Agenda

Day 1 Jun 15, 2014

8:30 AM — 12:00 PM

#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development

8:30 AM — 12:00 PM

#21: The Sunshine Act: Understanding the Essentials of Compliance

8:30 AM — 12:00 PM

#22: Preparing for a US FDA Advisory Committee Meeting

8:30 AM — 12:00 PM

#23: Leadership: How to Organize and Lead People in Group Work

8:30 AM — 12:00 PM

#24: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing

9:00 AM — 5:00 PM

#40: Analysis of Safety Data from Clinical Trials

9:00 AM — 5:00 PM

#41: Quality Oversight of CROs-Clinical Vendors

9:00 AM — 5:00 PM

#42: Regulatory Affairs for Biologics

9:00 AM — 5:00 PM

#43: Clinical Statistics for Nonstatisticians

9:00 AM — 5:00 PM

#44: Quality by Design: From Theory to Practice

9:00 AM — 5:00 PM

#45: Risk Management Plan

9:00 AM — 5:00 PM

#46: The Good Pharmacovigilance Practices In The EU: Lessons Learned and Frequently Asked Implementation Questions

1:00 PM — 4:30 PM

#30: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation

1:00 PM — 4:30 PM

#31: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges and Decision Criteria

1:00 PM — 4:30 PM

#32: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine

1:00 PM — 4:30 PM

#33: Bayesian Evidence Synthesis and Network Meta-analysis

1:00 PM — 4:30 PM

#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports

1:00 PM — 4:30 PM

#35: Understanding Translational Medicine: Benefits and Innovative Approaches

Day 2 Jun 16, 2014

8:30 AM — 10:00 AM

A Common Decision Framework for Health Technology Assessment and Regulatory Agencies: Is This of Benefit to Stakeholders?

8:30 AM — 10:00 AM

Beyond Operational Excellence: A Survey on Sponsor Expectations of Preferred Business Partners

8:30 AM — 10:00 AM

Bringing the Patient Voice to Clinical Development

8:30 AM — 10:00 AM

Central Statistical Monitoring Revealed: How to Enhance Data Quality and 'De-Risk' Studies Through Enhanced Risk-Based Monitoring

8:30 AM — 10:00 AM

Data Warehousing and Integration: Current Status, Key Success Ingredients and Alternative Approaches for Maximizing the Value of Your Data

8:30 AM — 10:00 AM

Delivering Value Through Medical Content to Health Care Providers

8:30 AM — 10:00 AM

Design and Sample Size Planning for Multiregional Clinical Trials

8:30 AM — 10:00 AM

DIA 2014 Student Forum: Maintaining Your Career - Continuing Education and Changing Your Track

8:30 AM — 10:00 AM

Does One Size Fit All? Understanding the Impact of Cultural Differences Across the Globe

8:30 AM — 10:00 AM

Formal Dispute Resolution at CDER: When, Why, and How

8:30 AM — 10:00 AM

Global Clinical Trials Symposium: Opportunities and Challenges

8:30 AM — 10:00 AM

Global Pediatric Development: We Are Making Progress

8:30 AM — 10:00 AM

Implementation of Quality by Design: Progress Update

8:30 AM — 10:00 AM

Making Better Go/No-Go Decisions: Improving Success Rates and Reducing Costs

8:30 AM — 10:00 AM

New Approaches to International Collaboration Between Regulators (Part 1 of 2)

8:30 AM — 10:00 AM

One Paddle for Two Boats? Policy Alternatives to Buoy Adoption of Precision Therapies and Their Companion Diagnostics

8:30 AM — 10:00 AM

Pioneering Regenerative Medicine: Trends in Regulations for New Therapy

8:30 AM — 10:00 AM

Protocol Deviations: Finding the Yellow Brick Road (Part 1 of 2)

8:30 AM — 10:00 AM

Risk Management in the US, EU, and Asia: Where Are We Now?

