Agenda

Day 1 Jun 23, 2013

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: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur

8:30 AM — 12:00 PM

#22: Global Reimbursement Systems: A Market Access Perspective

8:30 AM — 12:00 PM

#23: A Device Primer: 510(k)s, PMAs, IDEs

8:30 AM — 12:00 PM

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

9:00 AM — 5:00 PM

#50: Understanding and Navigating the Regulatory System in China

9:00 AM — 5:00 PM

#51: Quality Oversight of CROs-Clinical Vendors

9:00 AM — 5:00 PM

#52: Regulatory Affairs for Biologics

9:00 AM — 5:00 PM

#53: Clinical Statistics for Nonstatisticians

9:00 AM — 5:00 PM

#54: Art of Writing a Clinical Overview

9:00 AM — 5:00 PM

#55: Overview of Drug Development

9:00 AM — 5:00 PM

#56: Risk Communications

9:00 AM — 3:45 PM

#57: Preparing for a US FDA Advisory Committee Meeting

1:00 PM — 4:30 PM

#30: Analysis of Safety Data from Clinical Trials

1:00 PM — 4:30 PM

#31: Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned

1:00 PM — 4:30 PM

#32: Understanding Translational Medicine: Benefits and Innovative Approaches

1:00 PM — 4:30 PM

#34: Fourteen Steps from Research to Development

1:00 PM — 4:30 PM

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

1:00 PM — 6:00 PM

#40: Investigative Site Boot Camp: Innovative Solutions to your Operational Challenges

1:00 PM — 6:00 PM

#41: The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions

Day 2 Jun 24, 2013

8:30 AM — 10:00 AM

Opening Plenary

11:00 AM — 12:30 PM

CBER Town Hall

11:00 AM — 12:30 PM

Challenges and Solutions for Professional Development and Training of Clinical/Nonclinical Staff

11:00 AM — 12:30 PM

Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets

11:00 AM — 12:30 PM

Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials

11:00 AM — 12:30 PM

Electronic Health Records (EHRs) in Signal Detection and Evaluation

11:00 AM — 12:30 PM

European Town Hall: Implementation of New Safety Legislation and Other Hot Topics

11:00 AM — 12:30 PM

Evaluation and Selection of the Optimal Endpoints for Clinical Studies

11:00 AM — 12:30 PM

Finessing Scientifically Accurate, Comprehensible, Compliant, Clinically-focused Module 2 Summaries of an eCTD-based Submission

11:00 AM — 12:30 PM

Global Symposium

11:00 AM — 12:30 PM

Hot Topics in Statistics: Working Together Effectively to Transform Our Science

11:00 AM — 12:30 PM

How Can Translational Medicine Fill the Gaps in Life Sciences Industries?

11:00 AM — 12:15 PM

Innovative Partnerships for mHealth

11:00 AM — 12:30 PM

Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators

11:00 AM — 12:30 PM

Managing Data at Arms' Length: China

11:00 AM — 12:30 PM

Narrative Medicine and Pharmacovigilance

11:00 AM — 12:30 PM

Next Generation Medical Information Call Center

11:00 AM — 12:30 PM

Pediatric Drug Development: A New Paradigm Under FDASIA

11:00 AM — 12:30 PM

Portfolio Management Symposium

11:00 AM — 12:30 PM

Practical Considerations for GCP Audits in a Risk-based Environment

11:00 AM — 12:30 PM

Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon

11:00 AM — 12:30 PM

Shape Your Cost with Hard and Soft Coverage Analysis Trends

11:00 AM — 12:30 PM

Stage Gate Decision-making Workshop, Part 1 of 2

11:00 AM — 12:30 PM

The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials

11:00 AM — 12:30 PM

Trials, Studies and Programs: Diverse Operational Approaches to Generating Evidence in the Late-phase Environment

11:00 AM — 12:30 PM

Vendor Management Using Quality by Design and Risk Management Strategies

1:00 PM — 1:45 PM

IntraLinks Innovation Theater: Crossing the Threshold – Clinical Portals from a Site Perspective

