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DIA 2013 49th Annual Meeting
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DIA 2013 Live Learning Center
Track 01: Clinical Operations
Track 02: Project/Portfolio Management and Strategic Planning
Track 03: Innovative Partnering Models and Outsourcing Strategies
Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Track 05: Regulation of Product Advertising and Marketing in an Ever-changing World
Track 06: Medical Communication, Medical Writing and Medical Science Liaison
Track 07: Processes and Technologies for Clinical Research
Track 08:Regulatory Affairs and Submissions
Track 09: Medical Devices, In Vitro Diagnostics, and Combination Products
Track 10: Public Policy/ Health Care Compliance/ Law
Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Track 12: Pharmaceutical Quality
Track 13: Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Track 14: Clinical Safety and Pharmacovigilance
Track 15: Statistical Science and Quantitative Thinking
Track 16: Professional Development
Track 17: Rare/Orphan Diseases
Track 18: Global Regulatory
Track 19: Communities Showcase
Track 20: Executive Program
Track 21: Late Breaker
Track 22: White Paper Showcase
Plenary Sessions
Student Poster Session, Monday, June 24, 2013
Professional Poster Session, Tuesday, June 25, 2013
Professional Poster Session, Wednesday, June 26, 2013
Access Keynote Presentation by Dr. Daniel Kraft
http://futuremed2020.com/dia/
DIA 2013 Live Learning Center
CON DIA 2013 Live Learning Center
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Track 01: Clinical Operations
Access Keynote Presentation by Dr. Daniel Kraft
http://futuremed2020.com/dia/
100 Shape Your Cost with Hard and Soft Coverage Analysis Trends
101 Trials, Studies and Programs: Diverse Operational Approaches to Generating Evidence in the Late-phase Environment
125 Implementing Performance Metrics: How Investigator Sites Can Pave the Way for Running Successful Clinical Trials
126 Global Clinical Trials: The Role of Emerging Markets
200 Is This Trial Worth It? A Panel Discussion for Sites and Project Managers
201 Leveraging In-Pharmacy Education to Improve Patient Comprehension and Access to Clinical Trials
225 Domestic and Global Trends in Clinical Trial Budgeting
226 Optimizing Trial Feasibility by Leveraging Electronic Health Record Data and Engaging Investigators and Patient Advocacy Groups
241 Enrollment Analytics: Moving Beyond the Funnel
242 Taking the Measure of Metrics
265 Approaches to Risk-based Monitoring
266 Evaluating Sites for Optimum Site Selection and Performance
300 Clinical Trial Design for Optimal Patient Recruitment and Retention
301 Understanding Operational Feasibility: A Discussion of Current Methodologies, Primary Research Limitations and Opportunities
326 Driven by Data: More Effective Strategies to Reach Your Patient Recruitment Goals
327 Study Startup Symposium
328 Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives
341 Using Big Data to Design Smarter Studies
364 Innovative Ways of Working with Patients to Make Clinical Research More Productive, Less Costly and Less Burdensome for the Patient
365 Overcoming Unique Challenges of Pediatric Studies
400 Parents as Partners: Engaging Caregivers for Pediatric Trials
401 Hot Topics in Clinical Supplies
418 CRA's Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment
419 Impact and Interventions Related to FDASIA: Increasing Diversity in Clinical Trials
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Track 02: Project/Portfolio Management and Strategic Planning
102 Stage Gate Decision-making Workshop, Part 1 of 2
103 Portfolio Management Symposium
127 Stage Gate Decision-making Workshop, Part 2 of 2
128 Bridging the Gap Between Strategy and Execution
202 Careers Beyond Project and Portfolio Management: A Panel Discussion
203 The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols
227 Effective Diverse Team Collaboration and Management for Drug Development: Key Commonalities and Differences among Korea, China and Japan