8:30 AM — 10:00 AM

Stage Gate Decision-Making Workshop (Part 1 of 2)

8:30 AM — 10:00 AM

The Twitter Value Proposition for Life Science Professionals

11:00 AM — 12:30 PM

Assessment of Impact and Effectiveness of Risk Management and Minimization in the EU and US

11:00 AM — 12:30 PM

Defining, Measuring, and Assessing "Fit for Purpose" Quality in a Risk-Based Monitoring Model: Industry and Agency Perspectives

11:00 AM — 12:30 PM

Driving Toward Standardization: Overcoming Barriers - eDM, eTMF, and CTMS

11:00 AM — 12:30 PM

Effective Communication Model Between Drug Safety, Regulatory Affairs, and Clinical Development

11:00 AM — 12:30 PM

Electronic Clinical Outcome Assessments: Coming to a Device Near You!

11:00 AM — 12:30 PM

Engaging Patients through Digital and Social Media Communities

11:00 AM — 12:30 PM

Fact or Fiction: Patient Engagement in the Drug Development Process

11:00 AM — 12:30 PM

FDA Regulation of Therapeutic Products Derived from Human Stem Cells: Successfully Navigating the Regulatory Hurdles

11:00 AM — 12:30 PM

Improving Returns on Invested Capital in the Pharmaceutical and Biotechnology Industry

11:00 AM — 12:30 PM

Narrative Medicine: How to Tap into the Inherent Power of Words and Stories in the Clinical Trial Process

11:00 AM — 12:30 PM

New Approaches to International Collaboration Between Regulators (Part 2 of 2)

11:00 AM — 12:30 PM

Observational Studies of Comparative Effectiveness: How to Recognize Good Practice

11:00 AM — 12:30 PM

Pediatric Drug Development: Lessons Learned During FDASIA Implementation

11:00 AM — 12:30 PM

Pricing, Economics, Reimbursement, Market Share (PERMS) Strategy: An Interactive Holistic Approach in Rare Diseases

11:00 AM — 12:30 PM

Proarrhythmic Risk Assessment WITHOUT the Thorough QT: FDA and Pharmaceutical Company Perspectives

11:00 AM — 12:30 PM

Protocol Deviations: Finding the Yellow Brick Road (Part 2 of 2)

11:00 AM — 12:30 PM

R&D and Technology Outsourcing Today: An Industry Update

11:00 AM — 12:30 PM

Regulatory Submissions: Better, Faster, and Cheaper

11:00 AM — 12:30 PM

Risk Sharing or Risk Transfer? Striking the Perfect Balance in Strategic Partnerships

11:00 AM — 12:30 PM

Stage Gate Decision-Making Workshop (Part 2 of 2)

11:00 AM — 12:30 PM

Strategic Quantitative Thinking: Designing a Roadmap for Innovation

11:00 AM — 12:30 PM

Why Waste Time and Money? Data Standards from the Beginning: Working Together for Good Science and Good Submissions

1:00 PM — 2:00 PM

INC Research Innovation Theater: “Organizing for Change”… Lessons Learned in Preparing a Global Organization for Innovation

2:30 PM — 4:00 PM

Plenary Session & Keynote Address

Day 3 Jun 17, 2014

8:00 AM — 9:30 AM

Benefit-Risk Throughout the Product Life Cycle: How Should Benefit-Risk Be Evaluated and Communicated from Development through Marketing as New Information Emerges?

8:00 AM — 9:30 AM

Big Data, Big Impact: New Levels of Strategic Partnerships Between Sponsors-CROs

8:00 AM — 9:30 AM

Bioinformatics and Translational Medicine

8:00 AM — 9:30 AM

Capital Efficient Drug Development with Revolutionary Technologies: Calculated Risks

8:00 AM — 9:30 AM

CDRH Town Hall

8:00 AM — 9:30 AM

Clinical Outcomes Assessment and Patient Engagement Symposium

8:00 AM — 9:30 AM

CMC Development of Breakthrough Therapies

8:00 AM — 9:30 AM

Collaboration in R&D: What’s New for TransCelerate BioPharma?

