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SATURDAY, AUGUST 19
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| 09:00-11:00 |
Finance Committee |
(Barcelona) |
| 12:00-17:30 |
Board of Directors Meeting |
(Barcelona) |
| 19:00-21:00 |
Board of Directors Dinner |
(Invitation Only/TBD) |
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SUNDAY, AUGUST 20
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| 08:30-10:00 |
COMMITTEE MEETINGS |
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Membership/Public Relations |
(Barcelona A) |
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Education |
(Barcelona C) |
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Data Privacy |
(Tibidabo A) |
| 10:30-12:00 |
COMMITTEE MEETINGS |
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Publications |
(Barcelona A) |
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Correspondents |
(Pedralbes) |
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Bylaws & Policies |
(Barcelona C) |
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Public Policy/Ethics |
(Tibidabo A) |
| 10:30-13:00 |
EuroDurg |
(Barcelona B) |
| 12:00-18:00 |
EXHIBITS SET-UP |
(Hall Cataluna) |
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REGISTRATION |
(Tibidabo Foyer) |
| 14:00-18:00 |
[A] LONG RANGE PLANNING COMMITTEE MEETING |
(Tibidabo A) |
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[B] INTRODUCTION TO PHARMACOEPIDEMIOLOGY SEMINAR SESSION
Moderator: Jacques LeLorier |
(Barcelona) |
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Introduction, Jacques LeLorier
Pharmacovigilance, Nicolas Moore
Cohort Studies, Brian Strom
Case-Control Studies, Alexander Walter
Break
Data Base Studies, Thomas MacDonald
Confounding by Indication, Jacques LeLorier
Conclusions, Jacques LeLorier |
| 19:00-21:00 |
WELCOME RECEPTION
Host Bar - Cash Bar
Princesa Sofia Inter-Continental Hotel
An opportunity to catch up with your colleagues and meet new friends. |
(Mezzanine Level) |
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MONDAY, AUGUST 21
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| 07:00-16:00 |
REGISTRATION |
(Tibdabo Foyer) |
| 07:30-08:30 |
POSTERS SET-UP |
(Lleida) |
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EXHIBITS SET-UP |
(Hall Cataluna) |
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CONTINENTAL BREAKFAST |
(Lleida/Hall Cataluna) |
| 08:30-10:30 |
OPENING SESSION
Chair: Susana Perez-Gutthann |
(Girona/Tarragona) |
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Keynote Address:
Patrick C. Waller, Specialist in Pharmacovigilance, Medicines Control Agency, UK, & Chairman, CPMP Pharmacovigilance Working Party
Pharmacoepidemiology: A Tool for Public Health
Presidential Address:
Elizabeth Andrews, ISPE President, & Worldwide Director, Epidemiology, Glaxo Wellcome, Inc.
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| 10:30-11:00 |
REFRESHMENT BREAK
VIEWING OF POSTERS & EXHIBITS |
(Lleida & Hall Cataluna) |
| 11:00-12:30 |
CONCURRENT SESSIONS |
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[A] SPECIAL LECTURE: EVALUATION OF DOSE RESPONSE TRENDS
Kenneth J. Rothman, Editor, Epidemiology & Professor of Epidemiology, Boston University School of Public Health |
(Girona) |
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[B] DRUG USE AND PRESCRIBING PRACTICES I
15 Minute Oral Abstract Presentations
Moderators: Flora Haaijer-Ruskamp and Morten Anderson |
(Tarragona) |
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Hepatic Transaminase Testing Frequency and Patterns in Patients on HMG-CoA Reductase Inhibitors [78]
Susan E Andrade, James G Donahue, K Arnold Chan, Douglas J Watson, Richard Platt (United States)
Adherence to Prescribed Oral Hypoglycaemic Medication for Patients with Type 2 Diabetes in the Tayside Region of Scotland, UK [246]
PT Donnan, TM MacDonald, AD Morris (United Kingdom)
Noncompliance with Antihypertensive Medications: The Impact of Depressive Symptoms and Psychosocial Factors [138]
Philip S Wang, Rhonda L Bohn, Eric Knight, Robert J Glynn, Helen Mogun, Jerry Avorn (United States)
Intended and Unintended Impacts on Antihypertensive Drug Use by a Policy of Differential Cost Sharing for Angiotensin-Converting Enzyme Inhibitors [178]