243 Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions
244 Approaches to Quality Risk Management: Understanding What Matters
267 Strategic Planning of the Global Program to Facilitate Regulatory Approval and Market Access
302 Cost Management for Global Drug Development Projects
303 Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development
329 So You Want to Be a Project Manager: How to Find Your Way to a Challenging and Rewarding Career
342 Using Competence Models to Drive High Quality Drug Project Management
343 Challenges and Strategic Approaches to Biosimilar Development
366 Pharmaceutical Project Management: What's Really Important and How Can We Do Better?
367 Pharmacometric Methods: Essential for Optimal Drug Development Strategy
402 Orphan Drug Development Strategy by Big and Medium/Small Pharmaceutical Industries
420 The Importance of Country Selection in Clinical Study Design
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Track 03: Innovative Partnering Models and Outsourcing Strategies
104 The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
105 Innovative Partnerships for mHealth
129 Implementing Regulatory Outsourcing Partnerships: New Trends and Practices
204 Making CRO-Sponsor Partnerships Work: Executive Roundtable
228 Developing and Maintaining Sponsor/CRO Partnership Regulatory Submissions Processes: Challenges and Successes
229 Change Order Panel Discussion and Brainstorming Session: Can We Be More Efficient?
245 Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial
246 FDA Collaborations Broaden the Reach of Health Care Messages to Effectively Communicate with the Public
268 Investigator Budgets Impact on Patient Enrollment and Retention: How to Improve Sponsor/CRO/Site Processes to Increase Productivity
304 Evolving to Functional Service Providers (FSP): Successfully Transforming Existing Partnerships into FSP Relationships
305 Unique Nonprofit-Industry Partnerships to Develop and Disseminate Technology
330 Innovative Strategies for Evolving Sponsor, CRO and Site Alliances
331 Project Data Sphere: Clinical Trial Data-sharing in Cancer to Accelerate Innovation and Enhance Patient Health
344 Towards an Effective Virtual R&D Team for Faster Accessing of the East Asian Market
368 Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
403 Strategic Partnerships: Emerging Models and Their Impact on Drug Development
421 Transforming Relationships to Adapt to Evolving Organizational Strategic Goals
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Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
106 Global Symposium
130 Translational Aspects from Preclinical Animal Toxicology Studies to Early Human Health Risk Assessment: Needs and Limitations
205 The Thorough QT Study: Isn't There a Better Way to Do This?
230 Measuring the Impact of Subject Dual Enrollment on Study Data Validity and a Web-based Tool to Avoid Simultaneous Participation in Multiple Concurrent Clinical Trials
247 Human Abuse Liability Testing in CNS Drug Development
269 Optimizing the Transition from Preclinical to Clinical Research
306 Molecular Imaging: Utilizing It as an Effective Drug Development Tool
332 Pharmacometrics: Implications and Impact in Preclinical to Early Phase Clinical Development
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Track 05: Regulation of Product Advertising and Marketing in an Ever-changing World
206 Prescription Drug Marketing Regulatory Primer
231 FDA Enforcement Update: Advertising and Promotion
248 Drug Development for Commercial Success
270 Product Communications in the Preapproval Phase
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Track 06: Medical Communication, Medical Writing and Medical Science Liaison
107 Finessing Scientifically Accurate, Comprehensible, Compliant, Clinically-focused Module 2 Summaries of an eCTD-based Submission
207 The Regulatory Writing Game Show
208 Innovation and Evolution Within the Medical Science Liaison Role
232 Preparation of Clinical Study Reports and Summary Documents: Maximize Efficiency and Minimize Redundancy
249 The New European Pharmacovigilance Legislation: Guiding Medical Writers Through the Risks and Benefits
271 Protocol Trends and Strategies for Quality
307 Tethering the Channels of Scientific and Medical Content
333 Globalization of Medical Communications/Medical Science Liaisons: A Comparison of Guidance and Practice Differences
345 Recent Corporate Integrity Agreements: Impact on Industry-sponsored Publications and Medical Communications Activities
369 Learnings from Safety Communications Across the Industry: Patients and EMA, REMS, and FDA, Physicians, and Medical Information Groups
404 Key Learnings from the Approval and Launch of a 505(b)(2) Product from a Medical Communications Perspective
422 Insights into China: Practical Tips for Writing Publication and Regulatory Documents
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Track 07: Processes and Technologies for Clinical Research
108 Managing Data at Arms' Length: China
109 Evaluation and Selection of the Optimal Endpoints for Clinical Studies
131 That Awkward Stage: Transition from Paper Trial Master File to eTMF
132 CDISC SHARE: A Promising Approach to Therapeutic Area Standards Development
209 Development of a New Patient-reported Outcome (PRO) Measure for Depression: Progress and Results from the PRO Consortium
