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DIA 48th Annual Meeting 
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Track: 

Conference Set
Track Set
 Special Content Bundles
 Evaluations
 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: Product Advertising and Marketing
 Track 06: Medical Writing and Medical Communications
 Track 07: Processes and Technologies for Clinical Research
 Track 08: Regulatory Affairs and Submissions
 Track 09: Medical Diagnostics and Devices
 Track 10: Public Policy/Health Care Compliance/Regulatory Law
 Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), 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: Global Regulatory
 Track 18: Rare/Neglected Diseases
 Track 19: SIAC Showcase
 Track 20: Executive Program: Pioneering Partnerships
 Track 21: Late-breaker
 Track 22: White Paper Showcase
 Student Posters, Monday June 25, 2012
 Professional Poster Session 1, Tuesday June 26, 2012
 Professional Poster Session 2, Wednesday June 27, 2012
 Tutorials
 OTHER
 

Track 01: Clinical Operations

101  Investigator Site Relationship Management Workshop   
102  EMRs for Clinical Research: Hype versus Reality - A Management Primer     
103  Clinical Supply Chain Symposium     
125  Increasing Protocol Complexity Places Challenges on Research Site Budgeting     
126  Social Media: The Promise and Pitfalls for Patient Recruitment     
151  A Day in the Life of a Clinical Research Site: What's Getting in the Way?     
152  ePatient Recruitment, Study Sites, and the Digital Divide     
215  Understanding Risk-based Monitoring: Is It Art, Science, or Both?     
216  The Next Patient Recruitment Frontier: Leveraging Mobile Health Care Technology (mHealth) to Recruit Patients for Clinical Trials     
217  Update on Collaborative Projects of the Clinical Trials Transformation Initiative (CTTI)     
240  Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials     
241  Investigator Budgets' Impact on Patient Enrollment and Retention: How to Improve Sponsor/CRO/Site Selection Processes     
242  Sponsors and CROs: Don't Be Misled by Your Site Performance Data   
301  How Industry Can Partner with FDA in Defining a Risk-based Monitoring Program     
302  Collaboration and Globalization of Clinical Trials: What Does It Mean to Pharmaceutical Project Managers?     
326  Clinical Research in Emerging Regions Around the World     
327  Applying Longstanding Ethical Principles in a Period of Dynamic Change     
347  Clinical, Statistical, and Data Management Considerations for Developing Clinical Trial Protocols     
348  New Regulations and Guidance for Clinical Trials and Human Subject Protection     
349  Building Clinical Site Capacity for Research     
372  Standard of Care: Challenges for Sponsors, Sites, and Patients in Clinical Trial Budgets     
373  Special Populations Symposium     
374  Optimizing Study Monitoring Performance and Efficiency     
401  Clinical Trial Metrics Symposium     
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Track 02: Project/Portfolio Management and Strategic Planning

104  The Need for Organizational Flexibility in Portfolio Management     
105  Data Quality by Design (DQbD) to Improve the Quality of Clinical Trial Data in Multiregional Clinical Trials (MRCTs)     
127  Quality by Design in Clinical Development: Blessing or Burden?     
128  Get the Team to Take Charge!   
153  Enhancing Decision Making and Maximizing Portfolio Value Creation Using a Novel Portfolio Management Framework   
154  Keys to Successful Project Execution: Innovative Approaches to Critical Chain, Critical Path, and Risk Management     
201  Portfolio Optimization: Overview     
202  Project and Program Management Competency Models for the (Bio) Pharmaceutical Industry     
218  Optimizing Performance in Outsourced Projects in China and Other Asian Countries     
219  Improving Protocol Design: Current Industry Practices and New Approaches     
243  Planning Your Drug's Development Life Cycle     
244  Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products     
303  Integrating Pharmacogenomics and Companion Diagnostic Development into the Integrated Clinical Development Plan     
304  Asian Regulatory Agencies Relocated into Biotech Science Park as a Strategy for Global Drug Development     
328  Achieving Alignment in a Difficult and Diverse Environment     
329  Project Risk Management Simulation for Product Development   
350  Drug Development Strategies and Incorporation of an Established Project Management System     
375  Planning and Execution of a Global Oncology Program     
402  Managing Drug Development Portfolios in a Safety-heightened Environment     
414  Strategically Reduce Study Cost by Controlling Study Design Cost Drivers, with Attention to Studies with Biomarkers   
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Track 03: Innovative Partnering Models and Outsourcing Strategies

