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5th - 7th October 2011, Thistle City Barbican, London, UK
Organised By
Implementing clinical, legal, regulatory and developmental strategies for biosimilar safety and acceptance
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars
Dr. Ulrike Jägle, Senior Manager R&D Policy, Global Public Affairs, NovartisDr 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, CelerionDr 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 ServicesAnna Valeri, Non-Clinical Assessor, MHRAGeoff Hale, Chief Sciene Officer, Merck Millipore
Key Speakers
BOOK NOW!
9th Biosimilars
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
Pre-conference Workshop, Wednesday 5th October, 2011
Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situationLed 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
Associate Sponsor
BioPharmInsight
An Infinata BioPharm Solution
Gold Sponsor Silver Sponsor
Conference Introduction9th Biosimilars
5th - 7th October 2011, London, UK
Dear Colleague, Biopharmaceuticalsareanessentialtherapeuticoptionaccountingforasubstantial
partoftheglobaltherapeuticmarket.Withthepatentsofmanyblockbusterdrugscomingtoanend,anopportunityhasarisenforthemanufactureandapprovalofbiosimilars.
Inaclimatewheretheever-increasinghealthcarecostsareaconcern,biosimilarsare promising to increase access to essential drugs, lower treatment costs andprovidesavingstothehealthcaresystems.
Visiongain’s 9th Biosimilars Conference will look at the multiple facets ofbiosimilars, ranging from the evolving regulatory landscape and challengesin clinical development, to the legal and economic aspects. By attending thisconferenceyouwillgainacomprehensiveoutlookon thekey issuessurroundingbiosimilars.Donotmissthisopportunitytofurtheryourknowledgeinaninteractivelearningenvironmentandnetworkwithdiverseleadersintheindustry!
Reasons to register today: •Evaluatetheemergingmarkets:focusonfareast •Examineeconomicandcommercialprospects •Explorethechangingregulatorylandscapeofbiosimilars •Analysecomparabilitystudies:designingthemanufacturingprocessand
preclinicaltesting •Assesschallengesintheclinicaldevelopmentofbiosimilars:demonstrating
efficacyandovercomingimmunogenecity •Reviewkeyissuessuchasnaming,labellingandsubstitution:stepstoensure
patientsafetyinclinicalpractice •Identifystepsforsecuringacceptanceofbiosimilarsontothemarket •Gaininsightintotheclinician’sperspective:utilisingbiosimilarsandchallenges
foracceptance(focusonmonoclonalantibodies) •Developpostmarketingsurveillancestrategies •Investigatelegalaspectssurroundingbiosimilars:intellectualproperty,innovation
andmarketingapprovalissues •Utilisenetworkingopportunitieswithdiverseleaders Ilookforwardtomeetingyouattheconference Bestregards
Carrie Lancaster Conference Producer
Who should attend?Presidents, Vice Presidents, CEOs, Directors, Heads, Team Leaders, CSOs, Senior Managers, Senior Business Developers, Researchers, Parteners & Consultants involved in:
Biosimilars/Follow-on Biologics/Follow-on Proteins Biologics/Biopharmaceuticals/Biogenerics/Biotechnology Clinical Immunology Drug Safety Patient Safety Regulatory Affairs Quality Assurance/Quality Control Scientific Affairs Pharmacovigilance Research and Development Process Science & Manufacturing Analytical Characterization Business Development New Product Development Commercial Affairs Legal Affairs Intellectual Property Patent Law Regulatory Compliance Health Economics Pricing and Reimbursement Marketing and Sales
Branded and Generic Pharmaceutical Companies, Contract Research Organisations/ Contract Manufacturing Organisations, Drug Regulators, Academics & Government
Gold Sponsor:MerckMilliporeistheLifeSciencedivisionofMerckKGaAofGermanyandoffersabroadrangeofinnovative,performanceproducts,servicesandbusinessrelationshipsthatenableourcustomers’successinresearch,developmentandproductionofbiotechandpharmaceuticaldrugtherapies.Throughdedicatedcollaborationonnewscientificandengineeringinsights,andasoneofthetopthreeR&DinvestorsintheLifeScienceToolsindustry,MerckMilliporeservesasastrategicpartnertocustomersandhelpsadvancethepromiseoflifescience.HeadquarteredinBillerica,
Massachusetts,thedivisionhasaround10,000employees,operationsin64countriesandproforma2009revenuesof$2.9billion.MerckMilliporeoperatesasEMDMilliporeintheU.S.andCanada.
