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The drug delivery and packaging industries are rapidly expanding, with pre-filled
syringes alone predicted to exceed $4.0bn by 2015. Hence, pre-filled syringes provide
an excellent platform for driving innovation and adding market value to your product.
This unique and interactive workshop will explore the key factors affecting prefilled
syringe development and will provide an ideal opportunity for attendees to
debate design techniques and migration, extractables and leachables studies, with
an expert in the parenteral field. This workshop will also focus on best practice strategies
when working with regulatory authorities and producing an effective regulatory
strategy.

  • Discover efficient pre-filled syringe system development – from vial to PFS
  • Establish innovative solutions to common obstacles that may be encountered
  • Share insight with experienced specialists in the fields of leachables and extractables
  • Study relevant cases studies in migration and what we can learn from the past
  • Investigate the production of a regulatory strategy
  • Network with key industry executives
Chief Executives, Vice Presidents, Heads, Directors and Project Leaders of:
• Business Development
• Chemistry, Manufacturing,
Controls
• Commercial Operations
• Contract Management and
Partnering
• Drug Delivery Systems
• Drug Device Process
Development
• Drug Device Safety
• Drug Product Process
Development
• Formulation & Aseptic Filling
Technologies
• Industrial Development
• Labelling
• Medical Affairs
• Manufacturing
• Novel Drug Delivery Systems
• Packaging Development
• Parenterals
• Pharmaceutical Sciences
• Product/Pharmaceutical
Design & Development
• Quality Assurance
• Regulatory Affairs
• Safe Medication Practice
 

Workshop programme

8:30 Registration & Coffee

9:00 Welcome and Introduction

Horst Koller

Horst Koller, Head of Technical and Quality Support Syringes , Schott Schweiz A G

Anil Busimi

Anil Busimi, Head of Global Product Manager, SCHOTT Schweiz AG

9:10 Developing a Pre-Filled Syringe System

  • From vials to a PFS
  • Common obstacles that may be encountered
  • Horst Koller

    Horst Koller, Head of Technical and Quality Support Syringes , Schott Schweiz A G

    Anil Busimi

    Anil Busimi, Head of Global Product Manager, SCHOTT Schweiz AG

    10:10 Morning Coffee

    10:30 Producing a regulatory strategy

  • Fill-Finish of PFS
  • Extractable and Leachables
  • Migration studies
  • What can we learn from the past
  • Anil Busimi

    Anil Busimi, Head of Global Product Manager, SCHOTT Schweiz AG

    Horst Koller

    Horst Koller, Head of Technical and Quality Support Syringes , Schott Schweiz A G

    11:30 Interactive Q&A session

    Anil Busimi

    Anil Busimi, Head of Global Product Manager, SCHOTT Schweiz AG

    Horst Koller

    Horst Koller, Head of Technical and Quality Support Syringes , Schott Schweiz A G

    12:30 Close of Masterclass

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    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    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)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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