Saturday, April 6, 2019
8:30am – 12:00pm
ISPE Strategic Planning Committee Meeting
Saturday, April 6, 2019
1:00pm – 5:00pm
ISPE Board of Directors Meeting
- ISPE members are encouraged to contact staff if interested in attending the Board meeting
Sunday, April 7, 2019
7:00am – 6:00pm
Registration
Sunday, April 7, 2019
8:00am – 12:00pm
Introduction to Pharmacoepidemiology
Ticket 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
Sunday, April 7, 2019
8:30am – 12:00pm
2019 ICPE Scientific Program Committee Meeting
Sunday, April 7, 2019
12:00pm – 1:30pm
Lunch on your own
Sunday, April 7, 2019
1:30pm – 5:30pm
Advanced Topics in Pharmacoepidemiology
Ticket required.
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
Sunday, April 7, 2019
5:30pm – 7:00pm
Welcome Reception
Monday, April 8, 2019
7:30am – 8:15am
Continental breakfast/Exhibits/Poster Viewing
Monday, April 8, 2019
7:30am – 5:00pm
Registration
Monday, April 8, 2019
8:30am – 9:15am
Opening Remarks
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
Monday, April 8, 2019
9:15am – 11:00am
Regulatory and Industry Perspectives
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
Monday, April 8, 2019
11:00am – 11:30am
Coffee Break/Exhibits/Poster Viewing
Monday, April 8, 2019
11:30am – 1:15pm
Perspectives from Scientific Societies on Biologic Use, including Biosimilars
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
Monday, April 8, 2019
1:15pm – 2:15pm
Lunch Break/Exhibits/Poster Viewing
Monday, April 8, 2019
2:15pm – 3:45pm
Student Oral Session I (6 Talks)
Moderators:
Lindsay Wong, Chair, ISPE Student Council, University of Toronto
Ursula Kirchmayer, Department of Epidemiology, Lazio Region
Monday, April 8, 2019
3:45pm – 4:15pm
Refreshment Break/Exhibits/Poster Viewing
Monday, April 8, 2019
4:15pm – 5:45pm
Student Oral Session II (6 Talks)
Moderators:
Caroline Walsh, Co-Chair, ISPE Student Council, Royal College of Surgeons in Ireland
Gianluca Trifiro, University of Messina
Monday, April 8, 2019
5:45pm – 6:00pm
Closing Remarks
Monday, April 8, 2019
6:00pm – 7:30pm
Student/Early Career Professionals Meet & Greet
Tuesday, April 9, 2019
8:00am – 9:00am
Continental Breakfast/Exhibits/Poster Viewing
Tuesday, April 9, 2019
8:00am – 12:00pm
Registration
Tuesday, April 9, 2019
9:00am – 10:45am
Interchangeability of Originators and Biosimilars
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
Tuesday, April 9, 2019
10:45am – 11:15am
Coffee Break/Exhibits/Poster Viewing
Tuesday, April 9, 2019
11:15am – 1:15pm
Infrastructure for RWE on Biologics and Biosimilars
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
Tuesday, April 9, 2019
1:15pm – 1:30pm
Closing Remarks & Adjournment
Gianluca Trifirò, Co-Chair, ISPE 2019 Mid-Year Meeting Planning Committee
Ursula Kirchmayer, Co-Chair, ISPE 2019 Mid-Year Meeting Planning Committee