106  Best Practices in Managing Alliances: Using the Balanced Scorecard Methodology to Align Strategy and Operational Execution   
129  Managing a Complex Outsourcing Collaboration     
155  Pharma R&D in Asia: Opportunities, Models, and Challenges     
156  Pre-competitive Public Private Partnerships: The Changing Model of Pharmaceutical R&D     
203  The New Reality - Strategic Partnerships under Scrutiny: Are They Working, and How Long Will It Take to Ensure Success?     
220  The Unintended Consequences of Strategic Partnerships     
245  Collaborative Partnerships in Drug Development: An Executive Roundtable Discussion   
305  Risk-sharing Partnerships: Models for Managing Risk across the Clinical-commercial Continuum     
306  Patient Advocacy and Your Next Generation of Research: How Nonprofit Organizations Can Accelerate Product Development     
330  Partnering for Impact in Global Health     
351  Thinking Small! A Virtual Pharma Gets Big Work Done with Like-minded Partners     
352  Functional Service Provider Symposium     
376  Effectively Managing Global Trials Within a CRO Alliance Structure     
377  Sites, CROs, and Sponsor Relationship Obstacles and Opportunities     
403  Integrated Partnership: A Vaccine Case Study     
404  Multistakeholder Development Partnerships: Harnessing Differing Perspectives, Objectives, and Strengths for Success     
415  Preferred Provider Relationships: Yesterday's Obstacles, Today's Successes, and Tomorrow's Vision     
416  Using Technology to Build Successful Strategic Outsourcing Partnerships     
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Track 04: Nonclinical and Translational Development/Early Phase Clinical Development

107  First-in-human Challenges of Biologics and Biosimilars     
130  Renal Impairment Studies Design, Conduct, and Analysis     
157  Drug QT Derisking: Changes in When and How     
204  Novel Imaging Techniques Symposium     
221  Skin-drug Biotransformation: What Testing Should We Do?     
246  Product Candidate to Proof-of-concept: An Integrated Approach to Accelerate Programs     
307  Nanotechnology: Regulatory Challenges and Opportunities     
331  Can Human Carcinogenic Risk Be Communicated Without a Rodent Bioassay?     
353  Microdosing: Past Experience and Future Role in Translational Medicine     
378  Biomarker Focused Strategies for Personalized Medicine     
405  Hot Topics Symposium     
417  Strategies for Implementing Dried Blood Spot Drug Development and How the Technology Supports the 3Rs Principles     
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Track 05: Product Advertising and Marketing

308  Prescription Drug Marketing Regulatory Primer   
332  FDA Enforcement Update: Advertising and Promotion     
354  International Advertising/Promotion Coordination     
379  Leveraging Drug Development and Advertising/Promotion Regulatory Expertise to Drive a Robust Target Product Profile Process     
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Track 06: Medical Writing and Medical Communications

108  Advancing Benefit-risk Visualization and Communication     
131  Wrangling the Bestiary of Safety Documents: Coordination and Integration across Multiple Requirements     
158  Communicating Drug Safety Information Using Social Media: FDA and Industry Perspectives     
205  Medical Contributions to Promotional Tactics     
222  Publish or Perish: Retracted Scientific Literature     
247  From Design to Disclosure: Pleasing Multiple Masters     
309  Implementing Structured Authoring: Understanding the DITA Model and Its Applicability for Content and Metadata Management   
333  Efficient Regulatory Medical Writing for Global Submissions Including "ICH Outlier" Authorities     
355  Global Medical Information in Real-life Situations     
356  What Medical Writers Need to Know about MedDRAź   
380  Recent Advances in Adaptive Clinical Trial Designs for Medical Writers     
406  Study Recruitment Challenges, Tailored Medical Information Requests - OH MY! Have You Maximized All Your Options     
418  Medical Writing Competencies and Best Practices in the Global Environment     
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Track 07: Processes and Technologies for Clinical Research

