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Virtual

Jun 27, 2021 10:00 AM - Jul 01, 2021 4:30 PM

DIA 2021 Global Annual Meeting

Agenda

12:00 AM — 12:00 AM

12:00 AM — 12:00 AM

12:00 AM — 12:00 AM

10:00 AM — 11:45 AM

DIA Global Annual Meeting - Opening DIAmond and Plenary Session

12:00 PM — 12:30 PM

Advanced Clinical Innovation Theater: Decentralized Clinical Trials: The Wave of the Future

12:00 PM — 12:30 PM

How to Share Individual Patient-Level Data Safely for Pharma Innovation

12:00 PM — 12:30 PM

IQVIA Innovation Theater: Redefining Patient Engagement and Recruitment Beyond 2021

12:00 PM — 1:00 PM

Meet the DIA Fellows

12:00 PM — 12:30 PM

Results from a Survey of Biopharmaceutical on Attitudes Towards the Use of Wearables and Sensors in Clinical Research

12:00 PM — 12:30 PM

Syneos Health Innovation Theater: Accelerating Clinical Trial Recruitment - A New Path To Speed Enrollment

12:30 PM — 1:00 PM

Anju Software Innovation Theater: Utilizing Adaptive Technology Systems to Get the Most from Decentralized Trials

12:30 PM — 1:00 PM

Deloitte (ConvergeHEALTH) Innovation Theater: Automating Adverse Event Case Processing Through Machine Learning and Innovation

12:30 PM — 1:00 PM

Solution Circle: QPPV Perspective on Brexit - Is Your Pharmacovigilance System Compliant?

12:30 PM — 1:00 PM

Solution Circle: Where Do We Go From Here? DCTs and Patient Centricity Post-COVID-19

12:30 PM — 1:00 PM

UBC Innovation Theater: Critical Components for Successful Vendor Selection: CRO, PV, Registries and REMS Services

1:00 PM — 2:00 PM

Advanced Analytics, Cross-Industry Collaboration, and Data Sharing to Change the Paradigm in Clinical Quality

1:00 PM — 2:00 PM

COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches

1:00 PM — 2:00 PM

Defining Quality for Cell and Gene Therapy Products

1:00 PM — 2:00 PM

FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies

1:00 PM — 2:00 PM

Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science

1:00 PM — 2:00 PM

Leveraging Pharma Intelligence Data and Statistical Modeling to Inform Project Strategies

1:00 PM — 2:00 PM

Machine Learning Enabled Digital Data Flow and Advanced Real-World Evidence

1:00 PM — 2:00 PM

Market Access, Medical Affairs, and Regulatory Affairs Functions Working Together to Address Payor and Regulatory Requirements

1:00 PM — 2:00 PM

Measuring Clinically Meaningful Change of Function: A Case Study of Patient-Centered Clinical Outcome Assessments in Early Parkinson’s Disease

1:00 PM — 2:00 PM

Patient-Centric Engagement Strategies

1:00 PM — 2:00 PM

Skills of the Future/The Future of Work

1:00 PM — 2:00 PM

Statistical Considerations with the Patient in Mind

1:00 PM — 2:00 PM

Technology Changes Needed to Manage Drug Supply for Decentralized Trials

2:00 PM — 2:30 PM

ArisGlobal Innovation Theater: Minimizing Noise to Improve Your PV Case Processing

2:00 PM — 2:30 PM

IBM Innovation Theater: Embracing Hybrid - How New Technologies, Synergized with Proven Solutions, Will Shape the Journey to Commonplace Decentralized Trials

2:00 PM — 2:30 PM

PPD Innovation Theater: Continuous Development and Flexible Architecture of the PPD® Laboratories’ Central Lab Preclarus® Portal to Meet the Changing Needs of Clinical Trials

2:30 PM — 3:30 PM

Advancing ICH Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches

2:30 PM — 3:30 PM

Are You Ready for a NISS? Industry and Regulatory Perspectives on the US FDA Newly Identified Safety Signal Process

2:30 PM — 3:30 PM

Ensuring Patient Engagement Methodologies Are ‘Fit for Purpose’ from the Beginning: A Key Factor for Meaningful Outcomes

2:30 PM — 3:30 PM

FDA Science Strategies: Purposeful Scientific Leadership to Advance Innovation and Improve Patient Outcomes

2:30 PM — 3:30 PM

Health Canada Town Hall

2:30 PM — 3:30 PM

Hiding in Plain Sight: Quantifying Underdiagnosed Populations

2:30 PM — 3:30 PM

How are Medical and Health Economics Data Generated and Disseminated to Various Customer Segments?

