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The expansive field of drug surveillance has increased the complexity of problems across the board in relation to PV auditing and meeting the standard requirements. Companies continue to face challenges of understanding the key considerations when presenting to auditors and knowing how to adequately adapt to different regulatory environments and changes. Moreover, clarifying individual roles within the PV system is paramount to setting out clear goals and meeting regulatory expectations.

For any company looking to globalise their business, the governance of reporting adverse drug events by different centralised authorities, along with heterogeneous terminologies and competing priorities has created greater uncertainties and barriers to enter new markets. The daunting task of complying with multiple regulations also heightens the danger of unrealistic expectations as well as mounting costs and time that will have long-term implications on investment.
Therefore, the importance of a centralised database has never been more vital to employ knowledge sharing and product awareness.

Join SMi in tackling these issues: 2015 will bring a focus on drug surveillance and signal detection; analysis and prevention of adverse drug reactions with MedDRA, industry experiences and global regulatory coverage of developments. Furthermore, we will cover Eudravigilance, and the growing trend of outsourcing Pharmacovigilance, as well as navigate through the challenges of compiling PSUR’s and frequent safety reports and how to adapt better to regulatory updates by preparing key areas that will be most impacted.
 

Benefits to attending Pharmacovigilance, Drug Safety & Risk Management, 2015:

• Assessing the benefits and challenges behind outsourcing Pharmacovigilance practices.
• Evaluating the PSUR format, with case studies of its use and challenges
• The importance of a centralised drug safety database
• The importance of maintaining good PV practices
• Causality assessment
• The EU’s harmonization initiatives through MedDRA and Eudravigilance
• Routine reporting mechanisms and the drive towards consumer technology

 

 

   

ABPI; Academic Medical Center University of Amsterdam; AstraZeneca; Biogen Idec; Blue Sphere Health Ltd; Brasidas Group; Bristol Myers Squibb; Brunel University; Cancer Research UK; Creation Healthcare; Drug Discovery World; Evidera; GlaxoSmithKline; Innovate Legal; Institut de Recherches Internationales Servier; Janssen Strategic Marketing; Johnson & Johnson; Johnson&Johnson Pharmaceutical R&D; Lundbeck; Manufacturing Chemist; MedImmune; Norvartis Pharmaceuticals ; Novartis Limited; Novo Nordisk A/S; OHSU/ORCTAECH; Oregon Health & Science University; Roche; Roche Products Ltd; SAS; Statoo Consulting; STFC; Therapeutic Innovation Australia; University Of Birmingham;

Conference programme

8:30 Registration & Coffee

9:00 Chair's opening remarks

Graeme Ladds

Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd

9:10 OPENING ADDRESS: Reaching the required performance standards of Pharmacovigilance

Graeme Ladds

Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd

 

  • Evolve and diversify internal measures to best configure with diverse international regulation and updates  
  • Identifying market forces and events that influence Pharmacovigilance 
  • Clarifying the PV responsibilities of the innovator and generic company in partnerships
  • Recognizing where emerging trends, danger and money exist
  • Staying ahead of regulatory guidelines from multiple territories and technological innovation
  • 9:50 Reviews and infrastructure of Risk: Benefit management plans

    Lesley Wise

    Lesley Wise, VP Global PV Risk Management & Pharmaepidemiology, Takeda

     

  • Identifying the issue and characterising the urgency of each risk to sustain balance
  • Managing the weight of evidence to aid risk analysis and decision making 
  • Adopting proactive approaches to communicating adverse events
  • Mitigating uncertainties and dangerous “unknowns” through systematic and structured quantitative methods 
  • A plan of action for risk minimization and benefit optimization
  • 10:30 Morning Coffee

    11:00 Combining adverse events throughout clinical trials and post-marketing surveillance

    Peter De Veene

    Peter De Veene, Executive Director, Clinical Safety and Pharmacovigilance (CSPV), Daiichi Sankyo

     

  • Emerging challenges to monitoring adverse drug events in clinical trials
  • Establishing key performance indicators for making timely safety reports and continuous quality improvements
  • Targeted event collection  
  • Solidifying communication patient- physician communication
  • 11:40 SPOTLIGHT PRESENTATION: Forecasting risk through signal detection analysis

    Margot Stam Moraga

    Margot Stam Moraga, Associate Director, Benefit-Risk Management , Quintiles
    View Bio

     

