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The SMi Group is honoured to announce its second Cold Chain Distribution Conference. Innovative case studies on cold chain in new territories will be delivered as will advice on tracking and monitoring temperature down the supply chain. An exclusive presentation from the USP combined with the chance to hear from industry leading pharma companies, suppliers and couriers makes the SMi Group’s Cold Chain Distribution Conference an exciting and informative prospect.
 After another year of radical industry advances and global regulatory changes this conference promises to deliver essential updates and groundbreaking new developments ensuring that the event will be unlike any other you will attend this year.
  

7 Key Benefits of Attending

• HEAR FIRST HAND EXPERIENCE on confronting and overcoming the challenges facing cold chain in new territories
• UNDERSTAND HOW to manage risk and drive efficiency in global controlled temperature clinical trial supply chains
• OBSERVE how industry leaders track and monitor temperature down the supply chain
 LEARN FROM the USP’s recommendations for Good Storage and Shipping Practices
• DISCUSS HOW changes in regulations will affect cold chain distribution
• WITNESS AN exclusive presentation on the groundbreaking Haemophilia track and trace solution trial
• NETWORK with an array of exhibitors at the forefront of Cold Chain Distribution


Confirmed Speakers Include:

  • Richard Peck, European Cold Chain Technology & Support Engineer, Wyeth
  • Ian Holloway, Manager, Defective Medicines Report Centre, MHRA
  • Claudia Okeke, Associate Director, Information and Standards Development, United States Pharmacopeia
  • Nina Lawrence,  Business Development Manager, Fisher Clinical Services
  • Mike Meakin, European Quality Director, DHL Exel Supply Chain
  • Asi Veshler, Head Pharmacist, Novolog
  • Ralph Dillon, Managing Director, Chicago Office, Compliance Surety Associates
  • Nermeen Varawalla, Vice President Investigator Relations, Scientific & Medical Affairs, PRA International
  • Fergal  McGroarty, FIMLS, Project Manager National Haemophilia EPR, St James’ Hospital, Dublin
  • Nathan Kohner, Cold Chain Specialist, Almac Clinical Services
  • Alex Guillen, Cold Chain Specialist,  Escort DL systems

This Event is aimed at those with the following job functions, including;


• Director of Operations
• Material Management Director
• Head of Quality
• Quality Assurance Director
• Logistics Director
• Director of Warehouse Operations
• Head of Application Support
• Head of Clinical Supplies
• Director of Clinical Trials Management
• Director of Clinical Operations

The following companies have registered for this event:

  • GlaxoSmithKline
  • Roche
  • Johnson and Johnson
  • Wyeth
  • Teva Pharmaceuticals
  • Shire Pharmaceuticals
  • Schering Plough
  • Berlinger & Co AG
  • Pharm-up
  • Sicor Biotech UAB
  • Promega Corporation
  • Medical Research Council
  • Areas Global tb Vaccine Foundation
  • Durbin
  • Ambe Limited t/a Ambe Medical Group
  • Infinity Pharm
  • Terumo Europe NV
  • Cora Byrne
  • Calserv

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Ralph Dillon

Ralph Dillon, Director, ComplianceSurety Associates

9:10 DEVELOPMENT AND REALITY WITH VACCINE COLD CHAIN

  • Setting the parameters
  • Primary distribution and storage
  • Secondary distribution and storage
  • Storage and use at the point of use
  • Helen Underwood

    Helen Underwood, Director, Merck Sharp & Dohme

    Anthony Battersby

    Anthony Battersby, Director, Cold Chain Speacialist, FBA Health Systems Analysts

    9:50 MANAGING RISK AND DRIVING EFFICIENCY IN GLOBAL CONTROLLED TEMPERATURE CLINICAL TRIAL SUPPLY CHAINS

    Nina Lawrence

    Nina Lawrence, Business Development Manager, Fisher Clinical Services

  • Industry trends
  • The challenges of global cold chain studies
  • Cold Chain technologies
  • Supply Management Systems
  • Case studies
  • Future challenges and innovations
  • 10:30 Morning Coffee

    11:00 THE CONCEPT OF GLOBAL COLD CHAINS

  • Assurance of current Cold Chains
  • The importance of Innovation
  • Case Studies- RFID Active Tracking
  • Frozen Assurance and Packaging Reverse Logistics
  • Mike Meakin

    Mike Meakin, European Quality Director, DHL Exel Supply Chain

    Jonathan Blamey

    Jonathan Blamey, Head of Product Development, DHL Exel Supply Chain

    11:40 PANEL DISCUSSION- EFFECTIVELY MANAGING BOTH RISK AND COST TOGETHER

    Helen Underwood

    Helen Underwood, Director, Merck Sharp & Dohme

    Mike Meakin

    Mike Meakin, European Quality Director, DHL Exel Supply Chain

    Alex  Guillen

    Alex Guillen, Director, Escort Data Logging Systems / Cold Chain Solutions

    Nermeen Valawalla

    Nermeen Valawalla, Vice President Investigator Relations, PRA International

    Anthony Battersby

    Anthony Battersby, Director, Cold Chain Speacialist, FBA Health Systems Analysts

    12:20 Networking Lunch

    13:50 MAINTAINING QUALIFICATION OF MULTIPLE MARKET AIRFREIGHT SHIPMENTS

    Richard Peck

    Richard Peck, European Cold Chain Technology & Support Engineer, Wyeth

  • The difficulties of qualifying multiple markets, with multiple product presentations
  • Cold Chain Distribution - Theory vs Practice
  • The Climatic Zone Approach
  • The next steps!
  • 14:30 CHALLENGES FACING COLD CHAIN FOR CLINICAL TRIAL SUPPLIES IN EMERGING COUNTRIES: INDIA FOCUS

