Masters Degrees (Pharmacovigilance)

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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This programme gives you in-depth knowledge of the scientific basis of drug discovery and development, which has revolutionised the pharmaceutical industry in recent years. Our involvement with international drug companies has allowed us to keep our courses fully up-to-date. With our excellent facilities, emphasis on practical work, and teaching underpinned by the latest research, you will be qualified for research and development positions in pharmaceutical companies, as well as a wide range of other roles in industry.

About the course

The programme will have a heavy emphasis on practical work and will cover the following areas:
-Pharmacological and relevant physiological principles
-Molecular biology techniques in pharmacology
-The application of bioinformatics to drug discovery
-Quantitative aspects of pharmacology
-Case studies in drug discovery
-Molecular medicine
-Neuro-degenerative diseases
-Safety evaluationResearch project

You will undertake a practical project as part of your MSc enabling you to use our excellent facilities and to gain experience working alongside researchers in our Pharmacology Research Group. Current research projects include studies in:
-Gastrointestinal pharmacology, particularly with respect to diabetes
-Angiogenesis
-Cancer
-Cannabinoids as therapeutic agents
-Molecular pharmacology of vascular disease
-Modelling pharmacokinetics

Why choose this course?

-This is an intensive programme that will provide training in pharmacology, molecular biology and their application to drug discovery, using a problem based learning approach
-You will receive training in a range of pharmacological and molecular practical techniques as well as completing a research project
-Upon completion, you will be able to enter a successful career in the pharmaceutical industry or pursue further postgraduate research
-The School of Life and Medical Science will move into a brand new science building opening in September 2015 providing us with world class laboratories for our teaching and research. At a cost of £50M the new building provides spacious naturally lit laboratories and social spaces creating an environment that fosters multi-disciplinary learning and research

Careers

Graduates of the programme will be qualified for research and development positions in the pharmaceutical industries, to progress to a research degree or to consider regulatory, marketing or management roles in industry.

Teaching methods

Upon entering the programme, students are provided with introductory material to facilitate their transition to Master's level study. Cellular Molecular Biology is taught in parallel with Core Pharmacology, which both involve a high proportion of practical work. Students will experience a range of learning styles including conventional lectures, workshops and problem based learning. Teaching in Molecular Medicine and Pharmacovigilance & Drug Discovery Development uses case studies to foster skills such as working independently or as part of a team, demonstrating initiative and problem solving. You will also study a module in Biosciences Research Methods for Masters. All assessments are coursework only (including in-class tests), which are strategically phased throughout the course to provide regular feedback.

Structure

Modules
-Biosciences Research Methods for Masters
-Cellular Molecular Biology
-Core Pharmacology
-Drug Discovery Development and Pharmacovigilance
-Molecular Medicine
-Project-Mol Biology, Biotechnology, Pharmacology

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The Department of Oncology and the Department for Continuing Education’s CPD Centre offer a part-time MSc in Experimental Therapeutics that brings together some of Oxford's leading clinicians and scientists to deliver an advanced modular programme designed for those in full-time employment, both in the UK and overseas.

The Programme draws on the world-class research and teaching in experimental therapeutics at Oxford University and offers a unique opportunity to gain an understanding of the principles that underpin clinical research and to translate this into good clinical and research practice.

Visit the website https://www.conted.ox.ac.uk/about/msc-in-experimental-therapeutics

The first deadline for applications is Friday 20 January 2017

If your application is completed by this January deadline and you fulfil the eligibility criteria, you will be automatically considered for a graduate scholarship. For details see: http://www.ox.ac.uk/admissions/graduate/fees-and-funding/graduate-scholarships.

Programme details

The MSc in Experimental Therapeutics is a part-time course consisting of six modules and a research project and dissertation. The programme is normally completed in two to three years. Students are full members of the University of Oxford and are matriculated as members of an Oxford college.

The modules in this programme can also be taken as individual short courses. It is possible to transfer credit from up to three previously completed modules into the MSc programme, if the time elapsed between commencement of the accredited module(s) and registration for the MSc is not more than two years.

Programme modules:

- The Structure of Clinical Trials and Experimental Therapeutics
- Drug Development, Pharmacokinetics and Imaging
- Pharmacodynamics, Biomarkers and Personalised Therapy
- Adverse Drug Reactions, Drug Interactions, and Pharmacovigilance
- How to do Research on Therapeutic Interventions: Protocol Preparation
- Biological Therapeutics

Course aims

The aim of the MSc programme is to provide students with the necessary training and practical experience to enable them to understand the principles that underpin clinical research, and to enable them to translate that understanding into good clinical and research practice.

By the end of the MSc programme, students should understand the following core principles:

- Development, marketing and regulations of drugs
- Pharmaceutical factors that affect drug therapy
- Pharmacokinetics, pharmacogenetics and pharmacodynamics
- Adverse drug reactions, drug interactions, and pharmacovigilance
- Designing phase I, II and III clinical trials for a range of novel therapeutic interventions (and imaging agents).
- Application of statistics to medicine
- Laboratory assays used to support trial end-points
- Use of non-invasive imaging in drug development
- Application of analytical techniques

By the end of the programme, students should be equipped to:

- demonstrate a knowledge of the principles, methods and techniques for solving clinical research problems and translate this into good clinical and research practice
- apply skills gained in techniques and practical experience from across the medical and biological sciences
- develop skills in managing research-based work in experimental therapeutics
- carry out an extended research project involving a literature review, problem specification and analysis in experimental therapeutics and write a short dissertation

Guidance from the UK Royal College of Physician's Faculty of Pharmaceutical Medicine

The Faculty have confirmed that if enrolled for Pharmaceutical Medicine Specialty Training (PMST), trainees may be able to use knowledge provided by Experimental Therapeutics modules to cover aspects of a module of the PMST curriculum. Trainees are advised to discuss this with their Educational Supervisor.

Experimental Therapeutics modules may also be used to provide those pursuing the Faculty's Diploma in Pharmaceutical Medicine (DPM) with the necessary knowledge required to cover the Diploma syllabus. Applicants for the DPM exam are advised to read the DPM syllabus and rules and regulations.

Members of the Faculty of Pharmaceutical Medicine who are registered in the Faculty's CPD scheme can count participation in Experimental Therapeutics modules towards their CPD record. Non-members may wish to obtain further advice about CPD credit from their Royal College or Faculty.

