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SMi is proud to announce the return of their 5th annual Orphan Drugs event to London on the 19th -20th October 2016!


The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019.* With such growth and innovation witnessed in this field now is the best time to discuss and strategize the best route to market.
In the past year (2015) alone, the Food and Drug Administration have approved 21 new entities. The orphan drug market has seen a dramatic increase in pharmacologic cures for rare diseases, such as Gaucher’s disease (Cerezyme/Imiglucerase), atypical Hemolytic Uremic Syndrome (Soliris/Eculizumab) and Non-Hodgkin’s Lymphoma (Rituxan/Rituximab). Such entities have revolutionized medicine and paved the way for other drug candidates to enter this space. *


SMi’s 5th annual Orphan Drugs event will bring together leading industry professionals to discuss the latest regulatory developments, explore how to reduce costs and learn from the latest innovations in the orphan drug landscape.
 

* http://www.businesswire.com/news/home/20160406005885/en/Global-Orphan-Drug-Market-Set-Grow-191
*http://blogs.wsj.com/experts/2016/04/13/the-orphan-drug-acts-successes-outweigh-its-failures/
 

Abeona Therapeutics; Agency for Medicinal Products and Medical Devices of the Republic of Slovenia; AKU Society; Alexion Pharma International Intl; Apex Healthcare Consulting Limited; Boehringer Mannheim GmbH; Cello Health Insight - London; Chiesi Farmaceutici SpA; Debio Pharm S A; Dorphan; Findacure Development; GENETHON; Genetic Alliance; Grifols Deutschland; Grunenthal GmbH; GSK; GW Pharmaceuticals; I.D.E.A. Ltd; ICON Clinical Research; INC Research; Infusion Pharma Consulting LLC; Loulou Foundation ; Merck Serono; NDA Regualtory Science Ltd; Newcastle University; Orphazyme ApS; Otsuka Europe Development and Commercialisation; Otsuka Pharmaceutical Europe Ltd; Pfizer Group; PSR Group B.V.; PSR Orphan Experts; Raglan Capital; Rare Disease UK; Roche; Roche Products; Russian Respiratory Society; Shire Pharmaceuticals Limited; Society for Mucopolysaccharide Diseases; Swedish Orphan Biovitrum (SOBI) AB; Taylor & Francis Group; The Birmingham Childrens Hospital; The Medical Research Network; The Ultra Rare Diseases Disorder & Disabilities Foundation; Thomson Reuters; Tikomed; University College London; Zogenix Inc;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Tim  Miller

Tim Miller, President & CEO, Abeona Therapeutics

9:10 Market access for orphan drugs

Sheela Upadhyaya

Sheela Upadhyaya, Associate Director - Highly Specialised Technologies , National Institute for Health and Care Excellence

• A brief outline of the NICE Highly Specialised Technology
(HST) Evaluation process
• Topic selection and NICE HST Prioritisation Criteria
• Working with stakeholders: including patient support
organisations

9:45 Regulatory challenges for orphan products: Focus on emerging markets

Alex Bloom

Alex Bloom, Director of Regulatory Affairs, Cell Medica Ltd

• Measuring the differences in regulations cross border
and how the impact this has
• Analysing how these differences infl uence patient’s
access to drugs
• What can be done to ensure the integrity of these
standards?

10:20 Morning Coffee

10:40 A new business model for developing rare diseases treatments

Tony Hall

Tony Hall, Therapeutic Area Head, Orphan Diseases, Mereo BioPharma

The Mereo BioPharma business model
o acquisition of assets
o funding the programs
o what has been achieved to date
- Case study: osteogenesis imperfecta
o the need for an effective therapy in OI
o anti-sclerostin antibody as a potential treatment for OI
o the pathway to registration
 

11:15 Development of orphan drugs to prevent, diagnose and treat rare diseases

Tim  Miller

Tim Miller, President & CEO, Abeona Therapeutics

• Reviewing the challenges of orphan drugs development
and creating workable solutions of to overcome them
• How to establish early access to orphan drugs
• Analysing what regulatory bodies can do to support
companies investing in these drugs

