Home
overview

What is this event about?

With the high costs of development for a new drug, no company can afford to further increase costs through inefficiencies in the clinical trial supply chain.  As an attempt is made to reduce expenses through conducting clinical trials in the emerging markets of Asia, India, South America and Eastern Europe there is an increasing need to ensure that your logistics procedures are as efficient and cost effective as possible.

SMi's 4th annual Clinical Trial Logistics conference will address your concerns and provide you with the tools to safely and efficiently resolve your clinical trials logistical challenges on a global scale. This conference will also analyse the latest developments in labelling, packaging, inventory management, security, forecasting, partnering and outsourcing.

 

Fancy speaking at the conference?  Do you know of anyone who may be interested in speaking?  We are always on the look-out for new speakers for our upcoming conferences.  Let us know: smiproduction@smi-online.co.uk.


For sponsorship and exhibitioning opportunities, contact sponsorshipdept@smi-online.co.uk 

 Why should you attend this event?

Key topics to be covered include

  • Effectively managing clinical trials with limited drug supplies
  • Reducing temperature deviation in the shipment of clinical trial supplies
  • Legal and regulatory aspects of clinical trials in the EU and outsourcing logistics
  • Labelling of investigational medicinal products
  • Lean manufacturing and effective supply chain management
  • Packaging strategies for clinical trial supplies  
  • Logistical challenges of running trials in emerging economies
  • IVR and IWR
  • Forecasting supply demand

Network with senior representatives from the organisations already registered, including:

  • GlaxoSmithKline
  • AstraZeneca
  • Roche
  • Bayer Schering Pharma
  • Boehringer Ingelheim
  • Abbott
  • Eisai
  • UCB
  • Dainippon Sumitomo Pharma
  • Nycomed
  • MHRA
  • Norgine
  • CSL Bering
  • GW Pharma
  • Brecon Pharmaceuticals
  • Farma Mondo
  • Allos Therapeutics
  • Antisense Pharma
  • United Drug
  • KOWA

 

 

  • Catalent
  • Ambe Medical
  • Swiss Blood Stem Cells Foundation
  • Vertex
  • TD Packaging
  • Global Biopharm Solutions
  • Apax Partners
  • Aptuit
  • IPSEN
  • Beta Ltd
  • Hong Kong Hospital Authority
  • Verdandi AG
  • BioHealthCare
  • University of Cambridge
  • Fisher Clinical Services
  • World Courier
  • Brecon Pharmaceuticals
  • Bilcare

 

 Attending this conference will allow you to

  • Identify inefficiencies in your supply chain and develop strategies to remedy them
  • Understand the legislative requirements around clinical trial logistics
  • Learn from and network with senior figures in this area
  • Improve your labeling and packaging procedures
  • Understand the intricacies of performing clinical trials in emerging markets

Attendees at our previous conferences said

"Very good" Senior Representative, Wyeth

"Very good. Well organised" Senior Representative, Antisoma Research

"Informative and good networking opportunities" Senior Representative, Unichem

"Well organised and efficiently run and chaired" Senior Representative, DHL Express Europe

Who is speaking at the event? 

Our keynote speakers

Dawn Padfield
Director of Technical Development and Clinical Supply
Norgine

David Revel
Technology and Innovation Specialist
Sanofi-Aventis R&D

Heike Roeder
Director, Head of Global SOPs & Training
UCB

Rick Mann
Associate Director, Product Development, Clinical Supplies and Logistics
Dainippon Sumitomo Pharma

Nette Falkenberg
Clinical Supplies Co-ordinator
Novo Nordisk

Our expert speakers

Kay-Christian Karstadt, Executive Director GCTS, Multipharma

Federico Lupp, Director Sales Europe and Latin America, LifeConEx

Paul Ranson, Partner, Fasken Martineau LLP

Tony Wright, Managing Director, Exelsius Cold Chain

Robert Silber, Director, Supply Chain Management, FibroGen

Tim Saint, Business Development Manager, Marken

Sean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services

Geert Crawels, Director, Lodestone

Sue Lee, Manager BioPharm Systems R&D, World Courier

Mark Wright, Validation Consultant, GxPi

Mike Bradshaw, Senior Vice President, Ocasa

 

Who should attend this event?

Previous delegates came from a wide base around the world

You should attend this event if you are a Vice President, Director, Manager or Supervisor from within the pharmaceutical or biotech industry with responsibilities in the following areas:

  • Clinical Supply Operations
  • Clinical Trials Logistics
  • Clinical/Investigational Supplies
  • Shipping and Distribution
  • Clinical Labelling / Packaging
  • Clinical Trials Material Management
  • Clinical Supplies Manufacturing
  • Clinical Quality Assurance/Quality Control
  • Regulatory Affairs
  • Import-Export Trade Compliance
  • Project Management
  • Interactive Voice Response Systems (IVRS)
  • Clinical Research / Planning
  • Drug Supply Management
  • Sourcing and Procurement

 Where is the event taking place?

London Marriott Hotel Regent's Park

128 King Henry's Road
London
NW3 3ST

Phone: +44 (0)207 722 7711
Fax: +44 (0)207 586 5822
Sales: +44 (0)207 449 4412
Sales fax: +44 (0)207 722 5973 

www.marriott.co.uk/Regents-Park

Ideally located with easy access to London's major motorways, the London Marriott Hotel Regents Park is set in the quiet suburbs of Swiss Cottage; close to Lords Cricket Ground, London Zoo and the chic bars and restaurants of St Johns Wood and Primrose Hill. The nearby tube station offers direct access to Wembley and the O2 Centre, Bond Street, Westminster and Canary Wharf on the Jubilee line.