Assessment methods

To complete the MSc, students need to:

Attend the six modules and complete an assessed written assignment for each module.
Complete a dissertation on a topic chosen in consultation with a supervisor and the Course Director.

Dissertation:
The dissertation is founded on a research project that builds on material studied in the taught modules. The dissertation should normally not exceed 15,000 words.

The project will normally be supervised by an academic supervisor from the University of Oxford, and an employer-based mentor.

The following are topics of dissertations completed by previous students on the course:

- The outcomes of non-surgical management of tubal pregnancy; a 6 month study of the South East London population

- Analysis of the predictive and prognostic factors of outcome in a cohort of patients prospectively treated with perioperative chemotherapy for adenocarcinoma of the stomach or of the gastroesophageal junction

- Evolution of mineral and bone disorder in early Chronic Kidney Disease (CKD): the role of FGF23 and vitamin D

- Survey of patients' knowledge and perception of the adverse drug reporting scheme (yellow cards) in primary care

- The predictive role of ERCC1 status in oxaliplatin based Neoadjuvant for metastatic colorectal cancer (CRC) to the liver

- Endothelial Pathophysiology in Dengue - Dextran studies during acute infection

- Literature review of the use of thalidomide in cancer

- An investigation into the phenotypical and functional characteristics of mesenchymal stem cells for clinical application

- Identification of genetic variants that cause capecitabine and bevacizumab toxicity

- Bridging the evidence gap in geriatric medicines via modelling and simulations

Teaching methods

The class-based modules will include a period of preparatory study, a week of intensive face-to-face lectures and tutorials, followed by a period for assignment work. Attendance at modules will be a requirement for study. Some non-classroom activities will be provided at laboratory facilities elsewhere in the University. The course will include taught material on research skills. A virtual learning environment (VLE) will provide between-module support.

The taught modules will include group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers. Practical work aims to develop the students' knowledge and understanding of the subject.

Find out how to apply here - http://www.ox.ac.uk/admissions/graduate/applying-to-oxford

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Your programme of study

The University of Aberdeen is highly regarded for Clinical Pharmacology as the discipline has been taught and delivered for 30 years. It comes from research spanning 50 years. The programme draws on strengths within the university and medical area within disease discovery. Insulin was first developed at University of Aberdeen and the discovery of drug process, treatment and design has been developed and researched ever since. Aberdeen is also known for its research in food and nutrition and other areas. This programme is ideal for newly qualified graduates in medical science disciplines such as biomedical sciences, biochemistry, pharmacology, pharmacy, medicine and similar degrees.

Clinical pharmacology forms a critical part of the drug development process and our graduates are employed in the pharmaceutical and biotechnology industries. These industries are now in rapid growth due to a combination of innovations and strength within customised and other types of medicine and treatment industry areas. Further innovations which link into this industry come from the Internet of Things and more ability to treat and diagnose at source.

There is always a strong need for the discipline to provide a foundation to any new innovations which often come from multidisciplinary teams. Our aim is to train students in the major areas of clinical pharmacology including molecular pharmacology, drug metabolism and toxicology, therapeutics, pharmacokinetics, pharmcovigilance, regulatory affairs and experimental medicine. The programme aims to achieve this by a multi-disciplinary approach.

Courses listed for the programme

Semester 1
Molecular Pharmacology
Drug Metabolism and Toxicology
Therapeutics
Applied Statistics
Basic Skills- Induction
Generic Skills

Semester 2
Pharmacovigilance
Drug Development to Evidence Based Medicine
Pharmacokinetics
Basic Research Methods
Business of Science
Optionall
Health Informatics (distance learning

Semester 3
Research Project

Find out more detail by visiting the programme web page
https://www.abdn.ac.uk/study/postgraduate-taught/degree-programmes/37/clinical-pharmacology/

Why study at Aberdeen?

• You are taught by one of the top 10 medical schools in the UK with one of the largest campuses in Europe
• Teaching is from academic and clinical teachers within a clinical setting
• You get a great range of multidisciplinary learning from our research
• We are in the top 10 for university spin out and company formation

Where you study

• University of Aberdeen
• Full Time or Part Time
• September

International Student Fees 2017/2018

Find out about fees:
https://www.abdn.ac.uk/study/international/tuition-fees-and-living-costs-287.php

*Please be advised that some programmes have different tuition fees from those listed above and that some programmes also have additional costs.

Scholarships

View all funding options on our funding database via the programme page
https://www.abdn.ac.uk/study/postgraduate-taught/finance-funding-1599.php
https://www.abdn.ac.uk/funding/

Living in Aberdeen

Find out more about:
• Your Accommodation
• Campus Facilities
• Aberdeen City
• Student Support
• Clubs and Societies

Find out more about living in Aberdeen:
https://abdn.ac.uk/study/student-life

Living costs
https://www.abdn.ac.uk/study/international/finance.php

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This modular part-time programme is particularly suitable for academically gifted medical and dental trainees with the potential to be the independent researchers of the future.

Applications for admisson in October 2016 are now open, the deadline to receive applications by is Friday 29 July 2016 (12 noon UK time).

Description

This progamme is designed to be taken by Academic Clinical Fellows alongside work commitments, the Health Research programme exists to enable students to:

- develop skills of research, design and data analysis in both qualitative and quantitative research

- critically evaluate health research

- identify, critically appraise and incorporate the results of medical and social science research into the day-to-day decision-making of clinical, scientific and administrative practice

- apply the principles of evidence-based practice in health care settings

- plan how to implement the findings of research to improve health care

- use theories and principles underpinning clinical research to inform their own research practice.

The programme is delivered through the Department for Continuing Education, with the expertise in curriculum design and teaching drawn from the Nuffield Department of Primary Care Health Sciences, the Centre for Evidence-Based Medicine, and the Oxford University Clinical Academic Graduate School.

Visit the website https://www.conted.ox.ac.uk/about/postgraduate-certificate-in-health-research

Programme details

The Postgraduate Certificate is normally completed between 1-2 years. It consists of three assessed taught modules and includes thorough introductions to the principles of evidence-based practice in health, and to study design and research methods.