Sebastian Schneeweiss, Stephen B Soumerai, Robert J Glynn, Malcolm Maclure, Colin Dormuth, Alexander M Walker (United States, Canada)
Patterns of Use of Antihypertensive Drugs in a Population-Based Cohort of Adult Patients with Newly Treated Hypertension [303]
Chantal Bourgault, Bruno Rainville, Samy Suissa (United States, Canada)
Predictors of Adherence to Antidepressant Treatment in a Population of Elderly Outpatients [188]
Yola Moride, Guillaume Galbaud du Fort, Johanne Monette, Thierry Ducruet, Jean-François Boivin, Nathalie Champoux, Ralph Crott (Canada) |
| 13:00-14:30 |
COMMITTEE/COUNCIL MEETINGS |
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Development Committee |
(Barcelona A) |
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Ad Hoc Committee for Global Capacity |
(Barcelona B) |
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Student Council |
(Barcelona C) |
| 14:30-16:30 |
CONCURRENT SESSIONS |
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[A] METHODS
15-Minute Oral Presentations
Moderator: Samy Suissa |
(Girona) |
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A Comparison of Case-Cohort and Case-Only Methods in a Drug Safety Study of G.I. Events and Diclofenac [251]
Jixian Wang, Peter T Donnan, Thomas M MacDonald
Enhancing the Vaccine Adverse Event Reporting System (VAERS) To Assess Risk: A Capture-Recapture Analysis of Intussusception after Rotavirus Vaccination [73]
Thomas M Verstraeten, Andrew L Baughman, Penina Haber, Robert T Chen (United States)
Assessing Effect Modification in Matched Case-Control Studies [324]
Chantal Bourgault, Michael Edwardes, Cai Bing, Samy Suissa (United States, Canada)
Marginal Structural Models for Estimating Causal Effects in Longitudinal Studies [229]
Miguel A Hernán, James M Robins (United States)
Multiple Propensity Score for Analysis of Dose-Response Relationships in Drug Safety Studies [250]
Jixian Wang, Peter T Donnan, Douglas Steinke, Thomas M MacDonald
Logistic Regression Analysis and Artificial Neural Network: How Do They Compare? [347]
Farhad Salehi, Anick Berard (United States)
Approaches to Protecting Confidentiality of Statistical Data. What Can We Learn from the Statistical Community? [322] Donald J Willison (Canada)
Database Linkage: The Impact of Informed Consent on Study Validity [348]
Yola Moride, Claudine Laurier, Wendy Kennedy, Mary Egan, Anne Perrault, Fabrice Rouah, Christina Wolfson (Canada)
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[B] DRUG USE AND PRESCRIBING PRACTICES II
15 Minute Oral Abstract Presentations
Moderator: Emilio Sanz and John Ferguson |
(Tarragona) |
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Different Prescription Patterns of Antibiotics in Denmark and Italy - An Explanation of Different Bacterial Resistance Patterns? [45]
Lars Bjerrum, Alberto Vaccheri, Rosa Rizzo, Ulf Bergman, Nicola Montanaro (Denmark, Italy, Sweden)
Contraceptive Practice in Women with Lupus Erythematosus [125]
Alison L Whalley, Corinne S de Vries (United Kingdom)
Medical Treatments for Lower Urinary Tract Symptoms (LUTS) [163]
John W Logie, Gary M Clifford, Richard D Farmer (United Kingdom)
Contraindicated NSAIDs Are Frequently Prescribed to Elderly Patients with Peptic Ulcer Disease [120]
Loes E Visser, Arnold G Vulto, Hayo H Graatsma, Bruno H Stricker (The Netherlands)
The Influence of Day Care Attendance and Other Risk Factors on Use of Systemic Antibiotics in 0-2-Year-Old Children [123]
Nana Thrane, Charlotte Olesen, Henrik Carl Schønheyder, Jens Tølbøll Mortensen, Henrik Toft Sørensen (Denmark)
Patterns of Hormone Replacement Therapy in the UK [350]
Susan E Causier, Corinne S de Vries, Tim J Williams, Richard DT Farmer (United Kingdom)
High Failure Rates of Presumptive Helicobacter Eradication Therapy in General Practice [46]
David Williams, Patrick O Kelly, Alan Kelly, John Feely (Ireland) |
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[C] WORKSHOP: RECENT VACCINE SAFETY CONTROVERSIES-- ROTAVIRUS AND HEPATITIS B
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(Barcelona A) |
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Moderators: Robert Chen & Wendy Stephenson
Two recent controversies in U.S. and France highlight the role of pharmacovigilance and pharmacoepidemiology in vaccine safety. This workshop brings together the key participants to discuss the data, policy decisions, and the lessons learned.
