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A unique opportunity to learn from leading industry experts including:

  • Latif Al-Ayoub, Operations Director, Sensitech UK
  • Dr Michelle Frazier-Jessen, Division of Monoclonal Antibodies, FDA (tentatively confirmed)
  • John Taylor, Quality & Systems Manager, Medicines & Healthcare products Regulatory Agency (MHRA)
  • Dr Claudia Okeke, Associate Director, Information Standards & Development, United States Pharmacopoeia (USP)
  • Mark Brazenor, Vaccine Direct & Distribution Manager, Aventis Pasteur
  • Dr Afshin Hosseiny, Managing Director, Tabriz Consulting (formerly Director, Global Quality Assurance, GlaxoSmithkline)
  • Jörg Neumann, Senior Validation Manager, Quality Assurance, Chiron Vaccines
  • Dr David Slater, Manager, Logistics, Ortho-Clinical Diagnostics
  • Max Evans, Managing Director, Farillon
  • Dr Carol McCall, Corporate Marketing & Quality Manager, Alloga
  • Carla Reed, Vice President, Global Logistics & Distribution, Chainlink Research

    The essential event on:

  • REGULATORY COMPLIANCE
    Receive practical guidance from the FDA and MHRA on complying with the regulatory authorities and on preparing for regulatory inspection


  • BEST PRACTICE IN THE COLD CHAIN
    Learn how best to qualify and validate cold chain methods


  • CLINICAL TRIALS AND THE COLD CHAIN
    Discuss the challenges of cold chain compliance throughout the clinical trial process


  • SEA FREIGHT
    Discover the most innovative strategies for effective sea transportation


  • COLD CHAIN INDUSTRY STANDARDS
    Review the latest developments in establishing industry standards for temperature-controlled distribution
  • Conference programme

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Max Evans

    Max Evans, Managing Director, Farillon

    9:10 KEYNOTE ADDRESS: THE DISTRIBUTION PROCESS FOR TEMPERATURE SENSITIVE BIOLOGICS

    Dr Michelle Frazier-Jessen

    Dr Michelle Frazier-Jessen, Division of Monoclonal Antibodies, FDA

  • Stability concerns unique to biologic products
  • Formulation development
  • Stability indicating assays
  • Transportation studies
  • 9:40 COMPLYING WITH REGULATIONS ACROSS EUROPE

    John Taylor

    John Taylor, Quality & Systems Manager, Medicines & Healthcare products Regulatory Agency (MHRA)

  • An update on the latest guidelines
  • How to ensure your compliance
  • An insight into the common sources of failure
  • Future regulations for 15-25ºC products
  • Future directions for MHRA regulations - what policies should you be implementing now?
  • 10:20 THE TRANSPORT CHILL CHAIN

    Bob Goulborn

    Bob Goulborn, Business Development Manager, Healthcare Logistics

  • Background: MHRA - manufacturers – the customers
  • Customer requirements: manufacturers – the customers etc
  • Alternative strategies
  • The Healthcare Logistics answer
  • Challenges: validation of transport by the MHRA – drug development - home delivery
  • 11:00 Morning Coffee

    11:20 DEVELOPING CLEAR AND PRAGMATIC INDUSTRY STANDARDS

    Nigel Cryer

    Nigel Cryer, Business Development, Quality, DHL

  • The current status – seek first to understand
  • The need for clear industry standards
  • How is this being achieved?
  • Creating ubiquitous local and international regulations
  • What are the costs of over and under regulation?
  • How best to get it right?
  • 12:00 USP STANDARDS IN COLD CHAIN DISTRIBUTION

    Dr Claudia Okeke

    Dr Claudia Okeke, Associate Director, Information & Standards Development, United States Pharmacopeia (USP)

  • Current official standards relating to cold chain
  • Past USP shipping studies relating to cold chain
  • Currently proposed definitions
  • Future activities in the cold chain area
  • 12:40 Networking Lunch

    14:00 INTEGRATING THE COLD CHAIN INTO THE GLOBAL LOGISTICS ENVIRONMENT

    Carla Reed

    Carla Reed, Vice President, Global Logistics & Distribution, Chainlink Research

  • Temperature control is critical – when product is in motion and at rest
  • Accurate information related to product - specific cold chain requirements – who needs it and how should they access it?
  • Maintaining the integrity of the product – what technology is available?
  • Best practices in cold chain storage and transportation
  • Putting it all together
  • 14:40 BEST PRACTICES IN MAINTAINING YOUR COLD CHAIN

