29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management
Palais des congress de Montréal
Montréal, Canada
August 24-28th, 2013

Pre-Conference Course Presentations
(As of August 13, 2013)

Saturday, August 24 – Full Day Sessions
(Part 1: 8:30am-12pm, Part 2: 1:30-6pm)

Pharmacogenetics

Saturday, August 24 – Half Day Session
(Morning Course: 8:30am-12pm)

Introduction to Pharmacoepidemiology

Saturday, August 24 – Half Day Sessions
(Afternoon Courses: 1:30-6pm)

Pharmacovigilance & Signal Detection
Medical Device Epidemiology
Health Care Databases
Student Skills Workshop

Sunday, August 25 – Half Day Sessions
(Morning Courses: 8:30am-12pm)

Registries/Prospective Cohort Studies
Propensity Scores
Comparative Effectiveness Research
Intermediate Pharmacoepidemiology
Regulatory Pharmacoepidemiology/Health Care Decision Making
Introduction to Drug Utilization Research

Sunday, August 25 – Half Day Sessions
(Afternoon Courses: 1:30-6pm)

Advance Topics in Pharmacoepidemiology
Introduction to Therapeutic Risk Management
Advanced Drug Utilization Research
Benefit-Risk Assessment and Risk Communication Practices

Saturday
August 24, 2013

PRE-CONFERENCE EDUCATIONAL SESSIONS*
Morning Courses
(*Registration required)

8:00-Noon

Pharmacogenetics

Amalia M. Issa, Welcome/Bienvenue and Introduction
Dave Pulford, The Breadth and Depth of Pharmacogenomic Research: An Introduction
Bruce Carleton, Practical Issues with Pharmacogenomic Research
Paul Boutros, Introduction to Bioinformatics
Jill Bartlett-Esquilant, The Convergence of Pharmacoepidemiology and Pharmacogenomics

Break Out into Two Groups (Basic or Advanced Options)

Basic Session:

Moderator: Anke-Hilse Maitland van der Zee

Anke-Hilse Maitland van der Zee, Study Design in Pharmacogenomic Epidemiology

Geoffrey Liu, Genome Wide Association Studies and High Dimensionality Methods

Advanced Session:

Moderator: Amalia M. Issa

G. Pond, Adaptive Clinical Trial Designs in Biomarker Studies

Rayjean Hung, Mendelian Randomization: The Promise and Perils of Causal Relationships

Lunch and Talk (All Participants)
Amalia M. Issa, Transforming Health Care: Pharmacogenomics and Health Policy

8:00-Noon

Introduction to Pharmacoepidemiology

Almut Winterstein, FISPE, Cohort Studies
Sonia Hernandez Diaz, FISPE, Case-Control Studies
Tobias Gerhard, FISPE, Bias & Confounding

Suggested Reading:

PRE-CONFERENCE EDUCATIONAL SESSIONS*
Afternoon Courses
(*Registration required)

1:15-5:00pm

Pharmacogenetics (cont'd)

Moderator: Leah Sansbury

Andy Freedman & Steve Kimmel
Clinical Utility and Clinical Adoption: Top Ten Questions You Should Be Thinking About

Practicum workshop: Speed-Dating Roundtable Sessions
(Moderator: Leah Sansbury)

This fun and informative session offers an opportunity for small group and 1-to-1 interactions with the instructors and other course participants.

Roundtable 1: Clinical Utility and Clinical Adoption (Facilitators: Kimmel, Freedman)

Roundtable 2: Methods and Logistics (Facilitators: Sansbury, Carleton)

Roundtable 3: Basic Methods: Study Design Issues (Facilitators: McCarty, Maitland van der Zee)

Roundtable 4: Advanced Methods: Clinical Trials (Facilitator: Pond)

Roundtable 5: Policy and Regulatory Issues (Facilitators: Issa, Bartlett)

Roundtable 6: Databases, Biospecimens, and Analysis of Real Data (Facilitators: Pulford, Liu)

1:30-6:00pm

Pharmacovigilance & Signal Detection

Andrew Bate, Worldwide Safety Strategy, Pfizer Ltd, UK
Multiple Data Streams for Safety Surveillance: Leveraging Emerging Data Sources

