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The workshop will explore the analytical requirements for developing and validating assays in support of Preclinical and Clinical Biosimilar Drug Development. The main focus will be on the Immunogenicty assay requirements but the requirements for PK and Biomarker assays will also be discussed. This will be detailed analysis of both the regulatory and clinical requirements for immunogenicty assessment. Workshop will present Case studies of how assays have been developed and validated in support of Biosimilar drug Development

• To get an understanding of the clinical and regulatory considerations for immunogenicty assessments
• To get an understanding on how Immunogenicty assays can be developed and validated for Biosimilar Drug development
• See data from actual Case Studies
 

Workshop programme

13:30 Registration & Coffee

John Chappel

John Chappel , Head of Immunoassay, CPR Services

Bracha Timan

Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

14:00 Importance of Immunogenicity Assesments

  • Clinical Considerations
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

    14:30 Immunogenicity rates for the originator

  • PK profile
  • Disease populations
  • Risk based strategy
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

    15:00 Afternoon Tea

    15:30 Regulatory Guidance's and White Papers

  • EMA and FDA Guidance's
  • Industry White Papers
  • AAPS Biosimilar APC committee
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

    16:00 In-vitro Immune Stimulation Assays

     

    Screening and confirmatory Assays
    ·         What Assays to use
    ·         Development of 1 Assays v 2 Assays
    ·         Positive Control Selection
    ·         Calculation of Cut points
    ·         Statistical Requirements (do you need a Biostatistician)
    ·         Drug Tolerance
    ·         Sensitivity
    ·         Stability
     
    Neutralising Assays
    ·         Choice of Assays
    ·         Functional Assays v Competition Ligand Binding
    John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

    16:30 PK Assays in support of Biosimilar Development

  • Biomarker Assays in support of Biosimilar development
  • John Chappel

    John Chappel , Head of Immunoassay, CPR Services

    Bracha Timan

    Bracha Timan, Director, Head of Global Bioassays and Technology, TEVA Ltd

    17:00 Chairman’s Closing Remarks and Close of Day One

    +

    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

    HOTEL BOOKING FORM

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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, 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.

    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@smi-online.co.uk

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
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