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Virtual Event

2020年6月14日 (日) 午前 9:00 - 2020年6月18日 (木) 午後 5:00

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

アジェンダ

8:00 AM — 10:00 AM

DIA Global Annual Meeting – Opening DIAmond and Plenary Session

10:15 AM — 10:45 AM

Advanced Clinical Innovation Theater: Future Forward Trends for Overcoming the Talent Shortage in Clinical Research while Diminishing Risk

10:15 AM — 10:45 AM

ArisGlobal Innovation Theater: Leveraging Automation in PV

10:15 AM — 10:45 AM

Challenges in Advanced Therapy Development: A New Community

10:15 AM — 10:45 AM

Veeva Innovation Theater: Annual Industry Report - Trends, Insights, and Strategies to Modernize Clinical Operations

11:00 AM — 12:00 PM

Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model

11:00 AM — 12:00 PM

International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation

11:00 AM — 12:00 PM

Leveraging Clinical Pharmacology to Transform Real World Data into Real World Evidence for Special Patient Populations

11:00 AM — 12:00 PM

Outcomes as a Pathway to Value and Pharma, Payer, Provider Collaboration

11:00 AM — 12:00 PM

Patients First! How FDA is Making Patients a Priority

11:00 AM — 12:00 PM

To Shape the Future of Patient Labeling Across Regions

12:00 PM — 3:00 PM

Networking Lounge: Advanced Therapies

12:00 PM — 3:00 PM

Networking Lounge: COVID-19

12:00 PM — 3:00 PM

Networking Lounge: Data Science

12:00 PM — 3:00 PM

Networking Lounge: Digital Technology and Artifical Intelligence

12:00 PM — 3:00 PM

Networking Lounge: Diversity, Disparities, and Inclusiveness

12:00 PM — 3:00 PM

Networking Lounge: Emerging Professionals and Students

12:00 PM — 3:00 PM

Networking Lounge: Patient Focused

12:00 PM — 3:00 PM

Networking Lounge: Real World Evidence

12:30 PM — 1:00 PM

Collecting Meaningful Patient Experience Data

12:30 PM — 1:00 PM

Google Innovation Theater: Enabling Insights and Collaboration Across the Lifesciences Enterprise with Google Cloud and Accenture

12:30 PM — 1:00 PM

IQVIA Innovation Theater: COVID-19 Disruption Provides a Pivotal Opportunity to Accelerate Patient Engagement Innovation

12:30 PM — 1:00 PM

Parexel Innovation Theater: The Future is Now: The Rise and Rise of Decentralized Clinical Trials During the COVID Pandemic and Beyond

12:30 PM — 1:30 PM

Round Table Discussion: Patients First! How FDA is Making Patients a Priority

1:00 PM — 1:30 PM

Syneos Health Innovation Theater: Patient Engagement: Driving Better Care and Outcomes

1:00 PM — 1:30 PM

UBC Innovation Theater: Unlocking the Evidence-Generating Potential of the EMR

1:00 PM — 1:30 PM

WCG Innovation Theater: A Tale of Two Eras: Interpreting Clinical Operations Data Pre- and Post- COVID-19

1:30 PM — 2:30 PM

Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?

1:30 PM — 2:30 PM

How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should you Measure to Gain Insights?

1:30 PM — 2:30 PM

ICH 30th Anniversary Series: Harmonizing Global Requirements for Clinical Trials

1:30 PM — 2:30 PM

Is Your App a Drug, a Device, or Something Else Entirely?

1:30 PM — 2:30 PM

Non-Profit Organizations Role in Accelerating Preclinical Compound Testing to Fuel the Rare Disease Clinical Pipeline

1:30 PM — 2:30 PM

The Changing Role of the Data Professional

2:30 PM — 3:00 PM

Covance Innovation Theater: Driving Patient-Centric Trials: Moving Beyond the Hype

2:30 PM — 3:00 PM

IQVIA Innovation Theater 2: Digital Patient Orchestration, An Examination of the Patient Journey

2:30 PM — 3:00 PM

SAS Innovation Theater: The Role of Augmented Clinical Trials in the Response to COVID-19 and Beyond

3:00 PM — 3:30 PM

Appian Innovation Theater - Bayer: Shaping the Future to Meet Our Needs – A Digital Transformation

3:30 PM — 4:30 PM

Benchmarking and Identifying Opportunities to Improve Intentional Dose Non-Adherence in Clinical Trials

3:30 PM — 4:30 PM

Engaging Patients to Support the Modernization of ClinicalTrials.gov

3:30 PM — 4:30 PM

FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review

3:30 PM — 4:30 PM

Should a COVID-19 Vaccination be Legally Mandated and Can HTA Inform That Decision?