2:30 PM — 4:00 PM

Bridging the Gap Between Strategy and Execution

2:30 PM — 4:00 PM

CDISC SHARE: A Promising Approach to Therapeutic Area Standards Development

2:30 PM — 4:00 PM

Characterizing Drug Shortages and Their Causes: Anticipating Future Trends

2:30 PM — 4:00 PM

Cooperation Among Regulators: Impact on Stakeholders

2:30 PM — 4:00 PM

Defining Clinical Trial Innovation: Challenges and Opportunities for 2013

2:30 PM — 4:00 PM

Effectiveness Checks in the Clinical Research Setting

2:30 PM — 4:00 PM

Global Clinical Trials: The Role of Emerging Markets

2:30 PM — 4:00 PM

Implementing Performance Metrics: How Investigator Sites Can Pave the Way for Running Successful Clinical Trials

2:30 PM — 4:00 PM

Implementing Regulatory Outsourcing Partnerships: New Trends and Practices

2:30 PM — 4:00 PM

Key Multiplicity Issues in Clinical Trials

2:30 PM — 4:00 PM

Legal Jeopardy from the Conduct of Clinical Trials

2:30 PM — 4:00 PM

Navigating the Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs) and Combined ATMPs

2:30 PM — 4:00 PM

Quality Risk Management: An Old Hat?

2:30 PM — 4:00 PM

Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy

2:30 PM — 4:00 PM

Stage Gate Decision-making Workshop, Part 2 of 2

2:30 PM — 4:00 PM

That Awkward Stage: Transition from Paper Trial Master File to eTMF

2:30 PM — 4:00 PM

The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance

2:30 PM — 4:00 PM

The Secret of Stellar Careers: Serendipity plus Planning = Success

2:30 PM — 4:00 PM

Translational Aspects from Preclinical Animal Toxicology Studies to Early Human Health Risk Assessment: Needs and Limitations

2:30 PM — 4:00 PM

Update on Submission and GMP Expectations for Part 3 Combination Products

2:30 PM — 4:00 PM

Using Epidemiologic Methods to Advance Comparative Effectiveness Research

Day 3 Jun 25, 2013

8:00 AM — 9:30 AM

A Regulatory Perspective of Biosimilars in Emerging Markets

8:00 AM — 9:30 AM

Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting

8:00 AM — 9:30 AM

Biomarkers for Drug Development: How Are We Dealing with the Challenges?

8:00 AM — 9:30 AM

Careers Beyond Project and Portfolio Management: A Panel Discussion

8:00 AM — 9:30 AM

Data from Everyone: Using Smartphones and the Internet to Connect with Subjects

8:00 AM — 9:30 AM

Developing and Embracing a Culture of Quality in the Pharmaceutical Industry

8:00 AM — 9:30 AM

Development of a New Patient-reported Outcome (PRO) Measure for Depression: Progress and Results from the PRO Consortium

8:00 AM — 9:30 AM

DNA of Entrepreneurs: Calculated Risk-taking and Bringing Game-changing Technology to the World

8:00 AM — 9:30 AM

Ethical Issues in Clinical Trials

8:00 AM — 9:30 AM

Expediting Drug Development and Review for Serious Conditions

8:00 AM — 9:30 AM

GCP and Inspection Readiness

8:00 AM — 9:30 AM

Innovation and Evolution Within the Medical Science Liaison Role

8:00 AM — 9:30 AM

Is This Trial Worth It? A Panel Discussion for Sites and Project Managers

8:00 AM — 9:30 AM

Leveraging In-Pharmacy Education to Improve Patient Comprehension and Access to Clinical Trials

8:00 AM — 9:30 AM

Making CRO-Sponsor Partnerships Work: Executive Roundtable

8:00 AM — 9:30 AM

Moving to a Standards-based, Agile Clinical Development Lifecycle

8:00 AM — 9:30 AM

Payer Collaborations with Pharma: Real-world Evidence to Improve Patient Outcomes and Influence the Pipeline

