30th – 31st January 2012, Visiongain Conference Centre, London, UK

Organised By

Evaluating the best surveillance strategies and risk management to increase drug safety

To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pharmacovigilance

Dr. Philip Eichorn, Senior Director, Worldwide Safety and Regulatory, Pfizer

Dr. Beverley Forsythe, Executive Director Patient Safety, Oncology TA, AstraZeneca

Dr. Christina Stroem Moeller, Executive Director, Global Safety, Amgen

Dr. Enrica Alteri, Head of Risk Management and Epidemiology, Global Drug Safety, Merck Serono

Dr. Celestina Arrigo, Senior Director, Pharmacovigilance Data Quality Expert, UCB Pharma

Dr. György Zörényi, Global Safety Physician, AstraZeneca

Dr. Julia Appelskog, Nordic Drug Safety Manager, Johnson & Johnson

Dr. Sumit Munjal, Consultant Physician, Johnson & Johnson

Dr. Rachna Kasliwal, Director Pharmacovigilance, Endocrinology, Ipsen BioPharma

Professor Liam Smeeth, Professor of Clinical Epidemiology, London School of Hygiene and Tropical Medicine

Dr. Brian Edwards, Principal Consultant, Pharmacovigilance and Drug Safety, NDA Regulatory Services

Dr. Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting

Philippa Guy, Associate Director, Head of Drug Safety and EU QPPV, 2Health

Carol Markwell, Director, Drug Safety Solutions

Key Speakers

BOOK NOW!

7th Annual Pharmacovigilance

Driving the Industry Forward | www.futurepharmaus.com

Media Partners

Conference Introduction7th Annual Pharmacovigilance

30th - 31st January 2012, London, UK

Dear Colleague, The importanceofpharmacovigilancehasbeenapparent since theproblems

withthalidomideemergedinthe1960s.Sincethen,varioushighprofiledrugrecalls, and estimations that more than 750,000 injuries and deaths eachyear intheUSarecausedbyadversedrugreactions,1havemeanttightenedregulatorycontrols.

Itisestimatedthattheaveragespendonpharmacovigilanceis6%to13%ofacompany’stotalR&Dspend2.Fromproductdevelopmentinclinicaltrialstopostmarketingsurveillance,adversedrugreactionsaremonitoredandsafetysignalsinvestigated.

Regulations and procedures are continually developing, with changes in EUlegislationsetfor2012.Suchchangesincludeplanstomanageriskproactively,increase communication and transparency, and strengthen companies’pharmacovigilancesystems.

Visiongains 7th Annual Pharmacovigilance Conference will bring togetherindustryexpertstodiscusscurrentregulations,safetysurveillancepreandpostmarketingandreviewriskmanagementplanstoimprovedrugsafety.

By attending this conference you will: •Gaininsightintopharmacovigilancethroughouttheproductlifecycle,fromclinical

developmenttopatientcare •Leanaboutpharmacoepidemiologyanddrugsafety •Hear about the pharmacovigilance activities in biopharmaceutical product

development •Evaluateriskmanagementplansforimprovingdrugsafety •Discovertherightbenefit-riskbalance •Learn about good pharmacovigilance practice through advances in audits and

inspections •ReviewthecurrentandchangingregulationsintheEU,USandAsia •UnderstandhowtheroleoftheQPPVimpactspatientsafety •Assespostmarketingsurveillance •Discussthecurrentmethodsofreporting •ReviewtheuseofPeriodicSafetyUpdateReports(PSURs)post-authorisationfor

safetysignals •Examinetheprinciplesofsignaldetectioninpharmacovigilance •Networkwithexpertindustryprofessionalstobuildnewrelationships Ilookforwardtomeetingyouattheconference Bestregards

Sarah Pilgrim Conference Producer

Who will attend? VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of: Pharmacovigilance Pharmacoepidemiology Pharmacogenomics Drug/Product Safety Drug Development Information and Clinical Data Management Clinical Pharmacology Clinical Safety Periodical safety update reports Risk Management Research & Development Quality Assurance Patient Safety Signal Detection Safety Surveillance Outcomes Research Data Analysis Epidemiology Medical Affairs Regulatory Affairs and Compliance Information technology Sales and Marketing

Media Partners:PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supportedbymostoftheleading

pharmaceuticalcorporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.ItisbasedandlocatedinWarsaw,Poland.

