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Pharmacovigilance - MSc


Course Description

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

Visit the Pharmacovigilance - MSc page on the University of Hertfordshire website for more details!

Entry Requirements

A first or second class Honours degree in Biosciences, Pharmacy or Biological Chemistry; Or a professional qualification accepted as equivalent to the above; Or a qualification in veterinary science, medicine or dentistry; Or a first or second class Honours degree in disciplines that would be judged as equivalent to the above.

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Recipient: University of Hertfordshire

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