#myispe19

ISPE’S 2019 MID-YEAR MEETINGAPRIL 6-9, 2019 | RADISSON BLU ES. HOTEL | ROME, ITALY

ENDORSING ORGANIZATIONS

Istituto Superiore di Sanità

GOLD SPONSORSRTI Health Solutions Takeda Pharmaceuticals International Teva

SILVER SPONSORSOptum

BRONZE SPONSORSIQVIA Aetion

EXHIBITORSRTI Health Solutions Drug Safety Research Unit

ISPE 2019 MID-YEAR MEETING PLANNING COMMITTEEThe ISPE Board of Directors expresses its appreciation to the members of the 2019 Mid-Year

Planning Committee for their commitment and dedication to developing and outstanding

educational program.

Ursula Kirchmayer, Department of Epidemiology, Lazio Region, Committee Co-Chair

Gianluca Trifirò, University of Messina, Committee Co-Chair

Andrew Bate, Pfizer

Jaclyn Bosco, Co-Chair, ISPE Education Committee

Alison Bourke, FISPE, ISPE President

Gianni Corrao, University Milano Bicocca

Mark H. Epstein, ISPE Executive Secretary

Caitlin Knox, Co-Chair, ISPE Education Committee

Xavier Kurz, European Medicines Agency

Anna Rosa Marra, Italian Medicines Agency (AIFA)

Alessandro Mugelli, University of Florence

Sebastian Schneeweiss FISPE, Harvard Medical School

Shannon Sperati, ISPE Society Manager

Marco Tuccori, University Hospital of Pisa

Caroline Walsh, Co-Chair, ISPE Student Council

Lindsay Wong, Chair, ISPE Student Council

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THANK YOU TO OUR SUPPORTERS

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PROGRAM SCHEDULE

SATURDAY, APRIL 6

1:00pm – 5:00pm | ISPE Board of Directors Meeting | Room S

ISPE members are encouraged to contact staff if interested in attending the Board meeting

SUNDAY, APRIL 7

7:00am – 6:00pm | Registration | Hall

8:00am – Noon | Pre-conference Course | Introduction to Pharmacoepidemiology | Room S

This half-day course will provide participants with a short introduction to the basic principles and concepts of pharmacoepidemiology. The course includes lectures on cohort studies, case-control studies, and bias & confounding.Almut Winterstein, FISPE, University of Florida College of Pharmacy, Cohort Studies

Anton Pottegård, Clinical Pharmacology and Pharmacy, University of Southern Denmark, Case-Control

Tobias Gerhard, FISPE, Ernest Mario School of Pharmacy, Rutgers University, Bias & Confounding

8:30am – Noon | 2019 Scientific Program Committee Meeting | Room S

Noon – 1:30pm | Lunch on your own

1:30pm – 5:30pm | Pre-conference Course | Advanced Topics in Pharmacoepidemiology | Room M

Miriam Sturkenboom, FISPE, University Medical Center Utrecht – Innovative Approaches in Vaccine

Post-Marketing Surveillance

Stephen Evans, FISPE, London School of Hygiene and Tropical Medicine – Signal Detection: Where Do We

Stand?

Nicholas Tatonetti, Institute for Genomic Medicine, Columbia University – Observational Data for

Biomedical Discovery

Samy Suissa, McGill University, The Prevalent New-

User Design in Pharmacoepidemiology

5:30pm – 7:00pm | Welcome Reception | Room S

MONDAY, APRIL 8

7:30am – 5:00pm | Registration | Hall

7:30am – 8:15am | Refreshment Break/Exhibits/Poster Viewing | Es Libris Room

8:30am – 9:15am | Opening Remarks | Plenary

Room L&M

Alison Bourke, FISPE, ISPE President Gianluca Trifirò, Co-Chair, ISPE 2019 Mid-Year Planning CommitteeUrsula Kirchmayer, Co-Chair, ISPE 2019 Mid-Year Planning Committee

continued on next page

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PROGRAM SCHEDULE

MONDAY, APRIL 8 Continued

8:30am – 9:15am | Opening Remarks | Plenary

Room L&M (continued)

Welcome Remarks: • Italian Ministry of Health (invited)• Director of the Italian Medicines Agency• President of the Italian Society of Pharmacology• President of the Italian Association of Epidemiology

9:15am – 11:00am | Regulatory and Industry Perspectives | Plenary Room L&M

Moderators: Patrizia Popoli, President of the Scientific Committee of the Italian Medicines Agency, Italian National Health Institute