2:30 PM — 3:30 PM

Parallel Scientific Advice: Increasing International Dialogue Early in the Product Lifecycle

2:30 PM — 3:30 PM

Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors

2:30 PM — 3:30 PM

Risk-Based Remote Site Monitoring

2:30 PM — 3:30 PM

Risky Business: How to Successfully Manage Project Risk

2:30 PM — 3:30 PM

Role of Clinical Pharmacology Guidances and Policies in Enhancing Drug Development

2:30 PM — 3:30 PM

Walking the Talk: What Happens When Clinical Trialists Join Clinical Trials?

3:30 PM — 4:00 PM

Medidata Innovation Theater: Bench to Market in Record Time with Decentralized Technology

3:30 PM — 4:00 PM

Microsoft Innovation Theater: Massive Deep Learning Language Models and the Application to Life Sciences

3:30 PM — 4:00 PM

Phlexglobal Innovation Theater: Streamlining TMF Documentation Through Clinical Automation

4:00 PM — 5:00 PM

A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development

4:00 PM — 5:00 PM

Advancing the Science of Patient Input: How are WE doing? Multi-Stakeholder Perspective

4:00 PM — 5:00 PM

Challenges and Opportunities in Early Development of RNA Therapeutics

4:00 PM — 5:00 PM

Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and What We’ve Learned

4:00 PM — 5:00 PM

Culture of Quality: A Competitive Advantage

4:00 PM — 5:00 PM

Driving Innovation in Data Standards and Regulatory Submissions at FDA

4:00 PM — 5:00 PM

How Can We Compliantly Exchange Pre-Approval Information with Payers

4:00 PM — 5:00 PM

Implementation Progress of ICH Q12

4:00 PM — 5:00 PM

Launching Megatrials During a Pandemic: Lessons Learned from COVID-19 Vaccine Clinical Trials

4:00 PM — 5:00 PM

Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application

4:00 PM — 5:00 PM

Realizing the Value of Digital Biomarkers Across the Product Lifecycle

4:00 PM — 5:00 PM

Regulatory, Industry, Patient, and Academic Perspectives on Machine Learning in Clinical Trials

4:00 PM — 5:00 PM

Yes it's about Science, Yes it's about Patients but it's Also ALL About Business

8:00 AM — 8:45 AM

Unqork Innovation Theater: Unqork for Clinical Trials

8:00 AM — 8:45 AM

WCG Innovation Theater: Tailored Preparation for Site Success and Trial Continuity - WCG Site Augmentation

9:00 AM — 10:00 AM

Spotlight Symposia: Important Gaps to Fill with Diversity and Inclusion in Clinical Trials - Moving Beyond Recognition to Action

9:00 AM — 10:00 AM

Spotlight Symposia: Tales from the Front: Patient Equity and Engagement in Practice from Trial Design Through Execution

9:00 AM — 10:00 AM

Spotlight Symposia: Three Paths to Success in a Post-COVID World

9:30 AM — 10:00 AM

Acceleration of Clinical Research by Simultaneously Leveraging Real-World and Clinical Trials Data

9:30 AM — 10:00 AM

IQVIA Innovation Theater: Driving the Digitization of Clinical Development – Understanding the Impact of Innovative Digital Approaches

9:30 AM — 10:00 AM

Medidata Innovation Theater: Engaging Patients Pre- and Post-trial with Registries

9:30 AM — 10:00 AM

Oracle Innovation Theater: Untangling the Integration Mess of Today’s Digital eClinical

