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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

Agendas

The DIA Annual Meeting, the largest multidisciplinary event that brings together a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

8:30 AM — 9:30 AM

Adventures in Strategic Planning: Is the Functional Service Provider Model Dead?

8:30 AM — 10:00 AM

Clinical Quality Management Systems in the New Millennium

8:30 AM — 10:00 AM

Communicating Pharmaceutical Risks and Benefits: Why Is It So Hard and How Can We Do Better?

8:30 AM — 10:00 AM

Comprehensive Control Strategy: Building Confidence in Quality

8:30 AM — 10:00 AM

DIA 2015 Student Forum: Job Hunter's Toolkit - Some Things Change, Some Stay the Same

8:30 AM — 10:00 AM

Ebola Virus Disease Case Study: Global Harmonization to Increase Power and Accelerate Outcomes in Clinical Research Data

8:30 AM — 10:00 AM

Enabling Next Generation Sequencing Within Global Clinical Trials

8:30 AM — 10:00 AM

Forward Progress Through Collaboration: Internal and External to the FDA

8:30 AM — 10:00 AM

Health Canada's Approach to Achieve Regulatory Harmonization: An Update

8:30 AM — 10:00 AM

How Pharmaceutical Companies and CROs Are Harnessing Big Data and Cloud Computing to Increase R&D Innovation, Efficiency, and Collaboration

8:30 AM — 10:00 AM

How Sponsors Are Solving the Unique Data Collection Challenges of Late-Stage Studies

8:30 AM — 10:00 AM

In Vitro and In Vivo Preclinical Testing of Biosimilars: What Have We Learned?

8:30 AM — 10:00 AM

Next Generation Feasibility: How to Predict the Unpredictable and Plan for Success

8:30 AM — 9:30 AM

Patient-Centricity: Buzzword or Method to Improve Operational Efficiency?

8:30 AM — 10:00 AM

Project Management of Adaptive Trials: Infrastructure and Methodology

8:30 AM — 10:00 AM

Risk Management Plans Ten Years On: Where Are We Now and Where Are We Going?

8:30 AM — 10:00 AM

The Emerging Role of Medical Affairs in Biopharmaceutical Organizations: Challenges and Opportunities

8:30 AM — 10:00 AM

The Growing Role of the Patient Leading Into PDUFA VI: Negotiations and 2016

9:30 AM — 4:30 PM

Student Posters (MONDAY)

11:00 AM — 12:30 PM

Clinical Quality by Design: From Theory to Practice

11:00 AM — 12:30 PM

Codevelopment of a Drug in the Pharmaceutical Industry: Is It Ever Fun?

11:00 AM — 12:30 PM

Engaging Patients and Health Care Professionals Through Social Media and Big Data Systems

11:00 AM — 12:00 PM

Evolving Your Regulatory Information Management Strategy to Meet the Changing Business Environment

11:00 AM — 12:30 PM

Facilitating Rare Disease Patient Participation in Clinical Trials

11:00 AM — 12:30 PM

Global Drug Development in China: Opportunities and Challenges for Innovation

11:00 AM — 12:30 PM

How to Achieve Value of Operational Transformation: It Requires Innovation, Process Excellence, and Adoption

11:00 AM — 12:00 PM

Integrating Patient Engagement with EHR Data and eSource for Better Studies

11:00 AM — 12:30 PM

International Regulatory Convergence: Collaboration, Cooperation and Global Governance

11:00 AM — 12:30 PM

New Pandemics: Lessons Learned from the Ebola Experience

11:00 AM — 12:00 PM

Next Generation Nanomedicines and Nanosimilars: Regulators’ Perspective

11:00 AM — 12:30 PM

Pediatric Clinical Trials: Learning from Patients, Parents, and Investigative Sites

11:00 AM — 12:30 PM

Reducing Drug Shortages

11:00 AM — 12:30 PM

REMS Integration into the Health Care System: Three Perspectives in an Evolving Environment

11:00 AM — 12:30 PM

Statistical Evaluation of Therapeutic Equivalence for Locally-Acting Generic Products