Rotavirus Vaccine and Intussusception
Prelicensure and VAERS Signal, Robert Chen
Case-Control and Case-Series Studies, Trudy Murphy
Cohort Study, Frank DeStefano
The Industry Perspective, Wendy Stephenson
The Consultant Perspective, Alec Walker
The FDA Perspective, Miles Braun
Hepatitis B Vaccine and Demyelination
Pharmacovigilance and Case-Control Study, Annie Fourrier
GPRD Case-Control Study, Miriam Sturkenboom
The Policy Perspective, Bernard Begaud
Group Discussion
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| 1430-1645 |
[D] WORKSHOP: CENTRALIZED PREGNANCY REGISTRIES
Moderator: Diane L. Kennedy |
(Barcelona B & C) |
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Background, Evelyn Rodriguez
Monitoring Drug Risks in Pregnant Women-State of the Art, Allen Mitchell
Introduction to Pregancy Registries, Shelia Weiss
Methodological and Operational Changes in Running/Developing a Pregnancy Registry,
Elizabeth Andrews
Panel Session: Centralized Pregnancy Registries - A Viable Concept?
Moderator: Allen Mitchell;
Panelists: Holli Hamilton, Bengt Kallen, and Elisabeth Robert
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| 16:30-17:00 |
BREAK/POSTERS/EXHIBITS |
(Lleida & Hall Cataluna) |
| 17:00-18:00 |
COUNCIL MEETINGS |
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Academic Council |
(Barcelona) |
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Industry Council |
(Girona) |
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Government Council |
(Tarragona) |
| 1900-2030 |
RECEPTION, PATIO DE LOS NARANJOS
The site of the Catalan Government opens its doors to ISPE. Located in the Gothic area in the Barcelona city center, the reception will be held on a beautiful orange tree patio.
(Buses will depart from the Inter-Continental at 1815. Picture ID required. Return transportation not provided.) |
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TUESDAY, AUGUST 22
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| 0730-1600 |
REGISTRATION |
(Tibdabo Foyer) |
| 07:30-08:30 |
POSTERS SET-UP |
(Lleida) |
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EXHIBITS |
(Hall Cataluna) |
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CONTINENTAL BREAKFAST |
(Lleida/Hall Cataluna) |
| 08:30-10:30 |
SPECIAL PLENARY SESSION: GLOBAL BURDEN OF DISEASE AND DRUG POLICY: IMPLICATIONS FOR DRUG DEVELOPMENT, USE AND MONITORING
Moderator: Alexander M. Walker |
(Girona/Tarragona) |
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Chris Murray, Director, Programme on Evidence for Health Policy, World Health Organization, Perspectives on Global Burden of Disease and Cost-Effectiveness of Medicines in Populations
Michael Reich, Chair, Department of Population and International Health Harvard School of Public Health, The Global Drug Gap: Access Inequities and Policy Implications |
| 10:30-11:00 |
REFRESHMENT BREAK
VIEWING OF POSTERS & EXHIBITS |
(Lleida & Hall Cataluna) |
| 11:00-12:30 |
CONCURRENT SESSIONS |
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[A] CARDIOVASCULAR
15 Minute Oral Abstract Presentations
Moderator: Thomas MacDonald |
(Girona) |
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Risk of Developing Cataract in Patients Treated with Lipid-Lowering Drugs (LLDs) [29]
Raymond G Schlienger, Walter E Haefeli, Hershel Jick, Christoph R Meier (Switzerland, Germany, United States)
Oral Contraceptive Use in Relation to First Myocardial Infarction [118]
Lynn Rosenberg, Julie R Palmer, R Sowmya Rao, Samuel Shapiro (United States)