10:00 AM — 11:00 AM

Advancing Medicines’ Regulation in Europe: Key Strategies to 2025

10:00 AM — 11:00 AM

Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective

10:00 AM — 11:00 AM

Brave New World: Early Clinical Trials in a Pandemic

10:00 AM — 11:00 AM

Developing a Best-in-Class Learning and Performance Program for the MSLs of Today and the Future

10:00 AM — 11:00 AM

Global Harmonization of Complex and Innovative Trial Designs

10:00 AM — 11:00 AM

Managing Global Trials in Latin America: Covid Impact Update

10:00 AM — 11:00 AM

Novel and Innovative Approaches to Inspections: Verification of Quality and Compliance Using Remote Methodologies and New Technology

10:00 AM — 11:00 AM

Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall

10:00 AM — 11:00 AM

Pediatric Engagement in Research: Young People Have a Voice

10:00 AM — 11:00 AM

Perspectives on Real-World Data/Evidence Collection Through Expanded Access During the Covid-19 Pandemic

10:00 AM — 11:00 AM

Post COVID: Sites Evolving Role in the Clinical Trial Ecosystem

10:00 AM — 11:00 AM

Project Management in Times of Crisis: Perspectives from PMs Supporting COVID-19 Related Projects

11:00 AM — 11:30 AM

Generis Innovation Theater: Optimizing Regulatory Affairs with Structured Content Authoring

11:00 AM — 11:30 AM

Patient-Reported Outcomes: Going Beyond Clinical Trials

11:00 AM — 11:30 AM

PPD Innovation Theater: Capacity Management Through Upheaval

11:00 AM — 11:30 AM

Syneos Health Innovation Theater: Partnering to Innovate - The Way Forward for Decentralized Clinical Trials

11:30 AM — 12:30 PM

International Coalition of Medicines Regulatory Authorities (ICMRA): Harnessing Achievements During COVID-19 for the Future

12:00 PM — 1:00 PM

How to Ensure Quality in Cell and Gene Therapies

12:30 PM — 1:15 PM

Certara Synchrogenix Innovation Theater: Medical Writing and Submission Compilation Made Easy - Technology Solutions from Regulatory Experts

12:30 PM — 1:15 PM

Quest Diagnostics Innovation Theater: Healthcare Analytics Solutions, Leveraging Patient-Centric Data to Empower Pharmaceutical Organizations and CROs

12:30 PM — 1:15 PM

Statistics & Data Corporation (SDC) Innovation Theater: Artificial Intelligence and Machine Learning - Infrastructure and Team Architecture Enabling Efficient Capabilities

1:00 PM — 2:00 PM

Round Table Discussion: Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science

1:15 PM — 2:00 PM

ERT Innovation Theater: Check Your Blind Spots: A Holistic Approach to Patient-Centric Decentralized Clinical Trials

1:15 PM — 2:00 PM

Parexel International Innovation Theater: A Collaborative Trial Delivery Platform to Expedite Research

1:30 PM — 2:00 PM

Solution Circle: Conducting Clinical Trials in China

1:30 PM — 2:00 PM

The Clinical Impact of Medical Information for Healthcare Professionals

2:00 PM — 3:00 PM

Are External Control Arms Ready for Primetime?

2:00 PM — 3:00 PM

Diversity in Clinical Research: Practical Strategies for Taking Personal Action

2:00 PM — 3:15 PM

Driving Change Globally: Transforming the Regulators as Early Digital Adopters

2:00 PM — 3:00 PM

Epigenetic Drugs: Taking it to the Clinic- An Up-and-Coming Mode of Targeting Disease

2:00 PM — 3:00 PM

GCP Quality and Compliance: The Regulator’s Perspective

2:00 PM — 3:00 PM

Global Regulatory Harmonization for Increased Patient Access to Medicines Through the International Council for Harmonisation (ICH)

2:00 PM — 3:00 PM

How Can Real-World Evidence be Communicated Compliantly to Payers or Healthcare Providers?