109  New Ways to Learn What Happens to Patients AFTER Approval     
132  Capitalizing on Biometric Efficiencies: A Look at Data Start-up, Capture, Monitoring, and Reporting     
133  Implications of Mobile Health and Clinical Research      
159  PRO Measurement in Clinical Trials: Need for Education and Training     
160  Electronic Health Records (EHR)/Electronic Data Capture (EDC) Opportunities     
206  Defining Study Endpoints in 2012: The Journey Continues     
207  Evolving eContent Design and Exchange for Clinical Studies     
223  Labeling Claims Based on Patient-reported Outcome Measures: It Takes a Village!     
224  Lessons Learned from FDA-sponsored ARRA PCOR (American Recovery and Reinvestment Act Patient Centered Outcomes Research) Data Standardization Efforts     
248  Implementing Adaptive Clinical Trials: A Practical Perspective     
249  Innovative Ways of Looking at Computer System Validation     
310  Combining Patient Self-report and Clinician Oversight: Are Two Heads Better than One?     
311  eClinical Interoperability: Imagination, Integration, Implementation     
334  Identity Management Technologies in Clinical Trials     
335  Clinical Outcome Assessments in the Evaluation of Medical Products in Pediatrics     
357  Innovations Aimed at Improving Effectiveness and Speed of the Therapeutic Development Process     
358  Business Applications in the Cloud     
381  Sharing Clinical Data: Examples of What to Share and Benefits to Research and Patients     
382  Automation Through CDISC Standard Models: eProtocol, Data Submission, and Safety Reporting     
407  Cloud Computing in Regulated Environments   
408  The Cross-over Between Direct-to-patient Studies, Social Media, and EDC     
419  Data Warehousing: Buzz Word or Panacea?     
420  Economic Considerations and Management in the Modern Day Clinical Trial     
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Track 08: Regulatory Affairs and Submissions

110  Transforming Regulatory Information Into Actionable Regulatory Intelligence for Emerging Markets     
111  Effective Switching from Rx to OTC Status: Maximizing Revenue and Profit From Off-Patent Products     
134  Regulatory Roundtable on Biosimilars     
135  New Challenges from Outsourcing of Regulatory Operations     
136  Regulatory Strategies to Accelerate Approval in Emerging Markets Considering the Growing Complexity of Requirements and Supply Chains     
137  Challenges and Opportunities for Drug Development in China     
161  Analysis and Impact of PDUFA V: How the Changes Will Affect the Work of Regulatory Affairs Professionals     
162  Streamlining of Clinical Trial Review Process in Asian Pacific Region     
163  Vaccines: FDA and Japan Perspectives     
208  Meta-collaborations: A Call to Action   
209  Electronic Drug Registration and Listing: FDA and Industry     
225  Pediatric Development in the US: Implementation of 2007 PREA and BPCA Against a Backdrop of the EU Pediatric Legislation     
226  Drug Shortages 2012: Rewind, Repeat, Recovery     
250  An Ocean Apart? Integrating Distinct Health Authority Philosophies on Personalized Medicines and Companion Assays     
312  Patient Advocacy in Medical Product Development: The Evolving Relationship Between FDA and Its Patient Stakeholders     
313  Future Directions for eCTD Module 1     
314  Clinical Trial Disclosures: A US and EU Regulatory Update     
336  Building the Benefit-risk Toolbox: Is There a Consensus on a Scientifically Acceptable Framework?     
337  Global Product Development: Resolving Conflicting Scientific and Regulatory Advice from Multiple Health Authorities     
338  Pursuing Standards to Enhance eCTD Deliverables: PhRMA Electronic Regulatory Submissions (ERS) Group Annual Update     
359  Orphan Drug Development: Global Regulatory Challenges and Initiatives     
360  Operationalizing SDTM     
383  Adaptive Licensing: Bane or Boon for Drug Development?     
384  Update on Biosimilar Developments in the US     
421  Regulatory Handling of Ethnic Factors in Asian Clinical Trial Data #3, Implication for Simultaneous Global Development (SGD)     
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Track 09: Medical Diagnostics and Devices