8:00 AM — 9:30 AM

Communicating Clinical Trial Results: Targeting the Patient Audience

8:00 AM — 9:30 AM

Covering Industry Trends in the Biomedical Industry

8:00 AM — 9:30 AM

Drug Development and the Virtual Company

8:00 AM — 9:30 AM

Effective Leadership in Hybrid Team Between West and East Asia in New Drug Development

8:00 AM — 9:30 AM

Electronic Source Data in Clinical Investigations (Part 1 of 2): Regulatory Considerations

8:00 AM — 9:30 AM

Mitigating Missing Data in Clinical Trials: Moving Toward Global Behavioral Change Impacts Efficacy, Safety, and Quality

8:00 AM — 9:30 AM

Monitor Training: Building Essential Skills for Implementing Risk-Based Monitoring - Data Interpretation, Quality by Design

8:00 AM — 9:30 AM

Nanotechnology: Application to Medical Products

8:00 AM — 9:30 AM

PDUFA V New Molecular Entity Program: History, Implementation and Future of the Program

8:00 AM — 9:30 AM

Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall

8:00 AM — 9:30 AM

Prescription Drug Marketing Regulatory Primer

8:00 AM — 9:30 AM

Quality and Risk Management in an Increasingly Complex Clinical Research Environment: State of the Industry and Leading Practices

8:00 AM — 9:30 AM

Regulated Product Submissions and eCTD 4: The Path to Progress

8:00 AM — 9:30 AM

Regulatory and GCP Quality Trends in Emerging Markets

8:00 AM — 9:30 AM

The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances, and Precision Medicine (Part 1 of 2)

8:00 AM — 9:00 AM

The Regulatory Intelligence Function: Evolution Over the Past Decade in an Expanded Global Marketplace

8:00 AM — 9:30 AM

Updated Strategies for Effective Recruitment of Patients in Clinical Trials

8:00 AM — 9:00 AM

Using Comparative Effectiveness Research to Make Health Care Decisions: Exploring the Environment, Opportunities, and Challenges Through Real-World Examples

9:45 AM — 10:15 AM

ConvergeHEALTH by Deloitte Innovation Theater: Personalized Medicine Studies and Real-World Analytics for Oncology: M2Gen and ConvergeHEALTH Collaboration

10:30 AM — 12:00 PM

Development of an Integrated Orphan Drug Framework in Canada

10:30 AM — 12:00 PM

Device and Diagnostic Innovation

10:30 AM — 12:00 PM

Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design

10:30 AM — 12:00 PM

Efficient Distribution of Information Across Documents to Support Product's Benefit-Risk Ratio for Patients Worldwide

10:30 AM — 12:00 PM

Electronic Source Data in Clinical Investigations (Part 2 of 2): Practical Implementation

10:30 AM — 12:00 PM

EMA-FDA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges

10:30 AM — 12:00 PM

Europe Town Hall

10:30 AM — 12:00 PM

FDA Programs to Encourage Innovation: Maximizing the Opportunities and Confronting the Challenges of New Product Development

10:30 AM — 12:00 PM

GCP Inspection Findings: A Roundtable Discussion

10:30 AM — 12:00 PM

Health Care's Revolutionary Printing Press? 3D Printing - Blue Sky and Regulatory Path

10:30 AM — 12:00 PM

Impact of Bayesian Methods in Drug Development with a Focus on Comparative Effectiveness Research

10:30 AM — 12:00 PM

Improving Communication in the Informed Consent Process: The Advantages of eConsent

10:30 AM — 12:00 PM

Improving the Informed Consent Process

10:30 AM — 11:30 AM

Industry Trends, Successes, and Failures in Orphan and Rare Disease Therapeutics

10:30 AM — 11:30 AM

Juvenile Animal Studies and Pediatric Nonclinical Development

10:30 AM — 12:00 PM

Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products

10:30 AM — 12:00 PM

Manufacturing Challenges for Breakthrough Products

10:30 AM — 12:00 PM

National Strategy to Bridge the Gap Between Academic Innovation and Commercialization in Asia

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

Preparing for a Successful Product Launch

10:30 AM — 12:00 PM

Risk-Based Monitoring: From Concept to Practice

10:30 AM — 11:30 AM

Social Listening as a Tool to Inform Study Teams on Social Media Strategy for Recruitment and Building Patient-Centric Trials

10:30 AM — 12:00 PM

The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances, and Precision Medicine (Part 2 of 2)

10:30 AM — 12:00 PM

The State of Clinical Outsourcing: Do Outsourcing Partnerships Promote or Impede Progress Toward Clinical Trial Optimization?

