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Agenda

General Schedule
April 21-23
Eden Roc Hotel, Miami Beach, Florida, USA

Saturday, April 21
8:30am-5:00pm ISPE Board of Directors Meeting
1:00pm-4:00pm Registration Desk Open
 
Sunday, April 22
7:30am-4:15pm Registration
8:30am-12:30pm Introduction to Pharmacoepidemiology in Spanish
  • Introduction to Pharmacoepidemiology, Maribel Salas
  • Cohort Studies, Maribel Salas
  • Case-Control Studies, Sonia Hernandez-Diaz, FISPE
  • Hybrid Studies, Maribel Salas
  • Confounding and Bias, Ariel Arias
  • Introduction to Pharmacovigilance, Ariel Arias
8:30am-12:30pm Introduction to Pharmacoepidemiology in English
  • Introduction to Pharmacoepidemiology, Tobias Gerhard
  • Cohort Studies, Almut Winterstein
  • Case-Control Studies, Tobias Gerhard
  • Confounding and Bias, Soko Setoguchi, FISPE
  • Introduction to Pharmacovigilance, Syed Rizwanuddin Ahmad, FISPE
8:30am-12:30pm ICPE 2012 Scientific Program Committee Meeting
12:30pm-1:30pm Lunch on your own
1:30pm-4:30pm Advanced Topics in Pharmacoepidemiology in Spanish
  • Databases in Pharmacoepidemiology, Susana Perez-Gutthann, FISPE
  • Drug Utilization Measures, Maribel Salas
  • Estimation of Drug Exposure, Sonia Hernandez-Diaz, FISPE
  • Risk Management Plans, Ariel Arias
1:30pm-4:30pm Advanced Topics in Pharmacoepidemiology in English
  • Application of Bayesian Methods in Pharmacoepidemiology, Stephen Evans, FISPE
  • Time-Related Biases in Pharmacoepidemiology, Samy Suissa
  • Lessons about Confounding and Selection Bias Taught by the New User Design, Til Stürmer, FISPE
4:30pm-5:30pm Special Plenary Session (no exhibits)
  • Pharmacoepidemiology in the Cloud, Bram Hartzema, FISPE
5:30pm-7:00pm Welcome Reception
Cash Bar, all registered attendees are invited to attend
 
Monday, April 23
7:30am-4:15pm Registration
8:00am-5:00pm Symposium

ISPE Mid-Year Symposium
April 23, 2012
Eden Roc Hotel, Miami Beach, Florida, USA

Planning Committee:

Co-chairs: Bram Hartzema, FISPE, University of Florida and Maribel Salas, AstraZeneca
Members: Almut Winterstein, University of Florida; Catherine Harrington, Nova Southeastern University; Cheryl Blume, Pharmaceutical Development Group; Chris Delaney, University of Florida; Frank Andersohn, Charite University; George Rochester, FDA; Patrick Ryan, Johnson & Johnson; Paul Stang, Johnson & Johnson; Sebastian Schneeweiss, FISPE, Harvard Medical School, Tobias Gerhard, Rutgers University; Danica Marinac-Dabic, FDA; Veronica Wirtz, Inst. of Public Health, Mexico; William Kelly, WNK Consulting; Mark Epstein, ISPE, Andrew Jerdonek, ISPE

Sunday, April 22: Special Plenary Session (no exhibits)

  • 4:30-5:30pm Pharmacoepidemiology in the Cloud
    —Bram Hartzema, FISPE, University of Florida

  • 5:30-7pm Welcome Reception
    —Cash Bar, all registered attendees are invited to attend

Monday, April 23: ISPE Mid-Year Symposium
Table-top exhibits open 8am-4:15pm

7:30am-4:15pm Registration

Simultaneous translation English-Spanish and Spanish-English in all sessions

  • 8:00-8:15am Welcome from the Program Chairs and ISPE President
    —Bram Hartzema, FISPE, Co-Chair, Planning Committee
    —Maribel Salas, Co-Chair, Planning Committee
    —Nancy Santanello, FISPE, President

  • 8:15-9:30am Pharmacoepidemiology in Latin America
    This session will feature four 10-minute presentations, with time for questions, and a panel discussion.