112  Companion Diagnostics: Current and Future Developments     
138  Where is the 510(k) Today     
164  Discussion with Former Center for Devices and Radiological Health (CDRH) Management   
227  Combination Products     
251  Funding Innovation and Creating Opportunities in the Device, Diagnostic, and Drug Interface     
315  Oncology Medications: State-of-the-art Identification and Management of Potential CV Safety Issues During Development     
339  Current Advancement of Regulatory Reform for Medical Devices in Asia Pacific and Its Strategic Impact     
361  Update on Revision of European Medical Device Directives and Impact on Industry     
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Track 10: Public Policy/Health Care Compliance/Regulatory Law

113  Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials 
139  Regulatory Collaboration / 21st Century Innovation: Views of the Heads of Health Canada, the European Medicines Agency, and the US FDA   
165  Legal Jeopardy from the Conduct of Clinical Trials     
210  Legal Aspects of Clinical Trial Compliance     
228  Product Liability in the US and the EU     
252  Drug Rediscovery as an Innovative Tool to Meet Unmet Medical Needs     
316  Policy and Enforcement Trends: Are Regulators and Industry Heading in the Right Direction?     
340  Meeting the Therapeutic Needs of Older Patients: A Sustainable Collaborative Approach     
362  Emerging Development and Policy Trends in the Economics of the Biopharmaceutical Industry     
385  Emerging Role of the Patient Voice on Drug Policy in Japan     
386  Regulatory Capacity Building from 360 Degrees     
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Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)

114  Defining Quality in Clinical Trials     
140  Quality by Design: Is Your Clinical Trial Fit for Purpose?     
141  Good Laboratory Practice (GLP): Design and Inspection Readiness     
166  Conducting Clinical Trials in Developing Countries: Challenges in Meeting Good Clinical Practice (GCP) Compliance     
167  Building Quality into Clinical Trials: Regulatory Perspectives and Practical Considerations     
229  Misconduct and Management of Serious or Continued Noncompliance: What Are the Differences and Similarities?     
253  What Should You Put in a Clinical Quality Assurance (CQA) Agreement     
317  FDA and European Medicines Agency Collaboration: GCP Inspections and Beyond     
363  The Changing Face of Clinical Compliance: Regulatory, Technology, and Services     
387  Good Clinical Practice (GCP) through Good Documentation Practices (GDPs)   
409  The Role of Corrective and Preventive Action (CAPA) in GCP/GLP Audit Quality Management Systems     
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Track 12: Pharmaceutical Quality

115  ICH Update on Pharmaceutical Quality     
142  Postapproval Change Pathways in EU and US: Challenges and Opportunities for Harmonization     
168  Opportunities for Global Harmonization of Inspection Paradigm     
211  Quality Risk Management Workshop Part 1 of 2     
230  Preparing for CMC Meetings with the FDA     
254  Practical Implementation of Knowledge Management     
318  Auditing Pharmaceutical Quality Systems     
341  Regulatory Updates on Current Trends in Drug Quality and Manufacturing     
364  Quality Risk Management Workshop Part 2 of 2     
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Track 13: Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)

143  Demystifying Approaches to the Design and Analysis of Observational Studies of Comparative Effectiveness     
169  Application of Quality of Evidence Assessment Tools to the Evaluation of Observational Pharmacoepidemiologic Studies     
212  Recent Advancement of HTA and Its Impact on Health Care Reform and Product Life Cycle Management in the Asian Pacific Region     
231  The Effects of NICE Technology Assessments on Prescribing and Cost-sharing Behavior in the US     
255  Registries for Evaluating Patient Outcomes: Emerging Areas of Controversy     
319  Environment for Health Care Decision Making: The Role of CER, Evidence-based Medicine, Quality, and Value     
365  The Use of Health Technology Assessment (HTA) for Access and Resource Allocation Decision Making: International Examples     
388  The Role of Meta-analyses in Drug Safety: Methodological Considerations     
389  Benefit Versus Risk of Harm: Assessing Therapeutic Response and Interpreting Benefit/Risk with Patients   
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Track 14: Clinical Safety and Pharmacovigilance

