FDA Guidance Documents: Shaping the Future of RWD Curation and RWE Innovation

Sponsored by:

Date:

May 25, 2022

Time (PT):

11:00 AM

Duration (min):

IQVIA's experts lead a conversation on embracing FDA's guidance on the use of real world data (RWD).

The entire healthcare ecosystem is embracing a mission of innovation, including regulatory agencies like the FDA. Guidance documents on the use of RWD released over the past year are shaping the future of evidence generation and Regulatory Science. In addition to new methods and approaches, quality and curation of RWD collected from a variety of sources are key themes in FDA's guidance and can impact utilization. In this webinar, Mui Van Zandt, BS and Raina Olexa, MS discuss how your organization can navigate data quality, curation, and management challenges for better research.

Presenters

Raina Olexa

IQVIA (Regulatory Science & Strategy)

Senior Principal Scientist

Raina Olexa has over 20 years of medical research and pharmaceutical experience, working across all stages of the product lifecycle. She conducted pre-clinical neurobiology research to assess recovery of function in animal models of spinal cord injury before moving into the field of vaccine and biologics manufacturing.

Mui Van Zandt

IQVIA (Real World Data and Technology)

VP and GM

Mui Van Zandt is experienced in systems/application development, focusing on business analysis and project management. Her duties have spanned the spectrum of the system life cycle – from initial concept definition, analysis, design, testing, and implementation to operations and maintenance.

IQVIA

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise.

Content Partners

HealthEconomics.com

HealthEconomics.com is the world’s largest Connected Community™ for Value, Evidence and Access in the life sciences industry.

HealthEconomics.com provides a single global link to the health economic and outcomes research (HEOR), real-world evidence (RWE), and Market Access (MA) stakeholder communities. Since 1993, we have provided unparalleled access to drive business, improve knowledge, and connect researchers and payer decision-makers world-wide.

Our 27,000 engaged readers rely on HealthEconomics.com as the most reliable, credible and curated digital hub for the latest news, insights, educational opportunities, and industry benchmarks in HEOR, RWE and MA. Our advertisers, numbering more than 500 with a 91% retention rate, depend upon HealthEconomics.com for best-in-class global brand awareness and business development solutions. Our aim is to connect people with expert-driven content and resources — all in one place — with the corporate mission to advance communication about healthcare value.

Topics

Real-World Data (RWD)

Real-World Evidence (RWE)

FDA Guidance Documents: Shaping the Future of RWD Curation and RWE Innovation

Presenters

Raina Olexa

Mui Van Zandt

Sponsor

IQVIA

Content Partners

HealthEconomics.com

Topics

Watch Now

Related Content

From Clinical Data to Actionable Assets for Pharmaceutical R&D

Closing Gaps in Care: Health Equity and the Inflation Reduction Act - A Cutting Edge Conversation

From Clinical Data to Actionable Assets for Pharmaceutical R&D

Addressing Orphan and Rare Diseases - A Cutting Edge Conversation

RWE reality check: Routine patient health records and regulatory requirements

"S" Stands for Systematic: Demystifying the Systematic Literature Review

The Scientific and Operational Elegance of Study Replication with Real-World EHR Data: A Vitiligo and Alopecia Example

Practical AI: Adding Insight to the Patient Journey with Digital Phenotyping

Insights from the 2024 Salary Survey Report by HealthEconomics.com

Beyond Accelerated Approvals: External Control Arms

Delphi Panels: What Are They Good For?

Integrated Evidence Generation Planning: Driving Successful Reimbursement and Life Cycle Management

Patient Voices Matter: Transforming Industry-Sponsored Real-World Evidence with Patient-Centric Approaches

Navigating the Clinical Outcomes Maze: An Overview of Clinical Outcomes Assessments and Why Training Matters

Bridging the Gap: Strategies for Patient-Centered Real-World Evidence in Rare Diseases

The role of patient-centric technologies & tokenization in RWE studies

How to assess the quality of AI output when structuring unstructured medical data

Transforming clinical research: Scaling real-world data across diseases with expert-led AI

Synthesise RWE and AI. Transform patient-driven healthcare

Notice of Pre-Application Webinar for RFA-AG-24-009, "Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (U54 Clinical Trial Optional)"

Patient Data: Opportunities for Rare Diseases, Cell and Gene Therapies, and Oncology

Connecting Real-World Data and Domain Expertise to Enhance Trial Design and Planning

Pairing quality genomic data with longitudinal patient records

Keeping pace with the evolving global landscape in vaccine development

Improving Treatment Access & Outcomes by Integrating Social Determinants of Health Data with Real-World Evidence

How to Supercharge Real World Evidence Generation in Phase IV Trials

HEOR Writing: The Ins and Outs of Value Communications

The Future of Real-World Evidence: Pharma's Next Moves, Upcoming Webinar Hosted by Xtalks

Digital therapeutics: Software is now entering mainstream therapeutic care

Longitudinal Patient Data - Addressing Common Questions & Unlocking the Value of Real-World Data, Upcoming Webinar Hosted by Xtalks

Workshop: Harnessing the Power of EHR Data and AI to Advance Biomedical Research

Addressing Common Research Questions with Real World Data Best Practices

Optimize Your Decentralized Clinical Trials with Real-World Data

Real World Evidence for COVID-19: Making an impact now and into the future

Patient-Centric RWE Research & Remote Monitored Care: Learnings from a support program leveraging telehealth & connected devices

Marketplaces Drive Faster Science: HEOR, RWE & Market Access Sourcing

Partnering with Disease Registries: The Value and Impact for Real-World Evidence Generation

Improving Patient Outcomes: AI-Based Phenotyping for Diagnosis, Treatment, and Clinical Trials

What Every Researcher Needs to Know About Using Medicare Data for Real World Evidence

Medicare Part D: Price Negotiation Panel Discussion

Finding Value in Linking Real-World Data with Social Determinants of Health

Economic Impact of Representativeness in Clinical Trials: How Real-World Data Can Help

Designing Causal Inference Studies Using Real-World Data

Social Media Data: Opportunities and Insights for Clinical Research

Accelerating the Generation of Payer Insights and Evidence Across the Product Lifecycle to Achieve Optimal Access

Achieving Consensus When Everyone is an Expert, but No One Agrees

An Introduction to Infectious Disease Modeling

Syapse Real-World Dialogue: Advancing Patient Care through Real-World Data, Machine Learning, and Systems Biology

Evidence Synthesis for Sparse Evidence Base, Heterogeneous Studies, and Disconnected Networks

Optimize Your Value Story Through Integrated Evidence Generation - From Bench to Patient

Using Real-World Data to Explore and Demonstrate Comparative Effectiveness

Informing Market Access Earlier in Clinical Development: Prospective RWE Research to Characterize Real World Patient Populations