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in association with

Somerset House Consultants

www.somersethouseconsultants.co.uk

8.30am - 12.00pm

about the workshop

This half-day workshop focuses on the identification and mitigation of risk in the clinical trial supply chain, including dosage form manufacture, randomisation/packaging, transport, storage and dispensing at trial sites.  The increasingly international nature of clinical trials and the growth in the use of contract manufacturers mean that sponsor companies need robust strategies for managing and communicating risk and forming adequate mitigation plans.

The workshop will use examples from actual clinical trial supply projects and delegates will also be encouraged to share their own experiences.

At the end of this workshop, delegates will be able to:

  • Understand the nature of risk
  • Understand the benefits of quality risk management systems 
  • Understand current 'best practice' for clinical trial supplies manufacture
  • Identify where risks lie 
  • Measure and rank risks
  • Produce risk mitigation and control plans
  • Manage risk communication between sponsors and outsourcing providers
  • Meet ICH Q9/EU Annex 20 GMP requirements for Quality Risk Management in clinical trial supplies

Scroll down for the full programme...

about the leader

Robert Haslam, Managing Director, Somerset House Consultants

 

Robert Haslam 

 

Robert is a pharmaceutical industry director with over thirty-five years experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies.  He is the Managing Director of a consultancy providing quality assurance, manufacturing and development support to pharmaceutical companies; and is a EU 'Qualified Person' for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals.

Robert has extensive experience in GMP audits of drug substance, drug product and clinical trial manufacturers worldwide to meet FDA and EU requirements.  He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, correcting quality deficiencies, product development and outsourcing.

 

about the organisation

Somerset House Consultants is a privately owned, independent, CRO with long experience of design and management of pharmaceutical development, manufacturing, regulatory affairs and quality assurance programmes.

It specialises in helping emerging and "virtual" pharmaceutical companies worldwide to select, audit and manage sub-contractors for their outsourced development and manufacturing projects. It is flexible and responsive to meet your specific needs.

Workshop programme

8:30 Registration and coffee

9:00 Welcome and introductions

9:10 What is risk and how can it be measured?

9:50 What are the risks in clinical trials?

10:30 Coffee break

10:50 The practicalities of risk assessment

11:30 Discussion and questions

12:00 End of workshop

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Marriott Regents Park

128 King Henry's Road
London NW3 3ST
United Kingdom

Marriott Regents Park

This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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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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