Home
Best practice for benefit-risk assessment in the new PSUR
9 April 2013
Best practice for benefit-risk assessment in the new PSUR

The EMA expects MAHs to submit the new PSUR (from early 2013). This marks a paradigm shift. The PSUR will change from being a largely based on-line listings, narratives and simple sales-based incidence statistics to a benefit-risk assessment tool with a much more statistical and quantitative approach to adverse event data with the incorporation of efficacy (including patient-reported outcome) data. The master class will provide attendees with the essential skills to ultimately confront the newly revised and incorporated elements of benefit-risk analysis for the new PSUR in their company.

The master class, led by the Oxon Epidemiology team, will explore the purpose and structure of benefit risk analysis of the new PSUR. This master class will enable delegates to work with experts in quantitative risk based analysis and pharmacovigilance to help plan and submit a PSUR with an appropriate benefit-risk assessment

Masterclass agenda

clock

8:30

Registration & Coffee

clock

9:00

Chairman's Opening Remarks

clock

9:30

Welcome introductions

clock

9:45

Purpose and new legislation of the new PSUR (PBRER)

  • Implementation
  • Compliance
  • System Tracking
  • Quality
  • Auditability
  • Links with RMP and Signal Detectio
  • clock

    10:30

    Change in paradigm of the new PSUR with ‘GVP’ & understanding quantitative concepts

    clock

    11:00

    Morning Coffee

    clock

    11:20

    Change in paradigm of the new PSUR with ‘GVP’& understanding quantitative concepts

    clock

    12:00

    Methodologies of benefit-risk assessment

  • Approaches with advantages and disadvantages
  •  

    clock

    13:10

    Lunch

    clock

    14:00

    Statistical methods and data requirements

  • Clinical efficacy/ effectiveness data
  • Safety data
  • Patient reported outcome efficacy data
  • Meta-analysis of efficacy and safety data
  • Statistical signal analysis
  • Preferences and values
  • clock

    15:20

    Afternoon Tea

    clock

    15:40

    Discussion: Planning for the new PSUR for new and old products and resources

    clock

    16:15

    Practical Case: Planning risk benefit assessments for new and old drugs

    clock

    17:15

    Review of the day

    clock

    17:30

    End of Masterclass

    Holiday Inn Kensington High Street

    Wrights Lane
    Kensington
    London
    United Kingdom

    Holiday Inn Kensington High Street

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.