Compulsory Modules

• The Practice of Evidence-Based Health Care
• Introduction to Study Design and Research Methods

The third module may be chosen from the following list:

- Clinical Trial Management
- Ethics for Biosciences
- Mixed Methods in Health Research
- Knowledge into Action
- Evidence-based Diagnosis and Screening
- Introduction to Statistics for Health Care Research
- Systematic Reviews
- Randomized Controlled Trials
- Qualitative Research Methods
- The Structure of Clinical Trials and Experimental Therapeutics
- How to do Research on Therapeutic Interventions: Protocol preparation
- Biological Therapeutics
- Pharmacodynamics, Biomarkers and Personalised Therapy
- Adverse drug reactions, drug interactions and Pharmacovigilance
- Drug development, Pharmacokinetics and Imaging

Course aims

At the end of the course students will be able to:

- demonstrate a knowledge of the principles, methods and techniques appropriate for solving evidence-based health care/health-research problems and be able to translate (through a critical comprehension of the relative advantages and disadvantages) that understanding into good clinical practice

- demonstrate a range of research skills enabling them to complete research successfully, either as part of a research team or as an individual

- acquire, interpret and analyse biological information with a critical understanding of the appropriate contexts for their use through the study of the existing primary literature in the field

- apply skills and expertise gained across the medical and biological sciences expected of professional researchers

Students will know and understand:

- health-care organizations, their management and the changing context in which they operate

- the ethical issues in health research and research governance

- methods to integrate and synthesise different sorts of information, from diverse sources, when making both individual patient and health-policy decisions in a wide range of situations

- the key issues for evidence-based practice in their own professional area or specialty

- how to work comfortably in situations of uncertainty and make sound judgements in the absence of definitive evidence

- research methods and concepts in the field of health and health care

All graduates of the Postgraduate Certificate in Health Research will be able to:

- understand the role of most commonly used methods appropriate for specifying problems through a critical comprehension of the relative advantages and disadvantages of these methods

- understand and express the main principles of some commonly applied techniques and methods

- explain the rationale for the selection of tools used in the analysis of phenomena.

Assessment methods

To complete the Postgraduate Certificate students must:

- Attend and complete the 2 compulsory modules and 1 option module.

Students will also be expected to complete three written assignments, usually of no more than 4000 words, one on each of the chosen modules above.

With the exception of the online modules, the EBHC modules are based on an eight week study cycle. Week One is a preparatory week where you may be required to undertake some pre-reading and to familiarise yourself with the Virtual Learning Environment. During Week Two you are required to attend the face to face teaching week in Oxford. This is followed by an additional six weeks where you are expected to participate in online activities and submit your assignment

Level and demands

Candidates will, in all but exceptional circumstances be admitted to the Postgraduate Certificate with optional progression on successful completion to the Diploma, provided that a candidate:

- has successfully completed the final year of the Bachelor of Medicine and Bachelor of Surgery or Bachelor of Dental Surgery or equivalent; or

- has an appropriate degree or equivalent professional qualification in a profession allied to medicine with post-qualification experience

Applicants will be expected to demonstrate an approach to their study which includes demonstrable skills of critical analysis, wide contextual knowledge and the ability to manage their own time.

Additionally candidates should:

- have a good working knowledge of email, internet, word processing and Windows applications (for communications with course members, course team and administration)

- show evidence of the ability to commit time to study and an employer's commitment to make time available to study, complete course work and attend course and University events and modules

Successful candidates will normally provide evidence of all of the following:

- A professional interest in Health Research, evidenced by prior experience, qualification and work

- Motivation and ability to complete the course

- A clear and well argued understanding of the benefits of the course to the candidate's current employment and future prospects

Find out how to apply here - http://www.ox.ac.uk/admissions/graduate/applying-to-oxford

Visit the Postgraduate Certificate in Health Research page on the University of Oxford website for more details!

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This course will be held at the Medway Campus

- https://www.kent.ac.uk/locations/medway/

This programme builds on a very successful in-house training programme implemented by a major pharmaceutical company.

It was designed and conceived by pharmaceutical industry experts in drug discovery and will be delivered and assessed by experts in this field at the School of Pharmacy.

The MSc covers how fundamental science is applied to the discovery and development of medicines and the main aims are to:

- provide you with the experience of critically appraising the research questions and techniques that are routine in the pharmaceutical industry workplace

- produce graduates trained in the processes by which fundamental science is linked to the design and development of modern medicines

- provide expert preparation for students who wish to pursue a career in drug discovery, or wish to proceed to a PhD.

Visit the website https://www.kent.ac.uk/courses/postgraduate/736/applied-drug-discovery

Duration: One year full-time (campus based), two years part-time (distance learning)

About Medway School of Pharmacy

Medway School of Pharmacy is one of the few regional schools of pharmacy in the UK, a collaboration between the University of Kent and the University of Greenwich.

The impetus for the formation of the Medway School of Pharmacy came from the local community, who recognised the shortage of qualified pharmacists in all branches of the pharmacy profession in Kent.

The School is now recognised as an established school with accreditation from the General Pharmaceutical Council (GPhC) and the Health and Care Professions Council (HCPC). Graduates are employed in health disciplines in Kent and the south-east and more broadly across the UK.

Course structure

This programme is taught as either a classic one year full-time programme with attendance required on Mondays and Tuesdays for 48 weeks plus an additional study day off-campus, or delivered through distance e-learning using an interactive virtual learning environment on a two-year part-time basis.

The programme comprises 60 credits at certificate level, 60 credits at diploma level and 60 credits at Master’s level. You may choose to end your study at any one of these stages.

Modules

The following modules are indicative of those offered on this programme. This list is based on the current curriculum and may change year to year in response to new curriculum developments and innovation. Most programmes will require you to study a combination of compulsory and optional modules. You may also have the option to take modules from other programmes so that you may customise your programme and explore other subject areas that interest you.

Assessment

Assessment is by 100% coursework; including scientific reports, assignments, essays, a research project and portfolio entries.

Programme aims

This programme aims to:

- produce graduates trained in the processes by which fundamental science is linked to the design and development of modern medicines

- teach you an understanding of the drug discovery process

- provide you with expanded training in the biological sciences technical skills that underpin the processes of drug discovery

- provide you with the experience of critically appraising the research questions and techniques they use routinely in the workplace

- develop a variety of postgraduate level intellectual and transferable skills

- equip you with lifelong learning skills necessary to keep abreast of developments in drug discovery

- provide you with opportunities for shared multidisciplinary learning in drug discovery

- give you the experience of undertaking an independent research project

- provide expert preparation for students who wish to pursue and/or further a career in drug discovery, or wish to proceed to a higher degree (PhD) in topics related to the drug discovery process

- provide access to as wide a range of students as practicable irrespective of race, background, gender or physical disability from both within the UK and from overseas.

