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.
Speakers
![Stephanie Butler, Anlitiks](https://i0.wp.com/xtalks.com/wp-content/uploads/2024/06/SB_150.jpg?fit=150%2C150&ssl=1)
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.
![Kitty Rajagopalan, Anlitiks](https://i0.wp.com/xtalks.com/wp-content/uploads/2024/06/Kitty_150.jpg?fit=150%2C150&ssl=1)
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.
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
Xtalks Partner
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.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account