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JOINTLY SPONSORED BY

• ISPEInternational Society for Pharmacoepidemiology

• SIFItalian Society of Pharmacology

• SIMGItalian College of General Practitioners

ISPE 2011Mid-Year MeetingFlorence, ITALY>APRIL 9-11, 2011

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>scientific committee

CO-CHAIRGiampiero MazzagliaMD, PhD - Florence (Italy)

CO-CHAIRGianluca Trifirò

MD, PhD - Rotterdam (The Netherlands), Messina (Italy)

Frank AndersohnMD - Berlin (Germany)

Roberto BernabeiMD - Rome (Italy)

Achille P. CaputiMD - Messina (Italy)

Giovanni CorraoPhD - Milan (Italy)

Claudio CricelliMD - Florence (Italy)

Mark H. EpsteinScD - Bethesda, MD (USA)

Stephen J.W. EvansBA, MSc, Stat, FISPE

London (UK)

Nicholas MooreMD, PhD, FRCP, FISPE

Bordeaux (France)

Alessandro MugelliMD - Florence (Italy)

Sebastian SchneeweissMD, ScD, FISPEBoston, MA (USA)

Miriam SturkenboomPharmD, PhD, FISPE

Rotterdam (The Netherlands)

REG I S TRAT I ON

I SPE5272 River Road, Suite 630Bethesda, MD 20816 USAPh.: +1-301-718-6500Fax: +1-301-656-0989www.pharmacoepi.orgispe@paimgmt.com

ACCOMMODATIONSPONSORSHIP & EXHIBITION

AIM GROUP INTERNATIONALFlorence Office

Viale G. Mazzini, 7050132 Florence, ItalyPh.: +39-055-23388.1Fax: +39-055-3906908

www.aimgroup.eu/2011/ispeispe2011@aimgroup.eu

organizing secretariats

under the auspicies of

AIEItalian Epidemiological Association

AIFAItalian Medicines Agency

ARSRegional Agency for Health

EACPTEuropean Association for ClinicalPharmacology and Therapeutics

ISoPInternational Society of Pharmacovigilance

ISSItalian National Institute of Health

SIGGItalian Society of Gerontology and Geriatrics

SISMECItalian Society of Medical Statistics

and Clinical Epidemiology

Comune di FirenzeMunicipality of Florence

Università degli Studi di FirenzeUniversity of Florence

Università degli Studi di Firenze - Facoltà di MedicinaUniversity of Florence - School of Medicine

Dear colleagues,n behalf of the scientific Program organizing committee, we have thegreat pleasure to welcome you at the International society for Pharma-coepidemiology (IsPE) 2011 Mid-Year Meeting (9-11 April) in Florence.

This important scientific conference is jointly sponsored by the Italian so-ciety of Pharmacology (sIF) and the Italian college of General Practitioners(sIMG). IsPE is an international organization dedicated to advancing thehealth of the public by providing a forum for the open exchange of scien-tific information and for the development of policy, education, and advo-cacy for the field of pharmacoepidemiology, including areas such as drugsafety research, drug utilization research, comparative effectiveness re-search, and therapeutic risk management.The goal of the symposium is to promote collaboration on drug safety andeffectiveness research among stakeholders representing academia, phar-maceuticals, healthcare service providers, government/regulatory agen-cies, and the public.The one-day symposium on April 9 addresses innovative strategies for as-sessing the effects of drug use among the elderly population. of particularinterest is the potential to combine multiple electronic healthcare databasesand by doing so, create a powerful research tool for helping to understandbetter the risk-benefit profile of the medications.The title of the symposium is: New strategies for the Post-marketing Mon-itoring of Medical Products.In addition to the one-day symposium, IsPE  offers two half day shortcourses on April 10: Introduction to Pharmacoepidemiology and AdvancedTopics in Pharmacoepidemiology. We are excited because this is IsPE's firstmeeting in Italy.Florence, the "cradle of the Renaissance", is the capital city of the Italian re-gion of Tuscany. The historic centre of Florence continues to attract mil-lions of tourists each year and was declared a World Heritage site byuNEsco in 1982. The work of cimabue and Giotto, the fathers of Italianpainting, and the universal genius of Leonardo da Vinci and Michelangelo,are gathered in several museums, such as the uffizi, the most selectedgallery in the world.Welcome to Florence!on behalf of the organizing committee,