11:00 AM — 12:30 PM

The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps

11:00 AM — 12:30 PM

The What, Why and How of Coaching and Its Application in the Work Place

11:00 AM — 12:00 PM

What Contract Research Organizations Value in a Partner: Results of a Perception Survey

12:45 PM — 1:15 PM

Quintiles Innovation Theater: Improve Clinical Development by Enhancing Site Relationships, Technology, and Patient Engagement

1:30 PM — 2:15 PM

ConvergeHEALTH by Deloitte Innovation Theater: Transforming Clinical Research Models

2:30 PM — 4:00 PM

Plenary Session & Keynote Address

4:15 PM — 4:45 PM

BBK Worldwide Innovation Theater: Are You Patient-Centric? Why Your Answer Must Be Yes

5:00 PM — 5:45 PM

Teuteberg Innovation Theater: Expanding Patient Recruitment Globally With Social Media

8:00 AM — 9:00 AM

A Biopharmaceutical Company/Services Provider Partnership: Value to Both Companies and Progress to Date

8:00 AM — 9:30 AM

Can We Talk? Alternative Strategies for Communicating with FDA

8:00 AM — 9:00 AM

Centralized Ethics: How a Unique Partnership Between a CRO and an IRB Is Changing the Regulatory and Ethics Review Process

8:00 AM — 9:30 AM

Emerging Practices in Product Commercialization Planning: How Cross Collaboration Is Redefining Product Development Planning

8:00 AM — 9:30 AM

FDA GCP Compliance and Enforcement Updates

8:00 AM — 9:30 AM

Global Regulation of Advanced Therapies

8:00 AM — 9:00 AM

How to Succeed in Orphan Drug Regulatory Affairs

8:00 AM — 9:30 AM

Implementing Risk-Based Monitoring

8:00 AM — 9:30 AM

International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP): Will Your Company Be Ready by 2016?

8:00 AM — 9:00 AM

Learning By Doing: Regulatory Applications for Breakthrough Therapies

8:00 AM — 9:00 AM

Moving the Role of the CRC and CRA into the 21st Century: Opportunities and Challenges

8:00 AM — 9:30 AM

New Approaches to Submission Components

8:00 AM — 9:30 AM

New Challenges for a Data Monitoring Committee

8:00 AM — 9:30 AM

Pediatric Therapeutic Development: From Policy to Portfolios to Patients

8:00 AM — 9:30 AM

PMDA Town Hall

8:00 AM — 9:30 AM

Prescription Drug Marketing Regulatory Primer

8:00 AM — 9:30 AM

Regulatory Examination of Nonclinical Testing Requirements and Juvenile Animal Studies

8:00 AM — 9:30 AM

Remember That? Choosing Recall Intervals for Patient-Reported Outcome Measures

8:00 AM — 9:30 AM

Safety in Special Situations: Vaccines, Stem Cells and Beyond

8:00 AM — 9:30 AM

Social Media: Opportunities and Challenges in Pharmacovigilance and Clinical Research

8:00 AM — 9:30 AM

The Art and Science of Portfolio Management

8:00 AM — 9:30 AM

The Development of Patient Power: From Consumer to Active Participant!

8:00 AM — 9:30 AM

The Role of Innovation in Clinical Trial Advocacy: Developing and Executing Patient-Centered Strategies and Partnerships Throughout the Continuum

9:00 AM — 4:00 PM

Professional Poster Session 1 (TUESDAY)

9:30 AM — 10:30 AM

Tuesday Oral Presentations - Professional Poster Session 1A

9:45 AM — 10:15 AM

Covance Innovation Theater: Advances in Risk-Based Monitoring: Transforming Drug Development Through Efficient Workflows, Big Data and Elegant Software

10:30 AM — 12:00 PM

21st Century Pharmacovigilance: Improving Outcome Traceability for Products Across the Complexity Continuum, From Generics to Biologics and Vaccines

10:30 AM — 12:00 PM

Better Team Performance in Drug Development: Effective Relationship Building Across Cultures, Especially the West and Asia

10:30 AM — 12:00 PM

Breakthrough Medicines or Affordable Health Care: Do We Have to Choose?

