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SMi is excited to announce the latest event in their Asthma & COPD series, which returns to London on the 11th-12th April 2018.

With asthma and chronic obstructive pulmonary disorder (COPD) affecting about 500 million people worldwide, opportunities in drug development are vast and reducing serious attacks by improving adherence could save $19 billion a year in U.S. healthcare costs* http://reut.rs/2xqyBjZ

Recent advances in injectable biologics and smart medical devices as led to an increase in novel approaches to treating severe asthma and COPD as well as the regulations to take into consideration. As technology soars, the need for guideline updates from regulators has increased and continues to be modified.

Join us as we discuss current clinical trials and the innovative digital technology being used to improve clinical adherence. Leading industry experts will be looking at the use of ‘real world data’ human factors in the design of medical devices and triple combination treatments on the market. We will also be looking at asthma and COPD Phenotyping and biomarker application and differences between in the EU and US for the approval of biologics. We will be exploring the complexities of dry powder formulation and helping you determine clinical efficacy and endpoints.

Topics for 2018:

• Early detection and prevention of COPD and Asthma
• The use of triple combination therapies
• Health economics and market access for innovative treatments
• Regulatory updates in bioequivalence and drug-device combinations
• Enhancing dry powder formulation
• Asthma and COPD Phenotyping and biomarker application for personalised medicines

 

Who should attend:
Directors, principle scientists, senior scientists, associate directors, managing directors, medical directors, pharmaceutical experts, group leaders, inhalation toxicologists of the following departments:
 

• clinical pharmacology
• respiratory medicine/ science
• respiratory immunology
• pulmonary specialty
• respiratory physiology
 

3M Health Care; 6340596; Aerocrine AB; AstraZeneca; Atopix Therapeutics Ltd; Biomedical Systems; Boehringer Ingelheim; Boehringer Ingelheim Pharma AG; Chiesi Farmaceutici; Chiesi Farmaceutici S. P. A. ; Education for Health; Eurrus GmbH; GlaxoSmithKline R&D; Glenmark Research Centre; GSK Sant‚ Grand Public; HC Pharma Consultancy Ltd; Helsinki University Central Hospital; Imperial College London; Janssen; MedImmune; MHRA; Mylan Pharmaceuticals; National Taiwan University; Nemera; Peptinnovate; ph5insight; Presspart GmbH; Sonceboz SA; Teva Pharmaceuticals; Teva UK Limited; Teva UK Ltd; UNITHER Pharmaceuticals; University Of Cardiff; Vitalograph;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Wisia  Wedzicha

Wisia Wedzicha, Professor of Respiratory Medicine and Head of Respiratory Clinical Science, Imperial College London

9:10 Novel approaches to management and prevention of COPD exacerbations

Wisia  Wedzicha

Wisia Wedzicha, Professor of Respiratory Medicine and Head of Respiratory Clinical Science, Imperial College London

• COPD exacerbations are important in the natural history of COPD and key outcome measures
• A number of interventions reduce exacerbations and currently there is interest in which combinations of these therapies are optimal in exacerbation prevention
• How does intervention affect differing exacerbation phenotypes both at the acute event and for prevention?
 

9:50 Treating severe asthma with novel injectable antibody-based medicines

Rene van der Merwe

Rene van der Merwe, Vice President - Clinical Respiratory, MedImmune

• Data from clinical trials
• Mechanism of action in the reduction of targeted inflammatory biomarkers
• Position of new biologic asthma drugs in the market
 

10:30 Morning Coffee

11:00 Case study on gaining approval to market triple combination therapeutics

Tim Higenbottam

Tim Higenbottam, Senior Pharmaceutical Pysician, Allergy Therapeutics

• Data supporting the use of a ICS/LABA/LAMA fixed-dose combination inhaler
• How does this compare to ICS/LABA treatments?
• What are the potential drawbacks of triple combination treatment?

11:40 Development of inhaled interferon beta for the treatment and/or prevention of virus-induced exacerbations of COPD

Richard Marsden

Richard Marsden, Chief Executive Officer, Synairgen Ltd
View Bio

• Respiratory virus infections are a major driver of exacerbations of respiratory disease
• Background rational for use of inhaled interferon beta as an antiviral in both asthma and COPD
• Review of the results of Phase I and Phase II ‘proof-of-concept’ trial in asthma
• Clinical development in COPD to date and future plans

12:20 Regulatory requirements, human factors and usability for inhaled drug- device combination products

Quan Yang

Quan Yang, Pharmaceutical Assessor, MHRA

• EU regulations and updates for inhalation drug development, including combination considerations
• What are the expectations of the regulatory bodies?
• How does device type affect the development and approval process?
• Usability considerations and lessons learnt
• How best to interact with regulators when applying for approval of a novel device
 

13:00 Networking Lunch

14:00 How can smart inhalers be utilised to revolutionise the use of inhalers?