Adverse Effects of Low-Dose Amiodarone Use in Atrial Fibrillation in a Real World Setting [319]
Kristen Migliaccio-Walle, Heather E Jackson-Kelley, Jaime Caro (United States)
Use of Diuretics and ACE Inhibitors and the Risk for Acute Pancreatitis [217]
Anders Sundstrom, Lars Alfredsson, Kerstin Blomgren, Bengt-Erik Wiholm (Sweden)
Does Aspirin Attenuate the Effect of ACE Inhibitors on Health Outcomes of Very Old Patients with Heart Failure? [83]
Anne L Hume, Marliyn M Barbour, Kate L Lapane (United States)
The Risk of Hypoglycemia Associated with Angiotensin-Converting Enzyme (ACE) Inhibitors in Diabetic Patients Treated with Insulin [210]
Eric S Johnson, Tom D Koepsell, Gayle Reiber, Andy Stergachis, Rich Platt (United States) |
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[B] ANTIINFECTIVES
15 Minute Oral Abstract Presentations
Moderator: Gotfried Kreutz |
(Tarragona) |
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Fluoroquinolones and the Risk of Achilles Tendon Disorders [333]
Paul D van der Linden, Miriam C Sturkenboom, Ron M Herings, Hubert G Leufkens, Bruno H Stricker (The Netherlands)
Fluoroquinolones and Achilles Tendon Rupture [355]
Paul D van der Linden, Ron M Herings, Miriam C Sturkenboom, Hubert GM Leufkens, Bruno H Stricker (The Netherlands)
Antibiotic Use and the Risk of Myocardial Infarction [96]
Paul Brassard, Chantal Bourgault, James Brophy, Bruno Rainville, Marianne Xhignesse, Samy Suissa (Canada, United States)
Academic Detailing to Improve Use of Broad-Spectrum Antibiotics at an Academic Medical Center [173]
Daniel H Solomon, Laura Van Houten, Robert J Glynn, Lindsey Baden, Kelley Curtis, Harry Schrager, Jerry Avorn (United States)
Is the Pattern of Use of Second-Generation Macrolides Characteristic of a Second-Line Antibiotic? [345]
Claudine Laurier, Wendy A Kennedy, Lucy Boothroyd, Jean Lachaine, Patricia Manzi, Michele Pare (Canada)
The Risk of Liver Injury Associated with Minocycline [127]
Helen E Seaman, Ross A Lawrenson, Tim J Williams, Corinne S de Vries, Kenneth D MacRae, Richard DT Farmer (United Kingdom) |
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[C] WORKSHOP: PHARMACOEPIDEMIOLOGY IN SPAIN
Moderator: Francisco J. de Abajo |
(Barcelona A) |
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Pharmacoepidemiological research has increased exponentially in Spain in the last decade. This evolution will be examined through the experience gained by three groups working in different settings and using different tools. A discussion about new trends, projects and resources will follow.
Presenters:
Research Networks: the Need for Collaborative Projects in Pharmacoepidemiology, Joan R. Laporte
Pharmacoepidemiology: An Approach from a University-based Institute, Alfonso Carvajal
Automated Health Databases for Pharmacoepidemiological Research: from the GPRD to BIFAP, Luis A. García Rodríguez
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[D] WORKSHOP: SIGNAL IDENTIFICATION
Moderator: Hugh Tilson |
(Barcelona B & C) |
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With rapidly increasing capabilities in automated data processing accompanied by steadily declining costs, new approaches to identification of signals have emerged, based on a variety of statistical and computational techniques. The speakers will highlight practical considerations, including important methodological advantages as well as limitations, with representation of regulatory, industry and academic perspectives.
Presenters: Andrew Bates, Nicholas Moore, Vitali Pool, Judy Jones, and Jon Tierce.