11:50 Challenges with paediatric orphan drug development

Cecile De Coster

Cecile De Coster, Associate Director, Regulatory Affairs, Alexion Pharma International SÓrl

• Complex Issues in developing drugs and biological
products for rare diseases
• How to accelerate the development of therapies for
paediatric rare diseases
• Methods to overcome the challenges of trial design

12:25 Networking Lunch

13:25 Orphan drug industry and venture capital – key factors for a successful partnership

Robert Karl

Robert Karl, Partner, RBV Capital

• Investment in orphan drugs industry is a very attractive fi t
for venture capital
• What venture capital is looking for in orphan drug
Industry
• Key factors you should to consider when searching for
venture capital

14:00 Global orphan drug regulatory strategy

Aaron Barzey

Aaron Barzey, CEO, ADB Medical

• Global orphan drug regulations
• Joint FDA-EMA submissions
 

14:35 An alternative development path for rare disease therapeutics

James Mcarthur

James Mcarthur, Chief Scientific Officer, Cydan

• VC- funded biotech or pharma are the traditional partners for rare disease drug development
• A new model has evolved- focused, well funded, nimble - the rare disease accelerator
• Experience of the accelerator- 3 years of data

15:10 Afternoon Tea

15:30 A case study of patient foundations and industry working together

Michelle Berg

Michelle Berg, Vice President, Patient Advocacy, Abeona Therapeutics

• Education is key and it’s a two way street.
• Working together at all stages, ensuring effective
collaboration
• Providing consistent and accurate information

16:05 A patient group’s perspective on patient recruitment and retention

Oliver Timmis

Oliver Timmis, CEO, AKU Society

• Patient recruitment in Europe
• How to maximise patient retention
• Why patient groups can be an effective may to
manage the patient input of clinical trials

16:40 Developing a new model to fund drug repurposing for rare diseases.

Rick Thompson

Rick Thompson, Scientific Officer, Findacure

- the benefits of drug repurposing
- The use of a social impact bond to fund rare disease drug repurposing with a core aim of saving the NHS money.
- assessing the current costs of rare diseases to validate the  social impact bond model
 

17:15 Chairman’s Closing Remarks and Close of Day One

Tim  Miller

Tim Miller, President & CEO, Abeona Therapeutics

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Tim  Miller

Tim Miller, President & CEO, Abeona Therapeutics

9:10 Building a patient centric model for rare disease drug discovery

Tim Guilliams

Tim Guilliams, Founder & CEO, Healx

-          Role of patient groups in drug development
-          Applying artificial intelligence to drug repurposing
-          Supporting non-for-profit drug discovery
 

9:45 Rare disease clinical research: Collaboration the key to success

Judith  Ng-Cashin

Judith Ng-Cashin, Chief Scientific Officer, INC Research

· Focus on the patient experience and early engagement of patients and their advocates drives data quality and access to novel therapies
· Partnership with quality and experienced sites, leveraging their clinical expertise while providing operational support ensures quality despite complexity
· Fostering collaboration between patient advocacy groups, specialized sites, medical and scientific leaders, and operational experts in rare diseases accelerates drug development and patient access to medicines in rare diseases

 

10:20 Morning Coffee

10:40 The challenges in defending orphan products pricing

Ad  Rietveld

Ad Rietveld, Founder & Director, RJW & partners Ltd


• Pricing models for orphan drugs
• The changing environment for contracting options
• Increasing the likelihood of acceptance of contracting options by payers

11:15 Setting reimbursement strategies - How to establish a foundation for reimbursement

Nigel Nicholls

Nigel Nicholls, Director and Country Manager UK/Ireland, BioMarin Europe Ltd

• Analysing how payers are considering reimbursing drugs
that are coming on the market for orphan drugs and
rare diseases
• Can workable changes be made to improve current
reimbursement strategies?
• Creating a collaborative reimbursement strategy that
satisfi es and benefi ts all parties involved
• Taking a look at regulatory frameworks and how they
infl uence the reimbursement process

11:50 Advancing therapies for Duchenne Muscular Dystrophy (DMD)

12:25 Networking Lunch

13:25 The role of patient associations and how they are helping to fund the rare diseases field

Diana Ribeiro

Diana Ribeiro, CEO, Action Duchenne

• How do patient associations contribute to the funding
of orphan drugs companies today?
• What are the pros and cos of patient organisations
directly contributing to the funding of orphan drugs
companies
• The role of patient organiSations in promoting drug
development for their disease
• What lessons can be learnt?

