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The total R&D investment of bringing a new product to market has been estimated to be close to £400 million. All new products need go through clinical trials and every stage of a clinical trial involves logistics. The effective transport of clinical trials to investigator sites, and patient samples back to central laboratories are critical if a product is to be launched on time and within budget. Delays are expensive and even a few days could potentially cost millions of pounds. The pressure of bringing drugs to market quickly and cheaply, has lead to many clinical trials now being carried out in Asia, Eastern Europe and Latin American. Each country has its own guidelines which can be highly regulated, so it is crucial to understand the complexities of shipping materials to a variety of destinations.

SMi’s 2nd Annual Clinical Trials Logistics conference will address these 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 packaging, labelling, security, modelling and outsourcing.



Exclusive presentations from industry experts including:

  • Peter Orosz, Head of Clinical Supplies Coordination, Boehringer Ingelheim
  • Wencke Cannaerts, Associate, Clinical Services, Baxter World Trade
  • Mark Woolfe, Global Depot Manager, Almac Clinical Services
  • Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithKline
  • Rhian Jones, Clinical Pharmacy Coordinator, Wyeth
  • Eric de Wit, Senior Manager, Clinical Supply Chain Management, Amgen Europe B.V.
  • Patricia Stewart, Associate Director, Bioprocess Development, CSL Limited
  • Henriette Fugman Bech, Clinical Supply Co-ordinator, Novo Nordisk
  • Georges Portailler, Clinical Packaging Operations Industrialisation Master Plan, Clinical Supply Chain, Sanofi-Aventis
  • Heike Röder, Head of CTS - Planning Group, UCB Group
  • Bernie Cunningham, Director, Clinical Trial Supplies, OSI Pharmaceuticals
  • Raghib Ali, Clinical Lecturer, Clinical Pharmacology and General Medicine, Oxford University
  • Christa Janko, Head of Operations, Vienna School of Clinical Research
  • Georgia Bullock, Clinical Trials Supervisor, European Group for Blood and Marrow Transplantation
  • Theo Raynor, Professor of Pharmacy Practice, University of Leeds
  • Yiping Chen, Senior Trial Coordinator, Clinical Trials Service Unit & Epidemiological Studies Unit, Oxford University



Critical challenges that will be addressed:
  • IDENTIFY the key requirements in conducting trials in foreign countries
  • DISCOVER how to effectively package and label your clinical trials material
  • EXAMINE the transportation of difficult substances
  • UNDERSTAND inventory systems and modelling
  • EVALUATE outsourcing and partnership opportunities



You will benefit from attending 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
  • Clinical Packaging
  • Clinical Trials Material Management

  • Clinical Supplies Manufacturing
  • Regulatory Affairs
  • Clinical Quality Assurance/Quality Control
  • Import-Export Trade Compliance
  • Project Management
  • Clinical Research / Planning
  • Drug Supply Management


This conference will also benefit consultants, CROs, technology vendors and companies providing services to the above audience.



Last years' delegates included:

  • GlaxoSmithKline
  • Baxter World Trade
  • Genzyme BV
  • F.Hoffmann-La Roche        
  • Genmab A/S
  • Schering – Plough

  • Actelion Pharmaceuticals Ltd.  
  • Allergen
  • Brecon Phamaceuticals
  • GlaxoSmithKline Biologicals SA
  • Organon
  • Adallen Pharma Ltd.




For Speaking opportunities please contact Mamta Patel at mpatel@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

Rhian Jones

Rhian Jones, Clinical Pharmacy Coordinator, Wyeth

9:10 OUTSOURCING OPPORTUNITIES

Heike Roder

Heike Roder, Head of CTS - Planning Group, Schwarz Biosciences, UCB Group

  • Pros and cons of outsourcing
  • Sourcing external companies
  • Negotiating outsourcing agreements
  • Effectively communicating the project definition and scope
  • Building good working relationships
  • 9:50 CASE STUDY: THE CHALLENGES OF GLOBAL DEPOT MANAGEMENT IN NEW TERRITORIES

    Mark Woolf

    Mark Woolf, Global Depot Manager, Almac Clinical Services

  • Issues facing IMP distribution
  • Global strategies
  • Depot selection and management
  • Common pitfalls
  • 10:30 Morning Coffee

    11:00 CASE STUDY: FROZEN INVESTIGATIONAL MEDICINAL PRODUCT

    Eric de Wit

    Eric de Wit, Senior Manager, Amgen B V

  • Transportation
  • Distribution
  • Insourcing vs. outsourcing
  • The cost of the supply chain
  • Stability issues
  • 11:40 COLD CHAIN DISTRIBUTION

    Patricia Stewart

    Patricia Stewart, Associate Director, Bioprocess Development, CSL Ltd

  • Why is cold chain management so important for biological products
  • Preparation for shipment and shipping requirements
  • The shipping process
  • Validation and temperature monitoring
  • Management of unexpected events
  • Storage of clinical material at site
  • 12:20 Networking Lunch

    13:50 CLINICAL PACKAGING AND LABELLING

    Georges  Portailler

    Georges Portailler, Clinical Packaging Operations, Industrialisation Master Plan, Sanofi Aventis R&D

  • Technical innovation: to improve flexibility – flexible IP for phase 3 and FIM studies
  • To reinforce the safety and the compliance
  • Risk mitigation strategy
  • Information technology to insure full traceability
  • Clinical packaging look for process/methods in industrial to improve efficiency
  • 14:30 PACKAGING & LABELLING