O

Giampiero Mazzaglia, CO-CHAIR, ISPE ORGANIZING COMMITTEE

Gianluca Trifirò,CO-CHAIR, ISPE ORGANIZING COMMITTEE

ISPE> Upcoming Meetings <SAVE THE DATE

•27th International Conference on Pharmacoepidemiology

and Therapeutic Risk Management

<<<< August 14-17, 2011 >>>>Hyatt Regency Chicago

Chicago, IL USA

•6th ISPE Asian Meeting

<<<< October 28-30, 2011 >>>>Bejing, China

•2012 ISPE Mid-Year Meeting

<<<< April 21-23, 2012 >>>>Eden Roc Resort and Spa

Miami Beach, FL USA

•

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07:30 REGISTRATION

> Michelangelo Hall

09:00 INTRODUCTION TO PROGRAMGiampiero MazzagliaProgram Co-Chair,Health Search, Italian College of General Practitioners, ItalyGianluca TrifiròProgram Co-Chair,Erasmus University Medical Center,The Netherlands & University of Messina, ItalyWELCOME ADDRESSESAchille Caputi Italian Society Of PharmacologyPast-President, ItalyClaudio CricelliItalian College of General Practitioners President, ItalyStephen J.W. EvansFISPE, ISPE President, London School of Hygiene & Tropical Medicine, UK

MORNING SESSION> Michelangelo Hall

POST-MARKETING MONITORING OF MEDICALPRODUCTS: EXPECTATIONSAND FUTURE DIRECTIONSFROM REGULATORY AGENCIES, INDUSTRY, AND ACADEMIACO-CHAIRS

Achille P. CaputiUniversity of Messina, ItalyNicholas MooreFISPE, University of Bordeaux,France

09:15 KEYNOTE ADDRESSEvaluating drug effects in the post-Vioxx world: There must be a better wayJerry Avorn FISPE, Harvard MedicalSchool/Brigham & Women’s Hospital,USA

Q & A DISCUSSION

10:00 Active monitoring of medical product safety: A viewpoint from the ItalianMedicines AgencyDaniela MelchiorriItalian Medicines Agency & Committeefor Human Medicine Products, EMA

MORNING SESSION

10:30 Issues driving the Europeanregulatory agenda on drugrisk-benefit management: The importance of risk minimization activitiesAlmath SpoonerIrish Medicines Board & Pharma-covigilance Working Party, EMA

11:00 BREAK

11:30 Post-marketing drug safetymonitoring and risk minimization activities: Expectations and proposalsfrom drug industriesPhilippe Van der AuweraRisk Management Strategies, Hoffmann-La-Roche, France

12:00 Making sense of safety monitoring data: Bringing epidemiology and decision sciences togetherSebastian Schneeweiss FISPE, Harvard MedicalSchool/Brigham & Women’s Hospital,USA

12:30 LUNCH

AFTERNOON SESSION 1> Michelangelo Hall

NEW APPROACHES IN DRUGSAFETY SIGNAL DETECTIONCO-CHAIRS

Giovanni Corrao University of Milan Bicocca, Italy Marie Lindquist WHO Collaborating Centre for International Drug Monitoring, Sweden

13:30 From individual case report assessment to quantitative signal detection using spontaneous adr reporting:What are the lessons learned?Stephen J.W. Evans FISPE, London School of Hygieneand Tropical Medicine, UK

13:55 Data driven discovery-casestudies from patient recordsand spontaneous reportsNiklas NorenWHO Collaborating Centre for International Drug Monitoring, Sweden

S C I E N T I f I C

p r o g r a mSymposium Apri l 9, 2011New Strategies for the Post-marketing

Monitoring of Medical Products

Florence, ITALY > APRIL 9-11, 2011

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AFTERNOON SESSION 1

14:20 Does data mining on healthcare database add tosafety monitoring? Resultsfrom the EU-ADR projectMiriam Sturkenboom FISPE, Erasmus University MedicalCenter, The Netherlands