210 Data from Everyone: Using Smartphones and the Internet to Connect with Subjects
250 Innovative Computerized System Validation and Auditing
251 Changing View of Electronic Data Capture (EDC) and Implications for Data Quality
272 Real, Transparent Dialogue from Three Sponsors: Destination eTMF - Are We There Yet?
273 Real-world Electronic Health Records Data and Informatics Technology in Drug Development and Life Cycle Management
308 Enhancing Regulatory Science and Expediting Drug Development: eClinical and eHealth Tools
309 Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials
334 EDC Insights: Before, During, and After
335 Advancing Endpoint Adjudication
346 Coalition for Accelerating Standards and Therapies (CFAST): The Ultimate Drug Development Drivers
347 Cloud Technology for Decision Makers: What's Real and How to Validate It
370 Clinical Trial Visit of the Future: Leveraging Emerging Technologies to Crack the Patient Recruitment Challenge
371 Data Standards Strategy
405 eDM From Three Sponsors
406 Changing Landscape of IT in the Pharmaceutical Industry
423 Implementing a Paperless Trial for Phase 3: A Biotech's Lessons Learned
424 What's the Point? Can Point of Care Devices Enhance Clinical Trials?
425 Emerging Electronic Tools in Cardiovascular Outcomes Studies
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Track 08:Regulatory Affairs and Submissions
110 Pediatric Drug Development: A New Paradigm Under FDASIA
111 Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators
133 Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy
134 Navigating the Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs) and Combined ATMPs
211 Expediting Drug Development and Review for Serious Conditions
212 A Regulatory Perspective of Biosimilars in Emerging Markets
233 The Aging Population: Approaches to Ensure Safety and Efficacy
252 Electronic Submissions in PDUFA V
253 Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This?
254 US and EU Regulatory Update of Clinical Trial Disclosure
274 Labeling and Patient Medical Information (PMI)
275 Bringing the Views of "Payer Regulators" into Product Development to Align Label Outcomes and Safety with Patient Access
310 FDASIA: Impact of New Legislative Provisions on Innovative Drug Development
311 Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions
336 Advancing Alzheimer's Innovation: A Call to Action
337 A Comparison of Study Startup Regulations and Timelines in Several Major Emerging Markets and the Decision Process for Selection
348 Advancing Alzheimer's Innovation: Patient Advocacy, Caregiver Support and Health Care System Impact
349 FDASIA Patient Provisions: One Year Later
350 eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation
372 Advancing Alzheimer's Innovation: Clinical Development Successes and Challenges
373 Electronic Regulatory Submission (ERS) Development and the Impact on the Sponsor's Organization: Retooling R&D for ERS
374 Global Pediatric Development: Next Steps
407 NDA Submission Strategy for New Chemical Entity (NCE) Products in Asia Pacific Countries to Reduce Drug Lag
426 Certificate of Pharmaceutical Product (CPPs): How Can the Process for Obtaining from and Submitting to Health Authorities Be Made More Efficient? Moving from Ribbons and Wax to Electronic Solutions
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Track 09: Medical Devices, In Vitro Diagnostics, and Combination Products
112 Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon
213 Postmarket Surveillance Issues for Medical Devices
255 Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges
276 Diagnostic Biomarker Verification and Validation: A Cost-efficient, Speed to Market Adaptive Design Clinical Trial Model
312 How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)
351 Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics
375 Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors
408 Medical Devices Global Symposium
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Track 10: Public Policy/ Health Care Compliance/ Law
113 Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials
135 Cooperation Among Regulators: Impact on Stakeholders
136 Legal Jeopardy from the Conduct of Clinical Trials
214 Ethical Issues in Clinical Trials
277 Breakthrough Therapy: One Candle on the Birthday Cake - Are Innovators Enjoying Sweet Success or Is the Pathway Not Baked Yet?
313 Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."