Research areas

- Chemistry and drug delivery

This group has laboratories with dedicated state-ofthe art drug delivery, nanotechnology, spectroscopy, chromatography and organic synthesis facilities. It brings together researchers in medicinal chemistry and drug design, nanotechnology and materials science, drug delivery and pharmaceutics encouraging a multidisciplinary approach to research. Research covers synthesis and biological evaluation of potential anti-cancer agents, structurebased drug design, QSAR predication of ADMET properties, controlled release, particle engineering, powder technology, pharmaceutical technology, and novel drug delivery systems, with a focus on respiratory drug delivery.

- Biological sciences

This group is housed in recently refurbished laboratories with dedicated state-of-the-art molecular biological, electrophysiological, tissue culture and microscopy facilities. The research is divided into four main themes; infectious diseases and allergy; neuroscience; renal and cardiovascular physiology; and pharmacology. Examples of current work include: investigation of the use of non-pathogenic virus ‘pseudotypes’ to study pathogenic RNA, study of the properties of neuronal potassium channels and their modulation and the development of new therapies for patients that have developed acute kidney injury in collaboration with a major pharmaceutical company.

- Pharmacy practice

This group conducts research in two areas: public health and medicines optimisation, with a particular focus on cardiovascular diseases and mental health. Work in public health includes studies in physical exercise, alcohol, cardiovascular screening and spirometry testing, plus pharmacovigilance. Studies in medicines optimisation include work in dementia, bipolar disorder and stroke, with an emphasis on the patient perspective.

Careers

Graduates who obtain their PhD from Kent or Greenwich are highly sought after by prospective employers, both within the UK and overseas. Destinations for doctoral graduates include university academic departments, research institutes and leading pharmaceutical and biotechnological companies.

The taught postgraduate programmes are designed to promote the continuing professional development by providing sought-after skills. The programmes are beneficial for those who wish to develop their skills and/or to take the next step in their career. While the MSc in Applied Drug Discovery produces elite drug discovery personnel, who can pursue a career in the pharmaceutical industry or academia.

Find out how to apply here - https://www.kent.ac.uk/courses/postgraduate/apply/

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This course will be held at the Medway Campus

- https://www.kent.ac.uk/locations/medway/

This programme provides general-level hospital pharmacists – registered with the GPhC and working – with the core skills required to provide holistic pharmaceutical care in the practice setting.

The programme aligns with a nationally agreed pharmacy practitioner development strategy and is the result of a unique collaboration of higher education institutions across London and the south and east of England.

The programme develops your knowledge and skills in clinical pharmacy practice and medicines management. It works on a philosophy of student-centred workplace learning, supported by workbooks and contact days facilitated by experienced pharmacy practitioners. You are expected to take responsibility for managing your learning and achieving the programme objectives. The ethos and culture of the programme is to enhance and develop self-reliance and an adult approach to learning in support of continuing professional development.

Visit the website https://www.kent.ac.uk/courses/postgraduate/737/general-pharmacy-practice

About Medway School of Pharmacy

Medway School of Pharmacy is one of the few regional schools of pharmacy in the UK, a collaboration between the University of Kent and the University of Greenwich.

The impetus for the formation of the Medway School of Pharmacy came from the local community, who recognised the shortage of qualified pharmacists in all branches of the pharmacy profession in Kent.

The School is now recognised as an established school with accreditation from the General Pharmaceutical Council (GPhC) and the Health and Care Professions Council (HCPC). Graduates are employed in health disciplines in Kent and the south-east and more broadly across the UK.

Modules

For more about the structure of this course please visit the Medway School of Pharmacy website (http://www.msp.ac.uk/studying/postgraduate/cert-gen-pharm-pract/index.html).

Assessment

Assessment is by Objective Structure Clinical Examination (OSCE), multiple-choice questions, assignments, literature review, prescribing audit, change management project, and a competency-based portfolio review.

Programme aims

The PCert and PDip aim to:

- enable you to apply appropriate knowledge, skills and attitudes in order to carry out effectively the role of the general pharmacist practitioner within your pharmacy practice base and wider healthcare teams

- enable you to carry out effective consultations with patients respecting their diverse needs and with regard to confidentiality and consent

- enable you to identify, prioritise and resolve complex pharmaceutical care issues

- enable you to apply knowledge of pathophysiology, pharmacology and the clinical use of drugs and therapeutic guidelines to the treatment of common disease states

- enable you to access, gather, interpret, critically evaluate and summarise medicines information

- enable you to monitor the quality of services provided, identify, prioritise and resolve significant medicines management issues and monitor and evaluate outcomes

- enable you to establish population health needs and apply specialist pharmaceutical knowledge to public health issues.

The MSc aims are to:

- investigate a topic in depth

- evaluate current practice or a new service

- publish research and advance knowledge in pharmacy practice

- develop skills you require for the RPS Advanced Pharmacy Framework

- inspire you and others in your workplace to carry out much needed practice research

- support your future career and perhaps to help you explore new career paths.

Research areas

Chemistry and drug delivery
This group has laboratories with dedicated state-ofthe art drug delivery, nanotechnology, spectroscopy, chromatography and organic synthesis facilities. It brings together researchers in medicinal chemistry and drug design, nanotechnology and materials science, drug delivery and pharmaceutics encouraging a multidisciplinary approach to research. Research covers synthesis and biological evaluation of potential anti-cancer agents, structurebased drug design, QSAR predication of ADMET properties, controlled release, particle engineering, powder technology, pharmaceutical technology, and novel drug delivery systems, with a focus on respiratory drug delivery.

Biological sciences
This group is housed in recently refurbished laboratories with dedicated state-of-the-art molecular biological, electrophysiological, tissue culture and microscopy facilities. The research is divided into four main themes; infectious diseases and allergy; neuroscience; renal and cardiovascular physiology; and pharmacology. Examples of current work include: investigation of the use of non-pathogenic virus ‘pseudotypes’ to study pathogenic RNA, study of the properties of neuronal potassium channels and their modulation and the development of new therapies for patients that have developed acute kidney injury in collaboration with a major pharmaceutical company.