  • Optimising the predictive quality and information sought from signal detection
  • Validation and confirmation of risk and benefits from signal received  
  • Disproportionality screening analysis as a tool for signal detection and determining rare adverse events
  • Reducing the impact of the “masking” phenomenon
  • Emerging drug safety signals for report quality and content
  • 12:20 Networking Lunch

    13:20 MedDRA: Meeting evolving Pharmacovigilance needs

    Tomas Moraleda

    Tomas Moraleda, International Medical Officer, MedDRA MSSO

    14:00 Pharmacovigilance 2015 – greater integration and internationalization

    Doris Stenver

    Doris Stenver, Chief Medical Officer, Member of PRAC, Danish Health and Medicines Authority
    View Bio

    14:40 Afternoon Tea

    15:10 Pharmacovigilance management & risk minimisation procedures to ensure drug safety

    Kashif Sheikh

    Kashif Sheikh, Senior Safety Surveillance Advisor , Novonordisk

     

  • Strengthening the link between a drug and its related adverse events from pre-clinical to post-marketing
  • Drug Safety & Product Life Cycle Management
  • Reporting of Signals & Risks
  • How to Measure the Effectiveness of Risk Minimisation Activities
  • 15:50 Combining adverse event monitoring and drug surveillance

    Chetan Shatapathy

    Chetan Shatapathy, Director, Sanjeevani Pharma

  • Core and emerging challenges to monitoring adverse drug events
  • Formulating improvements and establishing key performance indicators for continual quality assessment 
  •  Timely and effective benefit-risk communication to patients and physicians
  • 16:30 Panel Discussion: Advocating communication to enhance risk management and intellectual property

     

    • What are the core and emerging challenges of adhering to Pharmacovigilance laws and risk management?
    • How do we advocate towards a greater patient -centric system? 
    • What has been the main methodology developments used to monitor ADR's more rigorously? 
    • Does the shift towards emerging markets pose a risk to drug safety and biased data reports? 
    • How can communication between regulators, regional authorities and patients be further enhanced? 
    Graeme Ladds

    Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd

    Tomas Moraleda

    Tomas Moraleda, International Medical Officer, MedDRA MSSO

    Margot Stam Moraga

    Margot Stam Moraga, Associate Director, Benefit-Risk Management , Quintiles
    View Bio

    Kashif Sheikh

    Kashif Sheikh, Senior Safety Surveillance Advisor , Novonordisk

    Chetan Shatapathy

    Chetan Shatapathy, Director, Sanjeevani Pharma

    17:10 Chair's Closing Remarks

    Graeme Ladds

    Graeme Ladds, CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Pipasha Biswas

    Pipasha Biswas, Executive Director & QPPV, Symogen Ltd

    9:10 Cause and Effect – Striving towards proactive surveillance through innovation

    Pipasha Biswas

    Pipasha Biswas, Executive Director & QPPV, Symogen Ltd

    9:50 Causality assessment of adverse drug events

    Brian Edwards

    Brian Edwards, Principal Consultant, NDA Regulatory Science Ltd

     

  • Performing up to standards: Requirements of the WHO-UMC causality assessment system
  • The strategy of pattern recognition and when it breaks down
  • Weighing the most useful information for decision making
  • Harness the impact of confounding factors
  • Determining the cause of rare adverse events
  • 10:30 Morning Coffee

    11:00 European drug safety under EudraVigilance

    Alistair Coates

    Alistair Coates, Director, EudraVigilance Consultants Ltd

    ·         Understanding the EudraVigilance System and where it fits within the entire European framework

    ·         How is it implemented in the pre- and post- marketing approval of medicinal drugs?

    ·         Challenges

    ·         Future outlook

     

    11:40 CASE STUDY: Good Pharmacovigilance (GPV) guidelines

    Julia Appelskog

    Julia Appelskog, QPPV , Bluefish Pharmaceuticals

     

  • Utilisation of PSUR’s as an effective Pharmacovigilance tool
  • Robust quality systems to ensure adequate and effective quality measures
  • Expectations and challenged of the PV system 
  • Organisational restructuring to adaptation to new updates
  • 12:20 Networking Lunch

    13:20 Post-marketing drug surveillance

    Saad Shakir

    Saad Shakir, Director, Drug Safety Research Unit

  • Best practice in design and conduct of PASS
  • Assessing risk: benefit using data from observational research
  • Barriers to quantifying adverse event/reactions
  • Informing on updates to drug labelling in post marketing
  • 14:00 Patient safety and tackling the challenges of under-reporting and patient communication