10:30 AM — 12:00 PM

Understanding Corporate Integrity Agreements/Trends: What Can We Expect and Why Is It Important?

10:30 AM — 12:00 PM

Update on Postmarketing Safety Reporting

11:45 AM — 12:30 PM

Covance Innovation Theater: Risk-Based Monitoring - Seeing the Forest for the Trees When Designing and Deploying an Enterprise Process

12:45 PM — 1:15 PM

Veeva Innovation Theater: Industry’s Largest eTMF Survey: Benchmarks and Insights

1:30 PM — 3:00 PM

Adapting GCPs to Evolving Drug Development Paradigm (Part 1 of 2)

1:30 PM — 3:00 PM

Asia Town Hall

1:30 PM — 3:00 PM

Breakthrough Therapy Designation: One Year After

1:30 PM — 3:00 PM

Challenges and Strategic Approaches to Development of a Novel Biologic Versus a Biosimilar

1:30 PM — 3:00 PM

Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn't)

1:30 PM — 3:00 PM

Computer System Validation in the Cloud: Cloud Is Here Today and Here to Stay

1:30 PM — 2:30 PM

Dare to Be Different: Comparing Biosensor Data to Patient-Reported Outcomes Data - Learnings from Asthma

1:30 PM — 3:00 PM

Digital Health: Mobile Medical Apps and the Future of Health Care Delivery

1:30 PM — 3:00 PM

EMA-FDA GCP Initiative: Current Status and Future Perspectives

1:30 PM — 3:00 PM

Embracing Change: The New Face of Clinical Data Management

1:30 PM — 3:00 PM

Enabling Participants' Access to the Electronic Clinical Trial Data: The Blue Button Project

1:30 PM — 3:00 PM

FDA Enforcement Update: Advertising and Promotion

1:30 PM — 3:00 PM

How Do We Keep Kids Safe? Pediatric Safety Monitoring From Beginning to End

1:30 PM — 3:00 PM

How to Make a Successful Electronic Registration and Listing Submission: NDC, Regulatory Compliance, and Technical Requirements

1:30 PM — 3:00 PM

Improving Investigative Site Selection Practices

1:30 PM — 3:00 PM

In-Sourcing, Out-Sourcing: Where Do We Go from Here?

1:30 PM — 3:00 PM

Introducing CDER's Office of Pharmaceutical Quality

1:30 PM — 2:30 PM

Optimization of and Enhancements to Interactive Response Technology to Ensure Efficient Investigational Product and Study Material Management

1:30 PM — 3:00 PM

Organs on a Chip: The Future of Efficacy and Safety Testing

1:30 PM — 3:00 PM

Predictive Enrichment: Design, Development Strategies, and Methodological Issues

1:30 PM — 3:00 PM

Promotional Material Management: From Review to Submission – Contemporary Ideas

1:30 PM — 3:00 PM

Unraveling Evidence-Based Medicine: A Scientific, Ethical, and Socio-Political Analysis

1:30 PM — 3:00 PM

Virtual Teams in Clinical Development

1:30 PM — 3:00 PM

Who’s Moving the PV Cheese? Three Game Changing Topics - Impact of Emerging New Requirements for E2B (R3), ICSR Quality Standards, and Benefit-Risk Management

1:30 PM — 3:00 PM

Yes and ... Applying Improvisational Skills to Improve Innovation

2:45 PM — 3:15 PM

BBK Worldwide Innovation Theater: Adopting New Strategies for the New Face of Patient Recruitment

3:30 PM — 5:00 PM

Adapting GCPs to Evolving Drug Development Paradigm (Part 2 of 2)

3:30 PM — 5:00 PM

Assessing Comparative Effectiveness Research Feasibility and Interpretability A Priori

3:30 PM — 5:00 PM

Building a Site Budget from the Ground Floor

3:30 PM — 5:00 PM

Development of Central Nervous System Drugs with Abuse Potential

3:30 PM — 5:00 PM

Electronic Standardized Study Data: Regulatory Considerations

3:30 PM — 5:00 PM

Evaluating Potential Contribution of Social Media to Postmarketing Medication Safety Surveillance