For further information please visit: www.merckmillipore.comSilver Sponsor:
AtPfizer,weapplyscienceandourglobalresourcestoimprovehealthandwell-beingateverystageoflife.Westrivetosetthestandardforquality,safetyandvalueinthediscovery,developmentandmanufacturingofmedicinesforpeopleandanimals.Ourdiversifiedglobalhealthcareportfolioincludeshumanandanimalbiologicandsmallmoleculemedicinesandvaccines,aswellas
nutritionalproductsandmanyoftheworld’sbest-knownconsumerproducts.Everyday,Pfizercolleaguesworkacrossdevelopedandemergingmarketstoadvancewellness,prevention,treatmentsandcuresthatchallengethemostfeareddiseasesofourtime.Consistentwithourresponsibilityastheworld’sleadingbiopharmaceuticalcompany,wealsocollaboratewithhealthcareproviders,governmentsandlocalcommunitiestosupportandexpandaccesstoreliable,affordablehealthcarearoundtheworld.Formorethan150years,Pfizerhasworkedtomakeadifferenceforallwhorelyonus.
For further information please visit: www.pfizer.comAssocaite Sponsor:
ORIONClinicalServicesisaEuropean-basedCROwithofficesinUK,Germany,France,Australia,US,RussiaandItaly.WeofferafullrangeofservicesinsupportoftheclinicaldevelopmentprocessincludingStrategicandoperationalregulatorysupport;Monitoring;ProjectManagement;MedicalWriting;QualityAssurance;DataManagementandStatisticsand
Pharmacovigilance–forbothpreandpostauthorisation.WeconductclinicalresearchacrossWestern,CentralandEasternEurope;Scandinavia,USA/Canada,AustraliaandpartsofthePacificRim.
For further information please visit: www.orioncro.com
Media Partners:PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supportedbymostoftheleadingpharmaceutical
corporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.
For further information please email: corporate@pharmiweb.com
BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.ItisbasedandlocatedinWarsaw,Poland.BiotechnologyWorldwasfoundedin
2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.
For further information please visit: www.biotechnology-europe.com
FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovideaplatformforsuccessfulbrandrecognition,
andforseniordecision-makerstohavethemeanstoprocureandplanimplementationstrategiesbasedonthetopicscovered.Positionedtobeanauthoritativeresourcewithintoppharmacompaniesaswellassmall,specialty,andbiotech,FuturePharmaceuticalsmagazineisgearedtocreateadeeppenetrationintoahighlytargetedandresponsiveaudience,bridgingthegapbetweentheindustries’topissuesandthesolutionstop-tiervendorscanprovide.
For further information please visit: www.futurepharmaus.comInPharmistheonlineplatformforexclusivepharmaceuticalnews,comment,contracts,services,jobsandeventsandishometoInPharmjobs.com,PharmafileandPharmafocus.
For further information please visit: www.inpharm.comTheleadingproviderofintelligencetothebiopharmaindustry.Detailedcompanyprofiles;investigational&approveddrugs;contactinfo;productforecasts;andexclusiveeditorialintelligence.Ourproprietaryjournalistscover
themostimportantsituationstakingplaceinthelifesciencesindustry,providingforwardlookinginsightintodrugpipelines,upcominglitigation,druglicensingdeals,andmergers&acquisitions.