June Raine, Medicines and Healthcare Products Regulatory Agency, London, UK

9:15am – 9:45am | European Regulatory Perspective Thijs Giezen, European Medicines Agency, Biosimilar Medicinal Products Working Party

9:45am – 10:15am | US Regulatory Perspective Gerald Dal Pan, US Food & Drug Administration

10:15am – 10:45am | The Industry’s Perspective Uwe Gudat, Fresenius Kabi SwissBioSim, on behalf of Biosimilar Medicines Group Annalisa Lezzi, AbbVie, on behalf of Assobiotec

10:45am – 11:00am | Discussion

11:00am – 11:30am | Coffee Break/Exhibits/Poster Viewing | Es Libris Room

11:30am – 1:15pm | Perspectives from Scientific Societies on Biologics including Biosimilars | Plenary

Room L&M

Moderators: Alessandro Mugelli, University of Florence

Sebastian Schneeweiss, FISPE, Harvard Medical School/Brigham & Women’s Hospital

11:30am – 12:00pm | The Perspective of the European Crohn’s and Colitis Organization (ECCO) Gionata Fiorino, Humanitas Clinical and Research Institute

12:00pm – 12:30pm | The Perspective of the American Society of Clinical Oncology (ASCO) R. Donald Harvey, Emory University

12:30pm – 1:00pm | The Perspective of the European League Against Rhuematism (EULAR) Tore K. Kvien, University of Oslo

1:00pm – 1:15pm | Discussion

1:15pm – 2:15pm | Lunch/Exhibits/Poster Viewing | Es Libris Room

2:15pm – 3:45pm | Student Oral Session I | Plenary

Room L&M

Moderators: Lindsay Wong, Chair, ISPE Student Council, University of Toronto

Ursula Kirchmayer, Department of Epidemiology, Lazio Region

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PROGRAM SCHEDULE

3:45pm – 4:15pm | Refreshment Break/Exhibits/Poster Viewing | Es Libris Room

4:15pm – 5:45pm | Student Oral Session II | Plenary

Room L&M

Moderators: Caroline Walsh, Co-Chair, ISPE Student Council, Royal College of Surgeons in Ireland

Gianluca Trifirò, University of Messina

5:45pm – 6:00pm | Closing Remarks

6:30pm | Student/Early Career Professionals Meet & Greet | Radisson Blu Lobby

TUESDAY, APRIL 9

8:00am – 12:00pm | Registration | Hall

8:00am – 9:00am | Refreshment Break/Exhibits/Poster Viewing | Es Libris Room

9:00am – 10:45am | Interchangeability of Originators and Biosimilars | Plenary Room L&M

Moderators: Jaclyn Bosco, IQVIA Gianni Corrao, University Milano Bicocca

9:00am – 9:30am | Armando Genazzani, University of Eastern Piedmont, Interchangeability of Reference Product and Biosimilars: Where Do We Stand?

9:30am – 10:00am | Bente Glintborg, DANBIO, Experience of Disease Registries

10:00am – 10:30am | Antonio Addis, Department of Epidemiology, Lazio Region, The Role of Observational Studies: An Example from the Italian Bio-Network

10:30am – 10:45am | Discussion

10:45am – 11:15am | Coffee Break/Exhibits/Poster Viewing | Es Libris Room

11:15am – 1:15pm | Infrastructure for RWE on Biologics including Biosimilars | Plenary Room L&M

Moderators: Marina Davoli, Department of Epidemiology, Lazio Region

Susana Perez-Gutthann, FISPE, RTI-Health Solutions

11:15am – 11:45am | Jeffery Brown, Harvard Medical School/Harvard Pilgrim Health Institute, Experiences from Networks in the US

11:45am – 12:15pm | Andrew Bate, Pfizer, Real World Data-Based Strategies for Biologics Postmarketing Surveillance

12:15pm – 12:45pm | Nello Martini, Drugs & Health, Real World Data on Biologics for Informed Regulatory Decision Making in the Era of Biosimilars

12:45pm – 1:15pm | Discussion

1:15pm – 1:30pm | Closing Remarks & Adjournment | Plenary Room L&M

Gianluca Trifirò, Co-Chair, ISPE 2019 Mid-Year Meeting Planning CommitteeUrsula Kirchmayer, Co-Chair, ISPE 2019 Mid-Year Meeting Planning Committee