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Following the success of last year’s event, the SMi Group is honoured to announce its third Cold Chain Distribution Conference. This conference is taking place in Central London on Wednesday 3rd and Thursday 4th December, 2008.
The conference will be tackling a series of key issues and case studies from the perspectives of pharmaceutical organisations, market regulators and logistics organisations.

The conference will be covering a wide range of topics including:

  • Reducing cost as a result of increasing energy prices
  • Making efficiency throughout risk assessment
  • Overcoming customs issues with clinical trial shipments
  • Transporting difficult substances
  • Thermal stability tracking
  • Examining problems and solutions to validation
  • The global regulatory environment
  • Implementation of the temperature-controlled pharmaceutical supply chain
  • Implementing cold chain practices throughout China and the New Territories
  • Enhancing packaging for an efficient and reliable supply chain
  • Meeting external environmental legislation and internal protocols with your cold chain
  • Product tracking and monitoring methods using RFID for different case scenarios
    And many more.
This year’s conference speakers will include:
  • Els Pamooij, Senior Project Manager, Commercialisation, Amgen
  • Anja Van Strien, Manager, Logistic Services IMPs, Schering Plough
  • Tony Wright, Managing Director, Exelsius - Cold Chain Management Consultancy
  • Denise De La Sierra, Vaccine Manager, Areas Global TB Vaccine Foundation
  • Jonathan Blamey, Vice President, Product Development & Strategy, Healthcare and Technology, EMEA, DHL Exel Supply Chain
  • Damian Walker, Regional Sales Manager, Trackflow
  • Dr-Ing. Herbert Ernst, Life Sciences Program Manager Professional Service, Sensitech
  • Geoff Giles, Director, iDipac
  • Mike Meakin, Head of European Quality, DHL
  • Cristiana Spontoni, Partner, Squire, Sanders & Dempsey L.L.P
  • Robert Nientker, EMEA Business Development Director, Life Sciences, Oracle

This Event is aimed at Vice Presidents, Directors, Managers, Scientists etc working in the following areas:

  • Operations
  • Material Management
  • Quality
  • Quality Assurance
  • Logistics
  • Warehouse Operations
  • Application Support
  • Clinical Supplies
  • Clinical Trials Management
  • Clinical Operations
  • Supply Chain
  • Outsourcing
  • Manufacturing
  • Finance
  • Thermal Monitoring
  • Environmental Awareness
  • Packaging
  • Shipping/Distribution
  • Labelling
  • Regulatory Affairs
  • Import-Export Trade Compliance
  • Drug Supply Management
  • Project Management
This conference will also benefit consultants, CROs, technology vendors and companies providing services to the above audience.
Last Year’s Attendees Included:
  • GlaxoSmithKline Clinical Trials
  • Wyeth Biopharma
  • Roche Products
  • Johnson and Johnson
  • Teva Pharmaceuticals
  • Shire Pharmaceuticals
  • Schering Plough
  • And many more
For Speaking opportunities please contact Rachel Francis at rfrancis@smi-online.co.uk
For Sponsorship opportunities please contact Alia Malick at amalick@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Jonathan Blamey

Jonathan Blamey, Vice President, Product Development and Strategy, DHL Exel Supply Chain

9:10 TRANSPORTING TEMPERATURE SENSITIVE PHARMACEUTICALS BY AIR

Tony Wright

Tony Wright, Managing Director, Exelsius Cold Chain Management

  • International Air Transport Association (IATA)  ‘chapter 17’ – what is the aim?
  • The new Time and Temperature Task Force – objectives and progress
  • Other industry initiatives designed to improve the air cargo supply chain process
  • Maintaining the dialogue between logistics providers and pharmaceutical manufacturers’
  • 9:50 INCORPORATING MEAN KINETIC TEMPERATURE INTO YOUR COLD CHAIN RISK ASSESSMENT

    Latif Alayoub

    Latif Alayoub, Commercial Director, Trackflow

  • 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
  • 10:30 Morning Coffee

    11:00 CASE STUDY: DEALING WITH GLOBAL COLD CHAIN DISTRIBUTION CHALLENGES FOR CLINICAL TRIALS

    Hansjoerg Nortmeyer

    Hansjoerg Nortmeyer, Head of Supply Chain Trial Managers, Sanofi Aventis

    11:40 OPTIMISING SUPPLY CHAIN STRATEGY

    Mike Meakin

    Mike Meakin, Vice President, Quality Assurance & Regulatory Affairs, Life Sciences & Healthcare EMEA, DHL Exel Supply Chain

  • Optimising supply chain strategies for your Cold Chain
  • Managing risk assessments
  • 12:00 Networking Lunch

    13:30 CRYOSHIPMENT OF CLINICAL SPECIMENS

    Denise De La Sierra

    Denise De La Sierra, Manager, Clinical Trials Administration, Aeras Global TB Vaccine Foundation