338 Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow
352 The Science of Compliance
376 Meeting the Challenges of Health Care Disparities and Clinical Trial Requirements in the Global Environment
377 Ethical Issues in Clinical Trials
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Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
114 Vendor Management Using Quality by Design and Risk Management Strategies
115 Practical Considerations for GCP Audits in a Risk-based Environment
137 Quality Risk Management: An Old Hat?
138 Effectiveness Checks in the Clinical Research Setting
215 GCP and Inspection Readiness
256 GCP Risk-based Monitoring
278 GCPs in Emerging Countries
314 How Will Risk-adapted Clinical Trials Be Inspected?
353 FDA/EMA/WHO Collaboration and Cooperation on Good Clinical Practice (GCP), Bioequivalence (BE) and Pharmacovigilance (PV) Inspections
378 Innovations in Proactive Quality Management: Best Practices and Variability in Approaches to Proactive Quality Management
409 eSource Symposium
427 Protocol Deviations: Avoidable Problems or an Unavoidable Risk
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Track 12: Pharmaceutical Quality
116 Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets
139 Update on Submission and GMP Expectations for Part 3 Combination Products
216 Developing and Embracing a Culture of Quality in the Pharmaceutical Industry
234 Strategies for the Development and Registration of Antibody Drug Conjugates
279 Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot
315 How to Prepare for Meetings, Both Internal and with the FDA
316 Current Developments in the Automated NDA Field Alert Reporting Project
339 Drug Shortages: Causes, Current State and Path Forward
354 Implementation of Quality by Design: Progress, Challenges and Opportunities - Industry Perspective
379 Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective
410 Postapproval Change Management: Challenges and Opportunities
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Track 13: Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
140 Using Epidemiologic Methods to Advance Comparative Effectiveness Research
217 Payer Collaborations with Pharma: Real-world Evidence to Improve Patient Outcomes and Influence the Pipeline
235 Big Data: Impact on Innovation
280 Utilizing Electronic Medical Records as an Innovative Methodology for Evaluating Therapeutic Effectiveness
317 The Environment for Health Care Decision-making: Collecting, Using and Understanding Comparative Effectiveness Research
355 The 2012 US Payer Landscape: Results from a Survey of Medical and Pharmacy Directors on Comparative Effectiveness Research
380 Informing Regulatory and Health Technology Assessment (HTA) Decision-making Processes: An Integrated Approach to Life Cycle Management
411 Patient-centered Predictive Modeling and Its Role in Creating a Learning Health System
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Track 14: Clinical Safety and Pharmacovigilance
117 Narrative Medicine and Pharmacovigilance
118 Electronic Health Records (EHRs) in Signal Detection and Evaluation
141 The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance
142 Characterizing Drug Shortages and Their Causes: Anticipating Future Trends
218 Social Media, Mobile Applications and Patient Support Programs: Challenges and Solutions for Handling Drug Safety Information
219 Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting
236 EU Update: PROTECT and EnCePP
257 Quality Assurance for Signal Detection Programs
258 Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and Benefit-risk Evaluations
281 Risk Management in the US, EU and Japan: The Challenges of Diversity
318 Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance
319 Pharmacovigilance Update for Japan, Developing Asia and Latin America
356 An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection
381 Developing a Patient Aid to Make Information about Treatment Benefits, Harms and Uncertainties Meaningful to Individual Patients and Enhance Their Decisions
382 Herbal-induced Liver Injury (HILI): How That May Impact Rx Benefit-Risk
412 Coding with Confidence
413 Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can?
428 Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations
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Track 15: Statistical Science and Quantitative Thinking
119 Hot Topics in Statistics: Working Together Effectively to Transform Our Science
143 Key Multiplicity Issues in Clinical Trials
220 Biomarkers for Drug Development: How Are We Dealing with the Challenges?
237 Statistical Considerations When Developing Antibacterial Treatments
259 Looking Closer into the Utility of Adaptive Approaches
282 Analysis Data Standards: Developing, Applying, Submitting and Reviewing
320 Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians
357 Clinical Trial Simulations and Modeling
383 Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives
414 Some Innovative Approaches to Handling Missing Data Problems in Clinical Trials
429 Bayesian Methods in Medical Product Development and Comparative Effectiveness
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Track 16: Professional Development
120 Challenges and Solutions for Professional Development and Training of Clinical/Nonclinical Staff
144 The Secret of Stellar Careers: Serendipity plus Planning = Success
221 DNA of Entrepreneurs: Calculated Risk-taking and Bringing Game-changing Technology to the World
238 Advanced Presentation Skills
239 DIA 2013 Student Forum: Getting a Job and Developing a Career
283 So You Want to Foster Innovation: A Neuroscience Primer on How Creative Ideas Arise from the Brain
284 Advanced Presentation Skills
321 How Economic and Technological Change Can Affect Professional Expectations: Case Studies in Succeeding in the Midst of Change