2:00 PM — 3:00 PM

How to Stay Grounded in Project Management Best Practices While Moving at the Speed of Light Integrating a New Company

2:00 PM — 3:00 PM

Innovative Statistical Strategies and Designs in Oncology Drug Development

2:00 PM — 3:00 PM

Navigating Non-Trial Preapproval Access as a Patient

2:00 PM — 3:00 PM

Opportunities for Harmonization of Clinical Trial Information in Regulatory Documents

2:00 PM — 3:00 PM

Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop

2:00 PM — 3:00 PM

Supporting Quality/CMC Development in Early Access Approaches (PRIME/Breakthrough Designation)

2:00 PM — 3:00 PM

Systems Thinking: A Better Way of Safety Management Planning

2:00 PM — 3:15 PM

Update on FDA's Real-World Evidence Program: Current FDA Demonstration Projects

3:00 PM — 4:00 PM

Patient Scholar Meet Up

3:00 PM — 4:00 PM

Round Table Discussion: Advancing Medicines’ Regulation in Europe: Key Strategies to 2025

3:00 PM — 4:00 PM

Round Table Discussion: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies

3:00 PM — 4:00 PM

Spotlight Symposia: Managing Stakeholders in the Decentralized and Hybrid Clinical Trial Ecosystem

3:00 PM — 4:00 PM

Spotlight Symposia: Requirements of Site Training Technology in the New Research Landscape

3:15 PM — 3:45 PM

Deloitte (ConvergeHEALTH) Innovation Theater: Using AI to Drive Clinical Data Automation

3:15 PM — 3:45 PM

DocuSign Innovation Theater: Maintain Compliance While Serving a New Generation of Digital-First Customers

3:15 PM — 3:45 PM

Labcorp Drug Development Innovation Theater: ICYMI - Game on! How Gamification Drives Engagement in Pediatric and Adolescent Clinical Trials

4:00 PM — 5:00 PM

A Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation

4:00 PM — 5:00 PM

Effective Medical and Scientific Stakeholder Engagement: Are Digital Solutions The Answer?

4:00 PM — 5:00 PM

Frameworks for Digital Endpoints via the IND Pathway

4:00 PM — 5:00 PM

Innovative and Efficient Trial Designs and Statistical Approaches in Small Patient Populations: Rare Diseases and Pediatrics

4:00 PM — 5:00 PM

Innovative Approaches to Trial Execution, Quality, and Compliance

4:00 PM — 5:00 PM

Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?

4:00 PM — 5:00 PM

Multinational Collaborative CMC Review for Efficient and Rapid Product Approval

4:00 PM — 5:00 PM

Pandemic Preparedness: Accelerating Treatments to Overcome Antimicrobial Resistance

4:00 PM — 5:00 PM

Parents Just Don’t Understand: Does This Apply to Healthcare Too?

4:00 PM — 5:00 PM

Treating Covid-19 Patients with Unproven Interventions Outside Trials: EUAs, Expanded Access, Right to Try, and Off-Label Use

4:00 PM — 5:00 PM

What Do We Do Now? Why You Need A Resource for Ethical Questions During Drug Development

9:00 AM — 10:00 AM

Spotlight Symposia: Patient Diversity Strategies: Building a Sustainable Program

9:00 AM — 10:00 AM

Spotlight Symposia: The Intersection of Patient Advocacy and Technology - Key To Building Effective Patient Communities

9:30 AM — 10:00 AM

Banook Group and Be Patient. Innovation Theater: Virtual Clinical Trials - How to Manage Direct-to-Patient Solutions in Real Life

9:30 AM — 10:00 AM

CMIC Holdings Innovation Theater: Make the Impossible Possible - An Innovative Partnership for Market Entry in Japan

9:30 AM — 10:00 AM

Including Data Science in DIA

9:30 AM — 10:00 AM

Medable Innovation Theater: Enabling Decentralized Clinical Trial Readiness for your Organization

10:00 AM — 11:00 AM

Best Practices for Project Managers Working in Drug Development Collaborations

10:00 AM — 11:00 AM

Clinically Meaningful: How is it Different from Statistical Significance?

10:00 AM — 11:00 AM

Collaboration Tools 2021: You Wouldn't Believe What's Available, Much of it for Free!