3:30 PM — 4:30 PM

The Rare Disease Clinical Outcome Assessment Consortium: Aiming to Fulfill Unmet Drug Development Endpoint Measurement Needs

3:30 PM — 4:30 PM

Virtual Clinical Trials

8:00 AM — 9:00 AM

ICH 30th Anniversary Series: The Role of Multidisciplinary Topics

8:00 AM — 9:00 AM

Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion

8:00 AM — 9:00 AM

Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials

8:00 AM — 9:00 AM

Patient-Centricity: How do We Measure Progress in Involving Patients in Drug Development and Drug Safety?

8:00 AM — 9:00 AM

Regulatory Agility During the COVID-19 Pandemic

8:00 AM — 9:00 AM

Using Artificial Intelligence to Inform Regulatory and Development Strategies

9:00 AM — 9:30 AM

Covance Innovation Theater: Managing Complexity: The COVID-19 Road To Recovery and Restoration

9:00 AM — 9:30 AM

IBM Innovation Theater: New Ways to Apply Decentralized Trials During Covid-19

9:30 AM — 10:30 AM

ACTIV: A Public-Private Partnership to Speed COVID-19 Therapies and Vaccines

9:30 AM — 10:30 AM

Balancing Clinical Trial Disclosure and Transparency with Global Data Protection Regulations

9:30 AM — 10:30 AM

Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update

9:30 AM — 10:30 AM

Data Driven Monitoring Enabled Through Analytics and Quality Risk Management

9:30 AM — 10:30 AM

GCP Quality and Compliance: The Regulators’ Perspective

9:30 AM — 10:30 AM

Project Management in Times of Crisis

9:30 AM — 10:30 AM

Qualitative, Quantitative, and Mixed Method Approaches to Capture the Patient Experience

10:45 AM — 11:30 AM

ArisGlobal Innovation Theater: The Evolving Role of CTMS in Risk Management

10:45 AM — 11:30 AM

Google Innovation Theater: Next Generation Biomedical and Clinical Research Platform with Google Cloud and Deloitte

10:45 AM — 11:15 PM

Round Table Discussion: Patient-Centricity: How Do We Measure Progress in Involving Patients in Drug Development and Drug Safety?

10:45 AM — 11:30 AM

Veeva Innovation Theater: The Next Big Step Toward a Collaborative Clinical Ecosystem

11:30 AM — 12:30 PM

Accelerated Approval and Emerging Surrogate Endpoints

11:30 AM — 12:30 PM

Disruptive Transformation in Safety Organizations

11:30 AM — 12:30 PM

Next Generation Analytics: Harnessing the Power of Nonclinical SEND Datasets to Improve Success in Early Clinical Development

11:30 AM — 12:30 PM

Non-Traditional Clinical Trials Require a Non-Traditional Workforce

11:30 AM — 12:30 PM

Patient-Centricity: How Do We Talk to and Listen to Patients?

11:30 AM — 12:30 PM

Sponsor and Regulator Challenges, Risks, and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk?

12:30 PM — 3:00 PM

Networking Lounge: Advanced Therapies

12:30 PM — 3:00 PM

Networking Lounge: COVID-19

12:30 PM — 3:00 PM

Networking Lounge: Data Science

12:30 PM — 3:00 PM

Networking Lounge: Digital Technology and Artifical Intelligence

12:30 PM — 3:00 PM

Networking Lounge: Diversity, Disparities, and Inclusiveness

12:30 PM — 3:00 PM

Networking Lounge: Emerging Professionals and Students

12:30 PM — 3:00 PM

Networking Lounge: Patient Focused

12:30 PM — 3:00 PM

Networking Lounge: Real World Evidence

12:45 PM — 1:30 PM

Bioclinica Innovation Theater: Rescuing Clinical Adjudication Studies - Special Considerations When Transitioning From an Under-Performing Adjudication Provider

