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Management of Risk in Clinical Trial Logistic Programmes
18 May 2011
Management of Risk in Clinical Trial Logistic Programmes

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 agenda

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8:30

Registration and coffee

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9:00

Welcome and introductions

clock

9:10

What is risk and how can it be measured?

  • Where do risks lie?
  • Prospective and retrospective risks - what can go wrong and what has gone wrong?
  • Risk challenges of outsourcing and global supply chains
  • Risk probability, severity and detectability
  • Risk assessment tools - flowcharts, process mapping
  • Risk ranking
  • Risk reduction or risk acceptance - what is acceptable risk?
  • clock

    9:50

    What are the risks in clinical trials?

  • Known unknowns and unknown unknowns
  • Is the CRO/CMO suitably experienced?
  • Is the manufacturing process robust?
  • Is the product stable?
  • Are storage and transport conditions adequate - temperature, humidity etc?
  • Is the supply chain secure - theft, counterfeiting, contamination, degradation?
  • How accurate are supply estimates and timescales?
  • Adverse events
  • clock

    10:30

    Coffee break

    clock

    10:50

    The practicalities of risk assessment

  • Who manages risk - QA, development, production, engineering, regulatory affairs, CROs?
  • Communicating risk - managers, investigators, patients, CROs, regulators
  • How is the Qualified Person involved?
  • Benefits and pitfalls of quality risk management programmes
  • How do you comply with ICH Q9/Annex 20?
  • clock

    11:30

    Discussion and questions

    clock

    12:00

    End of workshop

    VENUE

    Marriott Regents Park

    128 King Henry's Road, London, United Kingdom

    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.

    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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    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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