The EMA expects MAHs to submit the new PSUR (PBRER) which marks a paradigm shift. The PSUR will change from being largely a document based online listings, narratives and simple sales-based incidence statistics to a benefit-risk tool with a much more statistical and quantitative approach to adverse event data, and including the incorporation of efficacy data. Risk minimisation measures have negative as well as positive consequences and these should be evaluated. The masterclass will provide attendees with the necessary exposure to approach the elements of benefit-risk analysis for the new PSUR in their company for new and old drugs, and approaches to evaluate the positive and negative effects of risk minimisation measures.

Understand the requirements of the European GVP legislation for the New PSUR ?

Appreciate the concepts behind quantitative BRA and why and when quantification is necessary ?

Understand the process for undertaking BRA and the evidence and data requirements ?

Describe the role of quantitative models in BRA and understand regulatory expectations including the current opinion of the European working groups

Understand methodological options available and their pros and cons

Appreciate the principles and practice of statistical BRA including the advantages and disadvantages of the principal methods ?

Discuss how to implement/optimise BRA for the new PSUR in your company for old and new products, and learn what other companies are implementing ?

Learn approaches to evaluate the negative and positive effects of risk minimisation measures

Masterclass programme

9:00 Registration & Coffee

9:30 Welcome and Introductions

9:45 Regulatory expectations for the new PSUR (PBRER)

10:30 Understanding quantitative concepts (1)

11:00 Morning Coffee

11:20 Understanding quantitative concepts (2)

12:00 Methodologies of benefit-risk assessment

13:10 Networking Lunch

14:00 Statistical Methods & Data Requirements

15:20 Afternoon Coffee

15:40 Discussion: Planning for the new PSUR for new and old products in your company

16:15 Evaluation of the positive and negative effects of additional risk minimisation plans

17:15 Review of the Day

17:30 End of Masterclass



MSE Meeting Rooms

103a Oxford Street, London, United Kingdom


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MSE Meeting Rooms

103a Oxford Street
United Kingdom

MSE Meeting Rooms



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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, SMI 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@smi-online.co.uk

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UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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