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Clinical Trial Logistics
22 May - 23 May 2012
Clinical Trial Logistics

SAE Media Group’s flagship Clinical Trial Logistics conference returns for its sixth edition boasting high level Pharma speakers and an innovative and novel agenda. This year’s event builds on the successful foundations of previous years whilst incorporating new approaches to the management and successful operation of Clinical Trials. The event will be held in London on Tuesday 22nd and Wednesday 23rd of May 2012 and provides the most thorough appraisal and analysis of the clinical trial process.


Hear presentations from the big Pharma, regulatory and logistical perspectives. This provides a balanced and in depth analysis into the management and execution of clinical trials. Attendees will take away a keen understanding of core topics such as vendor partnering & selection, relationship management and transport validation studies. This year, they will also learn more about the logistics of maintaining and completing a clinical trial through studies in patient recruitment and retention and site selection, as well as risk management. This will give delegates a greater understanding of how their role in the Clinical Trial process fits in to the bigger picture and organisation of the endeavour.


This year we will be focusing on how to improve efficiency and cost effectiveness in your clinical supply chain. Presentations on Shipping validation, transportation studies, timely delivery of clinical trials & understanding and analysis of risk will help you to address any weaknesses in your supply chain, but more importantly, to build on your strengths. In keeping with this, presentations on potential challenges posed by the Olympics and distribution strategy for a virtual company provide unique focus to the discussion.


In the modern world it is more important than ever before to understand how your supply chain must take in to consideration the importance of long distance travel, security and fraud concerns, language and cultural barriers and the effective management of these considerations provides competitive advantage. If you understand the intricacies of your clinical supply chain you can take benefit and get ahead of the competition. The ultimate logistical plan aspires to no weak links in the supply chain and this event will allow attendees to learn from others and to share their own experiences to help their programme going forward.

With over 100 industry professionals attending, this event provides an ideal learning, networking and betterment opportunity. Stay ahead of the competitive curve by attending an expanding your understanding of the field and your business network at this can't miss event for 2012.


‘In 2008, more than $35 billion was spent on clinical research of investigational treatments, up from $18 billion in 2000, an 8.6% eight-year annual growth rate. During the period 2004 to 2008, clinical research spending from all sources grew by 9.0% each year’


Source: http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/CRO%2FSponsor/Sizing-Up-the-Clinical-Research-Market/ArticleStandard/Article/detail/660749


Kenneth A. Gatz, Senior Research Fellow at Tufts CSDD and Chairman of CISCRP – ‘Sizing Up the Clinical Research Market’ for Applied Clinical Trials Online. 

   

 

 Gold Sponsor:

 

This event is sponsored by:

 

Almac Group Biocair Catalent Creapharm QuickSTAT SCA Cool Logistics Sensitech Incorporated

     

If you are interested in exhibiting at this event please contact us at sponsorshipdept@SAE Media Group-online.co.uk

 

Feedback from last year's event included:

 “As a person, newly appointed into this industry

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Sue Lee

Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

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9:10

Quality challenges in clinical trial supply

Michael Hildebrand

Michael Hildebrand, Professor for Industrial Pharmacy, University Of Jena

  • Overview of actual regulations
  • Impact of regulations in daily practice
  • Roles of QA and QP
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    9:50

    Understanding analysing and preparing for risk

    Sue Lee

    Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

    General Patton said
    ““Take calculated risks. That is quite different from being rash.”

    • Risk is a necessary part of business
    • How should we assess risk and assign numerical value to it  
    • How to prioritise and prepare for risk
    • Should we Treat, Tolerate, Transfer or Terminate?

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    10:30

    Morning Coffee

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    10:50

    Advanced Medicinal Therapeutic Products – The Logistical Challenges They Pose

    Robert Smith

    Robert Smith, Global Director CPRS QA, Genzyme Therapeutics

  • What is an Advanced Therapeutic Medicinal Product (ATMP)
  • Regulations
  • Manufacturing Process
  • Testing Process
  • Logistical challenges
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    11:30

    Good Cold Chain Management Practices for Proper Storage of Medicinal Products

    Olivier Simonnot

    Olivier Simonnot, Strategic Marketing Manager EMEA, Sensitech

    •          Global Regulatory Efforts to Manage the Cold Chain

    –        Typical Guidance Language for Storage

    –        Inspections, Observations, and Results

    •          Technology Considerations to Comply with cGMP Storage Requirements

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    12:10

    Time and stability sensitive samples - success by design

    Scott Vincent

    Scott Vincent, Logistics Director, A4Pbio

  • Interactive Planning
  • Vendor choice & transit strategy
  • Reducing logistical hurdles - optimising delivery globally
  • Dealing with variable stability
  • Thinking outside of the box
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    12:50