The only luxury North London hotel in Swiss Cottage, the London Marriott Hotel Regents Park promises a delightful stay, offering spacious rooms graced by amenities both pampering and practical - from luxurious new bedding to wireless Internet access. A tempting choice of dining includes the vibrant flavours of Brasserie Centrale and the casual Chat's Cafe Bar. To stay fit, a well-equipped leisure club and indoor pool awaits.

Nearest train station:
West Hampstead, 1.9 km

Nearest underground station:
Swiss Cottage (Jubilee line), 0.5 km, 5 min walk

Conference programme

8:30 Registration and coffee

9:00 Chairman's opening remarks

Sean Smith

Sean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services

9:10 Effectively managing clinical trials with limited drug supplies

Robert Silber

Robert Silber, Director, Supply Chain Management, FibroGen

  • Working with stakeholders
  • Maximising efficiency
  • Developing flexible supply plans
  • 9:50 Clinical supply chain and cycle time reduction

    Sean Smith

    Sean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services

  • The challenges of logistics in emerging markets with a particular focus on India and China
  • Technologies to aid clinical supply chain in emerging markets
  • Financial comparisons and advantages, study examples
  • 10:30 Morning coffee

    11:00 Integrated cold chain solution: What to consider for a model to manage end-to-end (E2E) temperature controlled transportation to prevent disturbance of clinical trials

    Federico Lupp

    Federico Lupp, Director of Sales Europe and Latin America, LifeConEx

  • Logistics and process management integrated with geographic, climatic, packaging and supplier data
  • Criticality of standardisation and proactive intervention in a process
  • Quality agreement, control and assurance
  • Peace of mind in global cold supply chain
  • 11:40 Supply chain management best practices in end-to-end clinical trial supply chain management

    Geert Crauwels

    Geert Crauwels, Director, Lodestone Management Consultants

  • Strategies to reduce overages and optimising the supply chain for clinical trials
  • Adopting new business models
  • Leveraging best practice IT solutions
  • 12:20 Networking lunch

    13:50 Clarifying the role of the clinical supplies coordinator

    Nette Falkenberg

    Nette Falkenberg, Clinical Supplies Co-Ordinator, Novo Nordisk

  • The role and responsibilities
  • Challenges
  • Case studies 
  • 14:30 Innovative packaging strategies for clinical trial supplies

    David Revel

    David Revel, Technology and Innovation Specialist, Sanofi-Aventis

  • Security
  • Integrity
  • Traceability
  • 15:10 Afternoon tea

    15:40 Lean manufacturing and effective supply chain management to expedite an NDA

  • Using a clinical supplies team to manage manufacturing and packaging vendors
  • Effective planning and forecasting
  • Regulatory hurdles
  • Benefits to the industry
  • Rick Mann

    Rick Mann, Associate Director, Product Development, Clinical Supplies and Logistics, Sepracor

    16:20 Legal and regulatory aspects of clinical trials in the EU and outsourcing logistics

    Paul Ranson

    Paul Ranson, Partner, Fasken Martineau LLP

  • Overview of clinical research and logistics regulation in the EU
  • Key legal issues in logistics/outsourcing
  • Developing outsourcing practices and agreements to manage the risks
  • 17:00 Chairman's closing remarks

    17:10 Drinks reception

    18:30 End of day one

    8:30 Re-registration and coffee

    9:00 Chairman's opening remarks

    Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

    9:10 Supply of investigational medicinal products - the CMC perspective

    Dawn Padfield

    Dawn Padfield, Director of Technical Development and Clinical Supply, Norgine

  • Summary of CMC activities associated with IMP supply
  • Advantages and disadvantages of in-house supply management
  • The CRO option
  • 9:50 Labelling of investigational medicinal products

    Heike Roeder

    Heike Roeder, Director, Head of Global SOPs & Training, UCB

  • Label Text Requirement according to Annex 13 of the GMP
  • Translation and local requirement
  • Expiry date 
  • Pooling supplies, just in time labelling
  • 10:30 Morning coffee

    11:00 Comparator sourcing strategies

    Kay-Christian Karstadt

    Kay-Christian Karstadt, Executive Director, Multipharma

  • Sourcing options
  • Procurement design and provider selection
  • Reliable supply to trial sites
  • 11:40 Avoiding disappointment with your logistics partner

    Tim Saint

    Tim Saint, Business Development Manager, Marken

  • Agree relationship terms
  • Identify core teams
  • Project management
  • Study set up
  • Operational processes
  • Audit
  • KPIs
  • 12:20 Networking lunch

    13:50 Running successful clinical trials in China

    Mike Bradshaw

    Mike Bradshaw, Senior Vice President, Ocasa

  • Infrastructure
  • Facilities
  • 'Guxi'
  • Where are clinical trials allowed by the authorities?
  • 14:30 Logistical challenges of conducting clinical trials in emerging economies

    Sue Lee

    Sue Lee, Manager BioPharm Systems R&D, World Courier

  • What are the new challenges that face sponsors running trials in new countries and emerging economies?
  • How do you ensure smooth transit through customs and government agencies?
  • How do you guarantee temperature compliance in climate extremes?
  • How can depot strategies improve the supply chain?
  • 15:10 IVR/IWR - Specification, validation and implementation

    Mark Wright

    Mark Wright, Validation Consultant, GxPi

  • Managing drug supply efficiently
  • Guaranteeing the system meets business requirements
  • Getting the system live - plainning ahead to avoid start-up problems
  • Ensuring compliance
  • 15:50 Chairman's closing remarks

    16:00 Afternoon tea and networking with sponsors and delegates

    16:30 Close of conference

    +

    Workshops

    Do you really know what happens to your IMPs at the clinical trial site?
    Workshop

    Do you really know what happens to your IMPs at the clinical trial site?

    Marriott Hotel Regents Park
    19th May 2010
    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

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.