The patent expiry of a number of biologics that have revolutionised medical practice is imminent. Numerous programs have been initiated to develop corresponding follow-on products.

Regulatory agencies have issued guidance on abbreviated clinical requirements for marketing authorisations tailored to such replicates.

This workshop will provide a detailed overview over the thinking behind the abbreviated clinical evidence base, and the purpose the different components serve. The Master-class will speak to aspects such as the “sensitivity” of the selected clinical model, the role of clinical evidence in the “totality of evidence”, as well as operational aspects of the clinical trials. As product safety plays a central role in stakeholder expectations particular attention will be given to means to address this important topic.

Biosimilars has become a very active and exciting arena.

This masterclass will give you valuable insights into the principles that shape this space, including its challenges and opportunities

Network with your peers and gain new and valuable insights

Masterclass programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Uwe Gudat

Uwe Gudat, Head of Safety Biosimilars, Merck Serono

9:10 Session 1: Biologics: The process defines the product

9:50 Session 2- Biosimilarity: Extending analytical comparability

10:30 Morning Coffee

11:00 Session 3: Totality of Evidence: An exercise in Bayesian thinking

11:40 Session 4: The clinical data set: Support not proof

12:20 Networking Lunch

13:30 Session 5: PK: How the body acts on the drug

14:10 Session 6: Safety and Efficacy: How the drug acts on the body

14:50 Afternoon Tea

15:20 Session 7: Stakeholder expectations: Convergent or divergent?

16:00 Session 8: Where do we go from here?

16:40 Chairman’s Closing Remarks and Close of Day One


MSE Meeting Rooms

103a Oxford Street
United Kingdom

MSE Meeting Rooms



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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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