8:00 AM — 9:30 AM

Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall

8:00 AM — 9:30 AM

Postmarket Surveillance Issues for Medical Devices

8:00 AM — 9:30 AM

Prescription Drug Marketing Regulatory Primer

8:00 AM — 9:30 AM

Research Advances for Rare Diseases and Orphan Products

8:00 AM — 9:30 AM

Social Media, Mobile Applications and Patient Support Programs: Challenges and Solutions for Handling Drug Safety Information

8:00 AM — 9:30 AM

The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols

8:00 AM — 9:30 AM

The Regulatory Writing Game Show

8:00 AM — 9:30 AM

The Thorough QT Study: Isn’t There a Better Way to Do This?

8:00 AM — 9:30 AM

Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball

9:40 AM — 10:10 AM

Deloitte Innovation Theater: Race for Real World Data - Outcomes Data and Analytics: Uses, Approach and Issues

10:15 AM — 11:45 AM

Achieving Innovative Technology Results

10:15 AM — 11:45 AM

Advanced Presentation Skills

10:15 AM — 11:45 AM

Big Data: Impact on Innovation

10:15 AM — 11:45 AM

Change Order Panel Discussion and Brainstorming Session: Can We Be More Efficient?

10:15 AM — 11:45 AM

Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology

10:15 AM — 11:45 AM

Developing and Maintaining Sponsor/CRO Partnership Regulatory Submissions Processes: Challenges and Successes

10:15 AM — 11:45 AM

DIA 2013 Student Forum: Getting a Job and Developing a Career

10:15 AM — 11:45 AM

Domestic and Global Trends in Clinical Trial Budgeting

10:15 AM — 11:45 AM

Effective Diverse Team Collaboration and Management for Drug Development: Key Commonalities and Differences among Korea, China and Japan

10:15 AM — 11:45 AM

EU Update: PROTECT and EnCePP

10:15 AM — 11:45 AM

FDA Enforcement Update: Advertising and Promotion

10:15 AM — 11:45 AM

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

10:15 AM — 11:45 AM

Optimizing Trial Feasibility by Leveraging Electronic Health Record (EHR) Data and Engaging Investigators and Patient Advocacy Groups

10:15 AM — 11:45 AM

Preparation of Clinical Study Reports and Summary Documents: Maximize Efficiency and Minimize Redundancy

10:15 AM — 11:45 AM

Statistical Considerations When Developing Antibacterial Treatments

10:15 AM — 11:45 AM

Strategies for the Development and Registration of Antibody Drug Conjugates

10:15 AM — 11:45 AM

The Aging Population: Approaches to Ensure Safety and Efficacy

12:15 PM — 1:00 PM

Cambridge Semantics Innovation Theater: How Can Technology Change the Way Pharmas Handle Risk? Innovations in Drug Safety and Business Development

1:45 PM — 3:15 PM

Approaches to Quality Risk Management: Understanding What Matters

1:45 PM — 3:15 PM

Changing View of Electronic Data Capture (EDC) and Implications for Data Quality

1:45 PM — 3:15 PM

Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges

1:45 PM — 3:15 PM

Convergence in Regulatory Science Across the Strait

1:45 PM — 3:15 PM

Drug Development for Commercial Success

1:45 PM — 3:15 PM

Electronic Submissions in PDUFA V

1:45 PM — 3:15 PM

Enrollment Analytics: Moving Beyond the Funnel

1:45 PM — 3:15 PM

FDA Collaborations Broaden the Reach of Health Care Messages to Effectively Communicate with the Public

1:45 PM — 3:15 PM

First-in-Human Studies: How Much Complexity Is Too Much?

1:45 PM — 3:15 PM

GCP Risk-based Monitoring

1:45 PM — 3:15 PM

Human Abuse Liability Testing in CNS Drug Development

1:45 PM — 3:15 PM

Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This?

1:45 PM — 3:15 PM

Innovative Computerized System Validation and Auditing

1:45 PM — 3:15 PM

Is There a Recipe for Successful Implementation of Registries for Rare Diseases?