10:00 AM — 11:00 AM

Digital by Design: Embedding Digital Across the Enterprise and the Product Lifecycle

10:00 AM — 11:00 AM

From Opportunity to Strategy: Introducing Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process

10:00 AM — 11:00 AM

It’s Like Building the Airplane While Flying it: Biomarker Discovery and Development in Clinical Trials

10:00 AM — 11:00 AM

Lean Writing: Making Regulatory and Clinical Documents Simple and Straightforward

10:00 AM — 11:00 AM

Leveraging Smartphones as Measurement Devices for Remotely Conducted Performance Outcome Tests: Notes from the Field

10:00 AM — 11:00 AM

Model Informed Drug Development (MIDD) Pilot Program: Experience and Impact Over First Three Years

10:00 AM — 11:00 AM

Nitrosamines: What We Have Learned as Regulators and Industry Professionals for a New Path Forward

10:00 AM — 11:00 AM

Patient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging with Patients: What has been Learned?

10:00 AM — 11:00 AM

Real Talk About Artificial Intelligence and Automation in Clinical Research Today

10:00 AM — 11:00 AM

The FDA's Clinical Trial Diversity Initiative in the Setting of the Ongoing COVID-19 Pandemic

10:00 AM — 11:00 AM

Towards a Patient-Focused Drug Development Ecosystem: Adoption of Core Outcome Sets

10:00 AM — 11:00 AM

Worldwide COVID-19 Pandemic Effects on Real-World Data: Research Can Go On

11:00 AM — 11:30 AM

IQVIA Innovation Theater: Implementing a Rapid Registry (CARE) Solution for Real-World Insights About COVID-19 Symptom Persistence

11:00 AM — 11:30 AM

PPD Innovation Theater: Leveraging Innovative Approaches to Create Efficiencies for Long Term Follow Up (LTFU) Studies

11:00 AM — 11:30 AM

SAS Institute Inc., JMP Division Innovation Theater: Obtain Robust Estimates from Critical Quality Attribute Models Through Limits of Detection (LOD) Censoring

11:00 AM — 11:30 AM

Serving Two Masters: Research Glossaries for Industry and Patients

11:30 AM — 12:30 PM

When Can You Trust Real-World Evidence for Decision-Making?

12:30 PM — 1:30 PM

How Can DIA Help You Advance Your Career? Involvement With DIA

12:45 PM — 1:15 PM

Medidata Innovation Theater: A Vision for the Future of Clinical Data Management

12:45 PM — 1:15 PM

Pharm-Olam, LLC Innovation Theater:Agile Patient Recruitment Success - Evolving to Serve a Digital World

1:00 PM — 2:00 PM

Round Table Discussion: Artificial Intelligence: Real Applications and Regulatory Perspectives

1:00 PM — 2:00 PM

Round Table Discussion: Innovative and Efficient Trial Designs and Statistical Approaches in Small Patient Populations: Rare Diseases and Pediatrics

1:30 PM — 2:00 PM

Six Secrets for Successfully Leading Remote Teams

1:30 PM — 2:00 PM

Solution Circle: Navigating Decentralized Trials with Flexible Strategic Solutions

1:30 PM — 2:00 PM

Solution Circle: Writing for Patients and the Summary of Clinical Trial Results

2:00 PM — 3:00 PM

Assessing Risk in the Pharmacovigilance System for the Purpose of Audit and Inspection

2:00 PM — 3:00 PM

Best Practices in Governance Meetings

2:00 PM — 3:00 PM

Beyond Cancer: Why Pharma is Moving to High Quality Real-World Data for Immunology and Other Chronic Diseases

2:00 PM — 3:00 PM

Converge and Conquer: The Overlapping Roles of Data Management, Operations, Monitoring and More, and What it Means for Industry

2:00 PM — 3:00 PM

COVID-19 Pandemic and Beyond: Challenges Performing Inspections, Current State of Manufacturing Facility Regulatory Oversight Tools, and Learnings

2:00 PM — 3:00 PM

How Has FDARA Section 504 (RACE Act) Changed the Pediatric Oncology Landscape?

