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Biosimilars have attracted a great deal of interest recently and are seen by some as the new generic frontier, since it is widely thought that lower levels of competition will lead to higher margins in an industry notorious for its generally low margins on commodity generics. The Masterclass looks at the regulatory barriers to entry as well as what has actually occurred in those markets where Biosimilars have been launched. The programme also includes a look into what the future might bring in terms of a US Biosimilars pathway and competition for the high price Monoclonal antibody products that many Biosimilar companies are targeting.

 

The aim of this Masterclass is to give participants a good overview of the whole topic of Biosimilars while investigating in more depth those topics that merit it. While lower regulatory barriers in less regulated markets have allowed a biosimilars market to take off, the higher regulatory barriers in Europe and issues of interchangeability have resulted in a limited number of product launches so far and slow progress for those that are already in the market. Across the Atlantic, the situation is changing with the long awaited legislation now in place to simplify Biosimilars registration.
 

Those attending the Masterclass will gain:

  • A good overview of the Biosimilars picture across the world
  • Insight into the varying regulatory approaches prevailing in different regions
  • An understanding of the commercial situation as it is now and likely to develop in the future
  • Enough background to determine whether entering the biosimilars market is an appropriate strategy for their company

Masterclass programme

8:30 Registration & Coffee

9:00 Welcome & Introductions

9:10 Overview - Biosimilars? Biogenerics? Follow-on Biologicals?

9:45 Biosimilars - the commercial reality

11:30 Morning Coffee

11:45 The future

13:00 Masterclass End

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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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