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Poster Number Poster Title Poster Type Date/Time Poster Presenter
M 01 Use of Evidence-Based Medications in Treating Medicare Beneficiaries with Osteoporosis Student Mon, Jun 16 7:45AM Feng-Hua Ellen Loh
M 02 The Effects of Levalbuterol versus Albuterol in Pediatric Patients with Asthma: A Cohort Study in a Low-income Population Student Mon, Jun 16 7:45AM Jing Yuan
M 03 Direct Observation in Correlation to Levels of Adherence in a Clinical Study Student Mon, Jun 16 7:45AM Marguerite Monogue
M 04 Globalization and Racial Composition of Pivotal Clinical Trials Student Mon, Jun 16 7:45AM Todd Knepper
M 05 Budget Impact Analysis of Tofacitinib for Treatment of Rheumatoid Arthritis Student Mon, Jun 16 7:45AM Rituparna Bhattacharya
M 06 Financial Crisis of Pharmaceutical Firms in China: Using Z-Score Model Student Mon, Jun 16 7:45AM Xueyan Yang
M 07 Anticholinergic Use and Risk of Pneumonia in Elderly Medicare Beneficiaries: A Nested Case-Control Study Student Mon, Jun 16 7:45AM Satabdi Chatterjee
M 08 Improved Label and Liver Warning for Nonprescription Acetaminophen Products Student Mon, Jun 16 7:45AM Tien Ho
M 09 Association of Prescription Opioid Use and Mortality in Community-Dwelling Medicare Beneficiaries with Non-Cancer Conditions Student Mon, Jun 16 7:45AM Patience Moyo
M 10 The Harmonization of Risk Management in the EU and the US: The Example of Vandetanib Student Mon, Jun 16 7:45AM Agata Aleksandra Lazowska
M 11 A Cross Country Comparison of the Effect of Co-Payments for Prescriptions on Adherence to Medications Student Mon, Jun 16 7:45AM Sarah-Jo Sinnott
M 12 Unified Additional Requirement in Consideration of Regional Approval for Multiregional Clinical Trial Student Mon, Jun 16 7:45AM Zhaoyang Teng
M 13 Evaluating Factors Associated With Medication Reconciliation After Implementing an Electronic Medical Record (EMR) System Student Mon, Jun 16 7:45AM Brittany G. Mani
M 14 Cost-Effectiveness Analysis of EGFR Mutation Testing and Gefitinib as First-Line Therapy for Non Small Cell Lung Cancer Student Mon, Jun 16 7:45AM Yusuke Narita
M 15 Monitoring Medicines in Social Media, What are the Options? Example: Medicines Under Additional Monitoring in Europe Student Mon, Jun 16 7:45AM Maartje Van Der Sar
M 16 Health Canada’s Request for Reconsideration Process: A Retrospective Analysis Student Mon, Jun 16 7:45AM Lewis Lau
M 17 Who Benefits Most from Androgen Deprivation Therapy Among Newly Diagnosed Elderly Metastatic Prostate Cancer Patients? Student Mon, Jun 16 7:45AM Abdalla Aly
M 18 Experimental Conditions of Creating a New Topical Remedy Containing Glucosamine and Ketoprofen Student Mon, Jun 16 7:45AM Nataliia Davishnia
T 01 Development and Implementation of Product Safety Statistical Analysis Plans Professional Tue, Jun 17 7:15AM Barbara A. Hendrickson
T 02 Ensuring Patient Recruitment Success in Phase I Clinical Trials: The Important Role of Investigators Professional Tue, Jun 17 7:15AM Rachida Essalihi
T 03 Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency Professional Tue, Jun 17 7:15AM Jonathan Seltzer
T 04 Evaluation of Current and Future Medical Information Services Offered to Healthcare Providers by Pharmaceutical Companies Professional Tue, Jun 17 7:15AM Tracey Cannova
T 05 Evaluation of Site Enrollment Estimates Pre- and Post-initiation to Actual Enrollment Performance: An Assessment of Accuracy Professional Tue, Jun 17 7:15AM Nicole Turner
T 06 Country-Specific Clinical Data and Reporting Requirements in Support of Marketing Applications To Key Rest-of-World Countries Professional Tue, Jun 17 7:15AM Marianne K Pedersen
T 07 Effectiveness of REMS Patient Education: An Assessment of Patient Comprehension and Knowledge Retention Professional Tue, Jun 17 7:15AM Paul Sheehan
T 08 Development of an ELISA Method to Characterize C1q Binding Affinity Professional Tue, Jun 17 7:15AM Kelly S Colletti
T 09 Best Practices to Effectively Close a Complex, Global Study: Different Stakeholder Perspectives Professional Tue, Jun 17 7:15AM Catharine Provosty