    Nermeen Valawalla

    Nermeen Valawalla, Vice President Investigator Relations, PRA International

  • Demand for Cold Chain Management in Emerging Countries
  • Infrastructure and Logistic Challenges
  • Approaches to Delivering in Emerging Countries
  • India Case Studies
  • 15:10 Afternoon Tea

    15:40 TEMPERATURE MAPPING AND MONITORING, REGULATIONS AND SOLUTIONS

    Peter Rippington

    Peter Rippington, Senior Consultant, Trackflow Ltd

  • Regulators major cause of serious deficiencies are general storage and cold chain temp monitoring
  • Understanding of regulation on mapping and continuous monitoring
  • Review of regulatory approved mapping report contents
  • Review of regulatory approved continuous monitoring system and information storage
  • 16:20 GOOD STORAGE AND SHIPPING PRACTICES

    Claudia Okeke

    Claudia Okeke, Associate Director, Information and Standards Development, U S P - U S Pharmacopeia

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Ralph Dillon

    Ralph Dillon, Director, ComplianceSurety Associates

    9:50 DEVELOPING TEMPERATURE CONTROLLED SHIPPING DESIGN AND PRACTICES IN COLD CHAIN LOGISTICS

    Nathan Kohner

    Nathan Kohner, Cold Chain Specialist, Almac Clinical Services

  • Challenges of clinical trial shipping
  • Preparing and monitoring temperature controlled shipments
  • Working with couriers
  • Temperature controlled shipping methods
  • Temperate shipping
  • 10:30 Morning Coffee

    11:00 WHAT CAN BE LEARNT FROM THE SUCCESSFUL HAEMOPHILIA TRACK AND TRACE SOLUTION?

    Feargal McGroarty

    Feargal McGroarty, FIMLS, Project Manager, National Haemophilia system, St James' Hospital

  • An overview of the trial
  • How real time identification of Clotting Factor Concentrates (CFC’s) ensured immediate product recall
  • Obtaining 100% patient safety
  • The next step, individual patient web-based scanners
  • 11:40 HOW TO AVOID COLD CHAIN DISTRIBUTION OF BIOTECH PRODUCTS USING FIRST PRINCIPLES OF FREEZE DRYING

    Afzal Rahman Mohammed

    Afzal Rahman Mohammed, Drug Delivery Research Group, Aston University

  • Cold chain distribution and biopharmaceutical product development
  • Molecular dynamics of lyophilisation and its role in cold chain distribution
  • Fabrication of biotech products based on first principles of freeze drying
  • Quality assessment and stability testing
  • 12:20 Networking Lunch

    13:50 QUALITY IN SERVICE OF THE PHARMACEUTICAL COLD CHAIN MANAGEMENT

    Asi Veshler

    Asi Veshler, Head Pharmacist, Novolog

  • The language of quality
  • Regulatory requirements
  • The process of PCCM
  • Obtaining GSP & GDP for cold products
  • 14:30 TECHNOLOGY IMPROVEMENTS WITHIN TEMPERATURE CONTROL MEASURES

  • Wireless data loggers and their applications
  • Time saving and QC improvement by Secured Web based systems
  • Technology evolution on data loggers on alarm and display for faster decisions
  • New temperature control measures and related services by major airline
  • Alex  Guillen

    Alex Guillen, Director, Escort Data Logging Systems / Cold Chain Solutions

    15:10 MEASURING COLD CHAIN SUCCESS– QUALITY ASSURANCE RELEASE OF PRODUCT TO MARKET AND GOOD PRODUCT TO PATIENT

    Ralph Dillon

    Ralph Dillon, Director, ComplianceSurety Associates

  • Overview of cold chain from Product release perspective
  • Proven strategies to facilitate success
  • Applying ICH Q9 – Quality Risk Management  to  Cold Chain
  • Explanation of Quality Release Mapping
  • Quality Release mapping Exercise
  • Management of the Cold Chain for Product release
  • 15:50 Chairman's Closing Remarks and Close of Conference

    16:00 Afternoon Tea and Exhibition

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    Workshops

    Designing Cold Chain Supply Strategies in Clinical Trials
    Workshop

    Designing Cold Chain Supply Strategies in Clinical Trials

    Dexter House
    3rd December 2007
    London, United Kingdom

    Dexter House

    Royal Mint Court
    Tower Gateway
    London EC3N 4QN
    United Kingdom

    Dexter House

    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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