For further information please visit: www.biopharminsight.com
Driving the Industry Forward | www.futurepharmaus.com
Sponsorship and exhibition opportunitiesThiseventoffersauniqueopportunitytomeetanddobusinesswithsomeofthekeyplayersinthepharmaceuticalandbiotechindustries.Ifyouhaveaserviceorproducttopromote,youcandosoatthiseventby:•Hostinganetworkingdrinksreception•Takinganexhibitionspaceattheconference•Advertisinginthedelegatedocumentationpack•Providingbrandedbags,pens,gifts,etc.Ifyouwouldlikemoreinformationontherangeofsponsorshiporexhibitionpossibilitiesforvisiongain's9thBiosimilarsConference,pleasecontactus:Damian Gorman, +44 (0)20 7549 9934 damian.gorman@visiongainglobal.com
BioPharmInsight
An Infinata BioPharm Solution
Pre-Conference Interactive Workshop9th Biosimilars
Wednesday 5th October 2011
Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situation
Dr. Angela Thomas ChairofBiologicalsandVaccinesExpertAdvisoryGroup-ComissiononHumanMedicinesMHRA
Dr Anita O’Connor ManagingPartnerAnita O’Connor Consulting
Timings: 09:30- 10:00 Coffee&Registration10.00- 11.15 MorningSession
11.15- 11.30 CoffeeBreak 11.30- 12.45 MorningSession 12.45- 13.45 Lunch 13.45- 15.00 AfternoonSession 15.00- 15.15 CoffeeBreak 15.15- 17.00 AfternoonSession
Led by:
About your workshop leaders:Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH
Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH, is Consultant Paediatric Haematologist at the Royal Hospital for Sick Children in Edinburgh.
After qualifying in Medicine from the University of London in 1980, Angela trained in general medicine and then adult haematology, subsequently developing a special interest in paediatrics. She was a fellow in molecular biology at University College London and was awarded a PhD on Genetic Variation of the Fibrinogen Gene.
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 Haemophilia Centre at the Edinburgh Royal Infirmary with specific responsibility for paediatrics. She cares for children with a wide range of haematological disorders, including those with leukaemia, immune deficiency, haemolytic anaemias and bleeding disorders. She has a special interest in the education of paediatricians in the varied presentation of haematological disease, particularly bleeding disorders presenting as possible non-accidental injury.
In addition to her clinical post, Angela is a member of the Commission for Human Medicines (CHM) and chairs its Biologicals and Vaccines Expert Advisory Group. The CHM advises on the quality, safety and efficacy of human medicinal products and advises the Licensing Authority on the granting
Anita O’Connor
Anita O’Connor, PhD, is the Senior Director for Biopharmaceuticals at Celerion. Anita is responsible for the leadership of biopharmaceutical and biosimilar 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 financial industry on small and large molecule development. From 1989 to 2005, Anita worked for the US FDA in the Center for Biologics (CBER), the Center for Drugs (CDER), the Center for Veterinary Medicine (CVM), the Center for Food Safety (CFSAN) and the Office of the Commissioner (OC). As an FDA pharmacologist she worked on the submissions of several blockbuster biopharmaceuticals to include Orencia®, Avastin®, Kepivance®, Remicade®, Remaira®, and Rituxan®. She also reviewed vaccine and blood product INDs and BLAs. Other FDA experience extends to food safety, animal drugs, women’s health, medical devices, and regulatory science policy. During her tenure at FDA, Dr. O’Connor was detailed to the US House of Representatives to work on food safety and biotechnology issues for House Agriculture committee. In 2008, she wrote a chapter for a reference book on the preclinical development of biopharmaceuticals. She speaks and writes frequently on biopharmaceuticals and biosimilars.
About the workshop:
The purpose of the workshop is to allow you to engage in knowledge sharing with your peers in a smaller, less formal environment than the main conference. As such, the audience size will typically be no more than 20 participants in order to enable maximum interaction between the workshop leaders and the delegates. The format is also more interactive, with less emphasis on ‘lecture-style’ presentations and more emphasis on group discussions, exercises and Q&A sessions.