Gianluca Trifiro, Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands & Department of Clinical and Experimental Medicine, University of Messina, Italy
Electronic Medical Records and Claims Data for Drug Safety Signal Detection: Lessons Learned from the EU-ADR Project

Joshua Gagne, Brigham & Women's Hospital and Harvard Medical School
Semi-Automated, Distributed, Prospective Medical Product Safety Monitoring

1:30-6:00pm

Medical Device Epidemiology

Jessica Jalbert, LA-SER Group and Weill Cornell Medical College
Considering Provider Effects in Medical Device Epidemiology

Kristian Filion, McGill University
Medical Device Epidemiology: An Introduction

Danica Marinac-Dabic, Food & Drug Administration, Center for Devices & Radiological Health
International Infrastructure for Medical Device Epidemiology: A Glimpse into the future

Veronica Sansing, Food and Drug Administration, Center for Devices and Radiological Health
Differences Between Medical Device and Drug Regulation in the US

Ted Lystig, Medtronic
Making Sense of the Evidence: Bayesian Methods for Evidence Synthesis in Medical Device Epidemiology

Mary Beth Ritchey, Merck Research Laboratories
Evaluating Use of Drugs and Devices in Studies with Long-Term Outcomes

Michele Jonsson-Funk, University of North Carolina at Chapel Hill
Evaluating the Comparative Safety and Effectiveness of Mesh for Pelvic Organ Prolapse: Methodological Considerations

Paul Niklewski, Johnson & Johnson
Methodological Considerations when Evaluating the Safety of a Computer-Assisted Personalized Sedation System in the Real-World

1:30-6:00pm

Health Care Databases

Gillian Hall, Overview of Database use in Pharmacoepdiemiology

Matthew Reynolds, Selection of Databases for Pharmacoepidemiology Research

Yola Moride, FISPE, Canadian Data Resources

Kevin Haynes, Database Selection Workshop Activity Distributed Data Resources

Vincent Lo Re, Validation of Outcomes

1:30-6:00pm

Student Skills Workshop **STUDENTS ONLY**

Introduction to systematic review and meta-analysis

Tamar Lasky, MIE Resources
Systematic Literature and Meta-Analysis in Pharmacoepidemiology

Tarek Hammad, FISPE, Office of Surveillance & Epidemiology (OSE), Center for Drug Evaluation & Research (CDER), Food & Drug Administration (FDA)
Role of Meta-analysis in Drug Safety: Basic Concepts

Careers in Pharmacoepidemiology

Sonia Hernández-Diaz, FISPE, Harvard School of Public Health, Academia

Michael Taylor, Genentech, A Member of the Roche Group, Industry

Solomon Iyasu, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA), Regulator

Susana Perez-Gutthann, FISPE, RTI Health Solutions, Consultant

Sunday
August 25, 2013

PRE-CONFERENCE EDUCATIONAL SESSIONS*
Morning Courses
(*Registration required)

8:30-Noon

Registries/Prospective Cohort Studies

Nancy Dreyer, FISPE, Quintiles Outcome
Registries for Safety and Effectiveness: Designing Practical Studies Fit for Purpose (Part I, Part IV)

Saad Shakir, Drug Safety Research Unit, Portsmouth University
Special Challenges of Registries for Risk Management Plans (Part II)

Sonia Hernandez-Diaz, FISPE, Pharmacoepidemiology Program
Department of Epidemiology, Harvard School of Public Health
Pregnancy Registries: Methodological Points and Real Examples (Part III)

8:30-Noon

Propensity Scores

John Seeger, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School
Introduction and Overview of Propensity Scores in Pharmacoepidemiology

Jeremy Rassen, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School
Implications of Propensity Score-Based Analyses

8:30-Noon

Comparative Effectiveness Research

Jodi B Segal, Johns Hopkins University School of Medicine and Bloomberg School of Public Health

Joshua J Gagne, Brigham and Women's Hospital and Harvard Medical School

Eric S Johnson, Kaiser Permanente's Center for Effectiveness & Safety Research

Sebastian Schneeweiss, FISPE, Div. of Pharmacoepidemiology& Pharmacoeconomics, Department of Medicine, Brigham & Women's Hospital and Harvard Medical School

