Biopharmaceuticals are an essential therapeutic option accounting for a substantial part of the global therapeutic market. With the patents of many blockbuster drugs coming to an end, an opportunity has arisen for the manufacture and approval of biosimilars. Visiongain\'s 9th Biosimilars Conference will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects.

1. 9th Biosimilars
Implementing clinical, legal, regulatory and developmental strategies for
biosimilar safety and acceptance
5th - 7th October 2011, Thistle City Barbican, London, UK BOOK NOW!
Key Speakers
Dr. Ulrike Jägle, Senior Manager R&D Policy, Global Public Affairs, Novartis
Dr Ian Hudson, Director of Licensing, MHRA
Dr Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA
Dr Meenu Wadhwa, Leader Cytokine & Growth Factors Section, National Institute for Biological
Standards and Control
Fredrik Sundberg, Global Director, Strategic Market Development, GE Healthcare
Dr Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting
Annie Hubert, Director European Government and Public Affairs, Amgen
Dr Frank Moffart, Business Developments Emerging Markets, Solvias
Dr Steinar Madsen, Medical Director, Department of Drug Information, Norweigan Medicines Agency
Dr Anita O’Connor, Senior Director Biopharmaceuticals, Celerion
Dr Lincoln Tsang, Partner, FDA & healthcare-Arnold & Porter LLP
Sebastian Moore, Partner, IP-Herbert Smith LLP
Dr Carsten Brockmeyer, Biosimilars Expert & Managing Director, Brockmeyer Biopharma
Kristie Khul, Senior VP, Health, Markovsky + Company
Dr Jean-Yves le Cotonnec, CEO, Triskel Integrated Services
Anna Valeri, Non-Clinical Assessor, MHRA
Geoff Hale, Chief Sciene Officer, Merck Millipore
Pre-conference Workshop, Wednesday 5th October, 2011
Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situation
Led by: Dr. Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA &
Dr Anita O’Connor, Managing Partner, Anita O’Connor Consulting
Gold Sponsor Silver Sponsor Associate Sponsor
Organised By
Driving the Industry Forward | www.futurepharmaus.com
BioPharm
Media Partners Insight
An Infinata BioPharm Solution
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars

2. Conference Introduction
9th Biosimilars
5th - 7th October 2011, London, UK
Dear Colleague, Gold Sponsor:
iopharmaceuticals are an essential therapeutic option accounting for a substantial
B Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a
broad range of innovative, performance products, services and business relationships
part of the global therapeutic market. With the patents of many blockbuster drugs that enable our customers’ success in research, development and production of
coming to an end, an opportunity has arisen for the manufacture and approval of biotech and pharmaceutical drug therapies. Through dedicated collaboration on
biosimilars. new scientific and engineering insights, and as one of the top three R&D investors
in the Life Science Tools industry, Merck Millipore serves as a strategic partner to
n a climate where the ever-increasing healthcare costs are a concern, biosimilars
I customers and helps advance the promise of life science. Headquartered in Billerica,
are promising to increase access to essential drugs, lower treatment costs and Massachusetts, the division has around 10,000 employees, operations in 64 countries and pro forma
provide savings to the healthcare systems. 2009 revenues of $2.9 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada.
isiongain’s 9th Biosimilars Conference will look at the multiple facets of
V For further information please visit: www.merckmillipore.com
biosimilars, ranging from the evolving regulatory landscape and challenges Silver Sponsor:
in clinical development, to the legal and economic aspects. By attending this At Pfizer, we apply science and our global resources to improve health and
conference you will gain a comprehensive outlook on the key issues surrounding well-being at every stage of life. We strive to set the standard for quality, safety
biosimilars. Do not miss this opportunity to further your knowledge in an interactive and value in the discovery, development and manufacturing of medicines for
people and animals. Our diversified global health care portfolio includes human
learning environment and network with diverse leaders in the industry! and animal biologic and small molecule medicines and vaccines, as well as
nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues
Reasons to register today: work across developed and emerging markets to advance wellness, prevention, treatments and cures that
challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading
• valuate the emerging markets: focus on far east
E biopharmaceutical company, we also collaborate with health care providers, governments and local
• xamine economic and commercial prospects
E communities to support and expand access to reliable, affordable health care around the world. For more
than 150 years, Pfizer has worked to make a difference for all who rely on us.
