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We are proud to present Europe's leading Cold Chain Distribution conference. Our 7th annual event will be taking place on Monday 3rd & Tuesday 4th December, 2012 at the Marriott Regents Park, London

This year’s conference will feature talks from Merck, GlaxoSmithKline and the MHRA on cold chain regulations, logistics, management and GDP's. With KOL's from every aspect of the cold chain industry coming from across the globe, the conference provides a fantastic forum for the most up to date look at cold chain technologies, innovations and management strategies.

New to 2012

  • Regulatory requirements and streamlining of the cold chain process
  • Traceability, security and tracking to GS1 standards
  • Challenges and strategies of remote distribution
  • Cold storage case studies
  • Cost of Quality and cost effectiveness
  • World Courier Site Tour: Heathrow International Airport
  • A complimentary dinner at the Gilgamesh Restaurant

 

  

 

 

 

 

 

 

Key topics include:

  • Good Distribution Practice, regulations and compliance – A National Regulatory Body’s perspective
  • Risk management and mitigation
  • Latest technologies and transport innovations
  • Quality assurance in product storage
  • Controlled temperatures versus ambient techniques
  • Cost-effectiveness, reimbursement and ROI
  • Company auditing and security

This event is unmissable for professionals with job titles such as;

• Global Category Manager
• Logistics Manager CEE & Asia
• GDP Inspector
• Operations Director
• Business Development Manager
• Sr. Pharmaceutical Scientist
• Logistics Manager
• QA Manager
• Head of Service
• MD
• Product Specialist
• Pharmaceutical Warehouse Supervisor
• Senior Transportation Manager
• Regulatory Affairs Manager
• Supply Chain Supervisor
• Cold Chain Specialist
• Shipping Specialist
• Cold Chain & Shipping Validation Specialist
• Principle Supply Chain Analyst
• Clinical Supply Technician
• Senior Director
• Logistics manager
• Consultant - Supply Chain
• International Logistics Manager

 

Last years attendees included senior representatives from companies such as:

Ambe Ltd; Alliance Healthcare; United Drug; Apax Partners LLP; KOWA; Eisai Limited; Elpro-Buchs AG; World Courier; TNT UK Ltd; Sensitech EMEA; Biocair International Ltd; Marken Limited; Nordic Capital; Intelleflex; IATA; Dr Reddy's Laboratories; Biomap; Tailored Support Ltd; Dawson Rental; Portable Cold Storage Ltd; Intensive Media; Pharma Publications; Paper Pallet Company; Yourway Transport; AstraZeneca; Kuehne + Nagel Lt; Roche Products; Pfizer; Farma Mondo SA; F Hoffmann La Roche Ltd; Topa Packaging; Danvers International; Emballiso; Perrigo; QuickSTAT; Laminar Medica Ltd; Movianto UK; Genzyme Ltd; Intellectual Ventures Laboratory; IJS Global; Teva Pharmaceuticals Ltd; AOP Orphan Pharmaceuticals; Biocompatibles International plc; Pauwels Consulting; PDP Couriers; GlaxoSmithKline; MHRA; Healthcare at Home Ltd; Middlebrook Laboratories; Biotec Services International; Actavis UK Ltd; Elpro UK Ltd and Zetes 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Frank Reale

Frank Reale, Global Regulatory Operations, Merck

9:10 The logistics of providing cold chain investigational clinical supplies in a global environment

Frank Reale

Frank Reale, Global Regulatory Operations, Merck

  • How "Not So Apparent Regulations" impose hurdles and roadblocks for the safe and timely delivery of Investigational Clinical Trial material.
  • Country specific regulations that can be imposed that are specific to any given country
  • Regulations on investigational clinical supplies: the differing commercial material and potential delays, detentions, seizure of material and possible destruction
  • Understanding these regulations to ensure timely and safe delivery of material
  • 9:50 Current and Future Regulation of Cold Chain products

    Ian Holloway

    Ian Holloway, Manager, MHRA

  • Current GDP Guidelines and cold chain distribution 
  • Revision of Annex 16 of the GMP Guide and likely impact on cold chain operations 
  • Security within the supply chain and the Falsified Medicines Directive 
  • 10:30 Morning Coffee