T 10 Using Gamification in the Life Science Industry Professional Tue, Jun 17 7:15AM Niki Kutac
T 11 Burden of Clinical Trial Operations and Value of Supporting Solutions: Results from a Global Investigator Survey Professional Tue, Jun 17 7:15AM Elisa F. Cascade
T 12 The Role of Bioethics in the Pharmaceutical Industry: Informal Review of 5-Year Trends and One Company’s Systematic Approach Professional Tue, Jun 17 7:15AM Luann E Van Campen
T 13 A Survey of Boxed Warning Adverse Reaction Content from US Prescription Drug Labeling Professional Tue, Jun 17 7:15AM Christine M Cheng
T 14 Processes and Responsibilities within Bioanalytical and Clinical Operations to Ensure PK Sample Management in Phase 1 Studies Professional Tue, Jun 17 7:15AM Sandy Greene
T 15 Choosing Your Investment: What’s the Right Data Quality Solution for You? Professional Tue, Jun 17 7:15AM Nicole Lynn Zandy
T 16 Global Regulatory View of Nonprescription Medicines Classification Professional Tue, Jun 17 7:15AM Dinah Duarte
T 17 Validation of Next Generation Sequencing Panels for Targetable Mutations in NSCLC and TNBC Using FFPEs and Liquid Biopsies. Professional Tue, Jun 17 7:15AM Rachel Skelton
T 18 A Regulatory Informatics Approach to Identifying Trends in Minimal Residual Disease for the Hematologic Malignancies Professional Tue, Jun 17 7:15AM Elizabeth Rach
T 19 Characterizing Medical Information Requests from Payer Customers to Improve Database Planning for Respiratory Assets Professional Tue, Jun 17 7:15AM Sarah White
T 20 Assessing Current Monitor Performance on Monitoring Competencies for Risk Based Monitoring Professional Tue, Jun 17 7:15AM Penelope K. Manasco
T 21 Utilization of Cross-Pollination Meeting Series: A Potential Catalyst for Innovation Professional Tue, Jun 17 7:15AM Kelly Hageman
T 22 Evolution of Pharmacovigilance Regulations in the US and Europe Professional Tue, Jun 17 7:15AM Dena Cosgrove
T 23 Validation of an Internal Communications Streamlining Initiative Utilizing an External Communications Benchmarking Study Professional Tue, Jun 17 7:15AM Vinit Mehta
T 24 Electronic Investigator Site Files: The Hidden Gem that Completes Remote Risk Based Monitoring Professional Tue, Jun 17 7:15AM Libby Cerullo
T 25 Precision Laboratory Network (PLN): PBMC Processing and Nuclei Acid Isolation Suitability Study Professional Tue, Jun 17 7:15AM Michael Waddington
T 26 Use of Epidemiology Data to Inform Pediatric Clinical Trial Design and Execution and Its Impacts on MSL Support Professional Tue, Jun 17 7:15AM Laura E Wallace
T 27 A Strategic Approach to Portfolio Benefit-Risk Assessments (BRAs) Professional Tue, Jun 17 7:15AM Libbie Parker McKenzie
T 28 Avoid at Your Risk? The Potential for Naïve Sites to Rescue Failing Recruitment and Study Under-Performance Professional Tue, Jun 17 7:15AM David Horsburgh
T 29 The Role of Medical Writers in Preparing Responses to Post-Submission Queries From FDA, PMDA, and EMA Professional Tue, Jun 17 7:15AM Kai Yu Jen
T 30 The Evolution of an Enterprise Risk Based Monitoring Process Professional Tue, Jun 17 7:15AM Ben Dudley
T 31 A Multi-Modalities Medical Imaging Investigative Network for Clinical Trials in Cardiovascular, Neurology and Oncology Professional Tue, Jun 17 7:15AM Dominique Johnson
T 32 Analysis of Product Labeling Changes for Successful Prescription to Over-the-Counter Switches Professional Tue, Jun 17 7:15AM Kim Le
T 33 Utilizing the MSL Role to Characterize the Transition of Care of Patients with Attention Deficit Hyperactivity Disorder Professional Tue, Jun 17 7:15AM Nicole Griswold
T 34 Descriptive Evaluation of REMS Knowledge in An Integrated Healthcare System Professional Tue, Jun 17 7:15AM Nazia Rashid
T 35 International Comparison of Process and Procedures to Overcome Clinical Trial Applications Placed on Clinical Hold Professional Tue, Jun 17 7:15AM Kenichi Otani
T 36 Impact of FDA Advisory Committee Voting on FDA Approval Decisions for Drugs and Biologics Professional Tue, Jun 17 7:15AM Regina Ballinger
T 37 The Silver Lining of the PSMF: Flow Chart Displaying the Business and User Requirements Professional Tue, Jun 17 7:15AM Zsuzsanna Csutor