116  The Impact of Social Media on Product Promotion and Pharmacovigilance     
117  Approaches to Postapproval Pediatric Safety Surveillance     
144  AE Reporting in the Era of Web 2.0: The Challenges of Having a Two-way Conversation      
145  Epidemiologists in Industry and in CROs: Penultimate Generalists and Utterly Indispensible Scientists     
170  Electronic Health Records (EHR) and Medication Safety and Adherence     
171  Use It Early and Often: Epidemiology's Many Roles in Clinical Development and Beyond     
213  Data Monitoring Committee (DMC): When You Need One and When You Don't!     
232  Comparison of National-level Drug Utilization Patterns from Large Commercial Health Care Databases with Mini-Sentinel     
233  Pharmacovigilance in Japan and Risk Management Plans     
256  Noninterventional Minimal Risk Research: A 360° Perspective     
257  Stepping Up and Doing It Step by Step: Lessons Learned from Initial Endeavors Exploring Health Care Data for Signal Detection     
320  How to Be Prepared for Shifting Regulations on Combination Products     
321  Active Surveillance Using Large, Electronic Health Care Data Networks     
342  REMS: Are Our Written Communications Truly Mitigating Risks to Patients?     
343  The Out-Sourcing/In-Sourcing/Out-Sourcing Model for Pharmacovigilance     
366  Data Sources for Monitoring Usage of Drug Products and How to Use These Sources to Support Safety and REMS Evaluations     
390  Doping Abuse of Medicines in Sport: The Challenge to Industry and Regulators     
410  Coding with Confidence   
422  Immunogenicity of Therapeutic Peptides: Regulatory Science Implications     
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Track 15: Statistical Science and Quantitative Thinking

118  Hot Topics in Statistics: Industry, CRO, Academic, and Regulatory Perspectives     
146  Extrapolation to Estimate Treatment Effects in Subgroups of Special Interest     
172  Rates and Weights: Quantifying Clinical Impact and Judgment in Benefit-risk Assessment     
214  NDA/BLA Statistical Review and the CDISC ADaM Data Standards     
234  FDA Draft Guidance on Multiple Endpoints in Clinical Trials     
258  Noninferiority Trial Designs: Perspectives from Academia, Industry, and a Regulatory Agency     
322  Statistical Methods for Analysis of Integrated Safety Data     
344  From Adverse Events to Adverse Drug Reactions: Statistical Issues in Safety Labeling     
367  Impact of Bayesian Methods in Medical Product Development     
391  Statistical Comparative Effectiveness Research (CER): Closing the Gaps in the Consideration of Observational Evidence     
411  Open Source Statistical Software in Drug Development: Challenges and Opportunities     
423  Increasing Clinical Program Success with Modeling and Simulation     
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Track 16: Professional Development

119  Translational Medicine in Africa: Challenges and Opportunities for Product Development     
147  My Big Break: Women At the Top in the Biotechnology Sector     
173  Building International Competence in Drug Development Teams     
235  Advanced Presentation Skills   
236  Introduction to Narrative Medicine   
259  Definition and Validation of Core Competencies to Enhance the Quality of Clinical Trials and Those Who Conduct Them   
323  Emerging Needs in Clinical Research and Drug Development Sciences Education and Certification     
345  Employee Engagement     
392  Learning Through Knowledge Sharing and Virtual Worlds     
393  DIA 2013: Helpful Hints in Submitting an Abstract     
412  Left to Your Own Devices     
424  Building Rapport and Managing Communication Filters for Breakthrough Collaborations     
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Track 17: Global Regulatory