12:45 PM — 1:30 PM

Intersystems Innovation Theater: Investing in Real-Time, Real World Data to Accelerate Clinical Trials and Enhance Market Access

1:15 PM — 2:00 PM

Round Table Discussion: RIM Working Group Update

1:30 PM — 2:00 PM

Staying Connected in a Virtual World: Communications Stakeholder Engagement That Drive Results

1:40 PM — 2:00 PM

ConvergeHEALTH by Deloitte Innovation Theater: The Future of Clinical Trials is Now- How Can Digital Transformation Enable More Seamless Recruitment, Increase Patient Engagement, and Improve Adherence and Outcomes?

2:00 PM — 3:00 PM

Examining Diversity in Clinical Trials

2:00 PM — 3:00 PM

FDA Data Standards Update

2:00 PM — 3:00 PM

Patient Voice and its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures

2:00 PM — 3:00 PM

Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights

2:00 PM — 3:00 PM

Practical Solutions for Designing and Conducting a Digital Health Trial

2:00 PM — 3:00 PM

The FDA Complex Innovative Trial Design Pilot Program: Case Examples

2:00 PM — 3:00 PM

Utilizing Cloud-Based Platforms in Regulatory Contexts

3:15 PM — 3:45 PM

A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World

3:15 PM — 3:45 PM

On the Soapbox: At a Time of High Priced Medicines and a Global Pandemic - How Do We Make Medicines Accessible and Affordable to All?

3:15 PM — 3:45 PM

Parexel and Microsoft Innovation Theater: #KeepingPatientsFirst - An Integrated Research Platform for COVID-19

3:15 PM — 4:00 PM

Round Table Discussion: Examining Diversity in Clinical Trials

3:15 PM — 3:45 PM

Veeva Innovation Theater: It's Time to Rethink Your EDC

4:00 PM — 5:00 PM

Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning

4:00 PM — 5:00 PM

Engaging Caregivers in Research and Medical Product Development

4:00 PM — 5:00 PM

FDA Pre-Market Safety Assessment Program

4:00 PM — 5:00 PM

Incorporating the Patient Perspective in a Drug Development Program

4:00 PM — 5:00 PM

Lean Writing: Making Regulatory Documents Simple and Straightforward

4:00 PM — 5:00 PM

Projecting a Voice of Confidence in a World of Uncertainty

8:00 AM — 9:15 AM

Balancing Science, Regulation, and Social Good in Clinical Trial Participant Diversity

8:00 AM — 9:00 AM

Combining Multiple Real World Data Sources to Maximize Value

8:00 AM — 9:00 AM

Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance

8:00 AM — 9:00 AM

Detection of Anomalies in eCOA Data and Metadata for More Pre-Emptive, Evidence-Based Risk Management

8:00 AM — 9:00 AM

ICH 30th Anniversary: Achievements and Future Prospects

8:00 AM — 9:00 AM

Seamlessly Evolving Global Clinical Trial Liaison Field Medical Resources to Classic MSLs from Phase 3 to Launch

8:00 AM — 9:00 AM

Strategic Directions from Global Medicines Regulators: The ICMRA Statement on Combatting Antimicrobial Resistance

9:00 AM — 9:30 AM

Salesforce Innovation Theater: Recruit and Engage Trial Participants with a Connected Platform

9:30 AM — 10:30 AM

Global Rare Disease Town Hall

9:30 AM — 10:30 AM

ICH 30th Anniversary Series: Advancing Pharmaceutical Safety

9:30 AM — 10:30 AM

If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development

9:30 AM — 10:30 AM

Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?