2:00 PM — 3:00 PM

Interpreting and Writing About Clinical Trial Data

2:00 PM — 3:00 PM

Mixing Modes of Clinical Outcome Assessments in Response to COVID-19

2:00 PM — 3:00 PM

Patient Engagement and Quality by Design: Integrating the Patient Perspective in Clinical Trial Design

2:00 PM — 3:00 PM

Risk Minimization Program Evaluation: How Can we Advance the Science?

2:00 PM — 3:00 PM

Scientific Advances in Biosimilar Development

2:00 PM — 3:00 PM

Technology-Driven Endpoints for Patient Retention and Engagement for Clinical Trials

3:00 PM — 4:00 PM

How Can You Get Involved With the Global Annual Meeting?

3:00 PM — 4:00 PM

Round Table Discussion: Patient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging with Patients: What has been Learned?

3:00 PM — 4:00 PM

Spotlight Symposia: Innovation in Patient-Centered Research - The Journey from Patient Registries to Integrated Health Platforms

3:00 PM — 4:00 PM

Spotlight Symposia: Learnings from the World Health Organization's (WHO) COVID-19 Solidarity Trial- An Adaptive Trial Powered by Castor Technology

3:15 PM — 4:00 PM

CGI Innovation Theater: Data Mobility: Smart Transformation to a Cloud-Enabled Digital Organization

3:15 PM — 4:00 PM

RWS Innovation Theater: The Future of Digital Content in Life Sciences: Minimizing Risk and Improving Quality in Content Operations

4:00 PM — 5:00 PM

Breaking the Document Paradigm to Digitize Study Start Up: The Digital Data Flow Initiative

4:00 PM — 5:00 PM

Companion Diagnostics: Could Co-Development be Expedited to Facilitate Access to Accelerated Novel Therapeutics?

4:00 PM — 5:00 PM

COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies

4:00 PM — 5:00 PM

How to Streamline Project Management Methodology Across an Organization: End Reliance on Trackers and Emails

4:00 PM — 5:00 PM

Improving Efficiency and Quality of Regulatory Documents

4:00 PM — 5:00 PM

Risk-Based Quality Management and Monitoring: Practical Approaches

4:00 PM — 5:00 PM

The Covid -19 Digital Response of Countries and Companies: What is Here to Stay?

4:00 PM — 5:00 PM

The Intersection of Health Equity and Personalized Medicine

4:00 PM — 5:00 PM

The Rare Disease Clinical Outcome Assessment Consortium: Collaboration Aimed at Accelerating Rare Disease Drug Development

4:00 PM — 5:00 PM

Who Should Pay for Expanded Access?

9:00 AM — 10:00 AM

Spotlight Symposia: Decentralized Clinical Trials - Accelerate Drug Development Through Anytime, Anywhere Participation

9:00 AM — 10:00 AM

Spotlight Symposia: Pragmatic Innovation in Clinical Trials: Broader Access, Better Evidence, and Faster Approvals

9:00 AM — 10:00 AM

Spotlight Symposia: The Do’s and Don’ts of Compensating Research Participants: Guidance for Clinical Research Stakeholders

9:30 AM — 10:00 AM

Labcorp Drug Development Innovation Theater: Diversifying Clinical Trial Populations from the Ground Up

9:30 AM — 10:00 AM

Speed to Submission: How Fast Can You Truly Go?

10:00 AM — 11:00 AM

Development of Shared System and Shared REMS: Best Practices and Lessons Learned

10:00 AM — 11:00 AM

Fairness and Bias Detection and Mitigation in Machine Learning Algorithms: Real-World Evidence Applications and Examples

10:00 AM — 11:00 AM

How to Avoid Shortages? Insights from the EU Executive Steering Group on Shortages – Learnings from the COVID-19 Pandemic

10:00 AM — 11:00 AM

Integrated Assessment of US Marketing Applications: A View into FDA Internal Operations

10:00 AM — 11:00 AM

Patient-Focused Drug Development in Rare Diseases: Applying Guidances and Case Studies from the Field

10:00 AM — 11:00 AM

Recent Developments and Strategies in Pediatric Drug Development Documentation

10:00 AM — 11:00 AM

Reliability of Data Results in Clinical Trials (ICH E6 (R2)): What Does it Mean and How Can it be Accomplished?