T 38 Rock and a Hard Place: Mandated Multi-National Drug Utilization Studies in the Absence of Suitable Secondary Sources of Data Professional Tue, Jun 17 7:15AM Krista Payne
T 39 Medication Use Among Pregnant Women Enrolled in Medicaid Professional Tue, Jun 17 7:15AM Kristin Palmsten
T 40 eCTD Submission Capability to FDA for Academic Sponsor-Investigators: Process, Problems, and Possibilities Professional Tue, Jun 17 7:15AM E. Mitchell Seymour
T 41 Integrating ISO and Relevant Industry Standards to Improve Clinical Trial Project Management Processes Professional Tue, Jun 17 7:15AM Kathy D. Boardman
T 42 Can Asia Help Expedite Cancer Drug Development? Analysis of Three North Asian Countries’ Potential to do More Clinical Trials Professional Tue, Jun 17 7:15AM NaRae Baek
T 43 Electronic Data Capture in Oncology: A Review of Electronic Collection of Patient-Reported Outcomes Professional Tue, Jun 17 7:15AM Bhavini P. Srivastava
T 44 Patient-Informed Clinical Trials: Cross-Sectional Survey on a Patient Powered Research Network Professional Tue, Jun 17 7:15AM Sally Okun
T 45 Delivering Quality Systems Globally Professional Tue, Jun 17 7:15AM Craig Burnett
T 46 Creating Standard Analyses and Displays for Common Safety Assessments in Clinical Study Reports Professional Tue, Jun 17 7:15AM Karolyn Kracht
W 01 Evaluation of Operating Characteristics of MMRM Analysis Using All Available Longitudinal Data at Interim Compared to ANCOVA Professional Wed, Jun 18 7:15AM Weining Z. Robieson
W 02 Recent Developments in Scaled Average Bioequivalence Professional Wed, Jun 18 7:15AM Pascal Guibord
W 03 An Overview of Both Current Best Available and Next Generation of Drug Therapies for the Treatment of Depression Professional Wed, Jun 18 7:15AM Annette S. Williams
W 04 Health Literacy Assessment, Usability Testing, and Revision of a European Union Risk Management Plan Public Summary Professional Wed, Jun 18 7:15AM Karen Lockwood
W 05 Coordination of a Multi-site Cell and Gene Therapy Study in an Academic Medical Center: A Success Story Professional Wed, Jun 18 7:15AM Bambi Grilley
W 06 An Innovative Way of Providing Timely Responses to Questions Related to Ingredients/Allergens Professional Wed, Jun 18 7:15AM Irene Sheng
W 07 Evaluating and Supporting the Increasing Patient Need for Delivery of Clinical Trial Supplies Direct to Their Homes Professional Wed, Jun 18 7:15AM Esther Sadler-Williams
W 08 New Business Acumen Tool Guides Strategic Thinking: Learn How to Increase Your Value to the Company and to the Industry Professional Wed, Jun 18 7:15AM Ilyssa Levins
W 09 Complexity in Protocol Design: Does it Lead to Better Clinical Trial Outcomes? Professional Wed, Jun 18 7:15AM Rebecca Hummel
W 10 Corporate Integrity Agreement and Its Impact on Industry Professional Wed, Jun 18 7:15AM Abhishek Harde
W 11 Giving Clinical Trial Start Up A Project Management Make-Over: Reducing Cycle Times Through Critical Path Focus Professional Wed, Jun 18 7:15AM Ben Quartley
W 12 The Impact of Regulatory Reform in Mexico on Pharmaceutical Product Approval Rates Professional Wed, Jun 18 7:15AM Raul M. Vinueza
W 13 So How DO You implement eSource: Practical Tips for Enhancing Efficiency, Data Visibility, and Site Interactions Professional Wed, Jun 18 7:15AM Ed Seguine
W 14 Duloxetine Feeding Tube Study: Medical Information Example of Collaboration with Laboratory Scientists to Deliver Answers. Professional Wed, Jun 18 7:15AM Andrew Scot Buchanan
W 15 Targeting the Best Sites with an Analytical Site Selection Model Using Multiple Metrics Professional Wed, Jun 18 7:15AM Elizabeth Nielsen
W 16 Central Recruitment Methodologies in a Global Clinical Research Study of a Pediatric Autism Spectrum Disorder (ASD) Program Professional Wed, Jun 18 7:15AM Allan Christopher Spera
W 17 Evaluation of Shipping Systems to Maintain Sample Integrity in Clinical Research Professional Wed, Jun 18 7:15AM Mona Vimal
W 18 A Comparison of MedDRA SMQs Relative to Individual Preferred Terms for Signal Detection on a Large Insurance Claims Database Professional Wed, Jun 18 7:15AM Christopher Bone