1:45 PM — 3:15 PM

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

1:45 PM — 3:15 PM

Looking Closer into the Utility of Adaptive Approaches

1:45 PM — 3:15 PM

Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and Benefit-risk Evaluations

1:45 PM — 3:15 PM

Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial

1:45 PM — 3:15 PM

Quality Assurance for Signal Detection Programs

1:45 PM — 3:15 PM

Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions

1:45 PM — 3:15 PM

Reinventing the R&D Business Model: Heeding the President's PCAST Report on Innovation

1:45 PM — 3:15 PM

Taking the Measure of Metrics

1:45 PM — 3:15 PM

The New European Pharmacovigilance Legislation: Guiding Medical Writers Through the Risks and Benefits

1:45 PM — 3:15 PM

US and EU Regulatory Update of Clinical Trial Disclosure

3:25 PM — 3:55 PM

INC Research Innovation Theater: Innovating Clinical Development Through Data-driven Operational Strategy

4:00 PM — 5:30 PM

Advanced Presentation Skills

4:00 PM — 5:30 PM

Analysis Data Standards: Developing, Applying, Submitting and Reviewing

4:00 PM — 5:30 PM

Approaches to Risk-based Monitoring

4:00 PM — 5:30 PM

Breakthrough Therapy: One Candle on the Birthday Cake - Are Innovators Enjoying Sweet Success or Is the Pathway Not Baked Yet?

4:00 PM — 5:30 PM

Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access

4:00 PM — 5:30 PM

Development for Rare Disease Treatments

4:00 PM — 5:30 PM

Diagnostic Biomarker Verification and Validation: A Cost-efficient, Speed to Market Adaptive Design Clinical Trial Model

4:00 PM — 5:30 PM

Evaluating Sites for Optimum Site Selection and Performance

4:00 PM — 5:30 PM

Four Ways to Accelerate Clinical Portfolio Strategy

4:00 PM — 5:30 PM

GCPs in Emerging Countries

4:00 PM — 5:30 PM

Investigator Budgets Impact on Patient Enrollment and Retention: How to Improve Sponsor/CRO/Site Processes to Increase Productivity

4:00 PM — 5:30 PM

Korea Forum: Introduction to the Korean Ministry of Food and Drug Safety (MFDS) and Government R&D Program

4:00 PM — 5:30 PM

Labeling and Patient Medical Information (PMI)

4:00 PM — 5:30 PM

Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot

4:00 PM — 5:30 PM

Optimizing the Transition from Preclinical to Clinical Research

4:00 PM — 5:30 PM

Product Communications in the Preapproval Phase

4:00 PM — 5:30 PM

Protocol Trends and Strategies for Quality

4:00 PM — 5:30 PM

Real, Transparent Dialogue from Three Sponsors: Destination eTMF - Are We There Yet?

4:00 PM — 5:30 PM

Real-world Electronic Health Records Data and Informatics Technology in Drug Development and Life Cycle Management

4:00 PM — 5:30 PM

Risk Management in the US, EU and Japan: The Challenges of Diversity

4:00 PM — 5:30 PM

So You Want to Foster Innovation: A Neuroscience Primer on How Creative Ideas Arise from the Brain

4:00 PM — 5:30 PM

Strategic Planning of the Global Program to Facilitate Regulatory Approval and Market Access

4:00 PM — 5:30 PM

The Evolving Clinical Trial Disclosure Global Landscape

4:00 PM — 5:30 PM

Utilizing Electronic Medical Records as an Innovative Methodology for Evaluating Therapeutic Effectiveness

4:00 PM — 5:30 PM

Where Research, Medicine and Care Converge: A CMO Roundtable Discussion

5:30 PM — 7:30 PM

Movie Documentary: RARE

Day 4 Jun 26, 2013

8:00 AM — 9:30 AM

Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols

8:00 AM — 9:30 AM

Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials

8:00 AM — 9:30 AM

Clinical Trial Design for Optimal Patient Recruitment and Retention

8:00 AM — 9:30 AM

Collaborating to Streamline Drug Development: Are We Making Progress?

