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This workshop aims to cover key aspects associated with the formulation of biologicals for applications in pre-filled & dual chamber syringes.  The workshop will begin by looking at target product profile, to lay the foundation for discussion surrounding the subsequent development work, leading up to the final drug product and the key stages associated with that.  Attention will be given to challenging situations, such as the design of formulations for freeze-drying in dual chamber syringes.  Alongside these key considerations, time will also be spent on the selection process for primary packaging components and different devices.  Design of Experiments (DoE) and Quality by Design (QbD) in formulation development will also be included in this informative programme.

Topics to be covered include:

  • Target Product Profile
  • Stability Issues
  • Packaging selection challenges
  • Commercialisation challenges
  • Regulatory considerations

About Your Workshop Host:

Thomas Österberg is Senior Manager, Biologics at Product & Process Development, Pfizer, Sweden. He has more than 20 years of experience from pharmaceutical research & development and has managed the pharmaceutical development of several marketed protein drugs and among them the first "albumin free" Factor VIII product (Refacto®). Thomas has also worked extensively with biopharmaceutical evaluation of drug candidates, drug delivery technology and life cycle management of protein therapeutics.

Thomas gives presentations and lectures widely in the healthcare industry and on a number of university courses in pharmaceutical development. Thomas has a PhD in Pharmaceutics, is a certified Six sigma black belt and holds an Associate Professor title in Pharmaceutical Technology. Thomas has published about 20 scientific papers and is the co-inventor of several patents.
 

Workshop programme

13:30 REGISTRATION & COFFEE

14:00 WELCOME & INTRODUCTIONS

14:10 QUALITY TARGET PROFILE

15:30 AFTERNOON TEA

16:00 PHARMACEUTICAL FORMULATION

17:00 CLOSE OF WORKSHOP

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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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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