DIA Learning Center

DIA 2013 49th Annual Meeting

Click here to search this conference.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Plenary Sessions

010 Opening Plenary

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

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)

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)