Adverse Drug Reactions, Drug Interactions, Pharmacovigilance
- 1 Overview
- 2 Programme details
- 3 Certification
- 4 Accommodation
- 5 IT requirements
- 6 Fees
- 7 Funding
- 8 Payment
- 9 Tutors
- 10 Course aims
- 11 Teaching methods
- 12 Assessment methods
- 13 Application
- 14 Level and demands
- 15 REFERENCES:
The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Michael Theodorakis, Radcliffe Department of Medicine, University of Oxford, and will feature face-to-face lectures and tutorials from some of the country's leading clinicians and scientists.
The module can be taken as a stand-alone short course. It includes group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers.
The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course will provide students with the opportunity to learn more about and discuss the following topics :
- Safety of medicines for human use – principles and framework
- Adverse drug reactions – mechanisms, analysis, reporting, vulnerable populations
- Drug interactions – epidemiology, mechanisms, detection and prevention
- Principles of optimal pharmacotherapy
- Pharmacovigilance – principles, methodologies, risk management & pharmacoepidemiology
- Clinical trials – bioethics of drug safety, pharmacovigilance in trial design, applications for marketing authorisation
- Regulatory framework and legislation
This course can be taken:
- as a 5 day short course (for credit or not for credit)
- as part of the MSc in Experimental Therapeutics
- as part of the Postgraduate Diploma in Health Research
- as part of the Postgraduate Certificate in Health Research
This course will be held at the Department for Continuing Education, Rewley House, Oxford.
Short course participants who do not wish to undertake the assessed work required for academic credit but who do satisfy the course attendance requirements will receive a certificate of attendance. The sample above is an illustration only, and the wording will reflect the course and dates attended.
Those successfully completing the course for credit can request a CATS point transcript.
Accommodation is available at the Rewley House Residential Centre, within the Department for Continuing Education, in central Oxford. The comfortable, en-suite, study-bedrooms have been rated as 4-Star Campus accommodation under the Quality In Tourism scheme and come with tea- and coffee-making facilities, free Wi-Fi access and Freeview TV. Guests can take advantage of the excellent dining facilities and common room bar, where they may relax and network with others on the programme.
This course uses the Department’s online assignment submission system and online courseware. In order to participate in the course and to prepare and submit your course assignments you will need access to the Internet and a computer meeting our recommended minimum computer specification. Students of this course may use the student computing facilities provided in Departmental buildings.
Stand-alone short course: £2030.00
Students enrolled on the MSc in Experimental Therapeutics: £1790.00
Details of funding opportunities including grants, bursaries and scholarships are available on our sources of funding page.
The course fee includes:
- Course materials
- Refreshments and a three course lunch on each day of the course
- Access to the following University of Oxford libraries and services :
- Radcliffe Science Library
- Rewley House Continuing Education Library
- Bodleian Libraries e-Resources
- Access to facilities from the Department of Continuing Education, including :
- The Graduate School
- WebLearn virtual learning environment
- Wi-fi access through Oxford Wireless LAN (OWL).
Dr Michael Theodorakis
Tutor and Module Lead
Dr Theodorakis is a Senior Clinical Researcher at the Diabetes Trials Unit, Oxford Centre for Diabetes Endocrinology and Metabolism, University of Oxford. He is the Clinical Lead of large scale clinical trials and Principal Investigator on early phase studies with the Translational Research Group at the Oxford Biomedical Research Centre.
He is also an Honorary Consultant Physician in the Oxford University Hospitals NHS Foundation Trust. He has served in the past and continues to serve as a Member of Committees at the European Medicines Agency and other EU Commission workgroups along with his continuing membership in many prominent professional societies and scientific associations in Europe and the US.
Dr Theodorakis has long been involved in clinical research and has been especially active in translational research, focusing on innovative pharmacological design and development of novel compounds for human use.
The course has been designed to:
- introduce students to concepts of adverse drug reactions in terms of epidemiology and classification, mechanisms and monitoring and prevention
- enable students to undertake systematic reviews of adverse drug reactions
- enable students to understand and analyse drug interactions in terms of epidemiology, mechanisms and prevention
- enable students to appreciate beneficial drug interactions using combinations of drugs
- enable students to understand and use pharmacovigilance methodologies.
The course will be taught by a range of scientists leading these areas of research, and there will be significant time programmed to discuss the scientific and sometimes ethical issues raised by this area of medical research.Virtual learning environment (VLE) and access to some of the University of Oxford’s online resources will provide support for those taking the course for credit. It will include group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers.
A virtual learning environment (VLE) and access to some of the University of Oxford’s online resources will provide support for those taking the course for credit.
Assessment will be based on submission of a set written assignment, not exceeding 4,000 words. The assessment is only undertaken by those taking the course for academic credit.
Those wishing to may apply to take the course with accreditation. The University of Oxford Department for Continuing Education offers Credit Accumulation and Transfer Scheme (CATS) points for the course. Participants attending at least 75% of the taught course and successfully completing assessed assignments are eligible to earn credit equivalent to 20 CATS-equivalent points which may be counted towards a postgraduate qualification.
Application deadline: two weeks before the commencement of the course.
We strongly recommend that you download and save files before completing to ensure that all your changes are saved.
This course requires you to complete the application form and the additional information form below, and submit them alongside a copy of your CV. If you are applying to take this course for academic credit you will also need to complete section two of the reference form and forward it to your referee for completion. Please note that if you are not applying to take the course for academic credit then you do not need to submit a reference.
Please ensure you read the guidance notes before completing the application form as any errors resulting from failure to do so may delay your application.
- Short Course Application Form and Guidance Notes
- Additional Information Form
- Reference Form
- Terms and Conditions
Level and demands
The course will appeal to health professionals from a wide range of backgrounds, including: qualified doctors especially specialist registrars in clinical pharmacology or in training for other medical sub-specialities; clinical research fellows; pharmacists; nurses; graduates working in the pharmaceutical industry or in academic clinical trials.