BiotechnologyWorldwasfoundedin2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.For further information please visit: www.biotechnology-europe.com

FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovideaplatformforsuccessful

brandrecognition,andforseniordecision-makerstohavethemeanstoprocureandplanimplementationstrategiesbasedonthetopicscovered.Positionedtobeanauthoritativeresourcewithintoppharmacompaniesaswellassmall,specialty,andbiotech,FuturePharmaceuticalsmagazineisgearedtocreateadeeppenetrationintoahighlytargetedandresponsiveaudience,bridgingthegapbetweentheindustries’topissuesandthesolutionstop-tiervendorscanprovide.For further information please visit: www.futurepharmaus.com

InPharmistheonlineplatformforexclusivepharmaceuticalnews,comment,contracts,services,jobsandeventsandis

hometoInPharmjobs.com,PharmafileandPharmafocus.For further information please visit: www.www.inpharm.com

Driving the Industry Forward | www.futurepharmaus.com

Sponsorship and exhibition opportunities

Thiseventoffersauniqueopportunitytomeetanddobusinesswithsomeofthekeyplayersinthepharmaceuticalandbiotechindustries.Ifyouhaveaserviceorproducttopromote,youcandosoatthiseventby:

•Hostinganetworkingdrinksreception•Takinganexhibitionspaceattheconference•Advertisinginthedelegatedocumentationpack•Providingbrandedbags,pens,gifts,etc.

Ifyouwouldlikemoreinformationontherangeofsponsorshiporexhibitionpossibilitiesforvisiongain's7thAnnualPharmacovigilanceConference,pleasecontactus:

Damian Gorman, +44 (0)20 7549 9934 damian.gorman@visiongainglobal.com

1Visiongainreport,PharmacovigilanceandOtherPharmaRegulatoryDevelopments2010-20202SCIarticle,http://www.soci.org/Chemistry-and-Industry/CnI-Data/2010/17/A-risky-business

Poster PresentationAtabusyconferenceitishardtomakesureeveryonewhosharesyourinterestsknowswhatyouaredoing.MaximiseyourtimeatVisiongain’s7thAnnualPharmacovigilancemeetingbysharingyourresultsinaposterpresentation.Withaplethoraofkeydecisionmakers,takeadvantageofthisseniornetworkingopportunity.Pleasesendyour200wordabstract,inEnglish,to:info@visiongainglobal.comforapproval.ThedeadlineforsubmissionsisMonday16thJanuary,2012.Pleaseincludecontactdetailsforthecorrespondingauthor(s).Academicinstitutionswillnotbechargedafeeifbookedasfull-pricedelegates.Posterssubmittedbypharmaceuticalandbiotechnologyfirmswillbechargedafeeof£199.Posterssubmittedbyserviceproviders/vendorsarewelcomeandwillbesubjecttoevaluation.Uponapprovalafeeof£500willapply.Twodelegatesfromyourorganisationmustbebookedatfullpricetopresentaposter.PleasenotethatallposterswillbedisplayedatthediscretionofVisiongainLtdandaresubjecttoapproval.Duetolimitedspace,pleaseregisteryourinterestearly.

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Pharmacovigilance throughout the product life cycle – from clinical development to patient care

•Regulatorycompliance–expeditedandperiodicreporting

•Integratingsignaldetectionusingtotalityofinformation

•Implementingproactivesafetyriskmanagement

•Understandingbenefit-riskassessmentanddecisionmaking

•Bestpracticesfordevelopingtransparencywithsafetygovernancecommittees

Dr. Beverley Forsythe ExecutiveDirectorPatientSafety,OncologyTAAstraZeneca

10:20 Pharmacovigilance activities in biopharmaceutical product development

•Anoverviewintopharmacovigilanceactivitiesinbiopharmaceuticalproductdevelopment,includingcaseexamplesfromtwonewtomarketbiologicalproducts

•Highlightingthedifferenceswithbiopharmaandlongtermsafety

•Lookingatlongtermsafetystudies

Dr. Christina Stroem Moeller ExecutiveDirector,GlobalSafetyAmgen

11:00 Morning refreshments

11:20 Safety of biosimilars •Safetydatarequirementsandpharmacovigilanceissues

•RMPsandpostapprovalstudies

•Knownandpotentialsafetyissues

•Currentandfutureproblems

Dr. Sandy Eisen ChiefMedicalOfficerFrontline Pharma Consulting

12:00 Randomised evaluations utilising electronic health records to measure benefits and risks