Pharmacy practice
This group conducts research in two areas: public health and medicines optimisation, with a particular focus on cardiovascular diseases and mental health. Work in public health includes studies in physical exercise, alcohol, cardiovascular screening and spirometry testing, plus pharmacovigilance. Studies in medicines optimisation include work in dementia, bipolar disorder and stroke, with an emphasis on the patient perspective.

Careers

This programme provides progression for pharmacists towards advanced practitioner status.

Completion of the practice elements of the course leads to the award of the Certificate of Completion of General Pharmacist Training from an accredited training centre.

Find out how to apply here - https://www.kent.ac.uk/courses/postgraduate/apply/

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This course will be held at the Medway Campus

- https://www.kent.ac.uk/locations/medway/

This programme, approved by the appropriate professional/regulatory bodies, provides a distance learning option for qualification as a non-medical prescriber.

Eight contact days cover communication and diagnostic skills. Other topics on the syllabus include the legal, policy, professional and ethical aspects of prescribing, plus pharmacology and patient assessment and monitoring.

Visit the website https://www.kent.ac.uk/courses/postgraduate/740/independent-supplementary-prescribing

About Medway School of Pharmacy

Medway School of Pharmacy is one of the few regional schools of pharmacy in the UK, a collaboration between the University of Kent and the University of Greenwich.

The impetus for the formation of the Medway School of Pharmacy came from the local community, who recognised the shortage of qualified pharmacists in all branches of the pharmacy profession in Kent.

The School is now recognised as an established school with accreditation from the General Pharmaceutical Council (GPhC) and the Health and Care Professions Council (HCPC). Graduates are employed in health disciplines in Kent and the south-east and more broadly across the UK.

Course structure

You can take the Master’s programme as a stand-alone PCert in Independent/Supplementary Prescribing, or as one pathway into the Medicines Management programme, by studying prescribing as either the first or second year of the Medicines Management PDip.

On successful completion, the School will notify the appropriate professional/regulatory body that you have qualified as an independent/supplementary prescriber.

Modules

The following modules are indicative of those offered on this programme. This list is based on the current curriculum and may change year to year in response to new curriculum developments and innovation. Most programmes will require you to study a combination of compulsory and optional modules. You may also have the option to take modules from other programmes so that you may customise your programme and explore other subject areas that interest you.

Assessment

Assessment is by Objective Structured Clinical Examination (OSCE), assignments, case-study analysis, multiple-choice questions, short answer paper, narrative based on portfolio entries and attendance at a period of learning in practice.

Programme aims

This programme aims to:

- prepare pharmacists to practice as supplementary prescribers

- prepare nurses and midwives to practice as supplementary/independent prescribers

- develop the knowledge and skills required by an allied health professional to practice as a supplementary prescriber

- meet the standards set by the respective professional or regulatory body as required within the legislative framework.

Research areas

Chemistry and drug delivery
This group has laboratories with dedicated state-ofthe art drug delivery, nanotechnology, spectroscopy, chromatography and organic synthesis facilities. It brings together researchers in medicinal chemistry and drug design, nanotechnology and materials science, drug delivery and pharmaceutics encouraging a multidisciplinary approach to research. Research covers synthesis and biological evaluation of potential anti-cancer agents, structurebased drug design, QSAR predication of ADMET properties, controlled release, particle engineering, powder technology, pharmaceutical technology, and novel drug delivery systems, with a focus on respiratory drug delivery.

Biological sciences
This group is housed in recently refurbished laboratories with dedicated state-of-the-art molecular biological, electrophysiological, tissue culture and microscopy facilities. The research is divided into four main themes; infectious diseases and allergy; neuroscience; renal and cardiovascular physiology; and pharmacology. Examples of current work include: investigation of the use of non-pathogenic virus ‘pseudotypes’ to study pathogenic RNA, study of the properties of neuronal potassium channels and their modulation and the development of new therapies for patients that have developed acute kidney injury in collaboration with a major pharmaceutical company.

Pharmacy practice
This group conducts research in two areas: public health and medicines optimisation, with a particular focus on cardiovascular diseases and mental health. Work in public health includes studies in physical exercise, alcohol, cardiovascular screening and spirometry testing, plus pharmacovigilance. Studies in medicines optimisation include work in dementia, bipolar disorder and stroke, with an emphasis on the patient perspective.

Careers

Graduates who obtain their PhD from Kent or Greenwich are highly sought after by prospective employers, both within the UK and overseas. Destinations for doctoral graduates include university academic departments, research institutes and leading pharmaceutical and biotechnological companies.

The taught postgraduate programmes are designed to promote the continuing professional development by providing sought-after skills. The programmes are beneficial for those who wish to develop their skills and/or to take the next step in their career.

Find out how to apply here - https://www.kent.ac.uk/courses/postgraduate/apply/

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This course will be held at the Medway Campus

- https://www.kent.ac.uk/locations/medway/

The Medway School of Pharmacy’s innovative postgraduate distance-learning programme in Medicines Management equips healthcare professionals with the skills and knowledge to contribute effectively to medicines management services and to individual drug therapy decisions.

The programme emphasises clinical and costeffective prescribing in the context of holistic consideration of patient needs, and one of its pathways offers you the chance to qualify as an independent/supplementary prescriber.

Visit the website https://www.kent.ac.uk/courses/postgraduate/738/medicines-management

About Medway School of Pharmacy

Medway School of Pharmacy is one of the few regional schools of pharmacy in the UK, a collaboration between the University of Kent and the University of Greenwich.

The impetus for the formation of the Medway School of Pharmacy came from the local community, who recognised the shortage of qualified pharmacists in all branches of the pharmacy profession in Kent.

The School is now recognised as an established school with accreditation from the General Pharmaceutical Council (GPhC) and the Health and Care Professions Council (HCPC). Graduates are employed in health disciplines in Kent and the south-east and more broadly across the UK.

Course structure

You can register for the full MSc programme or undertake stand-alone modules. Modules can be put together to form a short course programme. Module length varies from five to 15 credits.

For the PCert, you must complete 60 credits, of which at least 20 must be from core modules. Diploma students must complete 120 credits, of which at least 40 credits must be from core modules. To gain the MSc, you must complete a 60-credit research project, write a dissertation and present the results as a poster.