8:00 AM — 9:30 AM

Cost Management for Global Drug Development Projects

8:00 AM — 9:30 AM

Current Developments in the Automated NDA Field Alert Reporting Project

8:00 AM — 9:30 AM

Enhancing Regulatory Science and Expediting Drug Development: eClinical and eHealth Tools

8:00 AM — 9:30 AM

Evolving to Functional Service Providers (FSP): Successfully Transforming Existing Partnerships into FSP Relationships

8:00 AM — 9:30 AM

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

8:00 AM — 9:30 AM

FDASIA: Impact of New Legislative Provisions on Innovative Drug Development

8:00 AM — 9:30 AM

How Economic and Technological Change Can Affect Professional Expectations: Case Studies in Succeeding in the Midst of Change

8:00 AM — 9:30 AM

How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)

8:00 AM — 9:30 AM

How to Prepare for Meetings, Both Internal and with the FDA

8:00 AM — 9:30 AM

How Will Risk-adapted Clinical Trials Be Inspected?

8:00 AM — 9:30 AM

Models for Genomic Research Success: Empowering Patient-Researcher Relationships and the Emerging Role of Crowd Sourcing in Rare Disease Research

8:00 AM — 9:30 AM

Molecular Imaging: Utilizing It as an Effective Drug Development Tool

8:00 AM — 9:30 AM

Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance

8:00 AM — 9:30 AM

Pharmacovigilance Update for Japan, Developing Asia and Latin America

8:00 AM — 9:30 AM

Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians

8:00 AM — 9:30 AM

Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions

8:00 AM — 9:30 AM

Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development

8:00 AM — 9:30 AM

Tethering the Channels of Scientific and Medical Content

8:00 AM — 9:30 AM

The Environment for Health Care Decision-making: Collecting, Using and Understanding Comparative Effectiveness Research

8:00 AM — 9:30 AM

Understanding Operational Feasibility: A Discussion of Current Methodologies, Primary Research Limitations and Opportunities

8:00 AM — 9:30 AM

Unique Nonprofit-Industry Partnerships to Develop and Disseminate Technology

8:00 AM — 9:30 AM

Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."

10:15 AM — 11:45 AM

A Comparison of Study Startup Regulations and Timelines in Several Major Emerging Markets and the Decision Process for Selection

10:15 AM — 11:45 AM

Advancing Alzheimer’s Innovation: A Call to Action

10:15 AM — 11:45 AM

Advancing Endpoint Adjudication

10:15 AM — 11:45 AM

Driven by Data: More Effective Strategies to Reach Your Patient Recruitment Goals

10:15 AM — 11:45 AM

Drug Shortages: Causes, Current State and Path Forward

10:15 AM — 11:45 AM

EDC Insights: Before, During, and After

10:15 AM — 11:45 AM

Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow

10:15 AM — 11:45 AM

Globalization of Medical Communications/Medical Science Liaisons: A Comparison of Guidance and Practice Differences

10:15 AM — 11:45 AM

Innovative Strategies for Evolving Sponsor, CRO and Site Alliances

10:15 AM — 11:45 AM

Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives

10:15 AM — 11:45 AM

Pharmacometrics: Implications and Impact in Preclinical to Early Phase Clinical Development

10:15 AM — 11:45 AM

Project Data Sphere: Clinical Trial Data-sharing in Cancer to Accelerate Innovation and Enhance Patient Health

10:15 AM — 11:45 AM

So You Want to Be a Project Manager: How to Find Your Way to a Challenging and Rewarding Career

10:15 AM — 11:45 AM

Study Startup Symposium

10:15 AM — 11:45 AM

Successful Mentoring Relationships

12:15 PM — 1:00 PM

SAS Innovation Theater: Picture This: Bringing Clinical Data to Life

1:45 PM — 3:15 PM

Advancing Alzheimer's Innovation: Patient Advocacy, Caregiver Support and Health Care System Impact