10:30 AM — 11:30 AM

Efficient Authoring of Submission Documents

10:30 AM — 12:00 PM

FDA Enforcement Update: Advertising and Promotion

10:30 AM — 12:00 PM

FDA Study Data Technical Conformance Guide (Part 1 of 2): An Overview

10:30 AM — 12:00 PM

FDA's International Posts: International Efforts, Regulatory System Strengthening and Inspections

10:30 AM — 12:00 PM

Good Regulatory Practice (GRP): A Regulatory Affairs Quality System for the 21st Century

10:30 AM — 12:00 PM

How Pharmaceutical Companies Can Engage Responsibly with Patients Online

10:30 AM — 12:00 PM

How to Trust Data from Wearable Devices Used in Clinical Trials

10:30 AM — 12:00 PM

Impact of FDA Oversight of Laboratory-Developed Tests Upon Innovation in the Targeted Therapy Setting

10:30 AM — 12:00 PM

Navigating Complex Biological and Regulatory Pathways to Bring Novel Gene and Cell Therapies to the Clinic

10:30 AM — 12:00 PM

Networking: It's Not What You Know, But Who You Know!

10:30 AM — 12:00 PM

Office of Pharmaceutical Quality Update

10:30 AM — 12:00 PM

Rare Disease Organizations and Industry Players: Collaborating Effectively to Advance R&D for Rare Disease Patients

10:30 AM — 12:00 PM

Recent Trends in Facilitating Decision Making in Drug Development

10:30 AM — 12:00 PM

Regulation of Combination Products in the 21st Century

10:30 AM — 12:00 PM

Risk-Based Quality Management in Clinical Trials: From the Vision to Its Regulation and Implementation

10:30 AM — 11:30 AM

Taking the Pulse of Outsourcing Relationship Structures and Their Impact

10:30 AM — 12:00 PM

The State of Pediatric Research in the United States

10:30 AM — 12:00 PM

The Use of Adaptive and Bayesian Approaches in Clinical Trials: Sharing Experiences and Case Studies

10:30 AM — 12:00 PM

Using Registries to Support Recruitment in Alzheimer's Disease (AD) Prevention or Delay-of-Onset Studies

11:35 AM — 1:32 PM

Tuesday Oral Presentations - Professional Poster Session 1B

12:00 PM — 12:45 PM

Quintiles Innovation Theater: Transform Clinical Development – Modernizing for Smarter Trials

1:00 PM — 1:30 PM

Veeva Innovation Theater: 2015 Paperless Trial Master File (TMF) Survey: Trends and Insights

1:30 PM — 2:30 PM

Collaborate to Innovate: Exploring a Seconds Market

1:30 PM — 2:30 PM

Continuous Improvement and Innovation in Manufacturing Approaches

1:30 PM — 2:30 PM

Developing Online Communities: Perspectives for Site and Patient Engagement

1:30 PM — 3:00 PM

Disruptive Forces in Health Care Innovation: Where Are They Leading Us?

1:30 PM — 3:00 PM

Engaging Patients as Partners: Effective Trial Communications to Build Trust and Improve Patient Participation

1:30 PM — 3:00 PM

Essential Approaches to Promotional Review of Mobile Health Apps: Technology That Is Here to Stay and Evolving Fast

1:30 PM — 3:00 PM

European Medicines Agency Scientific Guidance on Postauthorization Efficacy Studies

1:30 PM — 3:00 PM

FDA Study Data Technical Conformance Guide (Part 2 of 2): An Interactive Q&A Session

1:30 PM — 3:00 PM

Implementing Risk-Based Monitoring: Best Practices from Pharmaceutical Industries to Contract Research Organizations

1:30 PM — 3:00 PM

Life Cycle and Portfolio Management: Regulatory Agency and Pharmaceutical Company Approaches

1:30 PM — 3:00 PM

Roadmap to Measuring Clinical Trial Quality

1:30 PM — 3:00 PM

Success from Bench to Launch: Challenges and Opportunities with Development of Companion Diagnostics

1:30 PM — 3:00 PM

The Challenges and Opportunities of Digital Health Care: What Does the Future Hold?