120  European Town Hall: Part 1 of 2 - Hot Topics in Europe     
121  Pediatric Drug Development Progress: 15 Years Later and Across the Globe     
148  European Town Hall: Part 2 of 2 - Interacting With the European System     
174  An Update on EMA, FDA, and PMDA International Activities     
237  International Regulatory Cooperation: A Canadian Perspective     
238  Latin America Town Hall     
260  Update from the EMA-FDA Parallel Assessment Pilot     
261  SFDA Town Hall     
324  Risks to and Securing of Global Drug Supply Chains   
368  Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall     
369  CBER Town Hall     
394  The State of Electronic Submissions at CDER, CBER, and CDRH     
395  India Town Hall      
413  CDER Town Hall: Part 1 of 2     
425  CDER Town Hall: Part 2 of 2     
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Track 18: Rare/Neglected Diseases

122  Drug Development Strategies for Integrating Academia, Non-governmental Organizations (NGOs), and Industry Based on Experience in Neglected and Infectious Diseases     
149  Challenges of Orphan Drugs in the US, EU, and Japan     
262  Understanding the Challenges of Conducting Studies for Orphan Indications and Rare Diseases     
346  Natural History Studies for Rare Diseases and Orphan Conditions     
370  Social Media 2.0: The Power of Online Rare Disease Communities to Connect and Engage ePatients     
396  Rare Disease Clinical Research Consortia: Immediate and Rich Sources of Translational Research Data, Partnering Opportunities     
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Track 19: SIAC Showcase

265  Beyond Taxonomy     
266  Breaking News Update: Cutting Edge Statistical Methods in Clinical Development     
267  CDER Electronic Submissions Standards Update     
268  Controversial Guidance, eSource and Standards: How Does It All Fit Together in an eClinical World?     
269  Cross-sector Innovation Brings Tailored Therapies to Patients     
270  Electronic Data Capture (EDC): How Much Quality Is Enough?     
271  Emerging Professionals: Optimize your Transition into the Pharmaceutical Arena     
273  Reference Models and the Framework for the Destruction of Paper: How They Are Changing Our Industry     
274  Globalization of Phase 1: Trends and Challenges     
275  Good Pharmacovigilance Practice in a Global Environment     
276  Hot Topics in Clinical Trial Disclosure (CTD)     
277  Hot Topics in Regulatory Affairs Forum     
278  How Medical Writers Are Improving Global Practice and Collaboration     
279  Leveraging Technology in an Age of Readily Available Information     
280  Meet the Regulators: Helping You Ensure GCP Compliance by Knowing the Most Frequent and Serious Findings     
281  Navigating the Intersection of Outsourcing and Quality Oversight     
282  New Guidances on Quality Risk Management by FDA and EMA: Implications for Industry     
284  The Future of Project Management in the Pharmaceutical Industry: What Competencies Will Be Critical?     
285  Re-energize Your Career!     
286  Rx: A New World in Natural Health Products (NHP)     
287  Status of the Use of Electronic Health Records (EHR) in Clinical Research     
288  Who Owns the Service? Challenges in Collaboration Between IT and the Business     
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Track 20: Executive Program: Pioneering Partnerships

180  Collaborative Research with Members of the Payer Community     
560  Challenges of Precision Medicine: Diagnostics, Reimbursement, Partnership Co-development     
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Track 21: Late-breaker

123  Standards for Patients: Collaborations to Innovate Therapy Development     
263  A Challenge for the Industry: What Will it Take for a Sponsor to Use EHRs With a Regulated Research Protocol?     
397  Implementation of the Physician Payment Sunshine Act: Now What?     
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Track 22: White Paper Showcase

124  The New Health Report 2012: Rethinking the Risk Equation in Biopharmaceutical Development and Delivery     
150  Free Agency is Here: Exploring Workforce Impact on Clinical Outsourcing     
175  Raising the Bar for Regulatory Submission Document Quality: A Collaborative, Transitional Approach     
239  Value of Actigraphy in Clinical Trials     
264  The Unique Relationship between Global Patient Recruitment and Translation Management     
325  Enabling Remote Monitoring in Clinical Trials for Sponsors and Sites     
371  Implementation of Adaptive Clinical Trials     
398  Accelerating Cancer Clinical Trials     
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Student Posters, Monday June 25, 2012