    Raquel Rogers

    Raquel Rogers, Medical Director Pharmacovigilance , Takeda UK Ltd

    14:40 Afternoon Tea

    15:10 CASE STUDY 2: Risk management for well-established products assessment

    Mircea  Ciuca

    Mircea Ciuca, Head Medical & Clinical Drug Safety , Vifor Pharma

  •  Benefit-risk profile for old products
  • Practicalities in building first RMP for well-established products
  • Monitoring risks – are routine PV activities enough?
  • 16:30 Chair’s Closing Remarks and Close of Day Two

    Pipasha Biswas

    Pipasha Biswas, Executive Director & QPPV, Symogen Ltd

    +

    FEATURED SPEAKERS

    Doris Stenver

    Doris Stenver

    Chief Medical Officer, Member of PRAC, Danish Health and Medicines Authority
    Graeme Ladds

    Graeme Ladds

    CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd
    Margot Stam Moraga

    Margot Stam Moraga

    Associate Director, Benefit-Risk Management , Quintiles
    Peter De Veene

    Peter De Veene

    Executive Director, Clinical Safety and Pharmacovigilance (CSPV), Daiichi Sankyo
    Pipasha Biswas

    Pipasha Biswas

    Executive Director & QPPV, Symogen Ltd
    Tomas Moraleda

    Tomas Moraleda

    International Medical Officer, MedDRA MSSO

    Alistair Coates

    Director, EudraVigilance Consultants Ltd
    Alistair Coates

    Brian Edwards

    Principal Consultant, NDA Regulatory Science Ltd
    Brian Edwards

    Chetan Shatapathy

    Director, Sanjeevani Pharma
    Chetan Shatapathy

    Doris Stenver

    Chief Medical Officer, Member of PRAC, Danish Health and Medicines Authority
    Doris Stenver


    Doris Irene Stenver, MD, MPA
    Chief Medical Officer, Danish Health and Medicines Authority

    Education
    1986 Medical Degree from Copenhagen University, the Faculty of Medicine
    2007 Master Degree in Public Administration, Copenhagen Business School

    Clinical Experience
    During 12 years (1986-1998) she worked at university hospitals in the Copenhagen area. In 1995 she became specialist in internal medicine. Her clinical experience covers nephrology, endocrinology, haematology, cardiology and infectious diseases. Her research activities were primarily within the areas of haematology, immunology, nephrology and endocrinology.

    Regulatory Experience
    She joined the Danish regulatory authorities and the EU Pharmacovigilance Working Party in 1998. In 2012 she became member of the Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public.
     

    Graeme Ladds

    CEO, Director of Operations, Pharmacovigilance, PharSafer Associates Ltd
    Graeme Ladds

    Julia Appelskog

    QPPV , Bluefish Pharmaceuticals
    Julia Appelskog

    Short Bio

    Dr. Julia Appelskog is the QPPV at Bluefish Pharmaceuticals. She is a member of the European Generic Association (EGA) and the Chairman of the Drug Safety and PV working Group at Swedish Generic Medicines Association (FGL).

    She has more than 12 years of experience in Pharmacovigilance and 8 years of experience in biomedical research including experience in numerous therapy areas and product types such as medicinal products, including biopharmaceuticals and vaccines, medical device and cosmetics.

    Julia hold different leading positions within pharmacovigilance in large pharma companies, such as MSD, Johnson & Johnson and Sanofi Pasteur MSD. Her expertise spans the entire product life cycle. She has been involved in variety of intervention and non-interventional epidemiological and clinical trials and was responsible for the Quality Assurance, Regulatory Affairs and Medical Information.

    Dr. Appelskog has accomplished a PhD Thesis in cell biology at the Karolinska Institute (Sweden) in 2001, focusing on diabetes research. She has been a postdoctoral fellow at the Department of Clinical Neuroscience at Karolinska Institute, conducting research on epigenetic mechanisms, modification of DNA and its associated proteins in tumor cells. Julia is author of several scientific publications in diabetes and cancer research.

    Julia was involved in the evaluation of diabetic drugs at Current Drugs LTD and was a member of working group creating case definitions in Brighton Collaboration, providing support to vaccine safety research. She has been a member of PV Focus Group at AESGP to shape the regulatory environment and have been an active member of PV Committee at the Pharmaceutical Industry in Sweden (LIF) for more than 7 years. Since 2006, she has been given several presentations within pharmacovigilance field.
     