10:45 AM — 11:15 AM

IQVIA Innovation Theater: Modernizing Regulatory Evidence with Real World Studies

10:45 AM — 11:15 AM

Microsoft Innovation Theater: Journey to the Fully Digital Study Starts with Standards

10:45 AM — 11:15 AM

UBC Innovation Theater: What You Need to Know About Assembling an Integrated Registry

11:30 AM — 12:30 PM

Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics

11:30 AM — 12:30 PM

Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications

11:30 AM — 12:30 PM

Evolving Trials for the Digital Age

11:30 AM — 12:30 PM

Leading Through Complexity: Opportunities, Pitfalls, and Best Practices for Managing Successful Partnerships

11:30 AM — 12:30 PM

Recommendations for a Strategic Response to the COVID-19 Pandemic

11:30 AM — 12:30 PM

Report of CIOMS DILI Working Group

12:30 PM — 3:00 PM

Networking Lounge: Advanced Therapies

12:30 PM — 3:00 PM

Networking Lounge: COVID-19

12:30 PM — 3:00 PM

Networking Lounge: Data Science

12:30 PM — 3:00 PM

Networking Lounge: Digital Technology and Artifical Intelligence

12:30 PM — 3:00 PM

Networking Lounge: Diversity, Disparities, and Inclusiveness

12:30 PM — 3:00 PM

Networking Lounge: Emerging Professionals and Students

12:30 PM — 3:00 PM

Networking Lounge: Patient Focused

12:30 PM — 3:00 PM

Networking Lounge: Real World Evidence

12:45 PM — 1:15 PM

IQVIA Innovation Theater: Driving Quality Through Innovative Digital Trial Approaches in a Pandemic Era

12:45 PM — 1:15 PM

JMP Innovation Theater: Adverse Events in Clinical Trials: When Doctors Require a Statistical Perspective

12:45 PM — 1:30 PM

Round Table Discussion: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications

1:15 PM — 1:45 PM

Covance Innovation Theater: Tailoring Your Journey Map Using a Data Driven Approach to Accelerate Patient Recruitment and Improve Patient Retention

1:30 PM — 2:00 PM

The New DIA Statistics and Data Science Community

2:00 PM — 3:00 PM

Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process

2:00 PM — 3:00 PM

Best Practices for Virtual Meetings with FDA!

2:00 PM — 3:00 PM

Driving Quality Through Innovative Approaches

2:00 PM — 3:00 PM

Globalization of Medical Information

2:00 PM — 3:00 PM

Optimizing Communication with Patients to Support Meaningful Feedback into the Research Process

3:15 PM — 3:45 PM

Role of Medical Communications Experts in Building Accelerated Regulatory Dossiers and Securing First-Attempt Approvals

4:00 PM — 5:00 PM

Approaches for Cross-Functional Teams to Enhancing Quality of Decision-Making During the Development and Review of Medicines

4:00 PM — 5:00 PM

Drug Pricing in the United States: How and Why is it Different Than in the Rest of the World

4:00 PM — 5:00 PM

Immunogenicity of Biologics: Clinical Consequences

4:00 PM — 5:00 PM

Mindfulness: Beyond Meditation

4:00 PM — 5:00 PM

The Development of Novel Digital Endpoints

4:00 PM — 5:00 PM

Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct

8:00 AM — 9:00 AM

Best Practices in Developing Medical Information Responses

8:00 AM — 9:00 AM

Catalyzing the Integration of Digital Technologies in Healthcare Solutions

8:00 AM — 9:00 AM

Digital Risk Minimization: How Can We Advance Adoption?

8:00 AM — 9:00 AM

FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies

8:00 AM — 9:00 AM

FDA-PAHO: Landscape Report of Regulatory Situation in the Americas

8:00 AM — 9:00 AM

Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making

8:00 AM — 9:00 AM

Statistical Considerations for Using External Controls in Clinical Trials

9:30 AM — 10:30 AM

ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality

9:30 AM — 10:30 AM

Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details

9:30 AM — 10:30 AM

Orphan Drug Development in Personalized Medicine

9:30 AM — 10:30 AM

Qualification and Oversight in Decentralized Trials: Practical Considerations for Clinical Operations and Quality Oversight

9:30 AM — 10:30 AM

Telling Health Stories for Drug Development

9:30 AM — 10:30 AM

Trust: What Makes It: What Breaks It

10:30 AM — 11:00 AM

Information Overload: Best Practices to Manage Information and Remember Where the Information Is!