Alison  Moore

Alison Moore, Clinical Development Director, GSK

• The burden of asthma and COPD remains high despite many new medicines
• A major contributor is poor adherence to maintenance medications
• Smart inhalers are being developed to monitor the way patients use their inhalers
• Can the data from smart inhalers improve patient-clinician communication?
• Can smart inhalers lead to improvements in adherence and health outcomes?

14:40 Adherence to inhaled therapy : the challenges and opportunities of digital technologies

Richard Costello

Richard Costello, Professor, Royal College Of Surgeons In Ireland
View Bio

• Adherence and inhaler technique are poor in both COPD and asthma
• The causes of these problems need be understood as part of designing suitable interventions
• Results of clinical trials to promote adherence in asthma and COPD
• The future of digital monitoring in R+D and clinical practice

15:20 Repositioning Andrographolide for Steroid Resistance in COPD: Efficacy and Mechanism

Fred Wong

Fred Wong, Head and Associate Professor, Department of Pharmacology, National University of Singapore

• Steroid resistance is a major therapeutic challenge in COPD management
• Drugs able to enhance steroid efficacy in COPD can be attractive add-on therapies
• Andrographolide is a bioactive molecule widely used for common cold and sore throat
• Andrographolide is able to reverse steroid resistance in COPD models
 

16:00 Afternoon Tea

16:30 Assessing bioequivalence of orally inhaled products (OIPs)

Georg Brauers

Georg Brauers, Senior Manager Regulatory Affairs, Boehringer Ingelheim GmbH

• Guidelines for bioequivalence of OIPs around the world (US, Japan, Brazil, EU)
• EMA concept paper on update of OIP guideline
• In vitro in vivo correlation
 

17:10 Lipid mediators as targets for therapy in asthma

grzegorz Woszczek

grzegorz Woszczek, Principal Investigator, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King’s College London

• ORMDL3, sphingolipids and asthma- is there a link? Is sphingosine-1-phosphate an answer?
• Leukotrienes – is there a future for anti-leukotriene therapy?
• Prostaglandin D2 – new treatment, old targets

17:50 Chair’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Jonathan Phillips

Jonathan Phillips, Principal Scientist, Inflammation, Amgen

9:10 Genetic driven drug discovery for respiratory disease

Jonathan Phillips

Jonathan Phillips, Principal Scientist, Inflammation, Amgen

• Learnings/cautions from the first asthma gene: ADAM33
• Recent success with TSLP and IL-33
• Overview COPD genetics
• Identify/prioritise novel COPD drug targets

9:50 New therapeutic targets for COPD

Peter Barnes

Peter Barnes, Professor of Thoracic Medicine and Head of Respiratory Medicine , National Heart & Lung Institute

• The need for new treatments in COPD – beyond bronchodilation
• Targeting kinases involved in inflammation
• Targeting oxidative stress
• Targeting accelerated ageing and cellular senescence
 

10:30 Morning Coffee

11:00 How can we ensure better treatment for patients with chronic obstructive airway diseases by enhanced multinational observational studies?

Maria Gerhardsson de Verdier

Maria Gerhardsson de Verdier, Principal Scientist, Director Epidemiology, AstraZeneca

• Redefining diseases: where we are and where we need to go
• A real-world evidence map: need for comparable data across disease entity, severity and countries
• Development of personalised care: next steps
 

11:40 From efficacy to effectiveness, the Salford Lung Study in COPD and now Asthma

David Leather

David Leather, Medical Vice President, Global Respiratory Franchise, GSK

• A first in the world, Pragmatic RCT in everyday clinical practice with a pre- license medicine
• Last year COPD was published, now Asthma
• Hear about the operational challenges and solutions
• Learn how this data is being received in the external world
 

12:20 Networking Lunch

13:30 A Novel Approach to Designing ‘Innovative’ Generic Drug-Device Combination Products

Suresh Gupta

Suresh Gupta, Head of Human Factors and Usability Engineering, Cambridge Consultants
View Bio

  • Generic product market is expected to grow significantly in the coming years with many blockbuster products coming off patent
  • Recent changes in the regulatory landscape have created both opportunities and challenges to the industry
  • Designing a generic drug-device combination product requires a novel approach
  • This talk will discuss the requirements and challenges in designing a generic product
  • It will also discuss a novel approach of designing such a product, highlighting the areas of opportunities for innovation within the realm of constraints
  • 14:30 The emerging role of airway smooth muscle in the pathogenesis of severe asthma

    Yassine Amrani

    Yassine Amrani, Principal Investigator , NIHR Biomedical Research Centre
    View Bio