• xplore the changing regulatory landscape of biosimilars
E For further information please visit: www.pfizer.com
• nalyse comparability studies: designing the manufacturing process and
A Assocaite Sponsor:
preclinical testing ORION Clinical Services is a European-based CRO with offices in UK,
• ssess challenges in the clinical development of biosimilars: demonstrating
A Germany, France, Australia, US, Russia and Italy. We offer a full range of
efficacy and overcoming immunogenecity services in support of the clinical development process including Strategic
and operational regulatory support; Monitoring; Project Management;
• eview key issues such as naming, labelling and substitution: steps to ensure
R Medical Writing; Quality Assurance; Data Management and Statistics and
patient safety in clinical practice Pharmacovigilance – for both pre and post authorisation.We conduct clinical research across Western,
Central and Eastern Europe; Scandinavia, USA/Canada, Australia and parts of the Pacific Rim.
• dentify steps for securing acceptance of biosimilars on to the market
I For further information please visit: www.orioncro.com
• ain insight in to the clinician’s perspective: utilising biosimilars and challenges
G
for acceptance (focus on monoclonal antibodies) Media Partners:
PharmiWeb.com is the leading industry-sponsored portal for the
• evelop post marketing surveillance strategies
D
pharmaceutical sector. Supported by most of the leading pharmaceutical
• nvestigate legal aspects surrounding biosimilars: intellectual property, innovation
I corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and
and marketing approval issues international jobs to industry professionals across Europe and the US.
• tilise networking opportunities with diverse leaders
U For further information please email: corporate@pharmiweb.com
I look forward to meeting you at the conference BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is
Best regards based and located in Warsaw, Poland. Biotechnology World was founded in
2007 to provide the world’s biotech and pharma information and market to make it universally accessible
and useful for scientific and business processes. Its first step to fulfilling that mission was building the
BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels.
BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and
marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and
Carrie Lancaster Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities.
Conference Producer For further information please visit: www.biotechnology-europe.com
Driving the Industry Forward | www.futurepharmaus.com
Future Pharmaceuticals has forged powerful relationships with key
industry leaders to provide a platform for successful brand recognition,
and for senior decision-makers to have the means to procure and plan implementation strategies
based on the topics covered. Positioned to be an authoritative resource within top pharma
Who should attend? companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared
to create a deep penetration into a highly targeted and responsive audience, bridging the gap
Presidents, Vice Presidents, CEOs, Directors, Heads, Team Leaders, CSOs, Senior
between the industries’ top issues and the solutions top-tier vendors can provide.
Managers, Senior Business Developers, Researchers, Parteners & Consultants
involved in: For further information please visit: www.futurepharmaus.com
Biosimilars/Follow-on Biologics/Follow-on Proteins InPharm is the online platform for exclusive pharmaceutical news,
Biologics/Biopharmaceuticals/Biogenerics/Biotechnology comment, contracts, services, jobs and events and is home to
Clinical Immunology InPharmjobs.com, Pharmafile and Pharmafocus.
Drug Safety For further information please visit: www.inpharm.com
Patient Safety BioPharm The leading provider of intelligence to the biopharma industry. Detailed
Regulatory Affairs Insight company profiles; investigational & approved drugs; contact info; product
An Infinata BioPharm Solution
Quality Assurance/Quality Control forecasts; and exclusive editorial intelligence. Our proprietary journalists cover
Scientific Affairs the most important situations taking place in the life sciences industry, providing forward looking insight
Pharmacovigilance into drug pipelines, upcoming litigation, drug licensing deals, and mergers & acquisitions.
Research and Development For further information please visit: www.biopharminsight.com
Process Science & Manufacturing
Analytical Characterization
Business Development
New Product Development
Commercial Affairs Sponsorship and exhibition opportunities
Legal Affairs This event offers a unique opportunity to meet and do business with some of the key players in
the pharmaceutical and biotech industries. If you have a service or product to promote, you can
Intellectual Property do so at this event by:
Patent Law • Hosting a networking drinks reception
Regulatory Compliance • Taking an exhibition space at the conference
Health Economics • Advertising in the delegate documentation pack
Pricing and Reimbursement • Providing branded bags, pens, gifts, etc.