Agenda:
The EU
• The introduction of biosimilars
• Lessons learned
• The changing Paradigm
• New developments on the Horizon
The US
• The recent introduction of biosimilar legislation in the US
• The basics of the US legislation
• New developments since the law was passed
• Challenges to expect in the future
The regulatory challenges for Biosimilar Medicines in the UK
• European guidance
• How similar does similar have to be
• Experience to date
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
About visiongain: Visiongain is a specialist business information company focused on providing cutting edge products and services across the Pharmaceutical/Biotech, Telecommunications, Defence and Finance sectors, which include reports, conferences, online daily news and offline news analysis and bespoke consultancy. With a commitment to innovation and excellence, visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing the right information at the right time to facilitate the commercial decision-making process. Our pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality, in-depth reports covering focused and topical areas of concern. Our pharmaceutical conferences address the hottest commercial, regulatory and technical topics and provide an ideal forum for debate and networking for pharmaceutical professionals from around the world.
For further information, please visit: www.visiongain.com
09:00 Registration and refreshments
09:30 Opening address from the chair
Dr Virginia Acha DirectorofInternationalAffairs,StrategicAnalysisPfizer
09:40 Biosimilars: challenges and choices in developing a biosimilars business
•Rewards&Risks •Thestorysofar–whatisknown? •Definitions •Impactofglobalization •Majorstake-holders •Barriersandpotentialpitfalls •Regulatoryissuesincomparability •CasestudieshighlightinganalyticalCMCchallenges
Dr Frank Moffatt ProductManager,BiopharmaceuticalAnalysisSolvias
10:20 New European legislations and their implications for biologicals including biosimilars
•Aretherespecificissuesforuseofbiologicals,includingbiosimilarsinclinicalpractice?
•INNprescriptionandapplicabilityforbiologicals •Requirementofthenewpharmacovigilancedirective:identification
andtraceability •Naminginthecross-borderhealthcaredirective •R&Dbasedindustrypositiononbiosimilarshealthcarepolicies
Annie Hubert Director,EuropeanGovernmentandPublicAffairsAmgen
11:00 Morning refreshments
11:20 The changing regulatory landscape of biosimilars: a non-clinical assessor’s perspective
•ChangesintheEUregulatoryframework •Qualitymatters •Preclinicalissues •Immunogenicity •Choiceofbiomarkers
Anna Valeri Non-ClinicalAssessor
MHRA
12:00 Tools for in vitro PD comparability studies of biosimilar antibodies
•Comparativeinvitrostudiesprovidecrucialdatatoassessthecomparabilityofthebiologicalactivityofbiosimilarantibodies.Acomprehensivestudymayreduceoreveneliminatetheneedforinvivopre-clinicalstudies.Suchastudywillincludetarget-specificassaysaswellasgenericfunctionalassaystoassessbindingtocomplementandFc
receptors.