10:00 AM — 11:00 AM

Remaining Challenges to the COVID-19 Response

10:00 AM — 11:00 AM

The Data Scientist’s Handbook: ‘Good Science’ Principles in Non-Interventional Studies

10:00 AM — 11:00 AM

Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange

10:00 AM — 11:00 AM

Virtual Project Management: A Way Forward!

11:00 AM — 11:30 AM

ERT Innovation Theater: VIRTUAL VISITS: Innovations to Support Hybrid & Decentralized

11:00 AM — 11:30 AM

SAS Institute Inc., JMP Division Innovation Theatre: Ongoing and Periodic Safety Monitoring of Clinical Trials in the Cloud

11:00 AM — 11:30 AM

WCG Innovation Theater: Managing Adjudication in an Increasingly Remote World

11:30 AM — 12:30 PM

EHR Interoperability Supporting COVID-19 Critical Care and Research

11:30 AM — 12:30 PM

Emergency Use Pathways: What Leanings from COVID-19 Can be Generalized to Address Unmet Medical Needs?

11:30 AM — 12:30 PM

Managing the Remote World: Concrete Strategies for Productivity and Balance

11:30 AM — 12:30 PM

Meaningful Patient Engagement Highlighted Through Patient Preference Studies and Core Outcome Sets

11:30 AM — 12:30 PM

Mobilizing Manufacturing: Portable and Point of Care Manufacture of Medicines

11:30 AM — 12:30 PM

Needs Assessment: Key Factor in Value-Based Funding for Medical Device Innovation

11:30 AM — 12:30 PM

Real-World Evidence: A Global Regulatory Perspective and Discussion

11:30 AM — 12:30 PM

Regulator Perspective: Maintaining GCP During Covid-19 and Beyond the Pandemic

11:30 AM — 12:30 PM

Remote Implementation of Clinical Outcome Assessments During the COVID-19 Pandemic and Beyond

11:30 AM — 12:30 PM

The Journey to a Modernization of Analytics

11:30 AM — 12:30 PM

The Pain and the Pleasure: Lessons from Going Live with a Structured Content Management (SCM) System

11:30 AM — 12:30 PM

The Spirit of the IND Safety Reporting Final Rule

12:30 PM — 1:30 PM

Advancing Diversity, Equity, and Inclusion in Drug Development

12:30 PM — 1:30 PM

Make Connections and Advance Science in DIA Communities

12:30 PM — 1:30 PM

Round Table Discussion: Round Table Discussion: Virtual Project Management - New PMBOK Framework - Overview and Implications for Pharma!

1:30 PM — 2:00 PM

Solution Circle: The Burden of Safety Reporting on Sites - What Sponsors of Choice do Differently

1:30 PM — 2:00 PM

Value-Based Contracting in Action

2:00 PM — 3:00 PM

Career Compass: How do you Find and Define your Career Motivators (s) (True North) in a Transforming / Ever-Changing Workforce

2:00 PM — 3:00 PM

EMA-FDA Question Time

2:00 PM — 3:00 PM

Managing in Complexity: Emergency Use Authorizations Process and COVID-19 Lessons Learned

2:00 PM — 3:00 PM

Mindfulness: The Power to Be Here, Now

2:00 PM — 3:00 PM

Population Diversity Considerations in Clinical Trials

2:00 PM — 3:00 PM

Predictive Compliance, Risk, and Quality Management Transformation: Will your Data Hold up to a Data Integrity Inspection?

2:00 PM — 3:00 PM

Preparing Medical Information for Emergency Use Authorization (EUA) to a Full Launch During the COVID-19 Pandemic

2:00 PM — 3:00 PM

The Relationship Between Data, AI, and Bias

2:00 PM — 3:00 PM

What is the Breakthrough Risk Communications and Assessing Safety After Early Access to Pharmaceuticals?

3:30 PM — 4:30 PM

FDA Town Hall

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