M01  Effect Of Formulation pH On Micropore Closure In Microneedle Enhanced Transdermal Drug Delivery   
M02  Improvement of obstetrics and gynecology patient health by using "patient safety reporting system"   
M03  An Evaluation of the Gulf Cooperation Council (GCC) Centralized Regulatory Review Process for Pharmaceutical Products   
M04  Psychotropic Drug Use Among Autistic Individuals Enrolled In A State Medicaid Fee-for-service Program   
M05  Using Stochastic Control Methods and Pharmacokinetics to Individualise Drug Therapy   
M06  Seeking Predictable Subject Characteristics That Influence Clinical Trial Discontinuation.   
M07  Evaluating Consumer Understanding of Prescription Label Information: An Assessment of USP 2011 Recommendations   
M08  Development and Application of a Universal Benefit-risk Assessment Framework for Medicines   
M09  Examination of the Adoption of FDA's Bio-pharmaceutics Classification System (BCS): A Qualitative Study   
M10  Influence of Patient and Hospital Level Characteristics on Emergency Department (ED) Wait Time in US   
M11  Bias Assessment in Progression-Free Survival Analysis Using Interval-Censored Methods   
M12  Contract Research Organizations in China: Current and Future   
M13  The Death of New Racemic Drugs Was an Exaggeration   
M14  Drug Adverse Events Surveillance with CDISC Standards for Multiple Trials   
M15  Unmet Drug Information Needs and Clinical Adherence to Immunosuppressant Drugs of Kidney Transplant Recipients   
M16  Pharmacovigilance and Drug Repurposing Model and Application: A Case Study Using Electronic Health Record Data   
M17  Pursuing Orphan Designation in Japan: Benefits and Process   
M18  Influence of Clinical Research Investigator Fraud on Clinical Trial Participation   
M19  Recommendations for Improving e-Prescribing Technology Design and Use in Pharmacies   
M20  A Probabilistic Sensitivity Analysis to Estimate the Impact of Data Errors in a Randomized Trial to Eradicate H. pylori   
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Professional Poster Session 1, Tuesday June 26, 2012

T01  Risk Evaluation and Mitigation Strategy (REMS): 18-Month Assessment Report of Dalfampridine Extended Release 10 mg Tablets   
T02  Which ePRO Modality is Appropriate for your Study?   
T03  Situational Analysis of the Pharmacovigilance Activities in Brazilian Public Industries: Collaborate to Innovate is Essential   
T04  The "Storyline Document", A New Document Format for the Use in Pre-submission Meetings   
T05  VVSymQ™: A Simple, Validated Measure of Varicose Vein (VV) Symptoms That Can Be Administered Daily Using a Personal Digital Assistant (PDA)   
T06  Modeling and Simulation in Early Drug Development   
T07  Clinical Research and Development on Western Drug and Traditional Chinese Medicine Interaction in Taiwan   
T08  CDISC ODM End-to-End: One Sponsor's Approach   
T09  Safety Database Migration: Use of Standard E2B Files with Automated Loading as an Alternative to Traditional Migration   
T10  Survey of Pharmaceutical Industry Outcomes Liaison Practices   
T11  Making the Point: Emphasis of Claims in Prescription and Nonprescription Television Advertising   
T12  The Effect of A-Bromo-4-Chlorocinnamaldehyde on Coxsackie Virus B3-induced Myocarditis and the Mechanisms   
T13  Novel Approach to Literature Surveillance for Adverse Events using OvidSP and EndNote Auto-import Function and Customization   
T14  Capitalizing On U.S. Public Use Files To Answer Pharmacoeconomic Questions   
T15  Ustekinumab Risk Evaluation and Mitigation Strategy: Embarking and Executing on the New Era in Drug Safety   
T16  Infliximab Risk Evaluation and Mitigation Strategy: Embarking and Executing on the New Era in Drug Safety   
T17  Golimumab Risk Evaluation and Mitigation Strategy: Embarking and Executing on the New Era in Drug Safety   
T18  Systematic MedDRA Upgrade in Clinical and Post-marketing Safety Databases   
T19  Automated Semantic Web-mining for Analyzing Changes in Trial Records Over Time and Identifying Rescue Countries   
T20  Managing Standards with Governance and a Data Warehouse   
T21  Corporate Integrity Agreements: Comparison of Technology and Procedures and How They Have Changed Since Onset to Most Recent   
T22  Efficiency and Cost Benefit Analysis of Narrative Automation Using Six Sigma as Compared to Industry-wide Benchmarking of Narrative Writing Using Traditional Methods and Resources   
T23  Clinical and Regulatory Considerations for the Development of Therapeutic HIV Vaccines   
T24  Building an Analytical Roadmap to Support the New Risk-Based Site and Data Monitoring Strategy   
T25  R&D Knowledge Management starts with Higher Quality Data   
T26  Social Media and Pharmacovigilance: New Space for Signal Detection & Socialvigilance   
T27  Regulatory Labeling Experiences with the PSUR Worksharing Process   
T28  Implementation Status of CTD, eCTD and Paper-free Applications: A Global Overview   
T29  Autovaccine B7-H1IgV induced Antitumor Immunity and Enhanced HER2 DNA Vaccine-derived Immune Responses   
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Professional Poster Session 2, Wednesday June 27, 2012