1:45 PM — 3:15 PM

An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection

1:45 PM — 3:15 PM

Canadian Approaches to Regulatory Modernization and International Engagement

1:45 PM — 3:15 PM

Challenges and Strategic Approaches to Biosimilar Development

1:45 PM — 3:15 PM

Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs

1:45 PM — 3:15 PM

Clinical Trial Simulations and Modeling

1:45 PM — 3:15 PM

Cloud Technology for Decision Makers: What’s Real and How to Validate It

1:45 PM — 3:15 PM

Coalition for Accelerating Standards and Therapies (CFAST): The Ultimate Drug Development Drivers

1:45 PM — 3:15 PM

Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics

1:45 PM — 3:15 PM

eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation

1:45 PM — 3:15 PM

FDA/EMA/WHO Collaboration and Cooperation on Good Clinical Practice (GCP), Bioequivalence (BE) and Pharmacovigilance (PV) Inspections

1:45 PM — 3:15 PM

FDASIA Patient Provisions: One Year Later

1:45 PM — 3:15 PM

Implementation of Quality by Design: Progress, Challenges and Opportunities - Industry Perspective

1:45 PM — 3:15 PM

Recent Corporate Integrity Agreements: Impact on Industry-sponsored Publications and Medical Communications Activities

1:45 PM — 3:15 PM

Rising to the Challenge of Developing Novel Orphan Medicines for the Global Market

1:45 PM — 3:15 PM

Submitting an Abstract for the DIA 2014 50th Annual Meeting

1:45 PM — 3:15 PM

The 2012 US Payer Landscape: Results from a Survey of Medical and Pharmacy Directors on Comparative Effectiveness Research

1:45 PM — 3:15 PM

The Science of Compliance

1:45 PM — 3:15 PM

Towards an Effective Virtual R&D Team for Faster Accessing of the East Asian Market

1:45 PM — 3:15 PM

TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology

1:45 PM — 3:15 PM

Transition from SME to Subject Matter Educator Extraordinaire (SMEE)!

1:45 PM — 3:15 PM

Using Big Data to Design Smarter Studies

1:45 PM — 3:15 PM

Using Competence Models to Drive High Quality Drug Project Management

3:30 PM — 4:30 PM

SCOTUS DNA Patent Ruling: Implications for the Industry

4:00 PM — 5:30 PM

Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges

4:00 PM — 5:30 PM

Challenges for Stable Supply of Drugs and International Cooperation

4:00 PM — 5:30 PM

Clinical Trial Visit of the Future: Leveraging Emerging Technologies to Crack the Patient Recruitment Challenge

4:00 PM — 5:30 PM

Current Regulatory Landscape Impacting Medical and Scientific Communications

4:00 PM — 5:30 PM

Data Standards Strategy

4:00 PM — 5:30 PM

Developing a Patient Aid to Make Information about Treatment Benefits, Harms and Uncertainties Meaningful to Individual Patients and Enhance Their Decisions

4:00 PM — 5:30 PM

Electronic Regulatory Submission (ERS) Development and the Impact on the Sponsor’s Organization: Retooling R&D for ERS

4:00 PM — 5:30 PM

Ensuring Patient-centered Care: Partnering with Patient Advocacy

4:00 PM — 5:30 PM

Ethical Issues in Clinical Trials

4:00 PM — 5:30 PM

Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors

4:00 PM — 5:30 PM

Global Pediatric Development: Next Steps

4:00 PM — 5:30 PM

Herbal-induced Liver Injury (HILI): How That May Impact Rx Benefit-Risk

4:00 PM — 5:30 PM

Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective

4:00 PM — 5:30 PM

Informing Regulatory and Health Technology Assessment (HTA) Decision-making Processes: An Integrated Approach to Life Cycle Management

4:00 PM — 5:30 PM

Innovations in Proactive Quality Management: Best Practices and Variability in Approaches to Proactive Quality Management

4:00 PM — 5:30 PM

Innovative Ways of Working with Patients to Make Clinical Research More Productive, Less Costly and Less Burdensome for the Patient

4:00 PM — 5:30 PM

Latin America Town Hall

4:00 PM — 5:30 PM

Learnings from Safety Communications Across the Industry: Patients and EMA, REMS and FDA, Physicians and Medical Information Groups

4:00 PM — 5:30 PM

Meeting the Challenges of Health Care Disparities and Clinical Trial Requirements in the Global Environment

4:00 PM — 5:30 PM

Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives

4:00 PM — 5:30 PM

Overcoming Unique Challenges of Pediatric Studies

4:00 PM — 5:30 PM

Partnering and Outsourcing Challenges in India: The New Paradigm Shifts

4:00 PM — 5:30 PM

Pharmaceutical Project Management: What's Really Important and How Can We Do Better?

