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Risk Minimisation Measures: Implementation, Evaluation and Results of EU Studies
15 July 2014
Risk Minimisation Measures: Implementation, Evaluation and Results of EU Studies

Learn about risk minimistion studies, their implementation and evaluation in Europe from two EMA experts: a regulator on the EMA PRAC committee and a clinical pharmacoepidemiologist at ENCePP.

Masterclass agenda

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8:30

Registration and Coffee

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9:00

Context and regulatory background

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9:30

GVP regulations for risk minimisation

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9:40

Levels of risk minimisation measures for regulators

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11:00

Morning Coffee

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11:20

Available tools and guidance at the EU level

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13:00

Lunch

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14:00

How to select risk minimisation measures

  • Designs and data sources to evaluate the effectiveness of risk minimisation measures
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    15:00

    Review of the results of risk minimisation measures

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    15:30

    Afternoon Tea

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    15:45

    Usefulness of benefit-risk analysis

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    16:15

    Challenges and ways forward

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    16:45

    How to discuss risk minimisation measures and studies with regulators

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    17:05

    Using an evidence based toolkit

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    17:30

    End of masterclass

    VENUE

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    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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    WHAT IS CPD?

    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.

    CPD AND PROFESSIONAL INSTITUTES

    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.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    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.

    GLOBAL CPD

    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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