3:30 PM — 5:00 PM

FDA - Health Canada Regulatory Cooperation Council (RCC) Town Hall

3:30 PM — 5:00 PM

Gene Therapy Symposium

3:30 PM — 4:30 PM

How a New Collaboration Between a Biopharmaceutical Company and a CRO Is Improving the Quality, Speed, and Efficiency of Drug Development

3:30 PM — 5:00 PM

International Regulatory Advertising and Promotion Considerations

3:30 PM — 5:00 PM

Key Subgroup Analysis Issues in Clinical Trials

3:30 PM — 4:30 PM

Lessons Learned in the Development and Registration of Fixed-Dose Combination Products: CMC Focus

3:30 PM — 5:00 PM

Managing Innovation: Challenges and Opportunities Today and for the Future

3:30 PM — 5:00 PM

Misconduct and Management of Serious or Continued Noncompliance: Differences, Similarities, and Building a World-Class Program

3:30 PM — 5:00 PM

Orphan Drugs and Treatment of Rare Diseases in Asia

3:30 PM — 5:00 PM

Our First Year Under Sunshine: Impact on Medical and Scientific Communications

3:30 PM — 5:00 PM

Patient Registries: Designing, Implementing, and Leveraging to Accelerate Clinical Trials

3:30 PM — 5:00 PM

Perfecting the Protocol: Designing Studies for Success

3:30 PM — 5:00 PM

Power Up! Give Your Brain a Vacation

3:30 PM — 5:00 PM

Prequalification of Medicines for Neglected Tropical Diseases

3:30 PM — 5:00 PM

The Pharmacovigilance System Master File: Business as Usual? Can This File Help Industry?

3:30 PM — 5:00 PM

The Regulatory Writing Game Show

3:30 PM — 5:00 PM

Transforming Culture and Mindsets to Deliver a Higher Quality eTMF

3:30 PM — 5:00 PM

Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in the Global Regulatory Process

3:30 PM — 4:30 PM

Utilizing 505(b)(2) to Accelerate Drug Development Plans

Day 4 Jun 18, 2014

8:00 AM — 9:30 AM

Achieving Success in a Mega-Trial Sponsor/ARO/CRO Collaboration: Approaches to Overcome Challenges and Optimize Results

8:00 AM — 9:30 AM

Balancing Manufacturing Quality Improvements and Drug Shortage

8:00 AM — 9:30 AM

CDISC BRIDG Implementation: A Model for System Interoperability and as a Data Base Model

8:00 AM — 9:30 AM

Changing Global Regulatory Climates: Effects on Companion Diagnostics and Combination Products

8:00 AM — 9:30 AM

Clinical Trials Technology Implementation: Bringing Together Patient- and Site-Centric Approaches

8:00 AM — 9:30 AM

Designing Smarter and More Cost-Effective Phase 1 Protocols

8:00 AM — 9:30 AM

ICH Update: Emerging Guidelines

8:00 AM — 9:30 AM

Innovative Engagement Strategies to Inspire Higher Level Commitment and Performance

8:00 AM — 9:30 AM

International Cooperation in Rare Disease Research

8:00 AM — 9:00 AM

Leveraging Electronic Health Record Data to Understand Clinical Nuance in Complex Real-World Populations: A Case Study

8:00 AM — 9:00 AM

Life Cycle Management of Biopharmaceuticals: An Approach and Lessons Learned for an Imperative Business Practice

8:00 AM — 9:30 AM

Metrics Benchmarking, Predictive Analytics, and Virtual Population Simulation: New Tools to Contextualize and Forecast Trial Performance

8:00 AM — 9:30 AM

Optimizing Outsourcing Relationships: Data-Driven Strategies to Support Vendor Selection, Negotiation, and Management

8:00 AM — 9:00 AM

Professional Career Development Within Medical Affairs: A Perspective from Medical Communications, Medical Science Liaisons, and Medical Writers

8:00 AM — 9:30 AM

Proprietary Name Review: International Perspectives from the FDA, Health Canada, and EMA

8:00 AM — 9:30 AM

Regulatory Strategic Plan: Don’t Start Development Without One

8:00 AM — 9:30 AM

Research Site Quality Compliance Programs: Review of Industry Gold Standards

8:00 AM — 9:30 AM

Seeing Is Believing! Good Graphic Design Principles for Medical Research

8:00 AM — 9:30 AM

Signal Detection: Challenges and Strategic Aspects

8:00 AM — 9:30 AM

The Challenges of High Quality Risk Management with Single Shared System REMS and Physician Knowledge Surveys