•Wideagreementthatweneedbettermethodstoassessthebeneficialandadverseeffectsofdrugsineverydaypractice

•Thiscouldbeachievedwithlargescalesimplerandomisedtrialsembeddedinclinicalpractice

•Cliniciansoftenfacegenuineclinicaluncertaintywiththerapeuticchoicesmadeinaquasi-randomway

•Formalrandomisationcouldusefullyexploitthisuncertaintytoprovideevidencetoguidepractice

•Theincreasinguseofcomputerisedhealthrecordsmightallowustomountsuchtrialsthroughprospectiverandomisingofpatientswithsubsequentdatacollectionandfollowupundertakenelectronically

•Thetalkwillpresentthecaseforsuchtrials,discussthebarrierstotheirimplementationandhowsuchbarriersmightbeovercome

Professor Liam Smeeth ProfessorofClinicalEpidemiologyLondon School of Hygiene and Tropical Medicine

12:40 Networking lunch

13:40 Do we understand the leverage of pharmacoepidemiology on our patient safety practice? – a safety physician’s point of view

•Signalgenerationorsignalevaluation?Ourexperienceswithpharmacoepidemiology(PE)safetystudiesinthepost-marketingsetting

•Evaluationofexternalepidemiologysignalscomingfromnon-industrialstudies-arewegoodenoughtoaddressthem?Scientificandbusinessaspectsofapossibleinteractionwiththeacademicfield

•Generationandevaluationofsafetysignalsbydesigningin–housePEstudiesStrengthandlimitations

•Thehierarchyofevidence:randomisedstudiesvs.epidemiologysafetystudies

•Concordanceofquantitativesafetysignalsandtheresultsofpharmacoepidemiologystudies

•Thefuture:amovefrombeing“reactive”intobeing“proactive”.Howtoovercomethepossibleinternalandexternalhurdles?

Dr. György Zörényi GlobalSafetyPhysicianAstraZeneca

14:20 Audits and good pharmacovigilance practice

Dr. Celestina Arrigo SeniorDirector,PharmacovigilanceDataQualityExpertUCB Pharma

15:00 Afternoon Refreshments

15:20 Sponsor Spotlight Session

Takethisuniqueopportunitytobeapartoftheconferencetheme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactdamian.gorman@visiongainglobal.com

16:00 Pharmacovigilance audits / inspections

•Purpose,remitandscope

•Takingariskbasedapproach

•Practicalitiesandchallenges

•Maximisingthebenefit/learningacrossaudits

•Commonfindings

•Impactofnewregulations

Philippa Guy HeadofDrugSafetyandEUQPPV2Heatlh

16:40 Closing remarks from the Chair

16:50 Networking drinks

Take your discussions further and build new relationships in a relaxed and informal setting

Day 17th Annual Pharmacovigilance

Monday 30th January 2012

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

Day 27th Annual Pharmacovigilance

Tuesday 31st January 2012

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Special problems of pharmacovigilance for generic products

•Withthecurrentsearchfornewbusinessmodels,manybigpharmaareenergeticallyexploringandpursuingthegenericsmarket.

•Weoftenfindthereareallsortsofspecialcircumstancesthatarise,andthereoftenisn’ttheexpertiseinhousetodealwiththem.

•Whatistheimportanceofthepharmacovigilanceagreementifthere’sapartnercompanyinvolved?

•Whatdoesariskmanagementplanforagenericcompoundlooklike?

Dr. Phillip Eichorn SeniorDirectorWorldwideSafetyandRegulatoryPfizer

10:20 Effective risk management plan – practical approaches to maximise patient safety

•Newrequirementsforriskmanagementinpharmapackage

•Howtodesignarobustandcomprehensiveriskmanagementplan

•Executingariskmanagementplanthatincorporatesdevelopmental,clinicalandepidemiologicalsafetydatacombinedwithpostmarketsurveillancetoensureproductsafety

•Evaluatingpharmacovigilanceactivitiestocharacterisethepotentialoridentifiedrisksinatimelydefinedmanner;importanceofadditionalriskminimisationactivities

•Ensuringeffectiveriskmanagementthroughoutthefullproductlifecycle

•Communicatingsafetyandcomparativebenefit/risktohealthcareprofessionals,patientsandthepublic

