Drug Safety Research Unit

Postgraduate Certificate (PgC), Diploma (PgD) and

Masters (MSc) in Pharmacovigilance

A collaborative partnership with The University of Portsmouth School of Pharmacy and Biomedical Science

www.dsru.org www.dsru.org

RESPECTED

KNOWLEDGEABLE

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YOUR ROUTE TO CAREER EXCELLENCE

REGISTRATION

COURSE FEES

TO REGISTER CANCELLATIONS

To register for the PgC, PgD or MSc, please complete a registration form which is available upon request from the Education & Training team, EandT@dsru.org.

Course fees consist of individual unit fees and annual academic enrolment fees.

Individual unit fees = £1090.00 + VAT. A 15% discount on unit fees is applied when four units are invoiced together for fast-track registration, or two units are invoiced together for standard registration (see below).

Annual academic enrolment fees are payable for every two units of study in a 12 month period. For 2019/2020 the fee is £600.00 + VAT (two units) or £1200.00 + VAT (four units). Enrolment fees will increase slightly each year.

All fees are subject to UK VAT, currently 20%.

Tel: +44 (0)23 8040 8621Email: EandT@dsru.org Post: Drug Safety Research Unit, Bursledon Hall, Southampton SO31 1AA, UK

If a delegate has to cancel attendance on a course, under normal circumstances no refund of the course fee can be offered. Delegates may defer attendance to chosen units, however additional year fees may apply. In exceptional circumstances, cancellations will be dealt with on an individual basis. Cancellations must be received in writing.

Credits Enrolment fees Unit fees* Total

PgC Fast-track 60 £1200.00 £3706.00 £4906.00

PgC StandardYear 1 30 £600.00 £1853.00 } £4926.00

Year 2 30 £620.00 £1853.00

PgD Fast-trackYear 1 60 £1200.00 £3706.00 } £9852.00

Year 2 60 £1240.00 £3706.00

PgD StandardYear 1 30 £600.00 £1853.00

}£9932.00

Year 2 30 £620.00 £1853.00

Year 3 30 £640.00 £1853.00

Year 4 30 £660.00 £1853.00

MSc Project 60 £1950.00 £600.00 £2550.00

* Includes 15% discount on course fees applied to either fast-track registration when at least four units are invoiced at once or, standard registration when at least two units are invoiced at once.

DSRU Education & Research Limited (Reg. No 4213474) is a company limited by guarantee where all profits go to the Drug Safety Research Trust, an independent charity (No. 327206). The DSRU reserves the right to alter the dates, times, programmes, speakers or venues.

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Who should register?• Pharmaceutical industry personnel working in areas

including drug safety, clinical research, medical affairs, medical writing, regulatory affairs and medical information

• Staff from academic and research units working in drug safety or pharmacovigilance departments

• Regulatory authority staff• Independent medical writers• QPPVs

Programme features• Choice of units relevant to your career• Minimal time away from your workplace• Access to a virtual learning environment to support

your study• Lecturers who are internationally renowned experts in

their field• Recognition of prior learning, certified or experiential,

which may count towards the PgD and MSc awards• Delegates who have attended a relevant DSRU course

in the last two years may count that course towards the PgC, PgD or MSc by completing the necessary pre-course and post-course assignments.

Application processApplication forms are available upon request from the Education & Training team, EandT@dsru.org.

Standard entry requirements• Either a first or second class honours degree in the

biosciences, veterinary science, dentistry, pharmacy or medicine

• Or a degree in another subject together with a portfolio demonstrating suitability for study on this course (portfolio should include: CV, training certificates, Manager’s letter explaining suitability for the course, detailed job description and 6 months experience in Pharmacovigilance)

• Proficiency in English, as demonstrated by an approved test (if English is not your first language)

Fast-track or standard registration?On registration students choose either:• Fast-track registration (four units must be completed in

12 months)• Standard registration (two units must be completed in

12 months)The 12 month period commences on the date of your registration with the University of Portsmouth. Transfer between fast-track and standard registration is only possible at the point of re-registration.

LocationUnits are generally held in London or the Southampton area, UK. The venues are carefully chosen to provide pleasant accommodation and excellent travel accessibility.

• Three awards are available: • PgC – Three compulsory units with a further unit chosen from eight optional units (60 credits) • PgD – Three compulsory units plus five from eight optional units (120 credits) • MSc* – Three compulsory units plus five from eight optional units plus MSc research project

(180 credits)• Students will undertake 60 credits in the form of part-time study over a period of one or two years

for the PgC, a further 60 credits over the next one or two years for the PgD and then undertake a research project over one to three years for a further 60 credits for the MSc. The duration of each award depends on whether fast-track or standard route is selected.

• The University operates a system through which you can gain recognition of prior learning (certified/experiential). This is applicable to PgD and MSc awards.

• Assessments - The short taught courses are supplemented with pre and post-course assignments.

• Intake dates for 2019 - 2020; 2 September 2019, 6 January 2020, 1 June 2020.

* Students must complete the PgD before enrolling onto the MSc

WelcomeThere is a growing need for qualified professionals within pharmacovigilance, at regulatory authorities and in academia – yet competition for the best roles is highly competitive and challenging. Make yourself a prime candidate for the role you aspire to by studying with DSRU.In association with the University of Portsmouth, we’ve developed accredited postgraduate awards in pharmacovigilance. Learn from one of Europe’s leading pharmacovigilance training providers with an established reputation for academic excellence, to gain an industry recognised qualification in a flexible way that fits around your work and lifestyle.

KEY FEATURES OF OUR FLEXIBLE STUDY PROGRAMME

OVERVIEW OF UNITS FOR PGC, PGD AND MSC IN PHARMACOVIGILANCE

Unit Title Credit Points

Award

Back to Basics in Pharmacovigilance 15 PgC/PgD - Compulsory

Introduction to Pharmacoepidemiology 15 PgC/PgD - Compulsory

Medical Aspects of Adverse Drug Reactions 15 PgC/PgD - Compulsory

Assessment and Medical Evaluation of IndividualCase Safety Reports

15 PgC/PgD – Optional

Monitoring Safety in Clinical Trials and Drug Development 15 PgC/PgD – Optional

Risk Benefit Assessment in Pharmacovigilance 15 PgC/PgD – Optional

Global Pharmacovigilance Regulatory Requirements: What’s New? 15 PgC/PgD – Optional

Periodic Safety Reports (PSURs, PBRERs and Introduction to DSURs) 15 PgC/PgD – Optional

EU Regulations & Guidelines in Pharmacovigilance 15 PgC/PgD – Optional

Pharmacovigilance in Products Subject to Licensing Agreements 15 PgC/PgD – Optional

Pharmacovigilance Planning & Risk Management 15 PgC/PgD – Optional

MSc Research Project 60 MScContact usFor further information or to discuss your study and training needs, please contact us at EandT@dsru.org or telephone +44 (0)23 8040 8621.