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"Top quality topics,speakers and delegates..."Jessica Knights, Editor, Thomsonreuters, SMi's Conference

It is a constant challenge for Pharmaceutical companies to cut costs and improve their drug supply chain. 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 to go through clinical trials and every stage of a clinical trial involves logistics. During this process certain aspects should be taken into consideration such as capacity management, resource planning, regulations for outsourcing as well as aspects of packaging, labelling and distribution.

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 trial materials to a variety of destinations.
 

SMi’s 3rd Annual Clinical Trials Logistics 2009 conference will address these concerns and provide you with insight of how other companies do their supply prediction/forecasting, how a drug product/API demand is forecasts. This conference will cover outsourcing, adaptive clinical studies and provide you with 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, capacity management, resource planning modelling, partnering and outsourcing.

A Vice President, Director, Manager or Supervisor from within the pharmaceutical or biotech industry with responsibilities in the following areas:

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

 
  • 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
     
 
 
 
                   

Conference programme

8:30 Registration & Coffee

9:00 Chairman's opening remarks

Tony Wright

Tony Wright, Managing Director, Exelsius Cold Chain Management

9:10 ADJUSTMENT OF ENROLLMENT IN CLINICAL TRIALS

Hugo Maas

Hugo Maas, Pharmacometrician , GlaxoSmithKline

  • Poisson enrolment model
  • Uncertainty/variability analysis
  • Poisson mixed with Gamma
  • Bayesian approach
  • Further steps
     
  • 9:50 OPTIMISING THE CLINICAL PROGRAM FOR REGISTRATION IN THE EUROPEAN UNION

    Louis-Christian Clauss

    Louis-Christian Clauss, Senior Consultant, Hays Pharma

  • Type of application
  • Highlighting the strategies for achieving success in Europe
  • Meeting European requirements versus USA requirements
  • Scientific advice strategy
  • CTA vs IND
  • Strategies to getting to the market fast
  • BioSimilar in Europe
  • Risk Management Plan
  • 10:30 Morning Coffee

    11:00 CHALLENGES OF CLINICAL TRIAL LOGISTICS FOR BIOLOGICAL PRODUCTS

  • Lean about Handling of Biological products
  • Transporting issues and new methods
  • Discussing country specific regulations
  • Peter Mayne

    Peter Mayne, Director, Quality Assurance, OSI Pharmaceuticals (UK)

    11:40 QP ROLE IN CLINICAL TRIAL GMP

    Marc Weinzweig

    Marc Weinzweig, Managing Director & QP, Biotec Services International

  • Responsibilities of a QP
  • Clinical trials GMP
  • QP process and clinical trials
  • 12:20 Networking Lunch

    13:50 THE DECISION MAKING PROCESS FOR MANAGING CLINICAL SUPPLIES IN EMERGING MARKETS

    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
  • 14:30 PANEL DISCUSSION

  • Identifying problem areas
  • Building an adequate contingency
  • Implementation issues
  • Peter Mayne

    Peter Mayne, Director, Quality Assurance, OSI Pharmaceuticals (UK)

    Massimo Eli

    Massimo Eli, GCS Regional Lead, Schering Plough

    Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

    15:10 Afternoon Tea

    15:40 BOOKLET LABELS

    Erik Hahn

    Erik Hahn, Outsourcing Manager, Drug Supply Manager, Novartis Pharmaceuticals

  • Solutions & Design
  • Generation process & Time lines
  • Overprinting
  • Booklet label versus "Just in time" labelling
     
  • 16:20 FAST TRACK PACKAGING FOR PHASE I TRIALS

    David Spillett

    David Spillett, Business Development Manager, Penn Pharmaceuticals

  • Outlining multi-functional label solutions
  • Supporting solutions for documentation improvement
  • Dealing with multi –language trials
  • 17:00 Chairman's Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

    9:10 CLARIFYING THE ROLE AND DUTIES OF THE CLINICAL SUPPLIES COORDINATOR

    Karen Rasmussen

    Karen Rasmussen, Project Responsible Supplies Coordinator, Novo Nordisk

  • Predicting the quantities required
  • Coordinating the manufacture of clinical supplies
  • Selecting appropriate packaging design/materials
  • Liaising with External Packaging Facilities for larger trials
  • Managing IV/WRS
  • Summary
  • 9:50 MANAGING THE INTERFACE BETWEEN "CLINICAL SUPPLY" AND ITS CRITICAL PARTNERS

  • Upfront forecasting
  • Accurate and complete planning
  • Process mapping
  • Reaching of an agreement on design, labels, quantities, timelines and distribution strategy
  • Capacity evaluation and according schedule
  • Priority setting
  • Roles and responsibilities
  • Distribution management
  • Inventory management
  • Cross functional approach
  • Performance metrics
  • Massimo Eli

    Massimo Eli, GCS Regional Lead, Schering Plough

    Fabrice Piroird

    Fabrice Piroird, GCS Regional Lead, Schering Plough

    10:50 Morning Coffee

    11:20 SHIPMENT SECURITY

    Sue Lee

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

  • What are the new regulations on cargo screening and how do they affect your shipments?
  • How is your cargo screened and does it really involve sniffer dogs clambering over your sterile pharmaceuticals?
  • What is high risk cargo and why is your material likely to be considered as high risk.
  • How can you ensure your high value materials remain safe whilst in transit
  • 12:00 PREDICTIVE PATIENT RECRUITMENT AND SUPPLY MODELLING TO ENSURE SUCCESSFUL COMPLETION OF CLINICAL TRIALS

    Vladimir Anisimov

    Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithkline

  • Main sources of uncertainty and appropriate metrics for measuring success
  •  Modelling and predicting recruitment at the initial and interim stages
  • Adaptive adjustment of recruitment and number of clinical centres at any interim time
  • Evaluating study performance and site productivity
  •  Drug supply predictive modelling
  • Case Studies
     
  • 12:40 Networking Lunch

    14:10 REQUIREMENTS FOR SELECTING A COMPARATOR PROVIDER

    Kay-Christian Karstadt

    Kay-Christian Karstadt, Executive Director, Multipharma

  • Determining the sourcing complexity during the design process of the trial
  • Assessing the quality of the Provider
  • Specifying the quality of the sourced goods
  • Compiling a sourcing strategy
  • Considering your procurement options in a global market place
  • 14:50 OPTIMAL PLANNING FOR CLINICAL SUPPLY

    Vladimir Shnaydman

    Vladimir Shnaydman, President, ORBee Consulting

  • Challenges of clinical trials supply chain planning
  • Factors affecting complexity of supply chain planning
  • Analysis of current approaches
  • Technique for optimal clinical trial supply chain planning
  • Case study
  • 15:30 Chairman's Closing Remarks

    15:45 Afternoon Tea & Exhibition

    16:15 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.

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    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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