    11:00 A chemistry-based device with on-off switches for the profiling of temperature during cold-chain distribution

    Long Lin

    Long Lin, Professor/Director, University of Leeds

  • Background to the TSB-funded research and development project
  • A survey of various existing chemistry-based temperature monitoring devices
  • The importance of on-off switches in monitoring devices
  • Novel chemistry-based device with on-off switches
  • 11:40 The auditing of a transport company

    Sue Lee

    Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

  • Understand the audit process for transport companies and know what to focus on
  • Identify key audit criteria to ensure operational conformity and optimum results
  • Consider the regulatory requirements and how to streamline these with transport options
  • 12:20 Networking Lunch

    13:40 Panel Discussion: Perspectives and opinions on auditing in cold chain distribution

  • Delegates will be given the opportunity to discuss as a group auditing in the cold chain industry
  • Individuals will be able to put forward comments and thoughts on each of the topics raised within the discussion forum
  • The topics and points raised will be included in the conference literature
  • Frank Reale

    Frank Reale, Global Regulatory Operations, Merck

    Stephen Mitchell

    Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline

    Sue Lee

    Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

    Harvey Rubin

    Harvey Rubin, Director, University Of Pennsylvania

    14:20 Applying Cold Chain Reporting and Analysis of Key Performance Indicators (KPIs) for the Application of Continuous Process Improvement

    Richard  Peck

    Richard Peck, Senior Program Manager Life Sciences EMEA, Sensitech UK Ltd

  • Why Data Management is critical for managing temperature-sensitive supply chains
  • Review of regulation and guidance regarding Good Data Management and Good Documentation Practices
  • Review of available business analysis tools to support continuous improvement

     

  • 15:00 Afternoon Tea

    15:30 Energize the Chain: Bringing Vaccines to the Most Remote Parts of the Globe

    Harvey Rubin

    Harvey Rubin, Director, University Of Pennsylvania

  • Statement of the problem: The cold chain degrades the further away from the central storage points in the developing world
  • The extent of the problem: 2.5 million children die of vaccine preventable causes
  • The solution to the problem: Utilize energy available at cell towers sites to power vaccine refrigeration units even in the most remote parts of the world
  • Implementation: Public private partnerships organized through our non profit organization--Energize the Chain 
  • Examples of implementation: Zimbabwe and other countries
  • 16:10 Control Temperature processes along the supply chain

    Yoram Eshel

    Yoram Eshel, Senior Director, Global Transportation & Logistics, Teva Pharmaceutical

  • CRT Vs. Ambient – do they really maintain the required temperature?
  • The current paradigms about controlled temperature shipments.
  • How CRT shipments look like in real life?
  • How to practically mange your controlled temperature transportation
  • 16:50 Chairman’s Closing Remarks and Close of Day One

    17:00 Drinks Reception

    19:00 Networking Dinner

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Sue Lee

    Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

    9:10 The Management of Logistics Risks in the Pharmaceutical Supply Chain

    Stephen Mitchell

    Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline

  • Understanding the pharmaceutical supply chain
  • Identifying and assessing risks before and during the supply chain process
  • Mitigating risks as effectively as possible
  • Resources to help all companies improve their supply chain process: with specific cold chain examples
  • 9:50 Data Management in the Cold Chain Distribution

    Mathieu Materne

    Mathieu Materne, Global IT Validation Coordinator, Ucb Pharma

  • e-records in the pharmaceutical environment
  • Cold Chain data identification: methods and techniques
  • Cloud Computing : the easiest ways to implement a worldwide system
  • Reporting and data management, and examples of each
  • Interfacing, new technology and more
  • 10:30 Morning Coffee

    11:00 Cold chain distribution in resource-poor countries

    Amina Jindani

    Amina Jindani, Honorary Senior Lecturer, St George's, University of London

  • Outsourcing clinical trials in resource-poor countries
  • The regulations in different countries and how this affects the cold chain process
  • Maintaining the cold chain for drug shipments: tools and techniques
  • Maintaining the cold chain for sample transfer
  • The eventual outcomes of the supply chain, and an example of a cold supply chain in a resource-poor country
  • 11:40 Understanding and analysing Cost of Quality (CoQ)