Modules

The following modules are indicative of those offered on this programme. This list is based on the current curriculum and may change year to year in response to new curriculum developments and innovation. Most programmes will require you to study a combination of compulsory and optional modules. You may also have the option to take modules from other programmes so that you may customise your programme and explore other subject areas that interest you.

Assessment

Assessment includes case study analysis, critical appraisal of literature, assignments including short essays, a research project and dissertation.

Programme aims

This programme aims to:

- equip healthcare professionals with the skills and knowledge to contribute effectively to medicines management services and to individual drug therapy decisions in primary and secondary care.

- enable you to incorporate your learning directly into your workplace and to rise to the challenges presented by the new, patient-centred NHS.

Research areas

- Chemistry and drug delivery

This group has laboratories with dedicated state-ofthe art drug delivery, nanotechnology, spectroscopy, chromatography and organic synthesis facilities. It brings together researchers in medicinal chemistry and drug design, nanotechnology and materials science, drug delivery and pharmaceutics encouraging a multidisciplinary approach to research. Research covers synthesis and biological evaluation of potential anti-cancer agents, structurebased drug design, QSAR predication of ADMET properties, controlled release, particle engineering, powder technology, pharmaceutical technology, and novel drug delivery systems, with a focus on respiratory drug delivery.

- Biological sciences

This group is housed in recently refurbished laboratories with dedicated state-of-the-art molecular biological, electrophysiological, tissue culture and microscopy facilities. The research is divided into four main themes; infectious diseases and allergy; neuroscience; renal and cardiovascular physiology; and pharmacology. Examples of current work include: investigation of the use of non-pathogenic virus ‘pseudotypes’ to study pathogenic RNA, study of the properties of neuronal potassium channels and their modulation and the development of new therapies for patients that have developed acute kidney injury in collaboration with a major pharmaceutical company.

- Pharmacy practice

This group conducts research in two areas: public health and medicines optimisation, with a particular focus on cardiovascular diseases and mental health. Work in public health includes studies in physical exercise, alcohol, cardiovascular screening and spirometry testing, plus pharmacovigilance. Studies in medicines optimisation include work in dementia, bipolar disorder and stroke, with an emphasis on the patient perspective.

Careers

Graduates who obtain their PhD from Kent or Greenwich are highly sought after by prospective employers, both within the UK and overseas. Destinations for doctoral graduates include university academic departments, research institutes and leading pharmaceutical and biotechnological companies.

The taught postgraduate programmes are designed to promote the continuing professional development by providing sought-after skills. The programmes are beneficial for those who wish to develop their skills and/or to take the next step in their career.

Find out how to apply here - https://www.kent.ac.uk/courses/postgraduate/apply/

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These are modular part-time programmes, particularly suitable for academically gifted medical and dental trainees with the potential to be the independent researchers of the future.

It consists of two compulsory modules and four option modules selected from an extensive list of subjects. This provides the students with an opportunity to learn how the principles of health research can be translated into practical actions in selected areas.

The programmes are delivered through the Department for Continuing Education, with the expertise in curriculum design and teaching drawn from the Nuffield Department of Primary Care Health Sciences, the Centre for Evidence-Based Medicine, the Clinical Academic Graduate School and the Department of Statistics.

The two compulsory modules are:

- The Practice of Evidence-Based Health Care
- Introduction to Study Design and Research Methods

Three further modules may be chosen from List B
One further module either from List B or List C

List B:
- Clinical Trial Management
- Ethics for Biosciences
- Mixed Methods in Health Research
- Knowledge into Action
- Evidence-based Diagnosis and Screening
- Introduction to Statistics for Health Care Research
- Systematic Reviews
- Randomized Controlled Trials
- Qualitative Research Methods
- Essential Medical Statistics
- The Structure of Clinical Trials and Experimental Therapeutics
- How to do Research on Therapeutic Interventions: Protocol preparation
- Biological Therapeutics
- Pharmacodynamics, Biomarkers and Personalised Therapy
- Adverse drug reactions, drug interactions and Pharmacovigilance
- Drug development, Pharmacokinetics and Imaging

List C:
- Quality Improvement Science and Systems Analysis
- Human Factors, Teamwork and Communication
- Becoming a Medical Educator
- Teaching Evidence-Based Practice
- History and Philosophy of Evidence-Based Health Care

Course aims

This progamme is designed to enable students to:

- develop skills of research, design and data analysis in both qualitative and quantitative research

- critically evaluate health research

- identify, critically appraise and incorporate the results of medical and social science research into the day-to-day decision-making of clinical, scientific and administrative practice

- apply the principles of evidence-based practice in health care settings

- plan how to implement the findings of research to improve health care

- use theories and principles underpinning clinical research to inform their own research practice.

- demonstrate an ability to apply health research techniques appropriately for the solution of research questions;

- be able to apply health research solutions in a novel manner when analysing health research problems.

Find out how to apply here - http://www.ox.ac.uk/admissions/graduate/applying-to-oxford

Visit the Postgraduate Diploma in Health Research page on the University of Oxford website for more details!

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Obesity is a leading preventable cause of death worldwide and is highly prevalent in most modern industrialised nations. It is a global epidemic and a leading cause of several major non-communicable diseases including type 2 diabetes, cardiovascular disease and some cancers. Prevention and management is critical in reducing the considerable health costs of obesity. This online course will focus on enabling health care professionals to acquire the necessary knowledge and skills to treat patients effectively.

The course aims to create professionals who can independently access information and use the information to critically assess, evaluate and disseminate the evidence base related to Obesity and Weight Management. It will develop problem solving and clinical skills together with preparing students to take a leadership role.

On completion of the course students will have:
1. A systematic understanding of the care of patients in obesity and weight management.
2. A critical awareness of current issues affecting the care of patients undertaking weight and obesity management treatments.
3. An advanced knowledge of obesity and weight management that will facilitate decision-making in unpredictable and/or complex situations.
4. An ability to use knowledge to adapt professional practice to meet the changing demands of health care systems.

See the website http://courses.southwales.ac.uk/courses/1800-postgraduate-diploma-in-obesity-and-weight-management-online-delivery

What you will study

The course consists of 6 modules over one year, each of 6 weeks duration:

Module 1 – The adipocyte, regulation of appetite and nutrition
The module aims to develop a critical understanding of the physiology and regulation of the adipocyte, adipose tissue, human nutrition and appetite.