1:30 PM — 3:00 PM

Tool Is a Good Four-Letter Word

1:30 PM — 3:00 PM

Transatlantic Collaboration on Pediatric Study Plan/Pediatric Investigation Plan: Recent Experience

2:30 PM — 3:10 PM

Tuesday Oral Presentations - Professional Poster Session 1C

3:00 PM — 3:30 PM

BBK Worldwide Innovation Theater: mHealth: A New Era in Patient Engagement

3:30 PM — 5:00 PM

A Critical Examination of the Strengths and Weaknesses of Different Project Management Models

3:30 PM — 5:00 PM

Bringing Clinical Trial Practices into the 21st Century

3:30 PM — 5:00 PM

CDRH Town Hall

3:30 PM — 5:00 PM

CMC/GMP: Risk-Based Regulatory Review

3:30 PM — 5:00 PM

Conflict Resolution: Helping Teams Manage Through Conflict

3:30 PM — 5:00 PM

Continuing Growth in Combination Products: More Products, More Questions - Perspectives from FDA and Industry

3:30 PM — 5:00 PM

Data and Evaluation Needed for Robust Evidence: Regulators' Challenges

3:30 PM — 4:30 PM

Getting More Out of Outsourcing Agreements: Value Additions Through Synergies and Process Optimization

3:30 PM — 5:00 PM

Getting the Most Out of Scientific Advice in the US and EU

3:30 PM — 5:00 PM

Has the New Format PSUR/PBRER Achieved What Was Originally Intended?

3:30 PM — 5:00 PM

How Biomarkers Can Be Leveraged to Improve Return on Investment in Drug Development

3:30 PM — 5:00 PM

How Risk-Based Monitoring and eSource Methodologies Are Impacting Clinical Sites, Patients, Regulators and Sponsors

3:30 PM — 4:30 PM

Incorporating a VAT Tax Strategy Into Your Global Investigator Payment Plan

3:30 PM — 5:00 PM

Innovative Approaches to Patient Registries for Evaluating Outcomes

3:30 PM — 5:00 PM

Leadership and Process in Medical Writing

3:30 PM — 5:00 PM

Managing Protocol Deviations: Applying the Protocol Deviations Working Group SOP for Handling Protocol Deviations in Clinical Trials

3:30 PM — 5:00 PM

Optimizing Patient Labeling: A Panel Discussion Between Industry, Academia, and Prescribers

3:30 PM — 5:00 PM

Pediatric Clinical Trials: One Size Does Not Fit All

3:30 PM — 4:30 PM

Pediatric Drug Development

3:30 PM — 5:00 PM

Predictive Subgroup Methodologies and Molecular Basket Designs

3:30 PM — 5:00 PM

Progress Report on Emerging Nations and Regulatory Capacity Building

3:30 PM — 5:00 PM

Striking a Balance Between Ethical Treatment and Impact on Nonclinical Safety and Animal Rule Efficacy Study Interpretation When Using Prophylactic or Supportive Care

3:30 PM — 5:00 PM

The Free Exchange of Truthful and Non-Misleading Medical Information

3:30 PM — 5:00 PM

Translating New Knowledge from Regulatory Science into Postmarketing Safety Practice

8:00 AM — 9:30 AM

21st Century Cures: Which Are the Most Transformative Provisions and How Do They Accomplish Major Change?

8:00 AM — 9:30 AM

Benefit-Risk Assessment of Medicines: Three Perspectives on Current Methodologies and the Statistician’s Role in Implementation

8:00 AM — 9:00 AM

CDISC SHARE Repository: Laying the Tracks and Building the Stations for This New Metadata Train

8:00 AM — 9:30 AM

Challenges in Managing Global Regulatory Divergence

8:00 AM — 9:30 AM

Changes in Regulations That May Impact How Inspections Are Conducted: Regulatory Perspectives

8:00 AM — 9:00 AM

How to Make a Strategic Partnership Model Work at the Country/Site Level in Asia Pacific and Insight from a Regulatory Inspector

8:00 AM — 9:30 AM

Innovative Approaches to Predictive Clinical Safety and Signal Detection Utilizing Clinical Pharmacology Concepts

8:00 AM — 9:30 AM

Keys to Managing a Successful Regulatory Strategy and Submission

8:00 AM — 9:30 AM

Leveraging Diverse Patient Insights

8:00 AM — 9:30 AM

Mapping the Future for Trial Master File: Advancing Standards by Harmonizing Clinical and Technical Strengths

