Agenda

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

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

Samy Suissa, McGill University
The Prevalent New-User Design in Pharmacoepidemiology

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

Moderators:

Patrizia Popoli, President of the Scientific Committee of the Italian Medicines Agency (tbc), Italian National Health Institute

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  The Industry’s perspective, 
                                     Julie Marechal Jamil, Medicines for Europe
                                     Annalisa lezzi Abbvie, on behalf of Assobiotec

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 – 12:00 pm      Gionata Fiorino, European Crohn's and Colitis Organization
                                        (ECCO)

12:00 pm – 12:30 pm      Gary Lyman, American Society of Clinical Oncology (ASCO)

12:30 pm – 1:00 pm        Tore K. Kvien, University of Oslo, European League Against
                                         Rheumatism (EULAR)

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      Kristine Moll Harboe, Danish Medicines Agency:
                                    Interchangeabilityof Reference Product and Biosimilars:
                                    Where Do We Stand? 

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

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

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

11:45 am – 12:15 pm  Andrew Bate, Pfizer:   Global Real-World Data-Based
                                    Strategies for Biologics/Biosimilar postmarketing surveillance?

12.15 pm - 12:45 pm   Nello Martini, Drugs&Health:  Real World Data on Biologics and
                                     Biosimilars for Informed Regulatory Decision Making

12:45 pm - 1:15 pm    Discussion

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

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