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SMi’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@smi-online.co.uk

 

Feedback from last year's event included:

 “As a person, newly appointed into this industry I found this to be very helpful and informative, in my base building.”

"Thank you for giving us/my team the opportunity to attend this very informative conference.  Look forward to the future events."

“People with good experience and knowledge.”

“Very good symposium.  Lots of time for audience questions and  participation.  Speakers very good; spoke clearly and presented well"

 

 
  • Hear from leading industry speakers from major Pharma companies providing case study analysis and real data examples from their Clinical Trial Supply Chain
  • Learn how to plan your clinical trial strategy from start to end
  • Plan for how to deal with supply interruptions such as natural disaster and ensure that your logisitical operation is not compromised
  • Analyse the latest regulations, including CRT regulation, and the effect that this has on your supply chain
  • Discuss sub contractor selection and decision making - how do you maximise your partnerships?
  • Examine how to adapt to tax, customs & cultural differences in multi-national trails
  • Explore the possibilities of opening up opportunities in emerging and expanding markets
  • Study packaging and labeling management
  • Improve your supply chain security strategy
  • Maximise patient recruitment opportunities - improve your results and data samples
  • Debate distribution best practice and quality assurance management
  • Increase your understanding of the integrated supply chain
  • Network with key industry professionals

Hear Key Presentations;


When are transportation studies required and when not: A Risk based approach
•         Is transportation the same as storage?
•         Which products need are at risk and protection?
•         Which trade lanes, modes of transport are at risk?
•         When do we need to do transportation studies?
Nigel Cryer, Head Quality Operations,
Arrow Pharmaceuticals.


Understanding, analysing and preparing for risk
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?
Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa, World Courier.


Distribution strategy for a virtual company
         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
Frauke Bruns, Clinical Trial Supplies Group Leader, Actelion Pharmaceuticals.

 

This Year's Speakers Also Include:

 

Paul Fitton, Cleaning & Shipping Validation Lead, Johnson & Johnson
Alison Rees
, UK CRA Manager – Oncology, Novartis
Hitendra Parmar,
Medical Director, Pfizer
Vladimir Anisimov,
Honorary Professor in the School of Mathematics and Statistics, University of Glasgow (Former Senior Director, Quantitative Sciences, GlaxoSmithKline)
Mike Bradshaw, Global Sales & Marketing Director, Biocair
Olivier Simmonot
, Strategic Marketing Manager, Sensitech
Roger Lamb
, Healthcare Manager, GS1 UK
Angus MacLeod,
Senior Manager, Depot Management, Catalent Solutions
Scott Vincent
, Logistics Director, A4P Consulting - formerly Pfizer

 

Also; Participate in an Interactive Panel Discussion on 'Dynamic, flexible packaging & labelling materials'. Join in the debate with panellists Frauke Bruns, Sue Lee & Paul Fitton. This is your chance to ask any questions on this issue to leading industry experts as well as forwarding your own expertise in to the discussion.

 

Click here to see the full agenda.

 


Who Should Attend? 

Industry professionals working in the following areas;

  • Clinical Trial Supplies
  • Global Logistics Cold Chain Planning
  • Global Outsourcing Clinical R&D
  • Clinical Trial Material Management
  • European Commercial Distribution
  • Head of Clinical Trial Supply Outsourcing
  • Planning and Co-ordination
  • Research Operations
  • Supply Chain Management
  • Clinical Research Manager
  • Clinical Supplies Project Coordinator
  • Clinical Supply Chain Manager
  • Distribution & Channel Management
  • Global Clinical Supplies Unit
  • Clinical Trial Supply Coordinator
  • Global Logistics
  • Clinical Logistics and Distribution
  • Quality Assurance
  • Supply Chain Optimisation
  • Logistics
  • Packaging Department
  • Clinical Packaging Operations
  • Logistics Quality and Efficiency
  • Transportation
  • Clinical Supply Planning
  • Quality & Compliance
  • Clinical Supplies Forecasting and Infrastructure
  • Clinical Supply Management Systems & Planning
  • Shipping & Trade Compliance
  • Clinical Supply Logistics

 

 


SMI's Clinical Trial Logistics event has been attended by representatives from; 

 

A4P Consulting
Actelion Pharmaceuticals
Allergan
Almac Clinical Services 
Amgen BV
Biocair
Biogen Idec
Biomap
BTG 
Catalent Pharma Solutions Inc
Celgene .hiltern Cold Storage Group 
Cogent Validation Services Cool Logistics 
Creapham Europe  
Cryopak/Escort
Eisai Europe Ltd  
Elpro UK Ltd  
Ferring Pharmaceuticals A/S 
FibroGen Inc 
Genzyme Therapeutics 
GlaxoSmithKline 
GS1 UK  
GSK R&D 
Guys and St Thomas's NHS Foundation Trust 
GW Pharma 
GxPi 
Health Protection Agency 
Helsinn Healthcare SA 
Imperial College London 
Imperial College Renal Centre
Intelleflex Inc. 
IPSEN  
Kings College London 
KOWA 
Marken Limited 
Medco Health Solutions   
Mundipharma Research  
Pauwels Consulting 
Peeks Pharmacy 
Peter East Associates Ltd  
Pfizer Inc 
Pharma Publications 
Quanta Consulting  
Queen Mary  
QuickSTAT 
 
QuickSTAT 
ROCHE  
Roche Products Ltd  
SCA Cool Logistics 
SELCRN 
Sensitech 
Sensitech Incorporated  
SOFRIGAM 
South East London Cancer Research Network 
South London Health 
Teva Pharmaceuticals Ltd 
The Lewisham Hospital N H S Trust  
University Of Jena  
World Courier 
 

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Sue Lee

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

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
  • 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?

    10:30 Morning Coffee

    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
  • 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

    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
  • 12:50 Networking Lunch

    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

    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 
  • 15:30 Afternoon Tea

    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

    16:40 Chairman’s Closing Remarks and Close of Day One

    16:50 Drinks Reception - Hosted by World Courier

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Vladimir Anisimov

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

    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 

    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

    10:30 Morning Coffee

    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

    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

    12:20 Networking lunch

    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

    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.

    15:10 Afternoon Tea

    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

    16:20 Chairman’s Closing Remarks and Close of Day Two

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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:

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    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.

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    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.

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