4:00 PM — 5:30 PM

Pharmacometric Methods: Essential for Optimal Drug Development Strategy

4:00 PM — 5:30 PM

Rescuing and Repurposing Drugs: Challenges and Opportunities

4:00 PM — 5:30 PM

TransCelerate’s Collaborative Approach for Site Qualification and Training Efficiencies

5:30 PM — 7:30 PM

Movie Documentary: Here.Us.Now.

Day 5 Jun 27, 2013

9:00 AM — 10:30 AM

CDER Town Hall: Part 1 of 2

9:00 AM — 10:30 AM

Changing Landscape of IT in the Pharmaceutical Industry

9:00 AM — 10:30 AM

Coding with Confidence

9:00 AM — 10:30 AM

eDM From Three Sponsors

9:00 AM — 10:30 AM

eSource Symposium

9:00 AM — 10:30 AM

Hot Topics in Clinical Supplies

9:00 AM — 10:30 AM

Key Learnings from the Approval and Launch of a 505(b)(2) Product from a Medical Communications Perspective

9:00 AM — 10:30 AM

Medical Devices Global Symposium

9:00 AM — 10:30 AM

Mobile Learning and Social Media Symposium

9:00 AM — 10:30 AM

NDA Submission Strategy for New Chemical Entity (NCE) Products in Asia Pacific Countries to Reduce Drug Lag

9:00 AM — 10:30 AM

Orphan Drug Development Strategy by Big and Medium/Small Pharmaceutical Industries

9:00 AM — 10:30 AM

Parents as Partners: Engaging Caregivers for Pediatric Trials

9:00 AM — 10:30 AM

Patient-centered Predictive Modeling and Its Role in Creating a Learning Health System

9:00 AM — 10:30 AM

Postapproval Change Management: Challenges and Opportunities

9:00 AM — 10:30 AM

Some Innovative Approaches to Handling Missing Data Problems in Clinical Trials

9:00 AM — 10:30 AM

Strategic Partnerships: Emerging Models and Their Impact on Drug Development

9:00 AM — 10:30 AM

The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value

9:00 AM — 10:30 AM

Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can?

10:45 AM — 12:15 PM

Bayesian Methods in Medical Product Development and Comparative Effectiveness

10:45 AM — 12:15 PM

CDER Town Hall: Part 2 of 2

10:45 AM — 12:15 PM

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

10:45 AM — 12:15 PM

CRA’s Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Reg. Environment

10:45 AM — 12:15 PM

Cultural Awareness and Collaboration

10:45 AM — 12:15 PM

Emerging Electronic Tools in Cardiovascular Outcomes Studies

10:45 AM — 12:15 PM

Impact and Interventions Related to FDASIA: Increasing Diversity in Clinical Trials

10:45 AM — 12:15 PM

Implementing a Paperless Trial for Phase 3: A Biotech’s Lessons Learned

10:45 AM — 12:15 PM

Insights into China: Practical Tips for Writing Publication and Regulatory Documents

10:45 AM — 12:15 PM

Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations

10:45 AM — 12:15 PM

Protocol Deviations: Avoidable Problems or an Unavoidable Risk

10:45 AM — 12:15 PM

The Importance of Country Selection in Clinical Study Design

10:45 AM — 12:15 PM

Transforming Relationships to Adapt to Evolving Organizational Strategic Goals

10:45 AM — 12:15 PM

What's the Point? Can Point of Care Devices Enhance Clinical Trials?

Day 6 Jun 28, 2013

8:00 AM — 5:00 PM

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DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

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