OverviewThis conference provides an excellent platform to discuss the opportunities and challenges of ensuring an adequate supply of up-to-date medicines to meet the needs of animals around the world. The conference will also recognise the one world, one health concept which underlines that health in animals promotes health in humans.

Key Topic - AvailabilityDefining the problem•Whatdowemeanbyavailabilityandwhatshouldwedoaboutit?•Developedversusless-developedworld•Maintainexistingproductsversusbringingnewproductstomarket

Role of veterinary medicines in disease control•Vaccines-Currentapproaches•Antimicrobials–Maintainingappropriateaccessforveterinaryuse Regulation of medicines - Lessons from applying better regulation principles•MUMS(TheMinorUseandMinorSpecies)versus‘full’marketproducts•Whatis‘betterregulation’andwhatbenefitsdoesitbringtoregulatorsandindustry?•Cooperationinthelessdevelopedworld•Lessonsfromregionalcooperation•VICH4andtheoutreachprogramme

Innovation–Encouragingnewproductstomarket•Statusreportoninnovation•Regulatorsapproachtostimulatinginnovation•Buildingalliancestopromoteinnovation•Feedbackonsuccessesandkeylearnings

Learning ObjectivesThis conferencewill enableparticipants tokeepabreastof advances in researchanddevelopment inworking towardsanenvironment that isbothpredictableandexciting for theavailabilityofnewandinnovative veterinary medicines.

ProgrammeCo-ChairsBarbara Freischem, ExecutiveDirector,InternationalFederationforAnimalHealth(IFAH),AISBL,Belgium

David Mackay, HeadofUnitVeterinaryMedicinesandProductDataManagement,EuropeanMedicinesAgency,EU

ProgrammeCommitteeRene Aerts, Vice-PresidentR&DBiologicals,Intervet-Schering-PloughAnimalHealth,The Netherlands

Ellen de Brabander, ChiefScientificOfficerandHeadofGlobalR&D,MERIALLimited,USA

Elisabeth Erlacher-Vindel,DeputyHeadofScientificandTechnicalDepartment,TheWorldOrganisationforAnimalHealth(OIE),France

Kornelia Grein,HeadofSectorVeterinaryMedicines,EuropeanMedicinesAgency,EU

Rick Hill,Director,CenterforVeterinaryBiologicsUSDA,AnimalandPlantHealthInspectionService,VeterinaryServices,USA

Anja Holm,SeniorScientificOfficer,DepartmentofVeterinaryMedicinalProducts,DanishMedicinesAgency,Denmark,andChairoftheCommitteeforMedicinalProductsforVeterinaryUse(CVMP)

Jeffrey C. Mariner, VeterinaryEpidemiologist,InternationalLivestockResearchInstitute(ILRI),Kenya

Jan Slingenbergh,SeniorOfficer,InfectiousDiseases,EmergencyPreventionSystems(EMPRES),FoodandAgriculturalOrganisationoftheUnitedNations(FAO),Italy

Steven D. Vaughn, DVMDirector,OfficeofNewAnimalDrugEvaluation,CenterforVeterinaryMedicine,U.S.FoodandDrugAdministration,USA

Wilhelm von Trott zu Solz,representingBoehringerIngelheimAnimalHealth,Germany

WhoWillAttendProfessionals with an interest in the latest scientific developments in animal health from the pharmaceutical industry, academia, regulatory and governmental agencies worldwide.

Event #1110623-24 March 2011 European Medicines Agency, Canary Wharf, London, United Kingdom

Global Animal Health ConferenceGlobal Availability of Veterinary Medicines - Providing a Climate for Science and Innovation

AbouttheDIATheDIAisaneutral,global,professional,member-drivenassociationofnearly18,000biotechnology,pharmaceutical,clinical or medical, academic and regulatory professionals, students and patient representatives. Through its international meetings,trainingcourses,onlinelearningandmyriadofnetworkingopportunities,theDIAprovidesaglobalforumforknowledgeexchangethat fostersthe innovationofproducts, technologies,andservicesto improvehealthandwell-beingworldwide.HeadquartersareinHorsham,PA,USA,withofficesinBasel,Switzerland,Tokyo,Japan,Mumbai,India,andBeijing,China.Formoreinformation,visitwww.diahome.orgorcalltheDIAinEurope+41612255151.

AboutEMATheEuropeanMedicinesAgencyisadecentralisedagencyoftheEuropeanCommissionwhosemainresponsibilityistheprotection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

AboutIFAHIFAH(InternationalFederationforAnimalHealth)isthefederationrepresentingmanufacturersofveterinarymedicines,vaccines and other animal health products worldwide. It represents both corporate members and national as wellas regional animal health associations. These associations compriseboth localmedium-size enterprises (SMEs) andinternational companies.