8:00 AM — 9:30 AM

The Legal, Ethical, and Commercial Issues Impacting the Development and Accessibility of Pediatric Medicines

8:00 AM — 9:30 AM

The Sites Have Spoken: Implementing Paperless Trials and Risk-Based Monitoring from a Site’s Perspective

8:00 AM — 9:30 AM

Transforming ICH Toward Greater Global Harmonization

8:00 AM — 9:00 AM

Why Does Drug Development Need Project Management?

8:00 AM — 9:30 AM

Your Future Success as a Master’s Level Statistician: Learn from the Past of These Industry Masters

9:45 AM — 10:15 AM

Appirio Innovation Theater: The Big R&D Leap: Accelerating Pharmaceutical Innovation and Discovery Through Crowdsourcing

10:30 AM — 12:00 PM

An International Approach to Benefit-Risk Assessment of Medicines: An Evaluation by a Consortium of Established Agencies

10:30 AM — 12:00 PM

Approaches to Decrease the Time Gap Between FDA Approval and the Ability to Market a DEA Scheduled Drug

10:30 AM — 12:00 PM

Be a Change Agent: Leveraging Communication and Training Tools to Help Promote Project and Career Transformation

10:30 AM — 12:00 PM

Career Planning and Limitations for Mid- to Upper-Level Project Managers

10:30 AM — 12:00 PM

Clinical Supply Symposium

10:30 AM — 12:00 PM

Combination Products: An Overview of Clinical Benefits, Regulatory Issues, and Manufacturing Challenges

10:30 AM — 12:00 PM

Expanding the Scope: Empowering the Public in Pharmacovigilance

10:30 AM — 11:30 AM

Field-Based Medical Communications on a Global Scale

10:30 AM — 12:00 PM

From the Protocol to the Patient: Clinical Trial Data Disclosure

10:30 AM — 12:00 PM

GCP Audits in a Risk-Based Environment

10:30 AM — 12:00 PM

Implementation of GDUFA: Progress and Expectations

10:30 AM — 12:00 PM

Maximizing the Potential of Your EDC System

10:30 AM — 12:00 PM

Prediction of Safety: An Evolving Field for Selecting Low-Risk Compounds Towards an Effective Life Cycle of a Product

10:30 AM — 12:00 PM

Project Management Basics: Creating a High-Level Project Plan

10:30 AM — 12:00 PM

Public-Private Partnerships: An Innovative Strategy for Patient Registries

10:30 AM — 12:00 PM

Risk-Based Monitoring Symposium

10:30 AM — 12:00 PM

Separating Perceptions from Reality in the Acceptance of Adaptive Trials by Regulatory Agencies

10:30 AM — 12:00 PM

Site Certification of Early Phase Research Units: An International Perspective

10:30 AM — 12:00 PM

Site Selection and Feasibility Symposium

10:30 AM — 12:00 PM

Strengthening Public Policy for Sustainable Clinical Research Enterprise in Africa, Asia, and South America: Progress and Prospects

10:30 AM — 12:00 PM

The Patient Point-of-View: An Unrehearsed but Revealing Conversation to Rectify Patient Enrollment

10:30 AM — 12:00 PM

The Present and Future of Pharmaceutical Development Outsourcing: Where Are We Today and Where Are We Going?

10:30 AM — 12:00 PM

Update from the FDA-EMA Parallel Assessment Pilot

10:30 AM — 11:30 AM

Vendor Selection for a Small Company

11:45 AM — 12:15 PM

SAS/JMP Innovation Theater: Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP Clinical

12:30 PM — 1:15 PM

SAS Innovation Theater: Data Transparency and Sharing: Research Benefits, Risks and the Future

1:30 PM — 3:00 PM

A Cloud-Based Approach to Evaluating and Maintaining Global Regulatory Content Alignment

1:30 PM — 3:00 PM

Abstract and Article Publication Opportunities with DIA

1:30 PM — 3:00 PM

Adaptive, Progressive or Risk-Based Licensing Models: What Approaches Could Be Considered by Mature and Emerging Markets?

