Discover an informative webinar that explores the European Union (EU) joint clinical assessment and its profound impact on the health technology landscape.
The EU’s joint clinical assessment presents a paradigm shift in the assessment of new health technologies. While offering potential benefits such as streamlined evaluations and faster market access, it also brings forth a complex landscape of financial, regulatory and operational considerations for pharmaceutical companies.
This webinar will provide a comprehensive overview of the joint clinical assessment process, delving into its potential benefits, risks and challenges from multiple perspectives:
- Financial: Examine the financial implications of joint clinical assessment, including potential cost savings through reduced duplication of efforts and the need for early investments in data generation and dossier preparation
- Research & Development (R&D): Explore how joint clinical assessment influences R&D strategies, requiring early engagement with health technology assessment (HTA) bodies and potentially impacting clinical trial designs to meet specific data requirements
- Market Access: Discuss the potential for accelerated market access across multiple EU member states through a single assessment and the continued importance of navigating individual national reimbursement decisions
- Regulatory: Analyze the evolving regulatory landscape with joint clinical assessment, including the need for alignment with both European Medicines Agency (EMA) requirements and the specific expectations of the joint clinical assessment process
- Operational/Resource: Address the operational complexities of joint clinical assessment, including resource allocation, coordination with multiple stakeholders and the need for robust data management and communication strategies
Register for this webinar today to gain insights into the financial, regulatory and operational challenges and opportunities that joint clinical assessment presents for pharmaceutical companies.
Speakers
Stephanie Butler, PharmD, Principle 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.
Krithika "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. Her notable experience includes 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.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Real-world evidence
- Health economics and outcomes research
- Market access (value and access)
- Research and development
- Medical affairs
- Data science
- Biostatistics
- Commercialization
- Commercial operations
- Market analytics and forecasting
- Epidemiology and drug safety
- Clinical development
What You Will Learn
Attendees will learn about:
- The joint clinical assessment process and its implications for pharmaceutical companies
- Identifying potential financial, R&D, market access, regulatory and operational risks and opportunities associated with joint clinical assessment
- Strategies to proactively address these challenges and maximize the potential benefits of joint clinical assessment
- Best practices for navigating the complexities of joint clinical assessment and ensuring successful submissions
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.
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