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Biosimilars – Commercial Strategies & Regulatory Guidelines
9 December 2013
Biosimilars – Commercial Strategies & Regulatory Guidelines

The purpose of this Masterclass is to examine the regulatory barriers affecting biosimilar markets across Europe and the within the US. Biosimilar markets are increasingly attracting more interest and are seen as a new industry for some generic companies to exploit, as these companies attempt to adjust to the high competition and low profit margins found in the commodity generics market. Less regulated markets have seen biosimilars take off in recent years; however this is not the case across Europe and the US where regulatory barriers have slowed the development of this industry in these markets.

Attitudes across the Atlantic are slowly changing, and with the introduction of new legislation to help simplify biosimilar registration we take a look at how this has affected companies involved. The workshop also looks at whether any lessons can be learned following its introduction and whether this has met the expectations of stakeholders.

Masterclass agenda

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8:50

Registration and coffee

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9:15

Welcome and Introductions

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9:25

Biosimilars: What are they and what are the current challenges in Europe?

 

·         Commercial challenges of launching biosimilars in Europe
·         Regulatory challenges of launching a biosimilar in Europe
·         Case study: Successfully launched biosimilars in the UK to date
-          What obstacles did they have to overcome?
-          The future of Biosimilars ( Insulin, recombinant protein, monoclonal antibodies and interferons)

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10:00

Current regulatory processes in Europe

 

·         Current EMEA guidelines
·         Recent changes to these guidelines
·         How this will impact regulatory approval
·         Case Study: Successful and unsuccessful applications

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10:30

Current state of regulatory processes in the US

 

·         Recent changes to help assist regulatory approval times
·         How this differs from previous legislation
·         Europe vs US
·         The effectiveness of these changes and how this may shape the new regulatory system in Europe

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11:00

Morning Coffee

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11:15

Commercialising Biosimilars and Patent/ IP issues

 

·         The challenges of commercialisation in Europe
·         The reality of commercialising a biosimilar in the states

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12:05

The future landscape of Biosimilars

 

·         The current patent issues
·         Current EU patent system
·         Current US patent system
-          A case study: The Submarine Patent- Etanercept
 
·         Future EU unitary patent system: How would this work? What difference will it make?

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12:25

Discussion Session

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13:00

Close of Masterclass

VENUE

Holiday Inn Bloomsbury

Coram Street, London, United Kingdom

Holiday Inn London-Bloomsbury is just 2 minutes' walk from the Tube at Russell Square station, for speedy connections across the capital. We're 10 minutes by bus from Eurostar connections at St Pancras station, and a 45-minute taxi ride from London Heathrow Airport. Check into your stylish Guest room, air-conditioned and connected to wireless Internet.

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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Holiday Inn Bloomsbury

Coram Street
London WC1N 1HT
United Kingdom

Holiday Inn Bloomsbury

Holiday Inn London-Bloomsbury is just 2 minutes' walk from the Tube at Russell Square station, for speedy connections across the capital. We're 10 minutes by bus from Eurostar connections at St Pancras station, and a 45-minute taxi ride from London Heathrow Airport. Check into your stylish Guest room, air-conditioned and connected to wireless Internet.

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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, SAE Media 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@saemediagroup.com

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