8:00 AM — 9:30 AM

Patient Registries: Design, Development, and Recruitment

8:00 AM — 9:30 AM

Pharmacovigilance Concerns with the Use of Experimental Medicines for Ebola and Enterovirus B-68

8:00 AM — 9:30 AM

Rare Diseases and Subgroups Defined by Tumor Evolution: Common Themes and Challenges

8:00 AM — 9:30 AM

Real-World Use of Multi-Criteria Decision Analysis for Benefit-Risk Assessment: Lessons Learned in the Industrial Setting

8:00 AM — 9:30 AM

Recent Experiences with Adaptive Licensing and Facilitated Regulatory Pathways

8:00 AM — 9:30 AM

Returning Results to Study Participants: Health Literacy and Effective Language

8:00 AM — 9:30 AM

The Future of Clinical Trial Data Sharing

8:00 AM — 9:30 AM

The Impact of the eLabeling Rule on Industry and Stakeholders

8:00 AM — 9:30 AM

Transforming Industry Through Centralization of Key Business Practices: A Focus on Prequalification of Niche Suppliers

8:00 AM — 9:00 AM

Update: FDA CDER's Progress to Adapting Standardized Data to Select Clinical Sites for Inspection

9:00 AM — 4:00 PM

Professional Poster Session 2 (WEDNESDAY)

9:30 AM — 10:30 AM

Wednesday Oral Presentations - Professional Poster Session 2A

9:45 AM — 10:15 AM

SAS Institute Inc., JMP Division Innovation Theater: Benefit and Risk Signal Detection in Clinical Trials

10:30 AM — 12:00 PM

Best Evidence Generation: Regulatory Perspectives

10:30 AM — 12:00 PM

DEVELOP Excellent Presentations to INNOVATE the Way You Communicate Information and ADVANCE Your Career

10:30 AM — 12:00 PM

Digitization of Clinical Trials: Check the Pulse on Bringing Benefits to Patients

10:30 AM — 12:00 PM

Direct-to-Patient Strategies That Are Changing the Landscape of Clinical Trials

10:30 AM — 12:00 PM

Electronic Standardized Data in Regulatory Submissions

10:30 AM — 12:00 PM

Emerging and Mid-Sized Biopharmaceutical Companies Building Successful CRO Relationships: Overcoming the Challenges by Applying Alliance Management Principles and Technology

10:30 AM — 12:00 PM

FDA Sentinel Initiative

10:30 AM — 12:00 PM

Good Clinical Practice and Pharmacovigilance Issue Management and CAPA Effectiveness

10:30 AM — 12:00 PM

How Can International Guidances Enable Global Regulatory Convergence?

10:30 AM — 12:00 PM

How Collective Insights of Medical Affairs Customer-Facing Teams Work to Inform Strategy

10:30 AM — 12:00 PM

Implications of Clinical Test Result and ECG Variability on the Design, Conduct, and Interpretation of Early Phase Clinical Studies

10:30 AM — 11:30 AM

Incremental Innovation: How to Strategically and Practically Move Innovative Ideas into Action Within Your Company and Research Programs

10:30 AM — 12:00 PM

Integrated Cardiac Safety

10:30 AM — 12:00 PM

Medicine Development and Authorization: A Patient-Centered Approach

10:30 AM — 12:00 PM

Opening the Door to Data Transparency: What's the Verdict?

10:30 AM — 12:00 PM

Orphan Drug Development Challenges: Case Studies

10:30 AM — 12:00 PM

Pharmacovigilance Inspections: Achieving Compliance in a Global Environment

10:30 AM — 12:00 PM

Power Up! Give Your Brain a Break!

10:30 AM — 12:00 PM

Precision Medicine: Where Is the Technology Taking Us, How Fast and Who Is Driving?