Marketing and Sales If you would like more information on the range of sponsorship or exhibition possibilities for
visiongain's 9th Biosimilars Conference, please contact us:
Branded and Generic Pharmaceutical Companies, Contract Research
Organisations/ Contract Manufacturing Organisations, Drug Regulators, Damian Gorman, +44 (0)20 7549 9934
Academics & Government damian.gorman@visiongainglobal.com

3. Pre-Conference Interactive Workshop
9th Biosimilars
Wednesday 5th October 2011
Assessing regulatory challenges: US and Europe Perspectives and
Update on current regulation situation
Led by: Dr. Angela Thomas Dr Anita O’Connor Timings: 9:30 - 10:00 Coffee & Registration
0
1
0.00 - 11.15 Morning Session
Chair of Biologicals and Vaccines Expert Managing Partner 11.15 - 11.30 Coffee Break
Advisory Group-Comission on Human Anita O’Connor Consulting 11.30 - 12.45 Morning Session
12.45 - 13.45 Lunch
Medicines 13.45 - 15.00 Afternoon Session
MHRA 15.00 - 15.15 Coffee Break
15.15 - 17.00 Afternoon Session
About the workshop: About your workshop leaders:
The purpose of the workshop is to allow you to engage in Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH
knowledge sharing with your peers in a smaller, less formal Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH, is Consultant
environment than the main conference. As such, the audience Paediatric Haematologist at the Royal Hospital for Sick Children in Edinburgh.
size will typically be no more than 20 participants in order to
enable maximum interaction between the workshop leaders After qualifying in Medicine from the University of London in 1980, Angela
and the delegates. The format is also more interactive, with trained in general medicine and then adult haematology, subsequently
less emphasis on ‘lecture-style’ presentations and more developing a special interest in paediatrics. She was a fellow in molecular
emphasis on group discussions, exercises and Q&A sessions. biology at University College London and was awarded a PhD on Genetic
Variation of the Fibrinogen Gene.
Agenda: Angela was appointed in 1992 as a consultant paediatric haematologist
at the Royal Hospital for Sick Children in Edinburgh and is co-director of
The EU
the Haemophilia Centre at the Edinburgh Royal Infirmary with specific
• The introduction of biosimilars responsibility for paediatrics. She cares for children with a wide range of
• Lessons learned haematological disorders, including those with leukaemia, immune deficiency,
• The changing Paradigm haemolytic anaemias and bleeding disorders. She has a special interest in
the education of paediatricians in the varied presentation of haematological
• New developments on the Horizon
disease, particularly bleeding disorders presenting as possible non-accidental
The US injury.
• The recent introduction of biosimilar legislation in the US In addition to her clinical post, Angela is a member of the Commission for
• The basics of the US legislation Human Medicines (CHM) and chairs its Biologicals and Vaccines Expert
Advisory Group. The CHM advises on the quality, safety and efficacy of human
• New developments since the law was passed
medicinal products and advises the Licensing Authority on the granting
• Challenges to expect in the future
The regulatory challenges for Biosimilar Medicines in the UK
Anita O’Connor
• European guidance
Anita O’Connor, PhD, is the Senior Director for Biopharmaceuticals at Celerion.
• How similar does similar have to be Anita is responsible for the leadership of biopharmaceutical and biosimilar
• Experience to date drug development projects and programs for Celerion. She advises clients on
the pivotal elements and regulatory strategy needed for approval of biosimilar
and innovator biopharmaceuticals for the EU and US markets.
