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Progressing bispecifics depends on early strategic clarity, and understanding what is possible by using different approaches in different regions of the world. The masterclass will examine these options to help get the quickest First-Time In Human study (FTIH)  that is risk managed. It will then “back-fill” how these objectiveS can be reached and how to deal with the unexpected.
Each of the steps required to provide an agency with a credible manufacturing package, demonstrable efficacy and safety assessment, supporting a risk management plan for a FTIH study.
The masterclass aims to cover the most important aspects that should be part of the “big picture” to file an IND.
 

Why you should attend:

This Master Class will provide the top view for all disciplines and functions including discovery, manufacturing, nonclinical, regulatory and clinical to provide each with the challenges faced by the other disciplines


Who should attend:

• Scientists in Discovery
• Senior Scientists, Associate and Directors in Discovery, Manufacturing, Nonclinical, Regulatory and Clinical Support
• The contents is especially aimed to help small companies develop Bispecifics

 

Masterclass programme

10:00 Registration & Coffee

10:30 Welcome and Introduction

11:00 Top level Regulatory Strategy

11:45 Morning Coffee

12:00 Taking it into the clinic...

13:00 Networking Lunch

14:00 Non clinical efficacy testing

14:30 In vitro safety assessment

15:00 Afternoon Tea

15:30 In vivo safety assessment

16:00 Group Discussion and Q&A

16:30 Closing Remarks and Close of Masterclass

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VENUE

MSE Meeting Rooms

103a Oxford Street, London, United Kingdom

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MSE Meeting Rooms

103a Oxford Street
London
United Kingdom

MSE Meeting Rooms

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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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Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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