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Optimizing Pharmacovigilance in Affiliates
16 March 2011
Optimizing Pharmacovigilance in Affiliates

Overview of Workshop

Developing and maintaining an effective system for the monitoring of clinical trial status and activities in affiliate and outsourced organisations is essential. This runs especially true when the number of affiliates and their external partners can number in the hundreds.

The aim of this briefing is to address the importance of working with your affiliates in order to ensure optimal pharmacovigilance, and to ensure that processes are in place to enable an oversight by central functions and the EUQPPV. The format of the workshop will be presented as an interactive experience with ideas exchanged, and opportunities will be presented and strategies outlined for overcoming challenges faced when developing Pharmacovigilance activities.

  

Programme will include:

  • Facts and case studies of key Roche affiliates
  • Why not knowing what is going on with global affiliates
  • is a vulnerability to the company
  • Effective risk management and mitigation

About the Workshop Leader:

Katja Kusche, MD PhD is an Anaesthesiologist by training with 7 years hospital experience and 13 years in the Pharma Industry working on Drug safety. She spent her first 3 years on the affiliate level (HMR Germany), and since 2000 has worked at the Roche Global Safety Risk Management division. Katja is currently the Global Head Mature of Products in Safety Science at Hoffmann-La Roche.

 

 

Workshop agenda

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8:30

Registration & Coffee

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8:50

Welcome and introductions

Katja Kusche

Katja Kusche , Safety Science Global Head Mature Products, Hoffmann-La Roche Ltd

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9:00

Introduction into the topic

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9:30

Presentation of the Roche initiative to optimise PV in affiliates

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10:00

Discussion: The interaction between global safety departments and safety affiliate organisations

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10:30

Morning coffee

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11:00

Role and responsibility of Local Safety Responsible (LSR)

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11:30

Exercise/brain storming session

  • Local study activities - Ways to maintain central oversight
  • Cross functional collaboration at the affiliate - How to link to global drug safety
  • Local risk management activities and related assessments
  • clock

    12:30

    Wrap up with summary and questions

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    13:00

    Close of workshop

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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.

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    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)

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    ‘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.

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    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.

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