    Peter Orosz

    Peter Orosz, Head of Clinical Supplies Coordination, Boehringer Ingelheim GmbH

  • Planning of packaging & labelling
  • Supply chain of clinical supplies
  • Set-up of packaging design
  • Packaging materials
  • Managing multi-lingual labels
  • Packaging & labelling processes
  • Distribution
  • Complying with EU regulations
  • 15:10 Afternoon Tea

    15:40 PATIENT INFORMATION

    Theo Raynor

    Theo Raynor, Professor of Pharmacy Practise, University Of Leeds

  • What do patients want from medicines and clinical trial information?
  • What does the international research tell us?
  • What are the 10 principles for writing good patient information?
  • How do you involve patients in developing good materials?
  • What testing can be used to confirm that patients can find and understand the key points of information?
  • 16:20 CASE STUDY: ELECTRONIC DOCUMENT MANAGEMENT SYSTEMS AND LABEL APPROVAL

    Bernie Cunningham

    Bernie Cunningham, Director, OSI Pharmaceuticals

  • Version control while label is being developed
  • Visibility of previous labels
  • Visibility of approvals (who's desk is it "sitting" on)
  • Consistency of Layout
  • Query/report of labels based on attributes (country, language, dosage form etc)
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    Rhian Jones

    Rhian Jones, Clinical Pharmacy Coordinator, Wyeth

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Georges  Portailler

    Georges Portailler, Clinical Packaging Operations, Industrialisation Master Plan, Sanofi Aventis R&D

    9:10 KEYNOTE ADDRESS: CO-ORDINATING CLINICAL SUPPLIES

    Henriette Fugman Bech

    Henriette Fugman Bech, Clinical Supply Co-ordinator, Novo Nordisk

  • The role of the Clinical Supplies Co-ordinator
  • Predicting the quantities required
  • Co-ordinating the manufacture of clinical supplies 
  • Selecting appropriate packaging design/materials
  • Liaising with External Packaging Facilities for larger trials
  • Managing IV/WRS
  • Summary  
  • 9:50 DEVELOPING TRIALS IN NEW COUNTRIES & REGIONS

    Georgia Bullock

    Georgia Bullock, Clinical Trials Supervisor, European Group for Blood and Marrow Transplantation

  • Basic requirements of running a global clinical trial supply chain
  • Consolidating multiple clinical trials
  • Incorporating local studies with international studies
  • The regulatory requirements for each country
  • Managing multiple regulatory authorities and timescales
  • Analysing conflicting needs and priorities
  • 10:30 Morning Coffee

    11:00 CASE STUDY: CONDUCTING CLINICAL TRIALS IN INDIA

    Raghib Ali

    Raghib Ali, Clinical Lecturer, Oxford University

  • Why India?
  • Developing successful partnerships with Pharma, CROs, SMOs and sites in India
  • Integrating India into global clinical trials
  • Practical and ethical challenges    
  • Overcoming regulatory hurdles
  • 11:40 WYETH CASE STUDY

    Rhian Jones

    Rhian Jones, Clinical Pharmacy Coordinator, Wyeth

  • Randomization and packaging strategies
  • Distribution strategies
  • Estimating and forecasting clinical trials
  • Project team roles and responsibilities
  • Lessons learnt
  • 12:20 Networking Lunch

    13:50 CASE STUDY: HANDLING CLINICAL TRIALS IN THE FAR EAST

    Yiping Chen

    Yiping Chen, MRC Study Coordinator & Senior Investigator Scientist, Oxford University

  • Understanding the disease patterns and health care system
  • Assessing the legal, ethical and logistical difficulties of conducting clinical trials in China
  • Managing local depots and on-site transport of study drug and biological samples
  • Identifying the legal and regulatory requirements of import licensing and customs
  • Analysing the benefits and drawbacks of conducting large-scale trials in China
  • 14:30 TRAINING CLINICAL TRIALS PERSONNEL

    Christa Janko

    Christa Janko, Director Educational Program and Strategic Planning, Vienna School Of Clinical Research

  • Critical areas of clinical trial logistics
  • Decision-making regarding in-house versus outsourcing
  • Required skills and personnel
  • Case study: investigational products
  • Case study: data management
  • Effective training strategies
  • 15:10 Afternoon Tea

    15:40 INVESTIGATIONAL PRODUCT MANAGEMENT

    Wencke Cannaerts

    Wencke Cannaerts, Clinical Services Associate, Baxter World Trade S. A

  • Identifying the legal and regulatory framework
  • Understanding the logistical difficulties of handling investigational products: the view of the sponsor, the clinical locker and the patient
  • Analysing the strategies to achieve an effective distribution
  • Challenges in inventory management
  • 16:20 PREDICTIVE MODELLING OF PATIENT RECRUITMENT

    Vladimir  Anisimov

    Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithKline

  • Uncertainties in patient recruitment
  • Recruitment modelling
  • Recruitment model verification
  • Recruitment prediction    
  • Adaptive adjustment
  • Case studies
  • 17:00 Chairman’s Closing Remarks and Close of Conference

    Georges  Portailler

    Georges Portailler, Clinical Packaging Operations, Industrialisation Master Plan, Sanofi Aventis R&D

    +

    Workshops

    Resource Optimisation in Clinical Trials
    Workshop

    Resource Optimisation in Clinical Trials

    Crowne Plaza Hotel - The City
    20th May 2008
    London, United Kingdom

    Crowne Plaza Hotel - The City

    19 New Bridge Street
    London EC4V 6DB
    United Kingdom

    Crowne Plaza Hotel - The City

    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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