    • Importance of the non-contractile function of airway smooth muscle in severe asthma
    • In vivo evidence supporting a proinflammatory role of airway smooth muscle in asthma
    • Evidence showing that the development of steroid resistance in airway smooth muscle can be seen both in vitro and in vivo in patients with severe asthma
     

    15:10 Afternoon Tea

    15:40 Bronchial smooth muscle hyperresponsiveness, airways hyperresponsiveness and inflammation in asthma: time to think again

    Chris Corrigan

    Chris Corrigan , Professor of Asthma, Allergy and Immunology, Kings College London
    View Bio

    • Asthma is a disease of airways smooth muscle characterised by non-specific hyperresponsiveness to multiple stimuli: recent research suggests that abnormal expression and/or function of the Calcium Sensing Receptor on airways smooth muscle mediates this phenomenon
    • Airways inflammation amplifies the effects of smooth muscle hyperresponsiveness because it narrows the internal diameter of the airways, and also because certain products of inflammatory cells, such as eosinophil cationic proteins, are agonists of the Calcium Sensing Receptor, while conversely the Calcium Sensing Receptor is involved in the activation of certain inflammatory cells
    • Inhaled and oral corticosteroids reduce airways inflammation to varying degrees in different asthmatic patients but do not affect smooth muscle hyperresponsiveness
    • Calcium Sensing receptor antagonists, if delivered topically to the airways, likely offer the first opportunity to treat asthma at its root cause and in addition are likely to reduce airways inflammation
    Chris Corrigan, Professor of Asthma, Allergy & Respiratory Science, King’s College London

    16:00 The COPD- Lung cancer crossover: How can we focus our efforts on treating this disease?

    16:40 Chair’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Chris Corrigan

    Chris Corrigan

    Professor of Asthma, Allergy and Immunology, Kings College London
    David Leather

    David Leather

    Medical Vice President, Global Respiratory Franchise, GSK
    Fred Wong

    Fred Wong

    Head and Associate Professor, Department of Pharmacology, National University of Singapore
    Jonathan Phillips

    Jonathan Phillips

    Principal Scientist, Inflammation, Amgen
    Maria Gerhardsson de Verdier

    Maria Gerhardsson de Verdier

    Principal Scientist, Director Epidemiology, AstraZeneca
    Peter Barnes

    Peter Barnes

    Professor of Thoracic Medicine and Head of Respiratory Medicine , National Heart & Lung Institute
    Quan Yang

    Quan Yang

    Pharmaceutical Assessor, MHRA
    Rene van der Merwe

    Rene van der Merwe

    Vice President - Clinical Respiratory, MedImmune
    Richard Costello

    Richard Costello

    Professor, Royal College Of Surgeons In Ireland
    Richard Marsden

    Richard Marsden

    Chief Executive Officer, Synairgen Ltd
    Suresh Gupta

    Suresh Gupta

    Head of Human Factors and Usability Engineering, Cambridge Consultants
    Tim Higenbottam

    Tim Higenbottam

    Senior Pharmaceutical Pysician, Allergy Therapeutics
    Wisia  Wedzicha

    Wisia Wedzicha

    Professor of Respiratory Medicine and Head of Respiratory Clinical Science, Imperial College London
    Yassine Amrani

    Yassine Amrani

    Principal Investigator , NIHR Biomedical Research Centre

    Alison Moore

    Clinical Development Director, GSK
    Alison  Moore

    Chris Corrigan

    Professor of Asthma, Allergy and Immunology, Kings College London
    Chris Corrigan

    Chris Corrigan is professor of Asthma, Allergy & Respiratory Science at King’s College London in the Faculty of Life Sciences and Medicine, School of Immunology and Microbial Sciences. His research career spanning nearly 30 years has been directed at the immunopathogenesis of asthma, including therapy resistant asthma, aspirin exacerbated respiratory disease and the aetiology of non-topic asthma. He has more than 150 original research publications in peer reviewed journals. He teaches medical and postgraduate students. Clinically he is a consultant Allergist and Respiratory Physician at Guy’s and St. Thomas’s NHS Foundation trust, with particular responsibility for the adult allergen immunotherapy programme and the tertiary referral severe asthma service which embraces biological therapy. He is also Training Programme Director for adult Allergy for London and the South East, and Chair of the Allergy Specialist Advisory Committee of the Royal College of Physicians.