Geoff Hale ChiefScienceOfficer,Merck Millipore
12:40 Networking lunch
13:40 The current and ongoing regulatory law development in biosimilars •Thebasicframework •Regulatorystandardsforapproval •Product-classspecificissues
Dr Lincoln Tsang Partner
Arnold & Porter LLP
14:20 Successful development of biosimilars •DemonstratingCMCcomparabilitytotheRegulators
•AssessingImmunogenicity
Dr Jean-Yves le Cotonnec CEO
Triskel Integrated Services
15:00 Afternoon refreshments
15:20 Biosimilars: Building trust through scientific rigour •EMAhasbeensuccessfulinbuildingarigorouspathwayforbiosimilars •However,uptakeandtrustinbiologicsandbiosimilarsremainsanissue
inEurope •Strongsciencewillresolvethekeyquestionsthatwefaceanddrive
confidence
Dr Virginia Acha DirectorofInternationalAffairs,StrategicAnalysis
Pfizer
15:40 Biosimilars - a balanced view based on experience from both sides
•Increasedpatientaccess,supportingsustainablehealthcaresystems,commerciallyviable
•Broadeninggroupofcompaniesinterestedinoriginatorandbiosmilarbiologics
•Science-basedandfairbiosimilarpathways
Dr. Ulrike Jägle SeniorManagerR&DPolicy,GlobalPublicAffairs
Novartis
16:20 Biosimilar IP issues in Europe •Freedomtooperateissuesandconfrontingpatentswithbroad
protection-pitfallsandtips •SupplementaryProtectionCertificatesandbiosimilars–unresolvedissues
Sebastian Moore Partner,IPGroup
Herbert Smith LLP
17:00 Closing remarks from the chair
17:10 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 19th Biosimilars
Thursday 6th October 2011
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
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09:00 Registration and refreshments
09:30 Opening address from the chair
Geoff Hale ChiefScientist
Millipore BioPharma Services Europe
09:40 Licensing of biosimilars •ExperiencetodateintheEU •Regulatoryrequirementsandguidance •Scientificadvice •Futurebiosimilarproducts
Dr Ian Hudson DirectorofLicensing
MHRA
10:20 Innovative label-free solutions to support product comparability testing and process development operations •Enablinglabel-freetechnologysolutionsoverview •Improvingproductcharacterizationandoverallproductivityforbiologics •Monitoringpatientimmunogenicityinpre-clinicalandclinical development •Optimizingproteinpurificationandformulationconditions •Controllingbatch-to-batchcomparabilityduringmanufacturing •Validationmanagementstrategiesformeetingregulatoryexpectations
Fredrik Sundberg GlobalDirector,StrategicMarketDevelopment
GE Healthcare
11:00 Morning refreshments
11:20 Immunogenicity issues with biosimilars •Theimportanceofimmunogenicityissues •Strategiesandmethodsfordetectionofimmunogenicity •Update
Dr Meenu Wadhwa Leader,cytokine&GrowthFactorsSectionNational Institute for Biological Standards
and Control
12:00 Biosimilar market uptake – taking the question out of acceptance
•Examiningthebusinessrisksandmarketplaceopportunities •Measuringregulatorsandfinancialanalystsmandates •Projectingdataandclinicalconfidence •Trackinghealthprofessionalandpatientexpectations •Buildinganawarenessandthird-partyadvocacyprogram •Understandingneededservicesandcommunications •Settingacourseforpayersandpatientpull-through
Kristie Khul SeniorVP,HealthMarlovsky + Company
12:40 Networking lunch
13:40 Uptake of biosimilars in clinical practice
•Whatdodoctorsknowaboutbiosimilars?
•Whataretheobstaclestoincreaseduse?
•Whatdoweknowaboutpricesonbiosimilars?
•Whoshalldecidewhichdrugtouse?
Dr Steinar Madsen Medicaldirector,DepartmentofDrugInformationNorwegian Medicines Agency
14:20 Safety issues with biosimilars
•Overviewofsafetyissues
•Immunogenicity
•Postmarketingsurveillance
•Futureinnovation
Dr Sandy Eisen ChiefMedicalOfficerFrontline Pharma Consulting
15:00 Afternoon refreshments
15:20 The development of biosimilar monoclonal antibodies and other complex molecules
•Monoclonalantibodies:contextofmarket
•Manufacturingprocess
•Productheterogeneity
•Standardproductcharacterisation
•Biologicalcomparability
•Futureopportunities
Dr Carsten Brockmeyer ManagingDirectorBrockmeyer Biopharma
16:00 Chair’s closing remarks
16:10 End of Conference
Day 29th Biosimilars
Friday 7th October 2011
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
CA
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Registration Form9th Biosimilars
5th - 7th October 2011, London, UK
www.visiongain.com/biosimilars
9th Biosimilars 5th - 7th October 2011Location:ThistleCityBarbican
Address:CentralStreet,ClerkenwellLondonEC1V8DSUK