14:00 The rise of one-off gene and cell therapy treatments for rare diseases: is the future commercially viable?

Diego Ardigo

Diego Ardigo, ATMP Project and Clinical Program Leader, Chiesi Farmaceutici SpA

• Post-approval commitments, pricing & reimbursement, and patient access for gene and cell therapies: key considerations of the bumpy journey after marketing authorization.
• Development considerations in demonstrating long-term efficacy for advanced therapies in the orphan drug space.
• Critical issues in the generation and evaluation of value for advanced therapies. Are the currently available tools and approaches adequate? Is there a reasonable return on today’s investments in advanced therapies?
 

14:35 Why Turkey should feature early in launch plans for orphan drugs

Gulce  Belgin

Gulce Belgin, Director, Proceutica

- A key emerging market.
-Situation with Rare Diseases
- Regulatory framework
-Options for market access of orphan drugs
 

15:10 Afternoon Tea

15:30 Panel Discussion:How can partnerships improve the orphan drug field?

• How to make a multi-stakeholder partnership successful?
• What role does each stakeholder play?
• How can collaboration/partnership improve orphan drugs access to  market?
 

Tim  Miller

Tim Miller, President & CEO, Abeona Therapeutics

Nigel Nicholls

Nigel Nicholls, Director and Country Manager UK/Ireland, BioMarin Europe Ltd

Robert Karl

Robert Karl, Partner, RBV Capital

Daniel O'Connor

Daniel O'Connor, Medical Assessor, MHRA

16:00 Opportunities and challenges for biotech company to develop orphan drugs

Anders Waas

Anders Waas, Chief Executive Officer, Tikomed

• Strategy and tactics on the way – building a pipeline
• Effective drug development and research
• Partnering focus and timing of deals

16:35 Chairman’s Closing Remarks and Close of Day Two

Tim  Miller

Tim Miller, President & CEO, Abeona Therapeutics

+

FEATURED SPEAKERS

Robert Karl

Robert Karl

Partner, RBV Capital
Sheela Upadhyaya

Sheela Upadhyaya

Associate Director - Highly Specialised Technologies , National Institute for Health and Care Excellence
Tim  Miller

Tim Miller

President & CEO, Abeona Therapeutics
Tony Hall

Tony Hall

Therapeutic Area Head, Orphan Diseases, Mereo BioPharma

Aaron Barzey

CEO, ADB Medical
Aaron Barzey

Ad Rietveld

Founder & Director, RJW & partners Ltd
Ad  Rietveld

Alex Bloom

Director of Regulatory Affairs, Cell Medica Ltd
Alex Bloom

Anders Waas

Chief Executive Officer, Tikomed
Anders Waas

Cecile De Coster

Associate Director, Regulatory Affairs, Alexion Pharma International SÓrl
Cecile De Coster

Daniel O'Connor

Medical Assessor, MHRA
Daniel O'Connor

Diana Ribeiro

CEO, Action Duchenne
Diana Ribeiro

Diego Ardigo

ATMP Project and Clinical Program Leader, Chiesi Farmaceutici SpA
Diego Ardigo

Gulce Belgin

Director, Proceutica
Gulce  Belgin

James Mcarthur

Chief Scientific Officer, Cydan
James Mcarthur

Judith Ng-Cashin

Chief Scientific Officer, INC Research
Judith  Ng-Cashin

Michelle Berg

Vice President, Patient Advocacy, Abeona Therapeutics
Michelle Berg

Nigel Nicholls

Director and Country Manager UK/Ireland, BioMarin Europe Ltd
Nigel Nicholls

Oliver Timmis

CEO, AKU Society
Oliver Timmis

Rick Thompson

Scientific Officer, Findacure
Rick Thompson

Robert Karl

Partner, RBV Capital
Robert Karl

Sheela Upadhyaya

Associate Director - Highly Specialised Technologies , National Institute for Health and Care Excellence
Sheela Upadhyaya