1:30 PM — 3:00 PM

Benefit-Risk Assessments of Medicines: Framework Development and Use in Marketing Applications

1:30 PM — 3:00 PM

Broadening Health Care Communications: Learnings from Health Authority Initiatives

1:30 PM — 3:00 PM

Challenges and Opportunities Facing FDA’s International Posts

1:30 PM — 3:00 PM

Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 1 of 2)

1:30 PM — 3:00 PM

Complex Drug Projects: Complex Project Management

1:30 PM — 3:00 PM

Costing Strategies for Sustainable Drug Development

1:30 PM — 3:00 PM

EU Clinical Trial Data Transparency Debate: Where Are We?

1:30 PM — 3:00 PM

Exploring Bayesian Approaches Applied to New Treatments for Rare Diseases

1:30 PM — 3:00 PM

Functional Service Provider Relationships: Critical Factors to Ensuring Long-Term Success

1:30 PM — 3:00 PM

Hot Topics in Patient Recruitment: Global Demographics, Underrepresented Populations, and the Science Behind Patient Communications

1:30 PM — 3:00 PM

Innovative Direct-to-Patient Study Model to Capture PRO Instrument Validation Data for Submission to a Regulatory Authority

1:30 PM — 3:00 PM

Making Comments Count: Best Practices in Developing Comments for a Global Audience

1:30 PM — 2:30 PM

Managing Global Teams: Navigating Through Cultural, Lingual, and Geographic Challenges

1:30 PM — 3:00 PM

Medical Device Update: Unique Device Identification Rule, Medical Device Reporting Draft Guidance, and Postmarketing Clinical Research Reporting Requirements

1:30 PM — 3:00 PM

Natalizumab and Progressive Multifocal Leukoencephalopathy: A Risk Management Case Study

1:30 PM — 3:00 PM

Nesting Studies Within Patient Registries to Support Comparative Effectiveness Research

1:30 PM — 3:00 PM

Optimizing Orphan Drug Development and Using Appropriate Methodology: Key Tips for Success

1:30 PM — 3:00 PM

Phase 1 Studies in Renal and Hepatic Subjects: Considerations and Best Practices in Design and Conduct

1:30 PM — 3:00 PM

Recent Advancement of the Pharmaceutical Inspection Cooperation Scheme and Good Manufacturing Practices in the Asia Pacific Region

1:30 PM — 3:00 PM

Social Media in Patient Recruitment: How to Best Leverage the Digital Ecosystem

1:30 PM — 2:30 PM

The Role of Intelligent Signaling in Digital Disease Detection and Proactive Pharmacovigilance

3:30 PM — 5:00 PM

Benefit-Risk Evaluation in Drug Development

3:30 PM — 5:00 PM

Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 2 of 2)

3:30 PM — 5:00 PM

CMC Regulatory Pathways in the Emerging Markets: Focus on Asia Pacific

3:30 PM — 5:00 PM

Compliance, Potential Financial Implications, and Impact of New Safety Measures

3:30 PM — 5:00 PM

Effective Strategic Partnering Between Small Pharmaceutical Companies and CROs: Discussion and Case Study

3:30 PM — 5:00 PM

End-to-End Data and Metadata in Today's Clinical Trials

3:30 PM — 5:00 PM

Filling the Gaps and Speeding Up Results: What an Educated, Sophisticated Patient Population Can Do for You

3:30 PM — 5:00 PM

Health Authority Meeting Preparation: There Are No Do-Overs

3:30 PM — 5:00 PM

Industry in the Sunshine: How the “Sunshine” Provisions of the Affordable Care Act Will Change Industry Policy and Practice

3:30 PM — 5:00 PM

Informed Medication Use in Pregnancy: A Collaborative Approach to Address Needs for Data, Communication, and Engagement

3:30 PM — 5:00 PM

Optimize Protocol Design: A Path to Efficient, Lower Cost Trial Execution

3:30 PM — 5:00 PM

Patient Voice in Decision Making: How Are Regulators Making This Work?