    Networking Lunch

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    14:00

    Panel Discussion: Dynamic, flexible packaging & labelling materials

    • What is available in the market currently?
    • What can be improved?
    • Advantages to be gained
    • Improving cost efficiency

    Frauke Bruns

    Frauke Bruns, Clinical Trial Supplies Group Leader, Actelion Pharmaceuticals

    Sue Lee

    Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier

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    14:50

    Shipping validation supply chain & logistics

    Paul Fitton

    Paul Fitton, Owner, Commissioning & Qualification Services , Cogent Validation Services

  • Challenges involved in partnering
  • This section will discuss the stages of shipping validation projects and outline the levels of third party support required at the various stages by drug manufacturers .
  • Meeting the expectations of the auditor
  • This section will outline key requirements to be considered when developing the logistics & supply chain process in order to meet with the expectations of the auditor.
  •  Concept Laboratory Studies versus Real Time Studies
  • Globalisation & Partnering Support:
  • This section will outline the challenges faced when commencing product globalisation, its impact on the validation effort and the level of partnering needed to make it happen 
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    15:30

    Afternoon Tea

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    16:00

    Delivering clinical trials on time and on target

    Sharai Chitando

    Sharai Chitando, Lead Research Nurse, Guys and St Thomas's NHS Foundation Trust

    • Partner carrier selection
    • Site selection
    • Patient recruitment strategy
    • Patient retention and monitoring

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    16:40

    Chairman’s Closing Remarks and Close of Day One

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    16:50

    Drinks Reception - Hosted by World Courier

    Please join us for a drinks reception immediately after the panel discussion which closes the first day.  This will be a relaxed and social setting for you to network with delegates and sponsors and to follow up any questions you may have with speakers.

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Vladimir Anisimov

    Vladimir Anisimov, Honorary Professor in the School of Mathematics and Statistics, University of Glasgow

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    9:10

    Predictive clinical trial supply chain modelling (statistical methodology and software)

    Vladimir Anisimov

    Vladimir Anisimov, Honorary Professor in the School of Mathematics and Statistics, University of Glasgow

    •         Main uncertainties and risks in CT supply chain process
    •         Predictive patient recruitment modelling
    •         Risk-based supply chain modelling
    •         Software tools and implementation 

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    9:50

    Managing clinical trial logistics challenges in emerging markets.

    Angus MacLeod

    Angus MacLeod, Senior Manager, Depot Management, Catalent Pharma Solutions Inc

    • Distribution timeline
    • Regulatory difference
    • Management of logistics within the country

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    10:30

    Morning Coffee

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    11:00

    The Olympics: Potential Logistical Challenges

    Mike Bradshaw

    Mike Bradshaw, Global sales and marketing director, Biocair International Ltd

    • Impacts we are aware of e.g. road closures
    • Unforeseen hazards and issues e.g. airport closures
    • Contingency Planning:  What can be done to ensure minimum impact

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    11:40

    Cleaning Validation

    Paul Fitton

    Paul Fitton, Owner, Commissioning & Qualification Services , Cogent Validation Services

    • Risk Based Approach? Scientific rationale versus the Regulators expectations based on industry standard.
    • Cleaning Validation versus In Process Control  (IPC) sampling of routine cleaning activities.
    • Should MACO calculation data be included into CV projects for protein based products?
    • Implementing a successful CV project during routine manufacture

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    12:20

    Networking lunch

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    13:50

    Distribution strategy for a virtual company

    Frauke Bruns

    Frauke Bruns, Clinical Trial Supplies Group Leader, Actelion Pharmaceuticals

    distribution via contract packager versus transport specialist
    • Importer of record challenges
    • product cost versus transfer price
    • working with different CROs in 1 country on drug distribution, import license application and site monitoring

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    14:30

    Patient recruitment & retention in Clinical Trials – CNS case study

    Hitendra Parmar

    Hitendra Parmar, Medical Director UK & Ireland, Archimedes Pharma

    • Features of CNS trials that affect patient recruitment and retention.
    • Getting the patient into the trial in the first place.
    • Retaining the enrolled patient in the trial.
    • Recruitment and retention issues in Alzheimer’s Disease and dementia clinical trials.

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    15:10

    Afternoon Tea

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    15:40

    Maintaining data security throughout the distribution network

    Roger Lamb

    Roger Lamb, Healthcare Manager, GS1 UK

    • Role of Standards
    • Traceability in Healthcare
    • Coding in Traceability
    • Implementing Traceability

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    16:20

    Chairman’s Closing Remarks and Close of Day Two

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott 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

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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, SAE Media 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@saemediagroup.com

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
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    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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