    Max Evans

    Max Evans, Managing Director, Farillon

  • Overview of the main phases in the cold chain
  • Designing an efficient logistic strategy
  • Factors and challenges to consider whilst transporting products
  • Methods for demonstrating maintenance of required temperatures
  • 15:20 Afternoon Tea

    15:40 BEST PRACTICE FOR QUALIFICATION AND VALIDATION OF COLD CHAIN DISTRIBUTION

    Jörg Neumann

    Jörg Neumann, Senior Validation Manager, Quality Assurance, Chiron Vaccines

  • Introduction
  • Preparing qualification and validation activities
  • Qualification of transport systems
  • Validation of temperature controlled transport
  • Maintaining the validated status
  • 16:20 ADDING VALUE TO YOUR COLD CHAIN

    Robert Duncan

    Robert Duncan, Principal Consultant, PA Consulting

  • What are the main sources of wastage?
  • What can be done to reduce these costs?
  • Implementation of new technologies to maximise efficiency
  • Determining the ideal transport methods to support your operations
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Afshin Hosseiny

    Dr Afshin Hosseiny, Managing Director, Tabriz Consulting

    9:10 PREPARING FOR REGULATORY INSPECTIONS

    Dr Afshin Hosseiny

    Dr Afshin Hosseiny, Managing Director, Tabriz Consulting

  • Inspection readiness plans
  • Training staff on conducting and receiving audits
  • Pre-inspection audits
  • Corrective action planning/monitoring
  • Dealing with inspection findings
  • 9:40 ISSUES IN OUTSOURCED DISTRIBUTION

    Mark Brazenor

    Mark Brazenor, Vaccine Direct & Distribution Manager, Aventis Pasteur

  • Strategies for best tackling outsourced distribution
  • Selecting the right distributor for your products
  • What are the important considerations when doing this?
  • Establishing standard operating procedures for your logistic providers
  • Strategies to monitor your partners’ performance
  • How do you protect yourself if things go wrong
  • 10:20 MONITORING SYSTEMS IN THE COLD CHAIN

    Robert Wood

    Robert Wood, Operations Manager, Sensitech UK

  • Understanding your cold chain
  • Enhancing your cold chain
  • Who needs to be involved?
  • New technologies - RFID technology…
  • Using cold chain management systems to comply with regulatory requirements
  • Managing the cold chain - easier than you think
  • 11:00 Morning Coffee

    11:20 TEMPERATURE CONTROLLED packaging

    Tim Jennings

    Tim Jennings, Sales Manager, Laminar Medica

  • Thermal packaging available for pharmaceutical distribution
  • Impact of temperature regulations on the cost of packaging
  • New materials in cold chain maintenance
  • Studies of the effectiveness of packaging in various shipping methods
  • 12:00 EFFECTIVE DISTRIBUTION OF TEMPERATURE SENSITIVE GOODS BY SEA

    Dr David Slater

    Dr David Slater, Manager, Logistics, Ortho-Clinical Diagnostics

  • Why choose to move temperature sensitive product by sea?
  • Quality aspects of sea shipments
  • Designing the shipping system
  • 12:40 Networking Lunch

    14:00 INSURANCE CLAIMS

    Phil Skelton

    Phil Skelton, Senior Transportation Risk Manager, ACE Insurance

  • Importance of monitoring each stage of distribution with regards pursuing a claim
  • Effect on policy and premiums on successful use of monitoring equipment
  • Internal claims/self insurance
  • 14:40 PANEL DISCUSSION: IMPLEMENTING A COLD CHAIN STRATEGY

    Latif Al-Ayoub

    Latif Al-Ayoub, Operations Director, Sensitech UK

    Mark Brazenor

    Mark Brazenor, Vaccine Direct & Distribution Manager, Aventis Pasteur

    Dr Afshin Hosseiny

    Dr Afshin Hosseiny, Managing Director, Tabriz Consulting

    Nigel Cryer

    Nigel Cryer, Business Development, Quality, DHL

    15:20 Afternoon Tea

    15:40 TOTAL COMPLIANCE WITHIN THE COLD CHAIN

    John Evans

    John Evans, Director, Pharmaceutical Services, Polar Speed Distribution

  • Background to the current situation
  • MHRA requirements
  • Clients’ requirements
  • The bio cool approach
  • What will the future bring?
  • 16:20 BUILDING A FLEXIBLE PAN-EUROPEAN EUROPEAN COLD CHAIN

    Dr Carol McCall

    Dr Carol McCall, Corporate Marketing & Quality Manager, Alloga

  • Centralised stockholding - risk and benefit
  • Maintaining product integrity
  • Meeting patients' needs
  • 17:00 Chairman's Closing Remarks and Close of Conference

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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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