W 19 Introducing and Conducting Traditional Chinese Medicine Trials in the US: Challenges, Obstacles, and Potential Solutions Professional Wed, Jun 18 7:15AM John Yongbo Li
W 20 Coherence of Observed-to-Expected Disproportionality Methods Used for Pharmacovigilance at a Critical Threshold Professional Wed, Jun 18 7:15AM Geoffrey Gipson
W 21 Enhancing Project Management Tracking to Facilitate the Protocol Development Process Professional Wed, Jun 18 7:15AM Tracey Miller
W 22 Continued Tradition of Success: Critical Components of the Genzyme/Sanofi Oncology/MCPHS University Post-PharmD Fellowship Professional Wed, Jun 18 7:15AM Christina Marie Gallagher
W 23 Assessment of Violations Cited by OPDP in Untitled and Warning Letters Issued from 2004-2013 Professional Wed, Jun 18 7:15AM Phil Reveal
W 24 Accelerating Patient Recruitment Using In-Depth Market Research Insights: Collected via a 3rd Party - From Clinical Trial Site Staff Professional Wed, Jun 18 7:15AM Jeff Jamer
W 25 Implementing a Standard Report Set for Risk Based Monitoring Domains Professional Wed, Jun 18 7:15AM Christine Riley-Wagenmann
W 26 Investigation of Association Between COPD Treatment and Cardiac Events With or Without Treatment for Co-Existing Disease Professional Wed, Jun 18 7:15AM Ayako Takizawa
W 27 Reinventing the Study Build Process to Promote Consistency, Increase Build Efficiencies, and Reduce Overall Timelines Professional Wed, Jun 18 7:15AM Caroline Lin
W 28 Collaborative Development of an Open Source Repository for Standardized Analysis Using Cloud Services Professional Wed, Jun 18 7:15AM Hanming H Tu
W 29 Quality of Japanese Clinical Trials and Proposed Strategy for the Trial Sites Professional Wed, Jun 18 7:15AM Toshiyoshi Tominaga
W 30 A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols Professional Wed, Jun 18 7:15AM Gary Noel
W 31 Global Regulatory Considerations for Biosimilar Approval Professional Wed, Jun 18 7:15AM Holly Groelle
W 32 Impact of FDA Breakthrough Therapy Designation on the Regulatory Timelines of Chronic Lymphocytic Leukemia (CLL) Therapies Professional Wed, Jun 18 7:15AM Alex Wei
W 33 An Extension of Likelihood Ratio Test-Based Method for Signal Detection in a Drug Class with Application to FDA's AERS Database Professional Wed, Jun 18 7:15AM Yueqin Zhao
W 34 Maintaining Effective Pharmacovigilance Oversight: The Role of Remote Auditing Professional Wed, Jun 18 7:15AM Alun C Tanner
W 35 Data Empowered Decision Making in a Pharmaceutical Company: Project Libraries and Workflows - Real Life Experience Professional Wed, Jun 18 7:15AM Mikhail Samsonov
W 36 Sample Size Re-Estimation Can Be Very Inefficient Professional Wed, Jun 18 7:15AM David R. Bristol
W 37 So You Hired a CRO…Now What? Advancing Clinical Research by Leveraging Government Sponsor Relationships with CROs Professional Wed, Jun 18 7:15AM Jessica Holden Kloda
W 38 Office of Prescription Drug Promotion (OPDP) Enforcement Overview From 1997 to 2013 Professional Wed, Jun 18 7:15AM Cyril Alexandre Carrere
W 39 Enrollment of Pregnant Women in Medication Safety Research: MotherToBaby Pregnancy Studies Professional Wed, Jun 18 7:15AM Jennifer Zellner
W 40 A Model for Centralized Monitoring: Reducing Costs While Ensuring Compliance, Risk Mitigation and Quality Professional Wed, Jun 18 7:15AM Justin Stark
W 41 Customer Satisfaction and Communication Methods Used in Conducting Large Multi-Center Clinical Trials Professional Wed, Jun 18 7:15AM Barbara J. Del Curto
W 42 Easy as A,B,C? Adapting Pediatric Protocol Designs from Existing Adult Data and Study Templates Professional Wed, Jun 18 7:15AM Rona Claire Grunspan
W 43 The Construction and Promotion of Medication-Used Safety Education for Traditional Chinese Medicine in Taiwan Professional Wed, Jun 18 7:15AM Tsung-Ta Wu
W 44 Patterns of Regulatory Approval for Targeted and Immunotherapeutic Compounds Indicated for the Treatment of Metastatic Melanoma in the US and EU Professional Wed, Jun 18 7:15AM Jonathan Nguyen Diep
W 45 Retrospective Chart Review Studies: Key Considerations for Fullfilling Safety Reporting Requirements Professional Wed, Jun 18 7:15AM Dara Stein