Agenda

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

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

Registration Required:

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

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

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

Welcome address
Italian Minister of Health
Director, Italian Medicines Agency

     Moderator:
     June Raine, Medicines and Healthcare Products Regulatory Agency, UK

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

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

10:15 am – 10:45 am  TBD, Japanese Pharmaceuticals and Medical Devices Agency

10:45 am – 11:00 am  Discussion

     Moderators:

     Alessandro Mugelli, University of Florence
     Sebastian Schneeweiss, FISPE, Harvard Medical School/Brigham & Women’s Hospital

11:30 am – Noon        TBA, European Crohn's and Colitis Organization (ECCO)

Noon – 12:30 pm        TBA, Oncology

12:30 pm – 1:00 pm   Johannes W.J. Bijlsma, University Medical Center Utrecht, Rheumatology

1:00 pm – 1:15 pm     Discussion

Moderators:  

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

Ursula Kirchmayer, Department of Epidemiology, Lazio Region

Moderators:

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

Gianluca Trifiro, University of Messina

     Moderators:

     Jaclyn Bosco, IQVIA
     Gianni Corrao, Univeristy Milano Bicocca

9:00 am – 9:30 am      TBA, Interchangeability of Reference Product and Biosimilars: Where Do We Stand? 

9:30 am – 10:00 am    Tore K. Kvien, University of Oslo, The NOR-SWITCH Study – An Example for RCTs

10:00 am – 10:30 am  Francesco Trotta, Italian Medicines Agency, The Role of Observational Studies:
An Example from the Italian Bio-Network

10:30 am – 10:40 am Discussion

     Moderators:

     Marina Davoli, Department of Epidemiology, Lazio Region,                     

     Jesper Hallas, FISPE, University of Southern Denmark

11:10 am – 11:40 am  Benté Glintborg, DANBIO Disease Registries

11:40 am – 12:10 pm  TBA, The Industry’s perspective

12.10 pm - 12:40 pm   Jeffrey Brown, Harvard Medical School/Harvard Pilgrim Health Institute, Experiences from Networks in the United States

12:40 pm - 1:10 pm     Nello Martini, Drugs&Health, Real World Data in Research on Biologics and Biosimilars for Informed decisions regulatory making

1.10 pm - 1:20 pm   Discussion

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

Ursula Kirchmayer, Co-Chair, ISPE 2019 Mid-Year Meeting Planning Committee