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Development, Regulatory and Commercial Needs for Global Biosimilars
November 18, 2015
Development, Regulatory and Commercial Needs for Global Biosimilars

This workshop aims to give participants an in-depth understanding of the regulatory and development fundamentals and expedients for global biosimilars, in addition to commercial imperatives. The development of biosimilars requires special studies and a robust process. This interactive workshop will enable you to gain a thorough understanding of the requirements and options available, including considerations leading to a successful global development programme, East and West.

FEATURED SPEAKERS

Gerry McGettigan

Gerry McGettigan

CEO & Regulatory Expert; COO, Kinesys Consulting Ltd. (UK); amp biosimilars AG (Germany)
Graeme Deuchar

Graeme Deuchar

Product Development Expert, Kinesys Consulting Ltd

Gerry McGettigan

CEO & Regulatory Expert; COO, Kinesys Consulting Ltd. (UK); amp biosimilars AG (Germany)
Gerry McGettigan

Graeme Deuchar

Product Development Expert, Kinesys Consulting Ltd
Graeme Deuchar

Liz Yamashita

VP, Regulatory & Clinical Affairs, Oncobiologics
Liz Yamashita

Workshop agenda

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13:30

Registration & Coffee

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14:00

Introductions and Opening Remarks

Gerry McGettigan

Gerry McGettigan, CEO & Regulatory Expert; COO, Kinesys Consulting Ltd. (UK); amp biosimilars AG (Germany)

Graeme Deuchar

Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

Liz Yamashita

Liz Yamashita, VP, Regulatory & Clinical Affairs, Oncobiologics

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14:15

Session 1: Regulatory fundamentals and expedients

Gerry McGettigan

Gerry McGettigan, CEO & Regulatory Expert; COO, Kinesys Consulting Ltd. (UK); amp biosimilars AG (Germany)

Graeme Deuchar

Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

clock

15:00

Session 2: Commercial imperatives

Gerry McGettigan

Gerry McGettigan, CEO & Regulatory Expert; COO, Kinesys Consulting Ltd. (UK); amp biosimilars AG (Germany)

Graeme Deuchar

Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

clock

15:30

Coffee break

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16:00

Session 3: Development requirements and options

Gerry McGettigan

Gerry McGettigan, CEO & Regulatory Expert; COO, Kinesys Consulting Ltd. (UK); amp biosimilars AG (Germany)

Graeme Deuchar

Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

clock

17:00

Discussion & Q&A

clock

17:30

Close of Workshop


CEO & Regulatory Expert; COO
Kinesys Consulting Ltd. (UK); amp biosimilars AG (Germany)
Product Development Expert
Kinesys Consulting Ltd
VP, Regulatory & Clinical Affairs
Oncobiologics

Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

HOTEL BOOKING FORM

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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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UK Office
Opening Hours: 9.00 - 17.30 (local time)
SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smgconferences.com Email: events@saemediagroup.com
Registered in England - SMi Group Ltd trading as SAE Media Group




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