W01  A Comparison of Adverse Event Coding of Ophthalmic Medical Device Reports: MedDRAź and FDA Patient Problem Codes   
W02  Patient Preferences for Reminders in Clinical Trials: Improving Both Compliance and Patient Experience   
W03  Feasibility of Remote Medical Monitoring in Clinical Research Utilizing Web-based Electronic Medical Record System   
W04  Virtual Technology Solutions: Gain Efficiencies and Increase Control Over Global Sample Inventories During Clinical Research   
W05  Application of Control Charting for Pharmacovigilance Signal Detection   
W06  Preparation of Compassionate Use Data for Quality Regulatory Submissions: Experience with Glucarpidase Development for Methotrexate Toxicity   
W07  The Impact of Patient Recruitment Methods on Data Quality   
W08  The Gap Between Clinical Trials and Comparative Effectiveness: A Case Study   
W09  The MURDOCK Community Registry and Biorepository: Collaboration as the Driving Core of a Translational Research Engine   
W10  Identification of Biomarkers in Gastric Cancer of Chinese Based on SNPs Screening and its Evaluation in Clinical Application   
W11  Study of Unique Feature of Regulatory Framework Under Japanese Pharmaceutical Affairs Law in Japan   
W12  Validation of New Patient/Clinician Reported Outcome Tool- Capturing the Visual Impact of Varicose Veins   
W13  Innovative Strategies to Enhance Minority Recruitment for Clinical Trials   
W14  Regulatory CMC BLA and NDA Submissions: Differences and Correlations from Regulatory and Scientific Perspectives   
W15  Medical Device Development Project Management: Is a Paradigm Shift Needed?   
W16  Results of Patient and Physician Survey regarding Mobile Social Media Adoption and Preferences   
W17  Implementation of a Pharma Company's Publication Policy that Ensures Compliance in an Increasingly Scrutinized Environment   
W18  Pharma Quality Agreements   
W19  Creating a Data-Driven and Quantitative Site Index Score for Optimal Site Selection   
W20  Informatics - Linchpin or Afterthought of a Business Externalization Strategy   
W21  Post-Doctoral Pharmaceutical Industry Fellowships: Perceptions of required core skills by trainees and preceptors/managers   
W22  Statistical Evaluation of the Power of the Arc Sine Test against the CMH Test for Stratified Data for Smaller Proportions   
W23  Building Novel Clinical Research Capacity in Resource-Limited Settings: Lessons Learned at Three Mozambique Sites   
W24  Preparing to Share CDISC SDTM Data: A Practical Evaluation of Potential Error Sources and Effective Review Processes   
W25  Current Drug Master File (DMF) Status in Taiwan   
W26  Producing Rules for Portugal to Improve Rational Prescribing   
W27  To Develop a Process to Help Patients Adhere to a Prescribed Haemophilia Therapy Regime   
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