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From early 2013, the EMA will expect MAHs to submit the new PSUR which marks a paradigm shift. The PSUR will change from being a largely a document based on line listings, narratives and simple sales-based incidence statistics to a benefit-risk tool with much a more statistical and quantitative approach to adverse event data, and including the incorporation of efficacy data. The workshop will provide attendees with the necessary exposure to confront the elements of benefit-risk analysis for the new PSUR in their company.

Led by the expertise of the Oxon Epidemiology team, this unique masterclass will explore the purpose of the PSUR and th structure of benefit-risk analysis in this new paradigm.

This masterclass will present attendees with the opportunity to work with experts in in quantitative benefit-risk analysis and pharmacovigiliance to plan a draft PSUR and a benefit-risk analysis.

Key Benefits of Attending:

Understand the concepts of the new PSUR
Appreciate the vocabulary and methodology of benefit-risk analysis
Learn from best practices and details of benefit-risk analysis for PSURs
Maximise the skills available to your organisation to conduct good quality benefit-risk assessment for the new PSUR
Practice with real life case examples
Avoid the pitfalls of poor benefit-risk analysis

Masterclass programme

9:00 Registration & Coffee

9:30 Welcome and Introductions

9:40 What is the purpose of the PSUR?

10:00 Change in paradigm of the new PSUR with 'GVP'

10:20 New PSUR as a benefit-risk tool

11:00 Morning Coffee

11:20 Data requirements and structure of benefit-risk analysis for the new PSUR:

13:10 Networking Lunch

14:00 Planning the benefit-risk elements of the new PSUR

14:30 Exercise: Plan a benefit-risk analysis

15:00 Importance of quality in benefit-risk assessment

15:20 Afternoon Tea

15:40 Skills and collaboration with other departments

16:10 Exercises: Plan a draft PSUR for the risk benefit assessment sections

17:00 Discussion Session

17:30 End of Masterclass


Holiday Inn Bloomsbury

Coram Street
London WC1N 1HT
United Kingdom

Holiday Inn Bloomsbury

Holiday Inn London-Bloomsbury is just 2 minutes' walk from the Tube at Russell Square station, for speedy connections across the capital. We're 10 minutes by bus from Eurostar connections at St Pancras station, and a 45-minute taxi ride from London Heathrow Airport. Check into your stylish Guest room, air-conditioned and connected to wireless Internet.



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CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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Opening Hours: 9.00 - 17.30 (local time)
SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
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Website: http://www.smgconferences.com Email: events@saemediagroup.com
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