340 Successful Mentoring Relationships
358 Transition from Subject Matter Expert (SME) to Subject Matter Educator Extraordinaire (SMEE)!
359 Submitting an Abstract for the DIA 2014 50th Annual Meeting
384 Ensuring Patient-centered Care: Partnering with Patient Advocacy
415 Mobile Learning and Social Media Symposium
430 Cultural Awareness and Collaboration
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Track 17: Rare/Orphan Diseases
222 Research Advances for Rare Diseases and Orphan Products
260 Is There a Recipe for Successful Implementation of Registries for Rare Diseases?
285 Development for Rare Disease Treatments
322 Models for Genomic Research Success: Empowering Patient-Researcher Relationships and the Emerging Role of Crowd Sourcing in Rare Disease Research
360 Rising to the Challenge of Developing Novel Orphan Medicines for the Global Market
385 Rescuing and Repurposing Drugs: Challenges and Opportunities
416 The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value
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Track 18: Global Regulatory
121 CBER Town Hall
122 European Town Hall: Implementation of New Safety Legislation and Other Hot Topics
223 Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
261 Convergence in Regulatory Science Across the Strait
286 Korea Forum: Introduction to the Korean Ministry of Food and Drug Safety (MFDS) and Government R&D Program
323 FDA-Health Canada Regulatory Cooperation Council (RCC) Town Hall
361 Canadian Approaches to Regulatory Modernization and International Engagement
386 Challenges for Stable Supply of Drugs and International Cooperation
387 Latin America Town Hall
417 CDER Town Hall: Part 1 of 2
431 CDER Town Hall: Part 2 of 2
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Track 19: Communities Showcase
123 How Can Translational Medicine Fill the Gaps in Life Sciences Industries?
145 Defining Clinical Trial Innovation: Challenges and Opportunities for 2013
224A Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball
240A Achieving Innovative Technology Results
262 First-in-Human Studies: How Much Complexity Is Too Much?
287 The Evolving Clinical Trial Disclosure Global Landscape
324 Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols
362 Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs
388 Current Regulatory Landscape Impacting Medical and Scientific Communications
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Track 20: Executive Program
263 Reinventing the R&D Business Model: Heeding the President's PCAST Report on Innovation
288 Where Research, Medicine and Care Converge: A CMO Roundtable Discussion
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Track 21: Late Breaker
325 Collaborating to Streamline Drug Development: Are We Making Progress?
363 TransCelerate's Collaborative Approach to Risk-based Monitoring: The Methodology
389 TransCelerate's Collaborative Approach for Site Qualification and Training Efficiencies
SCR SRC - SCOTUS DNA Patent Ruling: Implications for the Industry
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Track 22: White Paper Showcase
124 Next Generation Medical Information Call Center
224B Moving to a Standards-based, Agile Clinical Development Lifecycle
240B Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology
264 Learning to Share – Sharing to Learn: Honoring Patients Through Collaboration and Transparency Exploring the emerging trend of data-sharing initiatives in the life sciences industry
289 Four Ways to Accelerate Clinical Portfolio Strategy
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Plenary Sessions
010 Opening Plenary
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Student Poster Session, Monday, June 24, 2013