Module 2 – Obesity: defining obesity, epidemiology and health risks
The module aims to develop a critical understanding of the epidemiology of obesity, including the importance of the distribution of adiposity, its epidemiology, the global problems of obesity and its relationship in different populations.

Module 3 – Causation of obesity and weight gain in relation to disease and genetics
The module aims to develop an in-depth knowledge and understanding of the medical and genetic conditions that can cause obesity and weight gain.

Module 4 – Weight Management – Diet, exercise and changing behavior
The module aims to enhance the clinical skills and knowledge required to effectively evaluate and treat obesity with emphasis on lifestyle and behavioural modifications.

Module 5 – Weight Management – Medical treatments and emerging therapies
The module aims to develop an understanding of the role of medications and emerging therapies used in weight management including pharmacovigilance and post-marketing surveillance.

Module 6 – Surgical approaches to weight management
The module aims to enhance the clinical skills and knowledge required to understand surgical weight management strategies.

Learning and teaching methods

Each of the 6 modules is taught online and includes self-directed learning, tutor stimulated discussion on case scenarios, examinations, group projects and independent projects. Reflective practice is also studied which involves considering how you can apply the knowledge gained into everyday work and practice.

Work Experience and Employment Prospects

The Obesity & Weight Management courses have been developed for health professionals who are interested in a leadership role within weight and obesity management including GP’s, doctors, nurses, physicians, surgeons, physiotherapists, dieticians, psychologists, and counsellors running clinics. Following successful completion of this specialised course, you will have the knowledge to further improve patient care and it could enhance your future career progression.

Assessment methods

Assessment methods will vary for each module and include case-based examinations, discussions and scenarios, reflective portfolio, forum discussions and group activities.

Facilities

As part of your online studies you will have access to the Learning Resources Centre materials at the University of South Wales. FINDit is the University’s portal which allows you to search for over 13,000 full-text journal articles, news articles, conference proceedings and approximately 160 databases via one search box- the majority of these materials are accessible online. Interactive study skills modules are available to study via Blackboard to enable you to utilise the library services fully.

Teaching

The course is delivered by a board who have an established international reputation in Obesity & Weight Management and delivering online education:
- Dr. Steve Davies – Consultant Endocrinologist and Director of Diploma MSc
- Dr Simon Williams – Principal Lecturer, Obesity and Physical Activity Epidemiologist
- Professor Nadim Haboubi – Consultant Gastroenterologist
- Dr Dev Datta – Consultant Clinical Biochemist

Work and Study Placements

Students will usually be employed as health care professionals before commencing this course. Consequently work or study placements are not available.

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This course will be held at the Medway Campus

- https://www.kent.ac.uk/locations/medway/

Start: At any time but preferably in September

Our research programme in Pharmacy gives you the integrated, broad-based research training needed to exploit current advances in pharmaceutical and biological sciences and pharmacy practice.

Within the school we have a number of home, EU and international postgraduate students who are undertaking doctoral research degrees. Graduates who obtain their PhD from Kent or Greenwich are highly sought after by prospective employers, both within the UK and overseas. Destinations for doctoral graduates include university academic departments, research institutes and leading pharmaceutical and biotechnological companies.

Visit the website https://www.kent.ac.uk/courses/postgraduate/171/pharmacy

About Medway School of Pharmacy

Medway School of Pharmacy is one of the few regional schools of pharmacy in the UK, a collaboration between the University of Kent and the University of Greenwich.

The impetus for the formation of the Medway School of Pharmacy came from the local community, who recognised the shortage of qualified pharmacists in all branches of the pharmacy profession in Kent.

The School is now recognised as an established school with accreditation from the General Pharmaceutical Council (GPhC) and the Health and Care Professions Council (HCPC). Graduates are employed in health disciplines in Kent and the south-east and more broadly across the UK.

Study support

- Postgraduate resources

Postgraduate students have access to all the facilities at the Medway School of Pharmacy, including clinical skills labs and a ‘simulation man’. As the School of Pharmacy is a joint venture between the two universities, students have access to facilities at Kent’s Medway and Canterbury campuses, and the University of Greenwich.

- Dynamic publishing culture

Medway School of Pharmacy has a research culture and as such postgraduate students publish regularly and widely in journals, conference proceedings and books. Among others, they have recently contributed to: International Journal of Pharmacy Practice; Nephron Physiology; Acta Physiologica; Purinergic Signalling; and European Journal of Pharmacology.

- Researcher Development Programme

Kent's Graduate School co-ordinates the Researcher Development Programme for research students, which includes workshops focused on research, specialist and transferable skills. The programme is mapped to the national Researcher Development Framework and covers a diverse range of topics, including subjectspecific research skills, research management, personal effectiveness, communication skills, networking and teamworking, and career management skills

Research areas

The Medway School of Pharmacy houses strong and vibrant research groups that span a range of pharmacy-related areas. Staff have a wealth of research experience, and UK and international links with both industry and academic institutions.

- Chemistry and drug delivery

This group has laboratories with dedicated state-ofthe art drug delivery, nanotechnology, spectroscopy, chromatography and organic synthesis facilities. It brings together researchers in medicinal chemistry and drug design, nanotechnology and materials science, drug delivery and pharmaceutics encouraging a multidisciplinary approach to research. Research covers synthesis and biological evaluation of potential anti-cancer agents, structurebased drug design, QSAR predication of ADMET properties, controlled release, particle engineering, powder technology, pharmaceutical technology, and novel drug delivery systems, with a focus on respiratory drug delivery.

- Biological sciences

This group is housed in recently refurbished laboratories with dedicated state-of-the-art molecular biological, electrophysiological, tissue culture and microscopy facilities. The research is divided into four main themes; infectious diseases and allergy; neuroscience; renal and cardiovascular physiology; and pharmacology. Examples of current work include: investigation of the use of non-pathogenic virus ‘pseudotypes’ to study pathogenic RNA, study of the properties of neuronal potassium channels and their modulation and the development of new therapies for patients that have developed acute kidney injury in collaboration with a major pharmaceutical company.

- Pharmacy practice

This group conducts research in two areas: public health and medicines optimisation, with a particular focus on cardiovascular diseases and mental health. Work in public health includes studies in physical exercise, alcohol, cardiovascular screening and spirometry testing, plus pharmacovigilance. Studies in medicines optimisation include work in dementia, bipolar disorder and stroke, with an emphasis on the patient perspective.