Session organizers: Robert Wise, Miles Braun, and Edward Bortnichak
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| 12:30-14:30 |
BUFFET LUNCH |
(Lleida/Hall Cataluna) |
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POSTER SESSION B |
(Lleida) |
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VIEWING OF EXHIBITS |
(Hall Cataluna) |
| 12:30-14:30 |
ICPE SCIENTIFIC PROGRAM COMMITTEE LUNCHEON |
(Stiges) |
| 14:30-15:30 |
GENERAL ISPE MEMBERSHIP MEETING
Edlavitch Award Presentation |
(Girona) |
| 15:30-16:00 |
REFRESHMENT BREAK
VIEWING OF POSTERS & EXHIBITS |
(Lleida/Hall Cataluna) |
| 16:00-18:00 |
CONCURRENT SESSIONS |
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[A] PEER-REVIEWED PAPERS
15 Minute Oral Abstract Presentations
Moderator: Richard Farmer |
(Girona) |
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A Negative Association between Myocardial Infarction and Previous Use of Antibiotics Is Restricted to Fluoroquinolones [391]
Ron MC Herings, Bert GM Leufkens, Jan P Vandenbroucke (The Netherlands)
Population-Based Case-Control Study of the Effects of Nonsteroidal Antiinflammatory Drugs on Breast Cancer Risk and Stage [6]
Colin R Sharpe, Jean-Paul Collet, Mary McNutt, Eric Belzile, Jean-François Boivin, James A Hanley (Canada) |
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[B] VACCINES
15 Minute Oral Abstract Presentations
Moderator: Jean-Paul Collet |
(Tarragona) |
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Infant Vaccination, Infant Wheezing, and Childhood Asthma [364]
Julie E Maher, John P Mullooly, Lois Drew, Frank DeStefano (United States)
Vaccinations against Hepatitis B and Graves' Disease [192]
Miriam C Sturkenboom, Olivier Heinzlef, Etienne Roullet, Sylvie Rozenberg, Bernard Begaud, Bruno Fautrel (The Netherlands, France)
Vaccinations Against Hepatitis B and Rheumatoid Arthritis [196]
Miriam C Sturkenboom, Bruno Fautrel, Sylvie Rozenberg, Bernard Begaud, Etienne Roullet, Olivier Heinzlef (The Netherlands, France)
Rotavirus Vaccine Reports to the Vaccine Adverse Event Reporting System: Assessing Safety Profiles of Non-Intussusception Reports [351]
Penina Haber, Gina Mootrey, Thomas Verstraeten, Robert Pless, Lynn Zanardi, Robert Chen (United States)
Risk and Effectiveness of Hepatitis B Vaccination. A Decision Analysis [335]
Ghada M Miremont, Louis R Salmi, Bernard Begaud (France)
The Impact of Vaccination on Varicella Incidence, Conditional on School Attendance and Temperature, in Antellope Valley, California [186]
Gary S Goldman, John W Glasser, Teresa J Maupin, Carol L Peterson, Laurene Mascola, Robert T Chen, Jane F Seward (United States)
Evaluation of Different Data Mining Approaches for Signal Detection in the Vaccine Adverse Event Reporting System [354]
Vitali Pool, Lawrence Barker, Robert T Chen (United States)
Risk of Wheezing Lower Respiratory Desease in Infants after Vaccination [359]
John P Mullooly, John Pearson, Lois Drew, Roberleigh Schuler, Paul Garguillo, Frank DeStefano, Robert Chen (United States) |
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[C] WORKSHOP: PEDIATRIC PHARMACOEPIDEMIOLOGY: AN UPDATE
Moderator: Hugh H. Tilson |
(Barcelona A) |
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This session aims to provide an update on the patterns and trends in U.S. medications for the treatment of youths with behavioral and emotional disorders. A government and public research perspective will introduce the audience to the growing acceptance of pharmacoepidemiologic data to augment clinical trials. Two data-based presentations offer studies that assess current U.S. utilization and help us to better understand the context in which medication is prescribed. The last presentation addresses pediatric safety issues and will use lamotrigine, an antiepileptic, as a case example of monitoring for safety.
Presenters:
Psychopharmacoepidemiology: Opportunities and Challenges, Junius J. Gonzales
Prevalence, Demographic and Clinical Correlates of Psychotropic Medications in US Youths, Julie Magno Zito
Population-based Psychotropic Use in Commercially-insured, Ambulatory Youths, Deborah Shatin and Carol Drinkard
Monitoring Long-term Safety in Children: Lamotrigine as a Case Example, Patricia Tennis
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[D] WORKSHOP: MULTIPLE DATABASE STUDIES
Moderator: W. A. Ray |
(Barcelona B & C) |
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Increased awareness of the utility of automated databases for pharmacoepidemiologic studies and advances in computer technology have motivated studies that involve multiple sites. However, there are important scientific and organizational issues that must be addressed if these studies are to be successful. Key issues addressed in this workshop will include: 1) rational for multi-database studies, 2) similarities to, and differences from, multi-site clinical trials, 3) site selection, 4) study organization and governance, 5) role of the protocol, 6) pilot studies, 7) quality control, and 8) data analysis.