M01 Evaluation of Cytochrome P450 2C19 Activity in Normal, Healthy Adult Subjects in a Western Indian Population
M02 Promoting Medical Technology Innovation: Lessons Learned from the Case of Bare Metal Coronary Stents
M03 Quality Clinical Trial Monitoring in Nigeria: The Impact of Regulatory Oversight and Resource Capacity
M04 A Cost Analysis of Skeletal Related Events Among Elderly Men with Stage IV Metastatic (M1) Prostate Cancer
M05 Challenges in Discovery and Development of Orphan Drugs and Possible Solutions: Indian Scenario
M06 Receipt of ACE Inhibitors or ARBs Among Medicare Beneficiaries with Diabetes and Hypertension
M07 Comparison of European Drug Approvals to US
M08 Awareness of Komfo Anokye Teaching Hospital (KATH) Clinical Staff of the DOTS Strategy for the Treatment of Tuberculosis
M09 The Registration of Biosimilar Medicines: The Case of Low Molecular Weight Heparines in View of the New CHMP Guideline
M10 Does the Essential Medicines Policy Succeed in China? Empirical Study on Rational Medicine Use in Primary Health Institutions
M11 Disparities in Influenza Vaccinations Among Community Pharmacy Patients and Non-Community Pharmacy Respondents
M12 Assessment of Severity Grading Differences Between Terms in Common Toxicity Criteria Used in Clinical Trials
M13 Update of Current Compliance With Required Reporting of Summary Results on ClinicalTrials.gov
M14 Communicating the Benefits and Risk of Medicines to Patients: The Pharmacy Student's Point of View
M15 Technological Innovations in Medication Packaging to Improve Patient Adherence: A Systematic Review
M16 Drug Disposal: Addressing Current Drug Disposal Practices and Pharmacovigilance
M17 Antimicrobial Susceptibility Trends of Urinary Tract Infections: A 10-year Regional Antibiogram of ESKAPE Pathogens
M18 Awareness and Use of Video Games for Rehabilitation and Therapy in Indian Healthcare Centers
M19 Current Challenges of Regulatory Systems in Low and Middle-Income Countries
M20 Research of the Non-therapeutic Impact Factors Correlation in Clinical Parameters Estimation During Clinical Trials
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Professional Poster Session, Tuesday, June 25, 2013
T01 Toward a New Regulatory Paradigm for Lipid Emulsions for Parenteral Nutrition
T02 Recruitment Metrics From Together RA: A Study in Rheumatoid Arthritis Patients to Evaluate Feasibility of Direct-to-Patient Research Approach
T03 Site-level Quality Assurance Outcome: Identification of Sponsor-provided Source Documents With Greatest Prevalence of Errors
T04 Potential Differences in Subjects From Physician Recruitment Versus Centralized Recruitment Campaigns in a Clinical Trial
T05 Global Clinical Trials: Challenges, Risks and Rewards
T06 A Comparison of the Statistical Properties of Confidence Intervals for the Difference in Two Proportions
T07 Comparing the Sensitivity of Safety Signal Identification When Using Three Methods: EBGM, U-Chart and Increased Frequency
T08 Develop a Project Management Training Program for Clinical Trials Sites to Manage Complex Clinical Trials Effectively
T09 Different Competencies and Skill Sets for Regulatory Medical Writers and Publication Writers
T10 Risk-based Centralized Monitoring of Clinical Trials: A Statistical Approach
T11 Failed Trials and Protocol Design: Is There a Relationship?
T12 The Evolving Oncology Clinical Trial Landscape in Asia: 10 Year Trend
T13 Anxiolytic-like Effect of Beta Receptor Agonist Amibegron May be Related to Interaction of Serotonin Receptor Subtypes
T14 What Are the Attributes That Companies Believe Would Help Agencies to Make Quality Regulatory Review Decisions?