14:45 The observational medical outcomes partnership (OMOP): Results and future perspectives Patrick Ryan Johnson and Johnson, USA

15:15 BREAK

AFTERNOON SESSION 2> Michelangelo Hall

PROMOTING DISTRIBUTEDNETWORKS FOR HYPOTHESISTESTING STUDIES: CURRENTINITIATIVES IN EUROPECO-CHAIRS

Roberto Bernabei University Cattolica del Sacro CuoreRome, Italy Miriam Sturkenboom FISPE, Erasmus University MedicalCenter, The Netherlands

15:45 The European Network of Centres for Pharmacoepi-demiology (ENCePP): Code ofconduct for multicentre observational studiesStella Blackburn Pharmacovigilance and Risk Management, European MedicinesAgency, UK

AFTERNOON SESSION 2

16:10 The future of vaccine safety assessment in Europe: The perspective from VAESCO projectJan Bonhoeffer University Children's Hospital, Basel,Switzerland & Brighton Collaboration

16:35 Federation of databases toevaluate the arrhythmogenicpotential of drugs: The ARITMO projectFabrizio De Ponti University of Bologna, Italy

17:00 A network of long-term care facilities: Experience from Europe and USAGiovanni Gambassi Sacro Cuore University of Rome, Italy

AFTERNOON SESSION 2

17:30 FINAL COMMENTSGiampiero MazzagliaHealth Search, Italian College of General Practitioners, ItalyGianluca Trifirò Erasmus University Medical Center,The Netherlands & University ofMessina, Italy

17:45 ADJOURNMENT

Symposium Apri l 9, 2011New Strategies for the Post-marketing

Monitoring of Medical Products

Florence, ITALY > APRIL 9-11, 2011S C I E N T I f I C

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Florence, ITALY > APRIL 9-11, 2011

COURSES April 10, 2011 COURSES April 10, 2011

07:30 REGISTRATION

MORNING 09:00 - 13:00 <> Dante Hall

INTRODUCTION TO PHARMACOEPIDEMIOLOGY

PharmacovigilanceMauro Venegoni, Regional Health Authority of Lombardy, Italy

Cohort studiesFrank Andersohn, Charité University of Berlin, Germany

Case-control studiesGiuseppe Traversa, Italian Health National Institute, Italy

ConfoundingCorinne de Vries, fISPE, University of Bath, UK

AFTERNOON 14:00 - 18:30 <> Michelangelo Hall

ADVANCED TOPICS IN PHARMACOEPIDEMIOLOGY

Conducting hypothesis testing research in healthcare databases: Workflows in single and multiple database studies Miriam Sturkenboom, fISPE,Erasmus University Medical Center, The Netherlands

Signal detection in electronic medical record and claims databases versus spontaneous reporting databasesKevin Haynes, University of Pennsylvania, USA

Update on effectiveness research using observational databasesTobias Gerhard, Rutgers University, USA

Quality of evidence of observational studies in drug safety: the work in progress of GRADENicola Magrini, CEVEAS Bologna, Italy

Multiple-treatments meta-analysisCorrado Barbui, University of Verona, Italy

S C I E N T I f I C

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MEETING VENUEGrand Hotel Baglioni ★★★★

Piazza Unità Italiana, 650123 - florence, Italy

EXHIBITIONA one-day technical exhibition is available onApril 9 (Giotto Hall).

HOW TO REACH FLORENCEflorence can be reached from the main citiesof Europe and Mediterranean countries bytrain and plane.

• By Plane- Florence International Airport “AmerigoVespucci” (connected to the main Euro-pean cities). It is located 4 km (2,5 miles)from florence and it can be reaches by taxiin 20 minutes or by shuttle service bus Volain Bus, a special connection servicefrom/to Vespucci Airport to/from SantaMaria Novella train station, jointly run byATAf and SITA bus companies. Taxi park-ing area is just outside the airport

- Pisa International Airport “Galileo Galilei”(connected to the main European cities).It is located in Pisa 60 km (38 miles) fromflorence and it can be reached in 1 hourby train from Santa Maria Novella train sta-tion: three trains every hour from Pisa Cen-trale and Pisa Airport from 6,00 am to10,00 pm.