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WEDNESDAY|23MARCH2011

08:00 REGiSTRATion

09:00 Session 1 opEninG SESSion SessionChairs: Barbara Freischem, ExecutiveDirector,InternationalFederationfor AnimalHealth(IFAH),AISBL,Belgium David Mackay, HeadofUnitVeterinaryMedicinesandProductData Management,EuropeanMedicinesAgency,EU

opening Address AndreasPott,ActingExecutiveDirector,EuropeanMedicinesAgency, EU

opening Address Barbara Freischem,ExecutiveDirector,InternationalFederationfor AnimalHealth(IFAH),AISBL,Belgium David Mackay, HeadofUnitVeterinaryMedicinesandProductData Management,EuropeanMedicinesAgency,EU

Availability of Veterinary Medicines EricMaree,PresidentoftheIFAHBoardofDirectors,Chairmanofthe ExecutiveBoardofVirbacS.A.,France

09:45 Session 2 THE nEED FoR VETERinARy MEDiCinES in A GloBAl ConTExT SessionChairs: Jeffrey C. Mariner,VeterinaryEpidemiologist,InternationalLivestock ResearchInstitute(ILRI),Kenya Wilhelm von Trott zu Solz,representingBoehringerIngelheimAnimal Health,Germany

What Are the needs for Veterinary Medicines at a Global level? JanSlingenbergh,SeniorOfficer,InfectiousDiseases,Emergency PreventionSystems(EMPRES),FoodandAgriculturalOrganisationof theUnitedNations(FAO),Italy

Recent oiE initiatives and Resolutions Relating to Veterinary Medicines and their Expected impact on Availability and Use ElisabethErlacher-Vindel,DeputyHeadofScientificandTechnical Department,TheWorldOrganisationforAnimalHealth(OIE),France

4 Key Contributions of Veterinary Medicines to Society WilhelmvonTrottzuSolz,representingBoehringerIngelheimAnimal Health,Germany

10:45 CoFFEE BREAK

11:15 Session 2 (continued) THE nEED FoR VETERinARy MEDiCinES in A GloBAl ConTExT SessionChairs: Jeffrey C. Mariner,VeterinaryEpidemiologist,InternationalLivestock ResearchInstitute(ILRI),Kenya Wilhelm von Trott zu Solz,representingBoehringerIngelheimAnimal Health,Germany

Experience with Regulating innovative products and Technologies EvaBennet-Jenkins,ChiefExecutiveOfficer,AustralianPesticides andVeterinaryMedicinesAuthority(APVMA),Australia

The Role of Veterinary Medicines in Building Trust in Safe Food – “Food Security” JeffWaage,Director,LondonInternationalDevelopmentCentre (LIDC),UnitedKingdom JonathanRushton,SeniorLecturer,TheRoyalVeterinaryCollege, UnitedKingdom

What is needed to promote Availability? AlbertDouffissa,Veterinarian–ExpertinDistributionofVeterinary MedicinesinCentralAfricanMarkets,Cameroon

Consolidation of the Animal Health industry and its impact on Availability JoachimHasenmaier,CEO,BoehringerIngelheim,Germany

panel Discussion

13:00 lUnCH

14:00 Session 3 REGUlATion AppRopRiATE FoR nEEDS SessionChairs: David Mackay, HeadofUnitVeterinaryMedicinesandProductData Management,EuropeanMedicinesAgency,EU Ellen de Brabander,ChiefScientificOfficerandHeadofGlobalR&D, MERIALLimited,USA

Presentationsfromthefollowingspeakersandaroundtable discussion •GaryBosch,GlobalHead,Research&Development,NovartisAnimal Health,Switzerland •BaptisteDungu,SeniorDirector,Research&Development, GlobalAllianceforLivestockVeterinaryMedicines(GALVmed), UnitedKingdom •RickHill,Director,CenterforVeterinaryBiologicsUSDA,Animaland PlantHealthInspectionService,VeterinaryServices,USA •AnjaHolm,SeniorScientificOfficer,DepartmentofVeterinary MedicinalProducts,DanishMedicinesAgency,Denmark,andChair oftheCommitteeforMedicinalProductsforVeterinaryUse(CVMP) •JeffreyC.Mariner,VeterinaryEpidemiologist,InternationalLivestock ResearchInstitute(ILRI),Kenya •StevenD.Vaughn,DVMDirector,OfficeofNewAnimalDrug Evaluation,CenterforVeterinaryMedicine,U.S.FoodandDrug Administration,USA

Discussion, Explanation of Break out Sessions

15:30 CoFFEE BREAK

16:00 Session 3 (continued) REGUlATion AppRopRiATE FoR nEEDS SessionChairs: David Mackay,HeadofUnitVeterinaryMedicinesandProductData Management,EuropeanMedicinesAgency,EU Ellen de Brabander,ChiefScientificOfficerandHeadofGlobalR&D, MERIALLimited,USA Discussion in Break out Sessions

Group 1: Whatarethemainobstaclestoavailabilityandhowcanthey beovercome? RhonaBanks,DirectorRegulatoryAffairs,Triveritas

Group 2:Whatis‘betterregulation’andhowcanitbepromoted? AnjaHolm,SeniorScientificOfficer,DepartmentofVeterinary MedicinalProducts,DanishMedicinesAgency,DenmarkandChair oftheCommitteeforMedicinalProductsforVeterinaryUse(CVMP)Continuing Education

TheSwissAssociationofPharmaceuticalProfessionals(SwAPP)andtheSwissSociety for Pharmaceutical Medicine (SGPM) have accredited the ‘GlobalAnimalHealthConference’with 12.5 credits.All participants are eligible forthese credits.