8:30-Noon

Intermediate Pharmacoepidemiology

Alec Walker, Whiscon
Dealing with Unmeasured Confounders
(Part I, Part II, Part III, Part IV, Part V)

8:30-Noon

Regulatory Pharmacoepidemiology/Health Care Decision Making

Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research Food & Drug Administration
United States Challenges in Regulatory Epidemiology

June Raine, Director, Vigilance and Risk Management of Medicines Division, Medicines and Healthcare Regulatory Products Agency
United Kingdom Challenges in Regulatory Epidemiology

8:30-Noon

Introduction to Drug Utilization Research

Lisa Pont, Sydney Nursing School, University of Sydney
Methodological Framework and Skills Needs in Drug Utilization Research

Hanne Strom, WHO Collaborating Centre for Drug Statistics
The Anatomical Therapeutic Chemical Classification and the Defined Daily Dose Methodology: Classifying & Quantifying Drug Use

Morten Andersen, Centre for Pharmacoepidemiology, KarolinskaInstute
Drug Utilization Research and Monitoring in Individual Based Registers - Study Design & Epidemiological Measures of Drug Use

Julie Zito, FISPE, School of Pharmacy, University of Maryland
Overview of Drug Utilization Research in the United States

PRE-CONFERENCE EDUCATIONAL SESSIONS*
Afternoon Courses
(*Registration required)

1:30-6:00pm

Advanced Topics in Pharmacoepidemiology

Irene Petersen, Department of Primary Care & Population Health, University College London
Multiple Imputation of Missing Data in Longitudinal Electronic Health Records

Jessica Myers Franklin, Div of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham & Women’s Hospital and Harvard Medical School
Simulation as a Tool for Understanding Pharmacoepidemiology

Rayjean J. Hung, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Bayesian Framework Analysis and Hierarchical Modeling for High Dimensionality Data

Linda Lévesque, Department of Community Health & Epidemiology, Queens University
Immortal Time Bias: Beyond the Basics

1:30-6:00pm

Introduction to Therapeutic Risk Management

Gerald Dal Pan, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food & Drug Administration
Requirements and Lessons Learned from Evaluating Risk Management Programs in the US

Elizabeth Andrews, FISPE, RTI Health Solutions
Overview of Risk Management and the Role of Evaluation

Stella Blackburn, FISPE, European Medicines Agency
Requirements and Lessons Learned from Evaluating Risk Management Programs in the EU

Carla Van Bennekom, Slone Epidemiology Center at Boston University
Examples of RMPs and Evaluations

Judith Jones, FISPE, The Degge Group, Ltd.
Workshop for Participants to Develop a Risk Management Plan, Including an Assessment Approach

1:30-6:00pm

Advanced Drug Utilization Research

Libby Roughead, School of Pharmacy & Medical Services, University of South Australia
Methods for Identifying & Managing Problems with Medicine Use in Practice

Petra Denig, University of Groningen
Developing Valid Prescribing Quality Indicators

Colin Dormuth, Pharmacology & Therapeutics, University of British Columbia
Evaluating Interventions in Drug Utilization: Analysis Methods

Jerry Avorn, Div. of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham & Women's Hospital and Harvard Medical School
Evaluating Practice or Policy

1:30-6:00pm

Benefit-Risk Assessment and Risk Communication Practices

Introduction to Benefit-Risk Assessment (B-RA) and Risk Communication (RC)

Gerald Dal Pan, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food & Drug Administration
Current Risk Communication Strategies

Becky Noel, Regulatory and Industry B-RA and RC Initiatives

Priya Bahri, Risk Communication in a Global Environment

Application and Case Study: Use of the PROACT-URL or BRAT Framework to Structure a B-R Assessment (Juhaeri Juhaeri)

The Regulatory Framework

Priya Bahri, EMA and DHPCs, Collaboration Between Regulator and Industry

Julie Zawisza/Gerald DalPan, FDA Current Risk Communication Strategies

The Academic Appraisal

Elaine Morrato, Developing Effective Risk Communication Strategies

Impact of Risk Communication

Peter Mol, Focus on the DHPC: What do we need to know on how and when it works?

Applied Risk Communication

Meredith Smith, Presenting Risk Information to Healthcare Professionals and Patients