11:30 AM — 12:30 PM

How the FDA’s MyStudies Platform is Accelerating the Use of Digital Technology in Clinical Research and Clinical Trials

11:30 AM — 12:30 PM

Keep Calm and Carry On: Mindfulness to Increase Work Productivity

11:30 AM — 12:30 PM

Quantitative Benefit-Risk Assessment: What Methods are Being Used? How Far has Industry Come?

11:30 AM — 12:30 PM

Reusing What You Wrote the First Time: Deja Vu All Over Again

2:00 PM — 3:15 PM

FDA Town Hall

5:00 PM — 6:00 PM

CRO Leadership Awards

5:00 PM — 5:00 PM

ON DEMAND - Advancing Risk Management: What Can Evidence-Based Practices to Disseminate Healthcare Evidence into Practice Teach Us?

5:00 PM — 6:00 PM

ON DEMAND - Unblinding The New Face of the Local Safety Officer

5:00 PM — 6:00 PM

ON DEMAND - Advancing Clinical Research Through Fast Healthcare Interoperability Resources: An Industry Perspective of Where We Are and Where To Go

5:00 PM — 6:00 PM

ON DEMAND - Advancing Clinical Trial Innovation Through Model-Informed Drug Development

5:00 PM — 6:00 PM

ON DEMAND - Advancing Effective Use of Digital Health Technologies in Parkinson’s Disease

5:00 PM — 6:00 PM

ON DEMAND - Applying the Concepts of Good Clinical Practice in Real World Evidence

5:00 PM — 6:00 PM

ON DEMAND - Artificial Intelligence: Use Cases from Real Trials

5:00 PM — 6:00 PM

ON DEMAND - Assessing the Adoption of Clinical Trial Results Summary Disclosure to Patients and the Public

5:00 PM — 6:00 PM

ON DEMAND - Best Practices for Randomization and Re-Randomization in Clinical Trials

5:00 PM — 6:00 PM

ON DEMAND - Bridging Bench to Bedside With Novel Biomarkers

5:00 PM — 6:00 PM

ON DEMAND - Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface

5:00 PM — 6:00 PM

ON DEMAND - Combination Therapies of Investigational Agents

5:00 PM — 6:00 PM

ON DEMAND - Communicate and Co-Create with Patients Across the Medicines Development Lifecycle: Principles and Best Practices

5:00 PM — 6:00 PM

On DEMAND - Communicating Value to Payers Pre-Approval in the US

5:00 PM — 6:00 PM

ON DEMAND - Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA

5:00 PM — 6:00 PM

ON DEMAND - Considerations for Long-Term Outcomes Data Collection for Value-Based Payment Arrangements

5:00 PM — 6:00 PM

ON DEMAND - Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR

5:00 PM — 6:00 PM

ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations

5:00 PM — 6:00 PM

ON DEMAND - Deploying Machine Learning in Data Management

5:00 PM — 6:00 PM

ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines

5:00 PM — 6:00 PM

ON DEMAND - Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges

5:00 PM — 6:00 PM

ON DEMAND - Electronic Informed Consent: Global Perspectives

5:00 PM — 6:00 PM

ON DEMAND - Faster, Better, Cheaper: The Changing Role of Real World Data in Drug Development

5:00 PM — 6:00 PM

ON DEMAND - Gaslighting at Work: How to Recognize and Respond to this Unique Form of Harassment

5:00 PM — 6:00 PM

ON DEMAND - Getting Real About Data Sharing for Drug Development and Drug Safety: What COVID-19 is Teaching us About the Possibilities and How to Move From Anomaly to Precedent

5:00 PM — 6:00 PM

ON DEMAND - Global Commission Harnessing Cutting-Edge Technology to Accelerate Diagnosis of Rare Diseases in Children

5:00 PM — 6:00 PM

ON DEMAND - Hype or Hope: Quantifying the Risk of Patients with Complex Diseases

5:00 PM — 6:00 PM

ON DEMAND - Impact of Advanced Data Analytics Capabilities on Quality and Compliance Activities: Overview and Case Studies

5:00 PM — 6:00 PM

ON DEMAND - Impact Patient-Centered Initiatives in Clinical Trial Design and Execution

5:00 PM — 6:00 PM

ON DEMAND - Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come

5:00 PM — 6:00 PM

ON DEMAND - Managing Global Clinical Trials in Emerging Regions: Latin America

5:00 PM — 6:00 PM

ON DEMAND - MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper?