    Moderators:
    —Bram Hartzema, FISPE, University of Florida
    —Anthony Wang, University of Sao Paulo

    Presentations:
    • The Importance of Promoting Pharmacoepidemiology in the Americas
      —Maribel Salas, AstraZeneca

    • The Challenges of Research in Pharmacoepidemiology in Latin America
      —Veronica Wirtz, Institute of Public Health, Mexico

    • Harmonization of Pharmacoepidemiology in Latin America
      —Claudia Vaca, Ministry of Health, Columbia, and Chair of the Harmonization Group in Latin America.

    • Public Health and Pharmacoepidemiology in Mexico
      —Pedro Rizo Rios, Ministry of Health, Mexico

    • Open Panel Discussion
  • 9:30-10:00am Break with Exhibitors

  • 10:00-10:45am Keynote Address

    Moderator:
    —Nancy Santanello, FISPE, Merck Research Laboratories

    Observational Studies of Drug Effect as Evidence for Randomized Trials
    Keynote Address: Samy Suissa, McGill University

  • 10:45am-12:00pm Database Development
    This session will feature three 15 -minute presentations, with time for Questions, and a panel discussion.

    Moderators:
    —Robert Reynolds, FISPE Pfizer —Chris Delaney, University of Florida

    Presentations:
    • The Development of Patient Registries
      —Nancy Dreyer, FISPE, Outcome
    • Database Development
      —Andrew Maguire, United BioSource Corporation
    • Distributed Practice Networks
      —Ricardo Perez Cuevas, Mexican Social Security Institute

  • 12:15-1:15pm Lunch

  • 1:15- 2:15pm: Formulary Development in the Americas
    Formulary Development in the Americas The session will feature four 10-min presentations with a panel discussion.

    Moderators:
    —Maribel Salas, AstraZeneca — Anthony Wang, Univesity of Sao Paulo

    Speakers:
    • Mexico
      —Pedro Rizo Rios, Ministry of Health, Mexico
    • Costa Rica
      —Albin Chaves Matamoros, Ministry of Health, Costa Rica
    • Brazil
      —Luciane Lopes, Services Pharmaceutical Department in Ministry of Health in Brazil, Professor PhD Research Sorocaba's University
    • Argentina
      —Luis Alesso, Universidad Nacional de Córdoba, Argentina

  • 2:15 –3:45pm Synthesis of Information of Observational Data for Decision Makers
    This session will feature four 15-minute presentations, with time for questions, and a panel discussion.

    Moderators:
    —Soko Setoguchi-Iwata, FISPE, Duke University
    —Susana Perez-Gutthann, FISPE, RTI Barcelona

    Presentations:
    • Meta-Analysis of Observational Studies with Low Event
      —Jon Shuster, University of Florida
    • Heterogeneity as an Opportunity and Limitation to the Interpretability of Meta-Analysis of Observational Studies
      —Jesse Berlin, Johnson & Johnson
    • Is statistical sophistication the answer to meta-analysis of observational data?
      —Stephen Evans, FISPE, London School of Hygiene and Tropical Medicine
    • Utilization of Meta-analysis of Observational Data in the Paradigm of Drug Safety in the FDA
      —Tarek Hammad, FDA
    • Panel Discussion

  • 3:45-4:15pm Break with Exhibitors

  • 4:15– 5:00pm Data Visualization and Analytics
    This session will feature three 15-minute presentations, with time for questions, and a panel discussion.

    Moderator: Elizabeth Andrews FISPE, RTI Health Solutions

    Presentations:
    • Opportunities for exploratory visualization in observational data analytics
      —Patrick Ryan, Johnson & Johnson
    • Statistical visualization of method summary
      —Xiaochun Li, Indiana University School of Medicine
    • Novel Visualization approaches in Safety Surveillance: Prospects and Perils
      —Andrew Bate, Pfizer Europe
    • Panel Discussion

  • 5:00-5:15pm Atando Cabos
    —Bram Hartzema, FISPE, Co-Chair, Planning Committee
    —Maribel Salas, Co-Chair, Planning Committee

  • 5:15-5:30pm 2012 ICPE
    —Susana Perez-Gutthann, FISPE, Chair 2012 ICPE Scientific Program Committee

  • 5:30pm
    Adjournment