    Robert Hayes

    Robert Hayes, Director, Cold Chain Consultants

  • Understanding the difference between Quality Assurance and Quality Control
  • Current regulatory thinking on managing quality
  • The Cost of Quality Model: assessing the cost of quality for internal and external activities for prevention and appraisal
  • Managing cost of quality to achieve best operational value
  • 12:20 Networking Lunch

    13:40 Achieving traceability based on GS1 Standards

    Roger Lamb

    Roger Lamb, Healthcare Manager, GS1 UK

  • Overview of important regulatory and industry developments
  • GS1 Standards for Healthcare: Process and technical (“Identify, Capture, Share”) standards
  • The Global Traceability Standard for Healthcare (GTSH)
  • Examples of successful implementations of standards
  • 14:20 Choosing an adequate temperature measurement procedure and device to insure a declaration of conformity without unknown risk

    Eric Devin

    Eric Devin, Development managing director, Cemafroid

  • The  theorical  basis of uncertainties, the impact on the validity of a declaration of conformity and its consequential interference on the true temperature of medical products
  • Medical components which are temperature sensitive especially in the  domain (+2, +8°C)
  • Transportation and storage of blood or vaccines
  • 15:00 Ensuring Quality During Cold Storage: Lessons from Biobanking

    John Cason

    John Cason, Director, Kings College London

  • Dealing with labile biological materials
  • Monitoring sample quality throughout storage
  • What biobanking can teach us about cold chain storage and how to apply these lessons learnt
  • Future challenges in the industry
  • 15:40 Chairman's Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Frank Reale

    Frank Reale

    Global Regulatory Operations, Merck
    Ian Holloway

    Ian Holloway

    Manager, MHRA
    Mathieu Materne

    Mathieu Materne

    Global IT Validation Coordinator, Ucb Pharma
    Stephen Mitchell

    Stephen Mitchell

    QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline
    Yoram Eshel

    Yoram Eshel

    Senior Director, Global Transportation & Logistics, Teva Pharmaceutical

    Amina Jindani

    Honorary Senior Lecturer, St George's, University of London
    Amina Jindani

    Eric Devin

    Development managing director, Cemafroid
    Eric Devin

    Francesca Burberi

    Technical Service and Manufacturing Science Senior Manager, Eli Lilly Italia SpA
    Francesca  Burberi

    Frank Reale

    Global Regulatory Operations, Merck
    Frank Reale

    Harvey Rubin

    Director, University Of Pennsylvania
    Harvey Rubin

    Ian Holloway

    Manager, MHRA
    Ian Holloway

    John Cason

    Director, Kings College London
    John Cason

    Long Lin

    Professor/Director, University of Leeds
    Long Lin

    Mathieu Materne

    Global IT Validation Coordinator, Ucb Pharma
    Mathieu Materne

    Nick Geary

    Business Development Director , Emballiso
    Nick Geary

    Richard Peck

    Senior Program Manager Life Sciences EMEA, Sensitech UK Ltd
    Richard  Peck

    Robert Hayes

    Director, Cold Chain Consultants
    Robert Hayes

    Roger Lamb

    Healthcare Manager, GS1 UK
    Roger Lamb

    Stephen Mitchell

    QA Manager, Quality & Compliance, Logistics, GlaxoSmithKline
    Stephen Mitchell

    Sue Lee

    Regional Quality Manager UK Ireland Middle East & Africa, World Courier
    Sue Lee

    Yoram Eshel

    Senior Director, Global Transportation & Logistics, Teva Pharmaceutical
    Yoram Eshel

    Workshops

    Site Visit to World Courier, Heathrow
    Workshop

    Site Visit to World Courier, Heathrow

    Central London
    5th December 2012
    London, United Kingdom

    Marriott Hotel Regents Park

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

    Marriott Hotel 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.

    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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