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Why should you attend this event?

This half day masterclass will provide an overview of the relevant practical aspects of developing and designing pre-filled syringe systems focusing on functionality testing and regulatory issues. Within the course ready-to-fill syringe system concepts will be presented and discussed.

Where does the event take place?

This Master Class will take place in central London, UK


Add to Basket - £599 


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What is this event about?

Recent years have seen a rise for pre-filled syringes from a niche product to the primary container of choice for most parenteral drug delivery systems.  This is the result of a number of factors, although the improved safety and increased convenience of a pre-fillable device is the leading reason.  The global market for pre-fillable syringes today comprises of more than 2.2 billion syringes, with over half of these supplied sterile. This Master Class aims to address the development of pre-fillable syringe systems as well as examine the documentation and regulatory issues faced by these systems.

Participants will learn the design approach for a pre-fillable syringe system in regards to functionality, container closure integrity, extractables and leachables, both from a vendor's and customer's perspective.

Who is leading this event?

The Master Class is being led by Horst Koller, Head of Regulatory Affairs, SCHOTT forma vitrum.

Horst Koller started his professional career in 1994 to work for Abbott Diagnostics GmbH managing the Process Engineering Group.

In 2000 he joined SCHOTT in the business segment Pharmaceutical Packaging. He has been a key player in building the manufacturing unit for the SCHOTT TopPac(R) polymer syringe within SCHOTT forma vitrum ag. He held different positions including Quality Manager, Head of R&D and Manager Scientific Advisory. In his current position he is the Head of Regulatory Affairs for Schott Pharmaceutical Packaging worldwide.
He is an active member as expert of ISO/TC 76/WG2 working group. He holds a degree as Dipl. Ing (FH) in Biotechnology.



Masterclass programme

8:30 Registration & Coffee

9:00 Welcome & Introductions

9:10 Development of Pre-Fillable Syringe Systems

10:30 Morning Coffee

11:00 Documentation and Regulatory Issues of Pre-Fillable Syringe Systems

12:30 Discussion Session

13:00 Close of Workshop


Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James



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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.


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.


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.


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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