3:30 PM — 5:00 PM

Pediatric Trials: Improvements through Bayesian Methods, Adaptive Designs, and Modeling/Simulation

3:30 PM — 5:00 PM

Powering Up Communications: Improving the Information Exchange Between Patients and Industry

3:30 PM — 5:00 PM

Predicting Drug Off-Target Protein Binding to Hypothesize Mechanisms for Safety Issues

3:30 PM — 5:00 PM

Product Crisis Management: Crisis, What Crisis?

3:30 PM — 5:00 PM

Project Management Plays Critical Roles in the New Challenging Environment

3:30 PM — 5:00 PM

Regulatory Challenges for Orphan Medicines

3:30 PM — 5:00 PM

Regulatory Perspectives in the Execution of Clinical Studies and Medical Product Commercialization in Asia Pacific

3:30 PM — 5:00 PM

Sustainable Solutions for Global Clinical Research Site Documentation

3:30 PM — 5:00 PM

The Realities of Late Life Cycle Management for Very Old Legacy Brands

3:30 PM — 5:00 PM

The Sponsor-Vendor-Vendor Relationship: A Fine Balance

3:30 PM — 5:00 PM

Transforming Organizational Knowledge into Product Information: Can Structured Authoring Save the Day?

3:30 PM — 5:00 PM

Why, When, and How Should Patients Be Involved in the Benefit-Risk Assessment of Medicines?

3:30 PM — 5:00 PM

Women as Transformational Leaders

Day 5 Jun 19, 2014

9:00 AM — 10:30 AM

Accelerating Research in a Large Health Care System: Streamlining Research Review and Study Initiation

9:00 AM — 10:30 AM

CDER Town Hall (Part 1 of 2)

9:00 AM — 10:30 AM

Exploring Responder-Patient Clinical Study Design Approaches

9:00 AM — 10:30 AM

FDA Drug Claims Substantiation after IMS and Caronia: Will Court Scrutiny Based on the First Amendment Lead to Change in Current Policy and Practice?

9:00 AM — 10:30 AM

GCP Quality Agreements

9:00 AM — 10:30 AM

Hot Topics in Medical Devices Labeling: US and Global

9:00 AM — 10:30 AM

Independent Consultant or Permanent Role: Get the Position You Want (Tips from Insiders)

9:00 AM — 10:30 AM

Keeping It Together: Syncing CRO Data and Metrics

9:00 AM — 10:30 AM

Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments

9:00 AM — 10:00 AM

Qualifying a Software Vendor in a Regulated Industry

9:00 AM — 10:30 AM

Question-Based Review (QbR): A Risk-Based, Standardized Pharmaceutical Quality Assessment Tool

9:00 AM — 10:30 AM

Safety in Special Situations: Stem Cells, Vaccines, and Combination Products

9:00 AM — 10:30 AM

Today's Dynamic Medical Science Liaison Environment

9:00 AM — 10:30 AM

Universal Health Coverage and Health Technology Assessment in Emerging Asia Pacific Countries

10:45 AM — 12:15 PM

A Hitchhiker's Guide to Working with Management Consultants

10:45 AM — 12:15 PM

Bringing Quality to Quality Metrics

10:45 AM — 12:15 PM

CDER Town Hall (Part 2 of 2)

10:45 AM — 12:15 PM

Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach

10:45 AM — 12:15 PM

Ethnic Difference in Clinical Trial Data: A 15-Year History of an Investigation by Regulatory Agencies and Industry

10:45 AM — 12:15 PM

How Can Studies that Inform Relative Effectiveness Best Be Incorporated into Global Drug Development Plans?

10:45 AM — 12:15 PM

Innovative Patient Recruitment Solutions for Rare Disease Clinical Trials

10:45 AM — 12:15 PM

Parents as Partners: Overcoming Unique Challenges to Pediatric Recruitment and Retention

10:45 AM — 12:15 PM

Risk-Based Monitoring: Where We Are and Where We Are Headed

10:45 AM — 12:15 PM

The Evolution of Strategic Partnerships and the Four P's of International Relationship Building

10:45 AM — 12:15 PM

Trends in Biosimilars Regulation Within Developed and Emerging Markets

10:45 AM — 12:15 PM

Walking the Tightrope of Talent Acquisition and Retention: The Balancing Act for Maintaining Productivity, Efficiency, and Quality

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DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

Agenda

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