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Speakersandagendaaresubjecttochangewithoutnotice.RecordingofanyDIAEuropetutorial/workshopinformationinanytypeof

media,isprohibitedwithoutpriorwrittenconsentfromDIAEurope.

Group 3:Inwhatareasdoesacommonregulatoryapproachbetween regionsmakesenseandwhatcanbedoneataninternationallevelto promoteconvergenceofapproach? StevenD.Vaughn,DVMDirector,OfficeofNewAnimalDrug Evaluation,CenterforVeterinaryMedicine,U.S.FoodandDrug Administration,USA

Reporting from Break out Groups and plenary Discussion

17:30 EnD oF DAy onE

19:00 ConFEREnCE DinnER

THURSDAY|24MARCH2011

08:30 Session 4 innoVATion in VETERinARy MEDiCinES AnD AppRopRiATE REGUlATion SessionChairs: Barbara Freischem,ExecutiveDirector,InternationalFederationfor AnimalHealth(IFAH),AISBL,Belgium Steven D. Vaughn,DVMDirector,OfficeofNewAnimalDrug Evaluation,CenterforVeterinaryMedicine,U.S.FoodandDrug Administration,USA

innovation in Veterinary Medicine: needs and challenges JeffreySimmons,President,ElancoAnimalHealth,USA

Embracing new innovation in Veterinary Drug Evaluation StevenD.Vaughn,DVMDirector,OfficeofNewAnimalDrug Evaluation,CenterforVeterinaryMedicine,U.S.FoodandDrug Administration,USA

innovative Medicines at the European Medicines Agency - Experience and challenges FalkEhmann,ScientificSupportandProjects,HumanMedicines DevelopmentandEvaluationUnit,EuropeanMedicinesAgency,EU

What Types of new innovations Can we Expect in the Future? EllendeBrabander,ChiefScientificOfficerandHeadofGlobalR&D, MERIALLimited,USA

Discussion

10:00 CoFFEE BREAK

10:30 Session 4 (continued) innoVATion in VETERinARy MEDiCinES AnD AppRopRiATE REGUlATion SessionChairs: Barbara Freischem, ExecutiveDirector,InternationalFederationfor AnimalHealth(IFAH),AISBL,Belgium Steven D. Vaughn,DVMDirector,OfficeofNewAnimalDrug Evaluation,CenterforVeterinaryMedicine,U.S.FoodandDrug Administration,USA

Risk Management and public Fears – How to secure trust and public support? SteveKopperud,ExecutiveVicePresident,PolicyDirectionsInc.,USA

particular Challenges Represented by Biologically Active Molecules in Food-producing Species NikolausKriž,DevelopmentandEvaluationofVeterinaryMedicines, EuropeanMedicinesAgency,EU MaheshKumar,ExecutiveDirector,GlobalBiologicsResearch,VMRD, PfizerAnimalHealth,USA

one World, one Health ReneAerts,Vice-PresidentR&DBiologicals,Intervet-Schering- PloughAnimalHealth,TheNetherlands

What are the impediments to Authorisation of new Veterinary Medicines and How can They Best be overcome? Panel Discussion

12:30 lUnCH

13:30 Session 5 MAinTAininG AVAilABiliTy oF ExiSTinG pRoDUCTS SessionChairs: Kornelia Grein,HeadofSectorVeterinaryMedicines,European MedicinesAgency,EU Rene Aerts,Vice-PresidentR&DBiologicals,Intervet-Schering-Plough AnimalHealth,TheNetherlands Challenges with Retaining Existing Antimicrobials LudwigKlostermann,BayerAnimalHealthGmbH,Germany

other Challenges to Maintaining Availability of Veterinary Medicines PeterHoldsworth,ChiefExecutiveOfficer,AnimalHealthAlliance, Australia GabrielBeechinor,DirectorofVeterinaryMedicines,Veterinary MedicinesDepartment,IrishMedicinesBoard,Ireland

The Veterinarians View on Global needs for Veterinary Medicines RensvanDobbenburgh,AUV,TheNetherlands

legislative Framework to Support Availability MartinusNagtzaam,EuropeanCommission,Belgium

15:20 Session 6 MEETinG THE AniMAl HEAlTH nEEDS FoR THE 21ST CEnTURy SessionChairs: Rick Hill, Director,CenterforVeterinaryBiologicsUSDA,Animaland PlantHealthInspectionService,VeterinaryServices,USA Elisabeth Erlacher-Vindel,DeputyHeadofScientificandTechnical Department,TheWorldOrganisationforAnimalHealth(OIE),France

16:00 EnD oF ConFEREnCE

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