10:30 AM — 12:00 PM

Putting It All Together: A Shared, Comprehensive, Integrated Global System for Clinical Research

10:30 AM — 12:00 PM

The Role of Labeling in Successful Human Factors Studies

10:30 AM — 12:00 PM

The Role of the Clinical Statistician in Understanding and Using ADaM Data Standards

10:30 AM — 11:30 AM

Utilizing an Effective Project Management Framework to Manage Clinical and Biopharmaceutical Projects With Better Results

11:35 AM — 1:30 PM

Wednesday Oral Presentations - Professional Poster Session 2B

12:00 PM — 12:30 PM

SAS Innovation Theater: Accelerate Value-Based Drug Development With Analytics

12:45 PM — 1:30 PM

Quintiles Innovation Theater: Driving Better Decision-Making with Real-World Data and Analytics

1:30 PM — 3:00 PM

A Global Update on Orphan Drugs

1:30 PM — 3:00 PM

A Proactive and Systematic Approach to Managing Product Risk Across the Life Cycle

1:30 PM — 3:00 PM

Big and MultiStream Data for Drug Evaluation: The Promise and Cautions

1:30 PM — 3:00 PM

Cardiac Safety Considerations in Pediatric Drug Development

1:30 PM — 3:00 PM

CBER Town Hall: Innovation and Public Health Response

1:30 PM — 3:00 PM

Conducting Courageous Conversations as a Strategy to Work with Difficult People

1:30 PM — 3:00 PM

Does Bioequivalent Always Mean Therapeutically Equivalent? Impact of FDA’s Proposed Rule on Generic Labeling

1:30 PM — 3:00 PM

Effective Discovery, Development and Use of Biomarkers in Early Drug Development

1:30 PM — 3:00 PM

Expediting Drug Development Through FDA’s Breakthrough Therapy Designation

1:30 PM — 3:00 PM

Frontier Issues in Electronic Information Integrity Today

1:30 PM — 3:00 PM

Globalization of Field Medical Science Liaisons: How to Take It to the Next Level

1:30 PM — 3:00 PM

Is Facebook Hurting Your Trial? Social Media and the Introduction of Bias in Clinical Studies

1:30 PM — 3:00 PM

Issue Resolution in Clinical Partnerships

1:30 PM — 3:00 PM

Measuring the Impact of Regulatory Pharmacovigilance in Europe and the United States

1:30 PM — 3:00 PM

No More Crying Wolf: FDA Issues Final Rule on Changes to Pregnancy and Lactation Information in Drug Labeling

1:30 PM — 3:00 PM

Operationalizing the Pragmatic Clinical Trial: The Role of PCORI and the Pharmaceutical Industry

1:30 PM — 3:00 PM

Project Management in Context: Reflections on the Project Manager Role from Other High-Risk Industries

1:30 PM — 2:30 PM

Regulatory Framework for Medical Devices in Europe

1:30 PM — 3:00 PM

Risk-Based Inspections and Compliance

1:30 PM — 3:00 PM

Searching for the Gold Nuggets: Text Analysis in Clinical Data

1:30 PM — 3:00 PM

The Challenges, Solutions and Right To Try Surrounding Expanded Access

1:30 PM — 3:00 PM

The Voice of the Sites: Collaborating to Build a Site Partnership Model to Enable Study Start-Up

1:30 PM — 3:00 PM

TransCelerate Collaboration: Harmonization Efforts to Find Solutions to Critical Industry Challenges

1:30 PM — 3:00 PM

Using Data Analytics to Detect Quality Issues

1:30 PM — 3:00 PM

Using Games and Play to Create an Innovative Learning Experience

2:30 PM — 3:10 PM

Wednesday Oral Presentations - Professional Poster Session 2C

3:00 PM — 3:30 PM

SIGNiX Worldwide Innovation Theater: Formula One Study Start-up: How To Get a 94% Reduction in Time By Going Paperless

3:30 PM — 5:00 PM

Accountable Care Organizations and Integrated Health Care

3:30 PM — 5:00 PM

Adapting Risk Management Principles to Nontraditional R&D Settings

3:30 PM — 5:00 PM

Asia Town Hall: Asia as a Drug R&D Center in the World

3:30 PM — 5:00 PM

Best Practices for Effective Engagement with Patient Groups Around Clinical Trials

3:30 PM — 5:00 PM

CFAST Initiative: Potential to Dramatically Increase ROI and Reduce Timelines in the Conduct of Clinical Trials