    David Leather

    Medical Vice President, Global Respiratory Franchise, GSK
    David Leather

    Fred Wong

    Head and Associate Professor, Department of Pharmacology, National University of Singapore
    Fred Wong

    Georg Brauers

    Senior Manager Regulatory Affairs, Boehringer Ingelheim GmbH
    Georg Brauers

    grzegorz Woszczek

    Principal Investigator, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King’s College London
    grzegorz Woszczek

    Jaquie Finn

    Head of Digital Health , Cambridge Consultants Ltd
    Jaquie  Finn

    Jonathan Phillips

    Principal Scientist, Inflammation, Amgen
    Jonathan Phillips

    Maria Gerhardsson de Verdier

    Principal Scientist, Director Epidemiology, AstraZeneca
    Maria Gerhardsson de Verdier

    Peter Barnes

    Professor of Thoracic Medicine and Head of Respiratory Medicine , National Heart & Lung Institute
    Peter Barnes

    Quan Yang

    Pharmaceutical Assessor, MHRA
    Quan Yang

    Rene van der Merwe

    Vice President - Clinical Respiratory, MedImmune
    Rene van der Merwe

    Richard Costello

    Professor, Royal College Of Surgeons In Ireland
    Richard Costello

    A graduate of the Royal College of Surgeons in Ireland in 1988. Following basic training in Ireland he undertook a Pulmonary and Critical Care Medicine Fellowship at the Johns Hopkins University Hospital from 1993 to 1997. He was then appointed Senior Lecturer in Respiratory Medicine at the University of Liverpool and then later as Professor of Respiratory Medicine at the Royal College of Surgeons in Ireland. He runs specialist clinics in severe asthma and COPD.
    Professionally, he has served as National Specialist Director of Training in Respiratory Medicine, as the clinical lead of the National Severe Asthma program, President of the Irish Sleep Society and as Director of Research at the Royal College of Physicians. He is President of the European Board of Pulmonology, Board Member of the ERS HERMES respiratory exam group, Board Member of the ERS Education council and Board Member of the Asthma Society.
    Academically, he is a Health Research Board of Ireland Clinician Scientist studying how technology can be used to optimise adherence to therapy and improve outcomes in patients with respiratory disease. He has published over 130 research papers. He has developed, patented and copyrighted technology related to assessment of inhaler adherence. His work is supported by grants of over 5Million from the EU, industry partners and the Health Research Board of Ireland.

    Richard Marsden

    Chief Executive Officer, Synairgen Ltd
    Richard Marsden

    Richard Marsden joined Synairgen in a consulting role as General Manager in November 2003, was appointed to the Board as Managing Director in June 2004 and appointed Chief Executive Officer in September 2009. Between 1998 and 2003 he worked as Projects Manager and Cystic Fibrosis Business Development Manager at Profile Therapeutics plc, where he managed the Cystic Fibrosis business and played a major role in the development of its proprietary pharmaceutical unit, Profile Pharma Limited. Prior to this, he worked for Zimmer Limited, Genentech (UK) Limited and Roche Products Limited.

    Suresh Gupta

    Head of Human Factors and Usability Engineering, Cambridge Consultants
    Suresh Gupta

    Suresh is the Head of Human Factors and Usability Engineering at Cambridge Consultants, UK.

    He has over fifteen years’ experience working within the medical device domain which includes eleven years’ of providing human factors expertise to the design and development of medical devices and combination products within a design consultancy environment. One of his specialisations is helping clients design generic and interchangeable biosimilar products.

    He has been responsible for managing, planning and implementing of a wide range of human factors activities ranging from front-end user requirements capture through to preliminary analyses, formative and validation studies, and risk management. Suresh has a track record of delivering successful human factors and usability projects to pharmaceutical and medical technology companies worldwide.

    He is also responsible for promoting human factors within medical product development, and growing the human factors capabilities and service offerings at Cambridge Consultants. Suresh has a PhD degree in engineering design, specialising in human factors, from Cambridge University.

    Tim Higenbottam

    Senior Pharmaceutical Pysician, Allergy Therapeutics
    Tim Higenbottam

    Wisia Wedzicha

    Professor of Respiratory Medicine and Head of Respiratory Clinical Science, Imperial College London
    Wisia  Wedzicha

    Yassine Amrani

    Principal Investigator , NIHR Biomedical Research Centre
    Yassine Amrani

    Dr Yassine Amrani is principal investigator at Leicester Biomedical Research Centre Respiratory in Leicester. For the last 20 years, Dr Amrani has been investigating the immunopathogenesis of lung diseases including asthma. His lab has made key observations showing how the interactions between pro-asthmatic factors and airway structural tissues, including as airway smooth muscle, could play a role in the pathogenesis of asthma (>90 articles). His group was among the first to propose that changes in calcium handling in airway smooth muscle may explain the development of airway hyperresponsiveness, a defining feature seen in asthmatic patients. His more recent work has focused on the non-contractile function of airway smooth muscle. His lab provided the initial evidence supporting the novel hypothesis that the failure of corticosteroid therapy to adequately manage patients with severe asthma could derive from their inability to affect the immunomodulatory potential of airway smooth muscle.

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    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

    [Programme] - Asthma & COPD 2018

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    [Interview] - MHRA

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    Asthma & COPD 2017 Sample Delegate List

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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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    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
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