Global Evolution of Real-World Data and Real-World Evidence in Regulatory Approval and Health Technology Assessments

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 21^st 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.

Speakers

Stephanie Butler, PharmD, Principal Practice Lead, Anlitiks

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.

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Kitty Rajagopalan, PhD, President & Chief Scientific Officer, Anlitiks

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.

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