3:30 PM — 5:00 PM

CIOMS IX: Practical Approaches to Risk Minimization and Its Evaluation

3:30 PM — 5:00 PM

Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women

3:30 PM — 5:00 PM

Dynamic Changes in Regulatory Landscape in Asia: Regulations for Global Drug Development

3:30 PM — 5:00 PM

Enforcement Update and Trends From a Global Perspective

3:30 PM — 5:00 PM

Enhanced Collaborative Strategies: FDA and Device Makers Focusing on Improved Device Clearance Processes

3:30 PM — 5:00 PM

Knowledge Management for the Product Life Cycle

3:30 PM — 5:00 PM

Making Evidence at Launch More Real-World: Pragmatic Trials, Current Developments and Operational Challenges

3:30 PM — 5:00 PM

Optimizing Investigative Site/Country Selection Using Online Feasibility Tools, Big Data, and Disruptive Technologies

3:30 PM — 5:00 PM

Outing Innovation: How Partnerships Help (and Hinder) the Movement Toward Novel Approaches to Clinical Development

3:30 PM — 5:00 PM

Pediatric Product Development in the 21st Century: Developing Research Networks to Get the Job Done

3:30 PM — 4:30 PM

Rare Diseases: Patients, Caregivers and Advocates as Equal Partners in Clinical Trial Process

3:30 PM — 5:00 PM

Speaking and Publishing Opportunities with DIA

3:30 PM — 5:00 PM

Statistical Support of Risk-Based Monitoring

3:30 PM — 4:30 PM

The Critical Role of Document Management Supporting Submissions: Regulatory Operations, IT and Vendor Perspectives

3:30 PM — 5:00 PM

The State of Informatics at CDER and CBER

9:00 AM — 10:30 AM

Accidental Drugs: A Historical Look at How Certain Drugs Came to Market and Policy Pathway Opportunities

9:00 AM — 10:00 AM

Aha: Moments of Breakthrough Thinking Leading to New Opportunities

9:00 AM — 10:30 AM

An Insider’s View of Cooperation Between the EMA and CDER/FDA: Question Time

9:00 AM — 10:30 AM

Bring Your Own Device (BYOD) Approaches to the Collection of Electronic Patient-Reported Outcome Data in Clinical Trials

9:00 AM — 10:30 AM

Innovations in Strategic Alliances and Overcoming Obstacles

9:00 AM — 10:30 AM

Innovative Designs for Cardiovascular Outcome Safety Trials in Type 2 Diabetes

9:00 AM — 10:00 AM

Lung-Map: A Future Clinical Trial with a Master Protocol Happening Now and the Value to Patients

9:00 AM — 10:30 AM

Mobile Health, Telemedicine, and Remote Sensors in Clinical Investigations: A New Era in Clinical Trial Design?

9:00 AM — 10:00 AM

Novel Data Sources and Tools for Pharmacovigilance

9:00 AM — 10:30 AM

Survey Results: How Project Managers Leverage Tools and Techniques

9:00 AM — 10:00 AM

The Ultimate in Patient-Centered Trials: Bringing Study Visits into the Home

9:00 AM — 10:30 AM

Tired of Reinvesting in Old R&D Systems? Several Large Pharmaceutical Companies and Other Leaders Are Flipping Paradigms

10:45 AM — 11:45 AM

A Systematic Approach to Study Start-Up

10:45 AM — 12:15 PM

CDER Town Hall

10:45 AM — 11:45 AM

DEVELOP Risk-Based Monitoring Strategies to INNOVATE Study Oversight and ADVANCE Study Execution

10:45 AM — 12:15 PM

Global Developments in the Regulation of Biological Therapeutics

10:45 AM — 12:15 PM

Just the Facts: A Model for Evaluating the ROI of Outsourcing Investigator Payments

10:45 AM — 11:45 AM

Leveraging Electronic Health Record Data in Close Collaboration with Health Systems to Accelerate Precision Medicine

10:45 AM — 11:45 AM

Making Technology a Key Component of Your Learning Strategy

10:45 AM — 12:15 PM

mHealth / mClinical and Clinical Trials: A Candid Discussion on Opportunities and Risks

10:45 AM — 12:15 PM

The Future of Pharmacovigilance Operations

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