Independent Prescribing from the University of Wolverhampton.

Your name will then be forwarded to the Registrar of the General Pharmaceutical Council (GPhC), and you will be eligible for annotation on the GPhC Register as an Independent Prescriber.

This entitles you, with the support of your employer (unless self-employed), to practice as a Supplementary or Independent Prescriber.

In order to be awarded the Postgraduate Certificate in Prescribing Studies, you will also have to study an 20 credit module on Pharmacoepidemiology.

Successful completion of both modules will lead to the award of the Postgraduate Certificate in Prescribing Studies, which will provide evidence to employing organisations of your ability to practice (including prescribing) at an advanced level in your chosen therapeutic area.

However, this is entirely optional and you may choose to exit after completing only the Practice Certificate in Independent Prescribing (module code 7PY019).

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This Masters in Medicine course is offered to medical graduates in training who wish to develop their research skills, broaden their research interests, and develop advanced knowledge in selected areas of clinical and scientific practice. The course syllabus and curriculum have been developed following consultation with medical trainees in Ireland in order to ensure that the course fulfills their needs in terms of higher medical training at national and international level. The aim of the course is to provide advanced training in key domains of excellence relevant to modern medical practice for all students while also providing specialist knowledge relevant to their individual chosen career pathways.

Students will be required to complete twelve taught modules (5 ECTS each) as follows:

Six core modules (in year 1):

Professional and Ethical Practice of Medicine,
Research Skills I,
Research Skills II,
Health Services Management,
Health Informatics,
Patient Safety for Clinical Specialists.

Six optional modules (year 2) from either Molecular and Translational Medicine (strand A):

Cellular Biology and Cell signalling Mechanisms,
Introduction to Genetics and Molecular Biology,
Molecular oncology,
Molecular Mechanisms of Human disease I and II, and
laboratory skills for clinical specialists

or Population Health and Health Implementation (Strand B):

Public Health for Clinical Specialists,
Global Health for Clinical Specialists,
Rehabilitation Medicine for Clinical Specialists,
Teaching and Learning for Clinical Specialists,
Pharmacoeconomics, Pharmacoepidemiology, and Drug Safety 56

Students will also be required to submit a dissertation (30 ECTS) based on an original research/ laboratory-based project at the end of the second year.

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