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This workshop will provide attendees with an overview of data requirements for ADCs through the development lifecycle, outlining the key CMC challenges and mitigation strategies for the product types, and first-in-man enabling preclinical development activities to ensure a smooth transition from bench to bedside. Clinical study designs from Phase 1 will be discussed through the use of case studies. The workshop will then take attendees on a journey through the additional data requirements to support Phase II and III clinical development. At each stage the differences in data requirements between the US and EU will be discussed. The final component of the workshop will introduce the route to ultimate approval of an ADC in the US and EU.

Individuals with responsibility for (or interest in) ADC research and development (including CMC, non-clinical and clinical research), and regulatory affairs.

Delegates will gain an understanding of:
• Regulatory and product development requirements for entry in to the clinical and marketing authorisation
• Common pitfalls and mitigation strategies in ADC development to allow anticipation of regulators’ concerns at clinical trial application and marketing authorisation application stages
• Regulatory requirement distinctions between the US and EU, and regulatory options available to expedite time to market
 

Who should attend:

Individuals with responsibility for (or interest in) ADC research and development (including CMC, non-clinical and clinical research), and regulatory affairs.

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks

9:15 CMC Development: ADC Specifics

Natalie Thomas

Natalie Thomas, Consultant, Clinical Network Services (UK) Ltd

Richard Turner

Richard Turner, Principal Consultant, Clinical Network Services (UK) Ltd

Simon Bishop

Simon Bishop, Associate Consultant, Clinical Network Services (UK) Ltd

10:15 Enabling First-in-Human Studies

10:45 Morning Coffee

11:15 Beyond Phase I Clinical Studies

11:45 Key regulatory drivers for an expedited global development

12:15 Closing Remarks

12:30 End of Workshop

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FEATURED SPEAKERS

Natalie Thomas

Natalie Thomas

Consultant, Clinical Network Services (UK) Ltd
Richard Turner

Richard Turner

Principal Consultant, Clinical Network Services (UK) Ltd

Natalie Thomas

Consultant, Clinical Network Services (UK) Ltd
Natalie Thomas

Richard Turner

Principal Consultant, Clinical Network Services (UK) Ltd
Richard Turner

Simon Bishop

Associate Consultant, Clinical Network Services (UK) Ltd
Simon Bishop

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.

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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.

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, 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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Opening Hours: 9.00 - 17.30 (local time)
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