    Kashif Sheikh

    Senior Safety Surveillance Advisor , Novonordisk
    Kashif Sheikh

    Lesley Wise

    VP Global PV Risk Management & Pharmaepidemiology, Takeda
    Lesley Wise

    Bio


    Dr. Lesley Wise is Vice President of Global PV Risk Management and Pharmacoepidemiology at Takeda, where she has responsibility for global risk management processes, benefit-risk assessment processes and implementation of risk management plans. In her current role, Lesley works closely with Pharmacovigilance, Regulatory and Medical Affairs colleagues to ensure a “joined up” approach to Benefit - Risk Management.

    Lesley has a background in epidemiology and statistics, which is useful in implementing benefit risk methods. She is also an honorary lecturer at the London School of Hygiene and Tropical Medicine and an associate editor of Therapeutic Advances in Drug Safety.
     

    Margot Stam Moraga

    Associate Director, Benefit-Risk Management , Quintiles
    Margot Stam Moraga

    Bio

    Margot has over 15 years of experience in the pharmaceutical industry. She has in-depth knowlegde in post-marketing pharmacovigilance and risk management, with a hands-on expertise in setting-up and implementation of safety signal management processes and signal detection methodologies.
    Margot holds a Masters degree in Biochemistry, complemented with a Masters in Public Health and a Masters in Human Nutrition.
    Prior to joining Quintiles, Margot was employed by Merck Serono for 14 years, where she held various positions with increasing responsibiility. In the Safety department she acted for 10 years as a safety product lead managing all pharmacovigilance aspects of several investigational and marketed products.
     

    Mircea Ciuca

    Head Medical & Clinical Drug Safety , Vifor Pharma
    Mircea  Ciuca


    Short Biography

     

    Mircea Ciuca, MD, is Head of Medical & Clinical Drug Safety at Vifor Pharma Switzerland, where he is leading a team of scientists and physicians involved in all aspects of pharmacovigilance. Prior to joining Vifor Pharma he held various positions in Drug Safety at large pharmaceutical companies (MSD, Astellas) in The Netherlands, after he had successfully established and led the medical-scientific department of a medium-sized CRO in Rotterdam. Mircea is specialized in Emergency Medicine and Obstetrics & Gynecology, has been involved in clinical practice and academic teaching for about 12 years, and has about 10 years experience in drug safety.
     

    Peter De Veene

    Executive Director, Clinical Safety and Pharmacovigilance (CSPV), Daiichi Sankyo
    Peter De Veene

    Pipasha Biswas

    Executive Director & QPPV, Symogen Ltd
    Pipasha Biswas

    Raquel Rogers

    Medical Director Pharmacovigilance , Takeda UK Ltd
    Raquel Rogers

    Saad Shakir

    Director, Drug Safety Research Unit
    Saad Shakir

    TBA

    Principal Research Fellow , Drug Safety Research Unit
    TBA

    Tomas Moraleda

    International Medical Officer, MedDRA MSSO
    Tomas Moraleda

    Official Media Partner

    Supporters

    Workshops

    MedDRA Coding Guidelines
    Workshop

    MedDRA Coding Guidelines

    Holiday Inn Regents Park
    13th May 2015
    London, United Kingdom

    Risk Minimisation and Signal Management
    Workshop

    Risk Minimisation and Signal Management

    Holiday Inn Regents Park
    13th May 2015
    London, United Kingdom

    VENUE

    Holiday Inn Regents Park

    Carburton Street, London, London, United Kingdom

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

    HOTEL BOOKING FORM

    Attendee list for Pharmacovigilance 2015: Is your name on the list?

    Download

    Pharmacovigilance guidance on new legislation

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    PharmacoVigilance Review: Journal on drug safety issues Editor – Rob Begnett This quarterly journal provides informed comment and analysis of international pharmaceutical regulations relating to the safe use of medicines and medicinal devices. It also carries reviews of current methods of pharmacovigilance. Order online at www.euromedcommunications.com Or email: publisher@euromedcommunications.com Tel: +44 (0)1428 752222 Fax: +44 (0)1428 752223

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    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


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    The British Pharmacological Society (BPS) is the primary UK learned society concerned with research into drugs and the way they work. Our members work in academia, industry, regulatory agencies and the health services, and many are medically qualified. The Society covers the whole spectrum of pharmacology, including laboratory, clinical, and toxicological aspects. Clinical pharmacology is the medical speciality dedicated to promoting safe and effective use of medicines for patient benefit. Clinical pharmacologists work as consultants in the NHS and many hold prominent positions in UK Universities.


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    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


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    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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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