Prior to joining Celerion in 2008 Anita founded ANITA OCONNOR
CONSULTING, LLC, where she advised clients from the pharmaceutical and
About visiongain: financial industry on small and large molecule development. From 1989
Visiongain is a specialist business information company focused on providing cutting to 2005, Anita worked for the US FDA in the Center for Biologics (CBER),
edge products and services across the Pharmaceutical/Biotech, Telecommunications, the Center for Drugs (CDER), the Center for Veterinary Medicine (CVM),
Defence and Finance sectors, which include reports, conferences, online daily
news and offline news analysis and bespoke consultancy. With a commitment
the Center for Food Safety (CFSAN) and the Office of the Commissioner
to innovation and excellence, visiongain offers flexible solutions to meet our (OC). As an FDA pharmacologist she worked on the submissions of several
clients’ business intelligence needs, providing the right information at the right blockbuster biopharmaceuticals to include Orencia®, Avastin®, Kepivance®,
time to facilitate the commercial decision-making process. Our pharmaceutical Remicade®, Remaira®, and Rituxan®. She also reviewed vaccine and
products include Pharma Business Daily, the leading daily email newsletter for the blood product INDs and BLAs. Other FDA experience extends to food safety,
pharmaceutical, biotech and healthcare industries, and a range of independent, animal drugs, women’s health, medical devices, and regulatory science policy.
high-quality, in-depth reports covering focused and topical areas of concern. During her tenure at FDA, Dr. O’Connor was detailed to the US House of
Our pharmaceutical conferences address the hottest commercial, regulatory Representatives to work on food safety and biotechnology issues for House
and technical topics and provide an ideal forum for debate and networking for
Agriculture committee. In 2008, she wrote a chapter for a reference book on
pharmaceutical professionals from around the world.
the preclinical development of biopharmaceuticals. She speaks and writes
For further information, please visit: www.visiongain.com frequently on biopharmaceuticals and biosimilars.

4. Day 1
9th Biosimilars
Thursday 6th October 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair 13:40 The current and ongoing regulatory law
Dr Virginia Acha development in biosimilars
Director of International Affairs, Strategic Analysis • The basic framework
Pfizer • Regulatory standards for approval
• Product-class specific issues
Dr Lincoln Tsang
09:40 Biosimilars: challenges and choices in developing
Partner
a biosimilars business
Arnold & Porter LLP
 • Rewards & Risks
CASE STUDY
 • The story so far – what is known?
 • Definitions 14:20 Successful development of biosimilars
 • Impact of globalization • Demonstrating CMC comparability to the Regulators
 • Major stake-holders • Assessing Immunogenicity
 • Barriers and potential pitfalls Dr Jean-Yves le Cotonnec
 • Regulatory issues in comparability CEO
 • Case studies highlighting analytical CMC challenges
Triskel Integrated Services
Dr Frank Moffatt
Product Manager, Biopharmaceutical Analysis 15:00 Afternoon refreshments
Solvias
15:20 Biosimilars: Building trust through scientific rigour
10:20 New European legislations and their implications for • MA has been successful in building a rigorous pathway for biosimilars
E
 • owever, uptake and trust in biologics and biosimilars remains an issue
H
biologicals including biosimilars
in Europe
• re there specific issues for use of biologicals, including biosimilars in
A
• trong science will resolve the key questions that we face and drive
S
clinical practice?
 • INN prescription and applicability for biologicals confidence
• equirement of the new pharmacovigilance directive: identification
R Dr Virginia Acha
and traceability Director of International Affairs, Strategic Analysis
• Naming in the cross-border healthcare directive Pfizer
 • R&D based industry position on biosimilars healthcare policies
Annie Hubert 15:40 Biosimilars - a balanced view based on experience
Director, European Government and Public Affairs from both sides
Amgen • ncreased patient access, supporting sustainable healthcare systems,
I
commercially viable
11:00 Morning refreshments • roadening group of companies interested in originator and
B
biosmilar biologics
11:20 The changing regulatory landscape of biosimilars: a • cience-based and fair biosimilar pathways
S
non-clinical assessor’s perspective
Dr. Ulrike Jägle
• hanges in the EU regulatory framework
C
Senior Manager R&D Policy, Global Public Affairs
• uality matters
Q
• reclinical issues
P Novartis
• mmunogenicity
I
• hoice of biomarkers
C 16:20 Biosimilar IP issues in Europe
 • reedom to operate issues and confronting patents with broad
F
Anna Valeri
protection-pitfalls and tips
Non-Clinical Assessor
• Supplementary Protection Certificates and biosimilars – unresolved issues
MHRA
Sebastian Moore
12:00 Tools for in vitro PD comparability studies of Partner, IP Group
biosimilar antibodies Herbert Smith LLP
• omparative in vitro studies provide crucial data to assess the
C
comparability of the biological activity of biosimilar antibodies. A 17:00 Closing remarks from the chair
comprehensive study may reduce or even eliminate the need for in vivo
pre-clinical studies. Such a study will include target-specific assays as
well as generic functional assays to assess binding to complement and Fc 17:10 Networking drinks
receptors. Take your discussions further and build new
Geoff Hale relationships in a relaxed and informal setting
Chief Science Officer,
Merck Millipore
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

5. Day 2
9th Biosimilars
Friday 7th October 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair 13:40 Uptake of biosimilars in clinical practice
Geoff Hale • What do doctors know about biosimilars?