Presenters:
Overview, Wayne A. Ray
Data Analysis Issues, Samy Suissa
Regulatory Perspective, Evelyn Rodriguez
Academic Perspective, Judith Jones and K. Arnold Chan
Database Provider, Nancy Dreyer and Paul Stang
Question and Answer, All
Summary, Wayne Ray
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|
| 1800-1930 |
SCHOLARSHIP RECIPIENT RECEPTION
(Invitation Only - Terraza Contraste) |
| 21:00-23:00 |
DINNER AT PUEBLO ESPAÑOL
Built for the 1929 Universal Exhibition, the Pueblo Español `Spanish Village' features buildings from across Spain, reflecting the different cultures that have come together through the centuries. (Buses will depart from the Inter-Continental at 2030. Tickets for this event will be included in the registration packets. Tickets must be presented to board a bus. Buses will return to Inter-Continental) |
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WEDNESDAY, AUGUST 23
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| 0730-1600 |
REGISTRATION |
(Tibdabo Foyer) |
| 07:30-08:30 |
POSTERS SET-UP |
(Lleida) |
| |
EXHIBITS |
(Hall Cataluna) |
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CONTINENTAL BREAKFAST |
(Lleida/Hall Cataluna) |
| 08:30-10:00 |
CONCURRENT SESSIONS |
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[A] TAPAS
15 Minute Oral Abstract Presentations
Moderator: Cathy Sigler |
(Girona) |
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Drug-Induced Liver Injury in Men with Lower Urinary Tract Symptoms (LUTS) [222]
Gary M Clifford, Richard DT Farmer (United Kingdom)
Modelling Dependence between Recurrent Events of Acute Coronary Syndrome [252]
Jixian Wang, Peter T Donnan, Thomas M MacDonald
Observational Data: Are Clinical Trials Really Self-Sufficient? [321]
Jaime Caro, Kristen Migliaccio-Walle, CAPRA Study Group (United States)
Seasonal Versus Perennial Allergic Rhinitis: Patient Characteristics and Disease Severity [177]
William H Crown, Abayomi O Olufade, Davina Ling, Rich Bizier (United States)
The Significant Burden of Peripheral Arterial Disease [320]
Kristen Migliaccio-Walle, Jaime Caro, Khajak J Ishak, CAPRA Study Group (United States, Canada)
Decreasing Pulmonary Related Hospitalizations with a Respiratory Syncytial Virus Prophylaxis Program in a Medicaid Managed Care Organization [297]
Michael Schaffer, Miguel A Amaya, Deneen D Vojta (United States) |
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[B] PREGNANCY & CHILD HEALTH
15 Minute Oral Abstract Presentations
Moderator: Wanju Dai |
(Tarragona) |
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Folic Acid Antagonists during Pregnancy and Risk of Cardiovascular Defects and Oral Clefts [227]
Sonia Hernández-Díaz, Martha M Werler, Alexander M Walker, Allen A Mitchell (United States)
Specific Congenital Malformations in the Offspring of Women with Epilepsy Treated with Antiepileptic Drugs: A Meta-Analysis [392]
Alejandro Arana, Lars Bjerrum, Wendy Roberts (Spain, Denmark, United Kingdom)
Venous Thromboembolism and Pregnancy [116]
EL Simpson, A Whalley, RA Lawrenson, RDT Farmer (United Kingdom)
Invasive Group a Streptococcal Infection and Antipyretic Use among Children with Primary Varicella [170]
Samuel M Lesko, Katherine L O'Brien, Benjamin Schwartz, Richard M Vezina, Allen A Mitchell (United States)
Liver Disorders in Infants Following Receipt of Hepatitis B Vaccine [337]
Piotr Kramarz, Frank DeStefano, Paul Gargiullo
Risk of Venous Thromboembolism in First Users of Oral Contraceptive Exposures with Different Times on Market [400]
Michael A Lewis, Kenneth D MacRae, Doerthe Kühl-Habich, Lothar AJ Heinemann (Germany, United Kingdom, Germany) |
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[C] WORKSHOP: SAFETY STUDIES-INDUSTRY
Moderator: Corrine S. deVries |
(Barcelona B & C) |
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This workshop will address the issues around conflict of interest that arise when academia performs drug safety studies for pharmaceutical companies. The workshop objectives are to stimulate open debate on these controversial issues, and to formulate discussion points that can be used when these issues are communicated.