  • Specimen shipping and handling is also as important as the drug being tested
  • Training site personnel for cryoshipper preparation
  • Troubleshooting and prevention of potential issues
  • Selection of the right courier and the importance of communication
  • Preserving the cold chain throughout entire shipping to storage at destination
  • 14:10 TEMPERATURE ASSURANCE RELATED TO PATIENT SAFETY

    Mike Meakin

    Mike Meakin, Vice President, Quality Assurance & Regulatory Affairs, Life Sciences & Healthcare EMEA, DHL Exel Supply Chain

    14:50 Afternoon Tea

    15:20 COLD CHAIN AROUND THE WORLD

    Anthony Battersby

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

  • Design criteria
  • Temperature monitoring
  • Equipment
  • 16:00 IS YOUR COOL CHAIN UNDER CONTROL?

    Stephane Lemaire

    Stephane Lemaire, Pharmaceutical Industry Director, Air France-KLM Cargo

    16:25 INDIA CASE STUDY: PHARMA AIR-TRANSPORT UNDER EXTREME CONDITIONS

    Jeffery Makhani

    Jeffery Makhani, Sales Manager, Delhi, Air France-KLM Cargo

  • The Indian Pharma Environment & It’s challenges
  • AF-KLM Cargo tailor made solutions for the Indian Market
  • Case study: how to meet the requirements of highly temperature sensitive flow ex India?
  • A quick look into the Pharma air-transport future in India
  • 16:50 Chairman’s Closing Remarks

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

    9:10 DHL FREIGHT SERVICES

    Thomas  Ellmann

    Thomas Ellmann, Head of Sector, Lifesciences and Healthcare, DHL Freight

    • Identifying the problem
    • Knowing the action to take
    • DHL’s approach/case study

    9:30 MANAGING PARTNERSHIPS, PROCESSES AND PACKAGING

    Geoff Giles

    Geoff Giles, Director, iDi Pac

  • Applying lessons learnt from marketed product shipments to clinical supplies and APIs
  • Complying with GMP Annex 13: Track & Trace in practice for clinical trial materials to ensure sufficient time for product recall
  • Developing and providing sufficient stability data for temperature sensitive clinical supplies
  • 10:10 Morning Coffee

    10:40 CONCISE COLD CHAIN QUALIFICATION

    Herbert Ernst

    Herbert Ernst, Life Sciences Program Manager Professional Services, Sensitech

  • Analysis of cold chain segment monitoring vs. complete cold chain monitoring
  • Interfaces in the cold chain: loading patterns and pre-cooling
  • Effects of consequential thermal damages
  • Approaches for improvement
  • 11:20 OPTIMIZING THE COLD CHAIN FROM BOTH A COMPLIANCE AND COST EFFECTIVE POINT OF VIEW

    Els Pasmooij

    Els Pasmooij, Senior Project Manager, Amgen Europe

  • Understanding your product requirements
  • Identifying your distribution lanes that need mitigation
  • Obtaining a "state of control" over the variable part of your cold chain
  • Communication with customers
  • 12:00 Networking Lunch

    13:30 COUNTERFEITING AND RELATED TRANSPORTATION ISSUES IN THE PHARMACEUTICAL COLD CHAIN

    Robert Nientker

    Robert Nientker, EMEA Business Development Director Life Sciences, Oracle

  • Brand Protection measures to prevent pharmaceutical counterfeiting and to comply with e-Pedigree rules and Serialization demands are currently important issues.
  • Packaging safety measures such as (2D Matrix) Serialization and subsequent Authentication at point of Dispensing (covert or overt authentication ), as well as RFID tagging are being introduced and piloted as response to these issues.
  • Cold Chain Management, Transportation and Control & Monitoring issues are important since the volume of Cold / Cool Chain Biologicals is increasing very substantially. Appropriate Security and Transportation solutions need to be implemented soon.
  • 14:10 DEVELOPING A PREFERRED VENDOR TO CHOOSE FOR YOUR COLD CHAIN

    Anja Van Strien

    Anja Van Strien, Manager, Logistic Services IMPs, Schering Plough

  • Deciding on choice of supplier when considering company size
  • Outsourcing development
  • Company collaborations
  • In-house and outsourcing
  • 14:50 LAW AND RESPONSIBILITIES FOR SUPPLY-CHAIN FAILURE IN THE EU

    Cristiana Spontoni

    Cristiana Spontoni, Partner, Squire, Sanders & Dempsey LLP

  • What are the legal and regulatory requirements of cold supply chain in the EU?
  • What are the obligations of manufacturers/importers, distributors, transporters, pharmacies and hospitals?
  • What are the potential consequences if something goes wrong?
  • How are liabilities shared in the supply chain?
  • Are there differences at national level?
  • 15:30 Chairman’s Closing Remarks and Close of Conference

    15:45 Afternoon Tea

    +

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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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