Tim Miller

President & CEO, Abeona Therapeutics
Tim  Miller

Tim Guilliams

Founder & CEO, Healx
Tim Guilliams

Tony Hall

Therapeutic Area Head, Orphan Diseases, Mereo BioPharma
Tony Hall

Sponsors and Exhibitors

Official Media Partner

Supporters

Workshops

Planning for success: developing the optimal orphan drug development
Workshop

Planning for success: developing the optimal orphan drug development

Holiday Inn Kensington Forum
18th October 2016
London, United Kingdom

Paving the way for achieving orphan drug market access
Workshop

Paving the way for achieving orphan drug market access

Holiday Inn Kensington Forum
18th October 2016
London, United Kingdom

VENUE

Holiday Inn Kensington Forum

97 Cromwell Road , London, United Kingdom

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

HOTEL BOOKING FORM

An Interview with Dr Tim Miller, President and CEO of Abeona Therapeutics

Download

An interview with Robert Karl, Partner, RBV Capital

Download

Sponsors and Exhibitors


ClinTec International

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http://www.clintec.com/

ClinTec International is an innovative, mid-sized, full-service global Contract Research Organisation and Functional Service Provider specialising in Oncology and Rare Diseases. With a local presence in over 50 countries, ClinTec has built a world-class team of permanent employees and country management delivering a high-quality, customer-centric service. As an entrepreneurial and award winning business, ClinTec is at the forefront of conducting clinical research programmes worldwide, including unique access to emerging markets such as Turkey, Middle East and Africa. ClinTec customises each engagement through a consultative and flexible approach, aligning every solution and service to the client’s individual requirements.


INC Research

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INC Research (Nasdaq: INCR) is a leading global contract research organization ("CRO") providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was named “Best Contract Research Organization” in December 2015 by an independent panel for Scrip Intelligence, and ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 110 countries.

Media Partners


Personalize My Medicine

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Personalize My Medicine (PMM) places people and patients at center by informing them of the latest advances in medical innovation relevant to their condition and promoting research and innovation for unmet medical needs through our dedicated crowdfunding platform designed for both patients and innovators. PMM researches, informs, and facilitates advancements in healthcare for anyone who wants to be more proactive about their own health by conducting surveys, setting up research networks, crowdfunding for medical innovation, and promoting medical innovation for orphan diseases. Please be invited to www.personalizemymedicine.com to find out more.


RareBase

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http://www.rarebase.co.uk

The RareBase Networking Portal links people and companies throughout the world with an interest in rare and paediatric diseases.

Media Partners


CanBiotech

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Drug Target Review

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Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


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Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


CLocate

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Farmavita

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Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
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Labiotech.eu

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Drug Discovery Today

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Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
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MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


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Farmavita

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Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
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British Pharmacological Society

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Technology Networks

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Absave

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Bentham Science Publishers is a major STM journal publisher of 116 titles and 200 plus open access journals and print/online book series (Bentham eBooks). Bentham Science answers the information needs of the pharmaceutical and biomedical research community. Leading journals include Current Drug Metabolism (Impact Factor 5.113) and Current Medicinal Chemistry (Impact Factor 4.859): FREE online journals and information: www.benthamscience.com


PMR

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http://www.pmrcorporate.com

PMR (www.pmrcorporate.com) is a British-American company providing market information, advice and services to international businesses interested in Central and Eastern European countries as well as other emerging markets. PMR's key areas of operation include business publications (through PMR Publications), consultancy (through PMR Consulting) and market research (through PMR Research ). Being present on the market since 1995, offering high international standards in projects and publications, as well as providing one of the most frequently visited and top-ranked websites, PMR is one of the largest companies of its type in the region.

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Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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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
Registered in England No: 3779287 VAT No: GB 976 2951 71




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