5:00 PM — 6:00 PM

ON DEMAND - Microbiome Therapies Beyond Fecal Microbiota Transplantation: Challenges and Opportunities

5:00 PM — 6:00 PM

ON DEMAND - Networking for Everyone: Extrovert/Introvert/Centrovert

5:00 PM — 6:00 PM

ON DEMAND - New Drugs Regulatory Program Modernization

5:00 PM — 6:00 PM

ON DEMAND - N-Nitrosamines Contamination Case Lessons Learned

5:00 PM — 6:00 PM

ON DEMAND - Older People Can’t Use ePRO and Other Industry Myths: An Interactive Debate

5:00 PM — 6:00 PM

ON DEMAND - Online Medical Information Resources and Channels

5:00 PM — 6:00 PM

ON DEMAND - Opportunities and Challenges for ICH E6 (GCP) Renovation

5:00 PM — 6:00 PM

ON DEMAND - Optimizing Study Start Up Processes: Site Selection, Budgeting, and Contracting

5:00 PM — 6:00 PM

ON DEMAND - Patient Preferences in the Medical Product Lifecycle: Evolving Uses, Stakeholder Considerations, and Applications

5:00 PM — 6:00 PM

ON DEMAND - Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk

5:00 PM — 6:00 PM

ON DEMAND - Pharmacovigilance Inspections: Leveraging Inspection Intelligence as a Driver of Quality in Your Organization

5:00 PM — 6:00 PM

ON DEMAND - Phase 1 Cell and Gene Therapy Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation

5:00 PM — 6:00 PM

ON DEMAND - PMDA Town Hall: The Path of a New Chief Executive Since His Appointment

5:00 PM — 6:00 PM

ON DEMAND - Project Management Playbook to Effective Stakeholder Management

5:00 PM — 6:00 PM

ON DEMAND - Quality Considerations for Complex Drugs

5:00 PM — 6:00 PM

ON DEMAND - Quality Oversight of Pharmacovigilance Processes

5:00 PM — 6:00 PM

ON DEMAND - Real World Use of Real World Evidence

5:00 PM — 6:00 PM

ON DEMAND - Recipe for Transformation to Higher-Performing Teams

5:00 PM — 6:00 PM

ON DEMAND - Regulatory Barriers to Entry for Biosimilars

5:00 PM — 6:00 PM

ON DEMAND - Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like?

5:00 PM — 6:00 PM

ON DEMAND - Revolutionizing Project Management Through Building Your Culture and Emotional Intelligence

5:00 PM — 6:00 PM

ON DEMAND - Setting a Strategic Foundation for Mutually Beneficial Collaborations Between Industry and Patient Organizations

5:00 PM — 6:00 PM

ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID)

5:00 PM — 6:00 PM

ON DEMAND - Storyboarding for Key Message Alignment in Marketing Applications

5:00 PM — 6:00 PM

ON DEMAND - Strengthening Food and Drug Regulatory Systems Abroad: Recommendations from the FDA-Commissioned NASEM Report

5:00 PM — 6:00 PM

ON DEMAND - Subscription Models to Incentive Antimicrobial Innovation

5:00 PM — 6:00 PM

ON DEMAND - Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse

5:00 PM — 6:00 PM

ON DEMAND - The DEEP Model: Long-Term Commitment to Partnering With Patients

5:00 PM — 6:00 PM

ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science

5:00 PM — 6:00 PM

ON DEMAND - The Power of Real World Data and the Innovative Approaches for Usage

5:00 PM — 6:00 PM

ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints

5:00 PM — 6:00 PM

ON DEMAND - Updates of Drug Evaluation and Inspection in China

5:00 PM — 6:00 PM

ON DEMAND - Using Data Visualization to Drive Meaningful Insights

5:00 PM — 6:00 PM

ON DEMAND - Utilization of Bayesian Statistics in Clinical Trials

5:00 PM — 6:00 PM

ON DEMAND - Wearables

5:00 PM — 6:00 PM

ON DEMAND - What Does THAT Mean? Communicating Study Risks and Benefits in Patient-Friendly Language

5:00 PM — 6:00 PM

ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data

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