Careers

Graduates who obtain their PhD from Kent or Greenwich are highly sought after by prospective employers, both within the UK and overseas. Destinations for doctoral graduates include university academic departments, research institutes and leading pharmaceutical and biotechnological companies.

Find out how to apply here - https://www.kent.ac.uk/courses/postgraduate/apply/

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Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related products.

The importance of internationally harmonized regulations and future trends in the industry will be examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices, good laboratory practices, good clinical practices, good documentation practices, the International Organization for Standardization (ISO), the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are emphasized and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

You will become familiar with the steps necessary for product submission; how to assemble documents and statistical evidence; the complexity of product registration, negotiation and follow-up, and how these are linked to the federal government and provincial formularies.

Course detail

Upon successful completion of the program, a graduate will:
• Describe the government processes within the Canadian health care system and provincial formularies.
• Explain the roles and responsibilities of a regulatory professional in industry.
• Explain the concepts in pharmacoeconomics as they relate to the socioeconomic aspects of health care and health care products.
• Explain Canadian and international health care legislation and regulations including (as examples) Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, Good Documentation Practices, International Standards Organization (ISO), Food and Drug Act Regulations, the Environmental Protection Act, Regulatory compliance/inspection, Drug Establishment Licensing and related standards and guidelines.
• Describe international harmonization of regulations and the impact on manufacturing and the submission process.
• Explain the Product Development Process.
• Outline the Quality Control Process.
• Demonstrate information technology skills in the use of software applicable to regulatory affairs submissions, in document and database management systems, in data correction techniques and in the use of the Internet for research.
• Define drug (prescription and non-prescription)/medical device/biologic submission process requirements.
• Prepare a drug/medical device/biologic submission to the Therapeutic Products Program (TPP) including supplemental documentation.
• Demonstrate the problem solving process as it relates to pharmacovigilance and post-marketing surveillance.
• Demonstrate effective interviewing and negotiating skills in managing a clinical study.

Modules

Semester 1
• REGA 5020: Health Care Legislation, Regulation and Guidelines
• REGA 5021: Product Development-Premarket
• REGA 5022: Product Development-CMC
• REGA 5023: Medical Products Safety
• REGA 5024: Communication
• REGA 5025: Pathophysiology and Pharmacology

Semester 2
• REGA 5030: Management of Regulatory Submissions
• REGA 5031: Management of Global Regulatory Submission
• REGA 5033: Regulation of Food Products and Agrichemicals
• REGA 5034: Medical Devices
• REGA 5035: Provincial Formularies and Reimbursement Policy
• REGA 5036: Emerging Biotechnology

Semester 3
• REGA 5040: Internship
• REGA 5041: Integative Seminar

Work Placement

Following two academic course-based semesters, students complete a three-month placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Most placements are in the following sectors: pharmaceutical, biotechnology, medical device organizations, government agencies or food industries.

Your Career

Our graduates work in a spectrum of fields such as pharmaceutics, biotechnology, medical devices, natural health product industries or in government.

How to apply

Click here to apply: http://humber.ca/admissions/how-apply.html

Funding

For information on funding, please use the following link: http://humber.ca/admissions/financial-aid.html

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This course is designed to advance and enhance a career in Clinical Research in the pharmaceutical industry, health service, contract research organisations, regulatory authorities, data management organisations and in medical writing.

It aims to provide the postgraduate students with an enhanced level of knowledge, understanding and skills in clinical research. It presents an overview of clinical trial processes and the regulations for bringing in a new chemical entity, and it provides an enhanced level of knowledge and understanding of therapeutic areas and their treatments in relation to clinical trials, drug registrations and drug safety.

The course is designed to increase the knowledge and skills of the student not only in Clinical Research but also in a diverse range of therapeutic areas. This allows the individual to move confidently between these therapeutic areas and therefore increase their potential value to employers. In the dissertation year, students are encouraged to carry out projects which have direct value to their employer and this potentiates the worth of their studies.

Distinctive features

• Lecturers from Pharmaceutical Industry provide an up-to-date development in Clinical Research
• Clinical Research trainers deliver a variety of teaching methods
• The therapeutic modules widen the skills of the student in an array of medical settings
• The diversity of employment backgrounds of participants affords an ideal environment for networking with other clinical research personnel.

Structure

The programme is studied over 3 calendar years of part-time study and is in a modular format. 

Taught modules are undertaken in the first two years, two in each year. Participants who successfully complete these modules may either receive a Postgraduate Diploma (PGDip) in Clinical Research as an exit award, or progress on to carry out an individual project in the third year for the MSc qualification.

Initial PgDip topics covered in the first two years include:

Clinical Research
Drug Development
Therapeutics of the Respiratory and Central Nervous Systems
Advanced Clinical Research
Regulatory Affairs
Complementary Therapeutics
Pharmacovigilance
Cardiovascular and Immunological Diseases and Oncology

The MSc is attained through completion of a dissertation in Year 3.

Teaching

The course will be taught through a series of lectures and workshops, coursework assignments and course journal preparations aimed at developing transferable skills in critical analysis.

Self-directed study forms an important part of the course, and you will be directed in study skills and guided in the areas for study. You will be expected to manage your own time to undertake significant independent study during the dissertation phase in particular.

 Students are expected to attend all timetabled sessions and are also expected to engage in independent study. Course materials are delivered in our Virtual Learning environment (Learning Central). 

Assessment

Knowledge and understanding are assessed both formatively and summatively by written examinations and by performance in course work, practice based course-work assignments, project work and dissertation.

Project work including the design of clinical report forms and other practice based assignments and case studies are assessed from written reports with feedback.  Statistical skills are acquired via didactive methods and tested using practice-based scenarios, likewise in relation to medicines safety and the detection of fraud in clinical research.  Critical appraisal skills are acquired throughout the programme through the interpretation and analysis of published clinical research data.  Production of the dissertation requires a substantive literature review and leads to enhanced written and presentational skills, the dissertation being examined by thesis.

Career Prospects

The course is designed to give students the skills and knowledge needed to advance and enhance a career in Clinical Research in the pharmaceutical industry, Health service, contract research organisations, regulatory authorities, data management organisations and in medical writing.

Successful students on this programme will have an advanced standing both clinically and academically, taking them to the forefront of the profession, and enhancing their personal and professional development.

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