Presenters and Suggested Questions:
- Academia Representative 1
- - Why should academia and industry not collaborate in drug safety studies?
- - What sets the research agenda?
- Licensing authority representative
- - Who should fund post-marketing surveillance studies, and who should perform them?
- - What evidence is required to declare that a product is 'safe'?
- Industry representative
- - Under what conditions) should academia and industry collaborate in drug safety studies?
- - Given that industry is more interested in product safety than in protection of their products:
- - How can industry control the enthusiasm of their employees to protect products when drug safety is debated?
- Academia representative 2
- - Why should academia and industry collaborate in drug safety studies?
- - What evidence is required to declare that a product is 'safe'?
- Questions to the audience:
- - Should the source of funding be taken into account when judging quality of research?
- - Does a declaration from a good quality study that a product is safe, guarantee that the product is safe?
- - Does an 'independent' advisory board guarantee objectivity, and if so, who should select its members to guarantee the board actually IS independent?
|
| 10:00-10:30 |
REFRESHMENT BREAK
VIEWING OF POSTERS & EXHIBITS |
(Lleida/Hall Cataluna) |
| 10:30-12:00 |
CONCURRENT SESSIONS |
| |
[A] PSYCHOTROPICS
15 Minute Oral Abstract Presentations
Moderator: Saad Shakir |
(Girona) |
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Association between Antidepressant Drugs and Hyponatremia [236]
Kris L Movig, Antoine C Egberts, Albert W Lenderink, Veronique G van den Akker, Henk M Goldschmidt, Hubert GM Leufkens (The Netherlands)
Selective Serotonin Reuptake Inhibitors (SSRIs) and Acute Myocardial Infarction (AMI) [26]
Christoph R Meier, Raymond G Schlienger, Hershel Jick (Switzerland, United States)
Antidepressant Exposure and the Risk of Hip Fracture: A Case-Control Study Using the UK General Practice Research Database (GPRD) [101]
Richard Hubbard, Liam Smeeth, Chris Smith, Sam Rowlands, Hassy Devalia, Alan Dean (United Kingdom)
Antipsychotic-Induced Parkinsonism in Newly Treated Outpatients [344]
Igor Schillevoort, Ron MC Herings, Raymund AC Roos, Paul AF Jansen, Hubert GM Leufkens (The Netherlands)
Complexity of Prior Antipsychotic Use Determines Future Risk of Parkinsonism in Patients Using Risperidone, Olanzapine or Haloperidol [257]
Igor Schillevoort, Ron MC Herings, Raymund AC Roos, Paul AF Jansen, Hubert GM Leufkens (The Netherlands)
Selegiline and Mortality in Subjects with Parkinson's Disease: A Longitudinal Community Study [248]
PT Donnan, DT Steinke, PG Davey, TM MacDonald (United Kingdom) |
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[B] OTHER STUDIES: SAFETY STUDIES
15 Minute Oral Abstract Presentations
Moderator: J W van der Velden |
(Tarragona) |
| |
Population-Based Case-Control Study of the Effects of Antidepressants on Breast Cancer Risk [25] Colin R Sharpe, Jean-Paul Collet, Mary McNutt, Eric Belzile, James A Hanley, Jean-Francois Boivin (Canada) **STUDENT PRIZE**
Glibenclamide and Obesity May Be Risk-Factors for Acute Pancreatitis [276] Kerstin Blomgren, Anders Sundstrom, Gunnar Steineck, Bengt-Erik Wiholm (Sweden)
Inhaled Corticosteroids and Adverse Gastrointestinal Effects [193] Michael D Murray, Bryan Aguirre, Clement J McDonald (United States)
High Prevalence of Subclinical Nephrotoxicity with HIV-Protease Inhibitor Indinavir [277] JP Dieleman, AM Rossum, van, ME Ende, van der, WL Blok, S Marie, de, D Telgt, DM Burger, R Zietse, BH Stricker, MJ Sturkenboom, IC Gyssens (The Netherlands)
Corticosteroid and Hormone Replacement Therapy Use in Patients with Rheumatoid Arthritis: Their Effect on Bone Mineral Density and Fractures [57] Anick Berard, Rick Adachi, Wojciech Olszynski (United States, Canada)
Asthma, Steroids and Adult Height [70] Maria R Gerhardsson de Verdier, Lars Larsson, Bertil Lindmark, Ensio Norjavaara (Sweden) |
