Global Evolution of Real-World Data and Real-World Evidence in Regulatory Approval and Health Technology Assessments
About this webinar
Real-world data (RWD) and real-world evidence have emerged as essential tools for augmenting traditional clinical trials in regulatory decision-making and health technology assessments (HTAs). This webinar offers a comprehensive exploration of the evolving global guidelines and policies surrounding the use of RWD/real-world evidence in these critical processes.
In this webinar, the attendees will learn about best practices for generating high-quality real-world evidence that aligns with regulatory and HTA standards. Moreover, the speakers will explore real-world case studies that demonstrate the successful integration of RWD/real-world evidence into regulatory and HTA processes, offering practical insights and lessons learned from these applications.
This webinar aims to equip participants with the necessary knowledge to effectively utilize RWD/real-world evidence in their regulatory strategies and decision-making processes and focuses on the following key discussion points:
- A detailed examination of existing guidelines and frameworks for using RWD/real-world evidence in major regions
- US Food and Drug Administration (FDA) guidance on RWD/real-world evidence for regulatory decision-making, including the 21st Century Cures Act and recent developments
- European Medicines Agency (EMA) initiatives and guidance on RWD/RWE, including the data analysis and real-world interrogation network (DARWIN EU®)
- Overview of RWD/real-world evidence policies in Asia (e.g., PMDA in Japan), Canada and Australia
The attendees will also get to learn how RWD/real-world evidence support regulatory submissions such as new drug applications and label expansions, contribute to post-market safety surveillance and inform HTA for reimbursement and pricing decisions.
The speakers will also cover how using RWD/real-world evidence can ensure the quality and reliability of data, address data privacy and ethical considerations and methodological considerations for robust analysis. Moreover, effective strategies for presenting real-world evidence to regulators and HTA bodies will be explored.
Register for this webinar today to understand the practical application of real-world data and real-world evidence in regulatory decision-making and health technology assessments.
Who should attend
This webinar will appeal to:
- Professionals in regulatory affairs
- Health economics and outcomes research
- Pharmacoepidemiology
- Clinical development
- Data science
- Market access
- Anyone interested in the evolving role of real-world evidence in demonstrating value of drugs, devices and biologics to healthcare decision-makers
What you will learn
Attendees will learn about:
- The current global landscape of RWD/real-world evidence guidelines and policies
- Best practices for generating high-quality real-world evidence that meets regulatory and HTA standards
- Real-world case studies demonstrating the successful integration of RWD/real-world evidence into regulatory and HTA processes
Featured Speakers
Stephanie Butler, PharmD
Stephanie Butler, PharmD, is a seasoned healthcare consultant specializing in data-driven market access solutions. Based in Austin, Texas, Stephanie brings over 20 years of experience in devising strategic solutions that bridge the gap between life-changing therapies and patient access and affordability.
As the Principal Practice Lead at Anlitiks Inc., a consultancy revolutionizing the way real-world data is transformed into actionable insights, Stephanie helps life-science companies address critical challenges in product development and market access through data-driven solutions, such as treatment/competitive landscape assessments, target population optimization, product value propositions and robust reimbursement and pricing strategies.
Stephanie is a strong advocate of leveraging technology to maximize efficiencies, helping customers speed the time-to-market of innovative, life-saving treatments. She is passionate about exploring the intersection of healthcare and disruptive technologies such as AI, real-world evidence and digital health solutions.
Kitty Rajagopalan, PhD
Krithika “Kitty” Rajagopalan, PhD, MPH, is the President & Chief Scientific Officer of Anlitiks Inc., an emerging, disruptive, tech-services consultancy in HEOR, RWE and market access. She is a life sciences industry veteran and well-published executive with nearly 30 years’ experience in the field of HEOR, RWE, pricing and market access.
Her multi-therapeutic area experience includes oncology, neurosciences, cardiovascular, immunology, and rare disease therapy areas. Notable experience with first-in-class PRO label claims across multiple therapeutic areas and successful track record of successful HTA assessments (NICE, PBAC, SMC, CDR, and other HTA bodies and US Public/Private payors). She is also the owner of copyrights of PRO instruments and has authored over 125+ manuscripts in peer-reviewed journals and presented over 650+ scientific papers.
She is a Pharmacist by training and has a Masters’ degree with a focus on Pharmaceutical Marketing and Consumer Behavior, a PhD focused on HEOR and a Diploma in Public Health.
Partner for this event
Anlitiks
Anlitiks, a pioneering force at the intersection of technology and science, revolutionizing the way real-world data is transformed into actionable insights. At Anlitiks, our core mission is to empower the life sciences sector by providing swift and efficient analysis of real-world data, turning it into evidence that fosters the development of superior therapeutic solutions and enhances patient health outcomes.
Our unique data-agnostic analytic platform-service model, RapidAnalyzer™, is designed to lead the industry in translating complex data into valuable evidence in real-time. We are committed to improving healthcare outcomes through our expertise in real-world evidence generation, market access, and HEOR-related activities. Our consultative approach and dedication to data-driven decision-making enable us to address critical challenges in product development and payment innovation, impacting healthcare globally.
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