Dr. Julia Appelskog NordicDrugSafetyManagerJohnson & Johnson

11:00 Morning refreshments

11:20 From risk management to benefit-risk management: a paradigm shift

•Impactondrugdevelopmentapproach

•Impactonlife-cyclemanagement

•Impactoncompanies’processes

•Meetingpatients’needs

Dr. Enrica Alteri HeadRiskManagement&Epidemiology,GlobalDrugSafetyMerck Serono

12:00 Benefit-risk assessment in pharmacovigilance

•Principles,methodologyandfinding‘thebalance’

•Stakeholdersandriskmanagement

•Newinitiatives-EMA

Dr. Sumit Munjal ConsultantPhysician–UK(Global)PharmacovigilanceJohnson & Johnson

12:40 Networking lunch

13:40 Post marketing surveillance and reporting of ADRs: what’s new?

•Impactofnewproposedlegislation

•Heterogeneityofdatasources

•Evidenceforgoodqualityprocesses

•Customisationoftrainingonthehumanfactor

•Placeofcontinuousimprovement

•RoleofEUQPPVindrivingpolicyandsettingstandards

Dr. Brian Edwards PrincipalConsultant,Pharmacovigilance&DrugSafetyNDA Regulatory Services

14:20 Methods in post-marketing drug safety surveillance

•Spontaneousreportinganddrugregistries

•Prescriptioneventmonitoring(PEM)

•Databaserelatedstudies

Dr. Rachna Kasliwal DirectorPharmacovigilance,EndocrinologyIpsen BioPharma

15:00 Afternoon refreshments

15:20 Sponsor Spotlight Session

Takethisuniqueopportunitytobeapartoftheconferencetheme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactdamian.gorman@visiongainglobal.com

16:00 PSURs– issues with content and submission

•Commoninspectionfindings

•Assessmentreports

•Worksharingandsynchronisation

•PlannedchangesinEurope

Carol Markwell DirectorDrug Safety Solutions

16:40 Closing remarks from the Chair

16:50 End of Conference

How to bookEmail:piyush.patel@visiongain.comWeb:http://www.visiongain.com/pharmacovigilance

UK Office:Tel: +44(0)207549 9961Fax:+44(0)2075499932 VisiongainLtdBSGHouse226-236CityRoadLondonEC1V2QYUK

General informationVenue:VisiongainConferenceCentre230CityRoad,London,EC1V2TT.UnitedKingdom.ClosesttubestationisOldStreet(NorthernLine).Accommodation:ThistleCityBarbican,CentralStreet,Clerkenwell,London,EC1V8DS,Phone:08713769004/+448453058304,Fax:08713769104/+448453058343http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.htmlTravelodgeLondonCityRoadHotel,7-12CityRoad,London,EC1Y1AE,Tel:08719846333,Fax:02076282503,http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340

Payment terms:Visiongainrequirethefullamounttobepaidbeforetheconference.VisiongainLtdmayrefuseentrytodelegateswhohavenotpaidtheirinvoiceinfull.Acreditcardguaranteemayberequestedifpaymenthasnotbeenreceivedinfullbeforetheevent.VisiongainLtdreservestherighttochargeinterestonunpaidinvoices.

Substitutions/name changes or cancellations: Thereisa50%liabilityonallbookingsoncemade,whetherbypost,fax,emailorweb.Thereisanorefundpolicyforcancellationsreceivedonorafteronemonthbeforethestartoftheevent.Shouldyoudecidetocancelafterthisdate,thefullinvoicemustbepaid.Conferencenoteswillthenbesenttoyou.Unfortunately,weareunabletotransferplacesbetweenconferences.However,ifyoucannotattendtheconference,youmaymakeasubstitution/namechangeatanytime,aslongasweareinformedinwritingbyemail,faxorpost.Namechangesandsubstitutions must be from the same company or organisation and are not transferable betweencountries.Pleasenotethatdiscounteddelegatesplacesatavisiongaineventarenonrefundable.

Invoice alterations:Therewillbeanadministrationchargeof£50foranychangestoaninvoice,excluding substitutions/name changes, requested by the customer. This will be charged to thecustomerbycreditcardpriortothechangesbeingmade.

Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executivebriefingcontent,timing,speakersorvenuewithoutnotice.TheeventmaybepostponedorcancelledduetounforeseeneventsbeyondthecontrolofvisiongainLtd.Ifsuchasituationarises,wewilltrytorescheduletheevent.However,visiongainLtdcannotbeheldresponsibleforanycost,damageorexpenses,whichmaybeincurredbythecustomerasaconsequenceoftheeventbeingpostponedorcancelled.Wethereforestronglyadviseallourconferenceclientstotakeoutinsurancetocoverthecostoftheregistration,travelandexpenses.

Data Protection: Visiongain Ltd gathers and manages data in accordance with the DataProtectionAct1988.YourpersonalinformationcontainedinthisformmaybeusedtoupdateyouonvisiongainLtdproductsandservicesviapost,telephone,faxoremail,unlessyoustateotherwise.Wemayalsoshareyourdatawithexternalcompaniesofferingcomplementaryproductsorservices.Ifyouwishforyourdetailstobeamended,suppressedornotpassedontoanyexternalthirdparty,pleasesendyourrequesttotheDatabaseManager,visiongainLtd,BSGHouse,226-236CityRoad,London,EC1V2QY.Alternatively,youcanvisitourwebsiteatwww.visiongain.comandamendyourdetails.Pleaseallowapproximately30daysforyourremovalorupdaterequesttobeappliedtoourdatabase.Followingyourremovalorupdaterequest,youmayreceiveadditionalpiecesofcommunicationfromvisiongainLtdduringthetransitionalperiod,whilstthechangesarecomingintoeffect.

Fee: Theconferencefeeincludeslunch,refreshmentsandconferencepapersprovidedontheday.This feedoesnot include travel, hotel accommodation, transfersor insurance, (whichwe stronglyrecommendyouobtain).

VAT: VATwillbechargedatthelocalrateoneachconference.DelegatesmaybeabletorecoverVATincurredbycontactingEurocashCorporationplc+44(0)1273325000,eurocash@eurocashvat.com.Eurocashspecialiseinrecoveringcross-borderVAT.

How we will contact you: VisiongainLtd’spreferredmethodofcommunicationisbyemailandphone.Pleaseensurethatyoucompletetheregistrationforminfullsothatwecancontactyou.

Unable to attendObviouslynothingcomparestobeingtherebutyouneednotmissout.Simplyticktheboxandsendwithyourpayment.YouwillreceivespeakertalksinPDFstwoweeksaftertheevent.

Yes, please send me speaker talks Price£550 VAT:£110 Total:£660

Conf.codePP

Standard PricesConference only Fee: £1299 VAT: £259.80 Total: £1558.80

Number of bookings: Total cost:

Promotional Literature DistributionDistribution of your company’s promotional literature to all conference attendees

Fee: £999 VAT: £199.80 Total: £1198.80

Details

Forename: Surname:

JobTitle: Company:

MainSwitchboardNumber:

Address:

Country: Postcode:

Phone: Fax:

Email:

Signature:

IconfirmthatIhavereadandagreetothetermsandconditionsofbooking

Methods of payment

Paymentmustbemadeinsterling

By Mail: Completeandreturnyoursignedregistrationformtogetherwithyourchequepayable

toVisiongainLtdandsendto:visiongainLtd,BSGHouse,226-236CityRoad,London,EC1V2QY,UK

By Fax: Completeandfaxyoursignedregistrationformwithyourcreditcarddetails

to+44(0)2075499932

By Phone:Calluson+44(0)2073366100withyourcreditcarddetails

By Credit Card:Fillinyourcarddetailsbelowandfaxbackto+44(0)2075499932

By Bank Transfer:

VisiongainLtd A/C:visiongainLtd

BarclaysBank SortCode:20-71-64

PiccadillyBranch AccountNo:60387118

48RegentStreet SwiftCode:BARCGB22

London,W1B5RA IBAN:GB80BARC20716460387118

Please debit my credit card:

Access MasterCard Visa AmericanExpress

Cardnumber:

ExpiryDate:

Securitynumber(last3digitsonbackofcreditcard):

Signature:

Cardholder’sname:

News updates

Pleasetickifyoudonotwanttoreceiveemailnewsupdatesinthefuture

Registration Form7th Annual Pharmacovigilance

30th - 31st January 2012, London, UK

www.visiongain.com/pharmacovigilance

7th Annual Pharmacovigilance 30th - 31st January 2012Location:VisiongainConferenceCentre

Address:230CityRoadLondonEC1V2TTUK

City Road

Old Street

City Road

Pentonville Road

Old Street

Angel