Chief Scientist
• What are the obstacles to increased use?
Millipore BioPharma Services Europe
• What do we know about prices on biosimilars?
• Who shall decide which drug to use?
09:40 Licensing of biosimilars Dr Steinar Madsen
 • xperience to date in the EU
E
Medical director, Department of Drug Information
 • egulatory requirements and guidance
R
Norwegian Medicines Agency
 • cientific advice
S
 • uture biosimilar products
F
Dr Ian Hudson 14:20 Safety issues with biosimilars
Director of Licensing • verview of safety issues
O
MHRA
• mmunogenicity
I
• ost marketing surveillance
P
10:20 Innovative label-free solutions to support product • uture innovation
F
comparability testing and process development
Dr Sandy Eisen
operations Chief Medical Officer
• Enabling label-free technology solutions overview Frontline Pharma Consulting
• Improving product characterization and overall productivity for biologics
CASE STUDY
• Monitoring patient immunogenicity in pre-clinical and clinical
development
15:00 Afternoon refreshments
• Optimizing protein purification and formulation conditions
• Controlling batch-to-batch comparability during manufacturing
• Validation management strategies for meeting regulatory expectations
15:20 The development of biosimilar monoclonal
Fredrik Sundberg antibodies and other complex molecules
Global Director, Strategic Market Development
• onoclonal antibodies: context of market
M
GE Healthcare
• anufacturing process
M
• roduct heterogeneity
P
11:00 Morning refreshments • tandard product characterisation
S
• iological comparability
B
11:20 Immunogenicity issues with biosimilars • uture opportunities
F
• The importance of immunogenicity issues
Dr Carsten Brockmeyer
• Strategies and methods for detection of immunogenicity
Managing Director
• Update
Brockmeyer Biopharma
Dr Meenu Wadhwa
Leader, cytokine & Growth Factors Section
National Institute for Biological Standards 16:00 Chair’s closing remarks
and Control
16:10 End of Conference
12:00 Biosimilar market uptake – taking the question
out of acceptance
 • xamining the business risks and marketplace opportunities
E
• easuring regulators and financial analysts mandates
M
• rojecting data and clinical confidence
P
• racking health professional and patient expectations
T
• uilding an awareness and third-party advocacy program
B
• nderstanding needed services and communications
U
• etting a course for payers and patient pull-through
S
Kristie Khul
Senior VP, Health
Marlovsky + Company

6. Registration Form
9th Biosimilars
5th - 7th October 2011, London, UK
Conf. code B2B
Standard Prices 9th Biosimilars
Conference and workshop Fee: £1699 VAT: £339.80 Total: £2038.80
5th - 7th October 2011
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80
Workshop only Fee: £599 VAT: £119.80 Total: £718.80
Location: Thistle City Barbican
Number of bookings: Total cost: Address:
Central Street, Clerkenwell
London
EC1V 8DS
Promotional Literature Distribution UK
Distribution of your company’s promotional literature to all conference attendees
Fee: £999 VAT: £199.80 Total: £1198.80
How to book
Details
Email: conferences@visiongainglobal.com
Forename: Surname: Web: http://www.visiongain.com/biosimilars
UK Office:
Job Title: Company: Tel: +44(0) 20 7336 6100
Fax: +44(0) 20 7549 9932
Main Switchboard Number: Visiongain Ltd
230 City Road
London
Address: EC1V 2QY
UK
General information
Venue: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 /
Country: Postcode: +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html
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