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[C] WORKSHOP: EVIDENCE IN DRUG WITHDRAWL
Moderator: Xavier Carne |
(Barcelona A) |
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The workshop will analyze all drug withdrawals from the Spanish market because of safety reasons during the last decade, the organ/system affected, and the type of evidence found in the literature supporting a causal relationship. There are important lessons to be learned from such an analysis by pharmacoepidemiologists on the different methods used and on the strategies that have been followed. |
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[D] WORKSHOP: PATIENT HEALTH MANAGEMENT: A NEW APPROACH TOWARDS OPTIMAL CARE -- THE IMPLICATION FOR PHARMACOEPIDEMIOLOGY
Moderator: Jean-Paul Collet |
(Barcelona B &C) |
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Presenters: Jean-Paul Collet, Robert Thivierge, Jeff Sidell, Josée Bourdages
This workshop presents a new approach for health care delivery, which emphasizes the implication of 2 important elements: patient participation and community/family involvement, as equally important as traditional health care participation.
The introduction will review the different existing approaches for disease management such as managed or integrated care and discuss their relative limitations (i.e., less than 50% good compliance for many chronic therapy).
The Patient Health Management (PHM) model then will be described with several examples presently implemented in Canada: Towards Excellence for Asthma Management (TEAM), Primary Prevention of Cardiovascular Diseases in Quebec, and Improving Cardiovascular Outcomes in Nova Scotia (ICONS).
A discussion will follow with three focus points:
- Perspective of the pharmaceutical industry (Merck-Frosst)
- Perspective of the government
- Importance of the approach for pharmacoepidemiology
More specifically, PHM is directly related to the study of drug effects in real life (effectiveness and safety); its main objective is optimal therapeutic coverage (including good prescription and good use of drugs by patient); finally because of this broad perspective, PHM faces specific challenges with regard to study designs, database management and field implementations. All these aspects will be covered through the different examples.
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| 12:00-14:00 |
LUNCH |
(Lleida/Hall Cataluna) |
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POSTER SESSION C |
(Lleida) |
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VIEWING OF EXHIBITS |
(Hall Cataluna) |
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NEW ISPE BOARD OF DIRECTORS LUNCHEON |
(Stiges) |
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| 14:00-15:30 |
HOT TOPIC SESSION: PHARMACOVIGILANCE, PHARMACOEPI, MARKET SURVEILLANCE: WHICH REALLY DRIVES THE REGULATORY DECISION? |
(Girona/Tarragona) |
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Pharmacovigilance has led to tight restrictions on the use of Cisapride, whereas formal epidemiologic studies have given no basis for concern. Are they studying the same events? Market studies evaluate the capacity of regulatory authorities and manufacturers to influence use; these studies can signal that radical action is called for because guidance has failed. When market studies conflict, are they studying the same process? Cisapride will serve as a case in point to explore the dynamics of regulatory and corporate control.
Presenters:
- Willem Jan Atsma ( Belgium)
- Hubert Leufkens (Netherlands)
- Wayne Ray (USA)
- Alexander Walker (USA)
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| 15:30-16:15 |
CLOSING SESSION |
(Girona/Tarragona) |
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Moderators: Bert Leufkens, ISPE President, and Elizabeth Andrews, ISPE Past President
Presentation of Awards:
Best Oral & Poster presentations
Tilson's Laser - The Final Word, Hugh Tilson
Adjournment of ICPE
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