• By TrainThere are 3 main train stations in florence:- Santa Maria Novella Central Station located

at 80 metres from congress venue; - Rifredi Station located at around 2 km

(1,2 miles)- Campo di Marte Station located at 1,5 km

(1 mile).

PUBLIC TRANSPORTATIONAll town buses stops in Piazza Stazione(Santa Maria Novella train Station) and there-fore they are reachable by walk from con-gress venue in 5 minutes.• Taxi 055 4390 or 055 4242 or 055 4798

HOTEL ACCOMMODATIONRooms are available at the Meeting Venue(Grand Hotel Baglioni****) at the followingrates:

Prices are for night, including breakfast and V.A.T.

AIM Group International selected other ho-tels at walking distance from the Congressvenue. for information and/or reservationplease contact the Official Housing Bureauand Travel Agency of the Conference:• AIM Group Intenational

Milan OfficeVia Ripamonti, 129 - 20141 MilanTel. +39-02-566011fax +39-02-56609043 E-mail: ispe2011.hotel@aimgroup.eu

CANCELLATIONS/REFUND POLICYNo refunds for cancellations received afterMarch 26, 2011.Substitute participants will be accepted atdiscretion of ISPE.

REGISTRATION AND INFORMATION DESKAvailable at the congress venue (MachiavelliRoom) with the following hours.• April 9 7:30 - 18:00• April 10 7:30 - 18:30

[ ] GENERAL INFORMATION [ ] [ ] GENERAL INFORMATION [ ]

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ISPE MEMBER IndustryAcademic/Government Student*/Retired/Special*

NON MEMBER IndustryAcademic/Government Student*/Retired/Special*

(1)APRIL 9Symposium

All Day

$ 295$ 170$ 55

$ 345$ 225$ 65

(2)APRIL 10intro to

PharmacoepyA.M. oNLY

$ 295$ 170$ 55

$ 345$ 225$ 65

(3)APRIL 10AdvancedTopics

P.M. oNLY

$ 295$ 170$ 55

$ 345$ 225$ 65

[ REGISTRATION fEES (US Dollars) ]

GRAND HOTELBAGLIONI

DouBLE sINGLEusE RooM

Euro 178,00

DouBLE RooM

Euro 212,00REGULAR MEMBERSHIP $ 245 RETIRED MEMBERSHIP $ 85STUDENT MEMBERSHIP $ 85 SPECIAL MEMBERSHIP $ 85

[ NEW ISPE Membership Not for Dues Renewal ]Join IsPE now and receive membership benefits through June 30, 2012

NOTES: * Student must provide ISPE with documentation of full-time status (e.g., clear copy of student ID with avalid date or letter from school or program) – email or fax (301-656-0989)

** Individual must be a citizen and resident in the middle or lower income country as identified by theUnited Nations (UN Human Development Report 2005, page 213).

OTHER MEETINGS (by invitation only)

April 10, 08:30-12:00 > Giotto HallICPE 2011 Scientific Program Committee

April 11, 08:30-16:00 > Giotto HallISPEBoard of Directors Meeting

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>ISPE 2011 MID-YEAR

SYMPOSIUM SPONSORS

CORPORATE BENEFACTORS

AstraZeneca R & DPfizer

PLATINUM

oracle

GOLD

Boehringer Ingelheim GmbHIngenix

outcomeRTI Health solutions

SILVER

REGIsTRAT-MAPI

BRONZE

csD Medical ResearchEpisource12

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REG I S TRAT I ON

I SPE5272 River Road, Suite 630Bethesda, MD 20816 USAPh.: +1-301-718-6500Fax: +1-301-656-0989www.pharmacoepi.orgispe@paimgmt.com

ACCOMMODATIONSPONSORSHIP & EXHIBITION

AIM GROUP INTERNATIONALFlorence Office

Viale G. Mazzini, 7050132 Florence, ItalyPh.: +39-055-23388.1Fax: +39-055-3906908

www.aimgroup.eu/2011/ispeispe2011@aimgroup.eu

organizing secretariats

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