T15 Quality Systems for Contract Clinical Supply Operations: Using Risk Analysis to Meet Global Requirements
T16 So You Have a CTMS, Now What? Using Technology to Optimize Clinical Operational Processes - the DAIDS RSC Experience
T17 Measuring Outcomes in Phase 1 Clinical Trials
T18 Advantages and Mass Balance Results Dosing [14C]-Oncology Drugs to Normal Healthy Volunteers: Compiled Data from 22 AME Studies
T19 Impact of Public Comments on Prescription Drug Benefits in Essential Health Benefits Final Ruling
T20 With the Changing Life Sciences and Regulatory Landscapes: Evolutions in Drug Safety and Pharmacovigilance Operating Models
T21 New Survey Data Results: Patient Preferences for Reminders in Clinical Trials With Patient Diaries
T22 Developing Site Monitoring Triggers to Support Risk-based Monitoring
T23 The Use of Compliant Text Messaging to Increase Patient Engagement in a Study Comparing Oral Contraceptive Symptoms
T24 Monitoring without SDV or Regulatory Document Collection: The Monitor's Critical Role and How it Has Changed
T25 Advancing Patient Registry Methodology with an Outcome Measures Framework
T26 Spontaneous Ventricular Arrhythmias in Early Clinical Trials: a Report from a Single and Repeated Ascending Dose Study
T27 Gamification in the Pharmaceutical Industry: An Innovative Approach to Education and Awareness Among Patients and Health Care
T28 Characterization of Renal Biomarkers for Use in Drug Development: Biomarker Evaluation in "Healthy Volunteers"
T29 Asian Investigators Enrollment Prediction: An Assessment of Accuracy Against Actual Performance
T30 Embracing Social Media and what it means for maintaining Compliance
T31 Return on Innovation Investment for Life Science Technologies
T32 Comparative Safety of Second-Generation Antipsychotics and Risk of Pneumonia
T33 Consequences of Non-compliance to Osteoporosis Medication Among Osteoporotic Women
T34 Managing Global Clinical Trial Processes Using Operational Business Intelligence(BI) and Key Performance Indicators(KPI)
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Professional Poster Session, Wednesday, June 26, 2013
W01 Inspections: Streamlining Backstage Operations Using the Cloud
W02 Highly-Automated Analysis of QTcI/QTcF in Thorough QT (TQT) Study
W03 Determinants for Predicting Serious Adverse Event (SAE) Rates Across Study Duration in Selected CNS Indications
W04 Remote Informed Consent Review: Results of Implementation in Phase III Trial
W05 Characteristics of a US Rheumatoid Arthritis Cohort: Baseline Data from CORRONA
W06 A Trio of Talent: Scientific Collaboration Inside a CRO
W07 Labeling for Devices: A Global Solution
W08 Microdose Study on Three Aromatase Inhibitors
W09 Current Scenario of Clinical Research Sites in Thailand: A Ground Up Approach to Clinical Site Selection in Emerging Countries
W10 Evaluation of Pain Drugs: Role of Undetected Underlying Sleep Pathologies
W11 Selective Blockade of RyRIII May Present a Protective Effect against Neuronal Insult in Cell Model
W12 Development of Guidance for Handling Adverse Drug Reaction Reports at National Level
W13 The Translational Medicine-Medical Science Liaison: A New Role for a New Era in Drug Discovery
W14 Randomized Placebo-Control Trial of Arginine Therapy for Treatment of Children with Sickle Cell Disease and Vasoocclusive Pain
W15 Best Practices for Optimizing Global Biospecimen Collections for Prospective and Retrospective Clinical Research
W16 Comparison of the US Package Insert and the EU Summary of Product Characteristics
W17 Genotoxic Evaluation of a Chloroalcohol Resulting From Acid Degradation of an Oral Pharmaceutical Containing an Oxetane Ring
W18 Recruitment Metrics From a Direct-to-patient Approach to Enroll Patients in a Diabetes Practice-based Research Network
W19 Development of a Quality Program for Clinical Research Sites of Brazilian Clinical Research Cancer Network
W20 The Role of Product Identification Systems in Pharmacovigilance (PV) for Biologics in the Biosimilars Era
W21 Please Pass the New Template: Enhancement of Postauthorization Safety Study Protocol Templates Aligned With Guidelines
W22 What Medical Writers Contribute and What They Need to Know
W23 Preventing Shortages of Biologic Medicines
W24 A Prospective Clinical Trial of a Scoliosis Growth Modulation Clip/Screw Device: Initial Safety Results
W25 Comparative Risks of Organ Dysfunction Associated with Individual Antiepileptic Drugs Following FDA Black Box Warning
W26 Registry of Patient Registries (RoPR): Supporting Registries for Comparative Effectiveness Research
W27 A Self-service Approach to Reporting Using Dimensional Data Warehouse Architecture
W28 Burden of Post-treatment Fractures in Terms of Health Care Cost and Utilization Among Patients on Osteoporosis Treatment
W29 The Impact of Tyrosine Kinase Inhibitors on Stage IV Distant Renal Cell Carcinoma Overall Survival
W30 Factors Affecting Strategies in Asthma and COPD Clinical Trials
W31 Application of Clinical Drug Trial Methodology to the Evaluation of Nutraceuticals
W32 Regulatory Systems Assessments in Selected Low-and Middle-income Countries (LMICs)
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