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Looking for a Publication? Search the bibliography for: publications assessment pro label claims granted fda compared ema 2006���2010
… acceptance Gain reimbursement and Health Technology Assessment (HTA) approvals Differentiate your product FDAMA … a decision model , chart review , analysis of healthcare claims , literature review, or meta-analysis —to answer your … efficacy versus effectiveness analyses Health Technology Assessment Strategic consulting, systematic reviews, network …
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward
… centralise the clinical domains of the health technology assessment (HTA) process on a European level. Non-clinical … authorisation process of the European Medicines Agency (EMA). The goal is endorsement of the final JCA report within … in advance, and nimbly adjust to the final scope and label changes. In addition, we provide a range of strategy, …
… RTI-HS Leads Consortium Working on EMA-funded Project to Aid Real-World Data Use Share on: February 1, 2021 The European Medicines Agency (EMA) MINERVA project (Metadata for data discoverability and … and effectiveness of their medicines is at the center of EMA’s authority. In addition to data from clinical trials, …
… centralise the clinical domains of the health technology assessment (HTA) process on a European-wide level. The 4 … authorisation process of the European Medicines Agency (EMA). The goal is endorsement of the final JCA report within … Lowering Medicare Costs Emergence of the Joint Clinical Assessment in the European Union and the Inflation Reduction …
… PRO Analysis Portfolio Across Multiple Cancers OPPORTUNITY … the result. Analyses included: Descriptive analyses of PRO questionnaire completion rates and score changes over …
… , MBA, MSc, Principal Scientist, Patient-Centered Outcomes Assessment at RTI Health Solutions. Transcript A frequent … to labeling, and we often get requests saying we want label based on some questionnaire - EQ-5D or QLQ-C30 or AQLQ … whole process of getting a labeling from regulators - the FDA or the EMA. Before we start the process of labeling, the …
… Recent FDA Drug and Device Guidelines for Sharing Pre-Approval … far in advance of approval decisions. As a result, the FDA has now released guidance to help manufacturers share … under investigation Anticipated timeline for possible FDA approval of the product or of the new use Product pricing …
… Health Preference Assessment Do you know what your patients value and what … Risk tolerance assessments Let our Health Preference Assessment team help you understand your patients’ (or other … better product and market decisions. Health Preference Assessment at RTI Health Solutions Christine Poulos, Senior …
… Final FDA Guidance on Real-World Data and Real-World-Evidence for … the United States Food and Drug Administration (FDA) has now released final guidance about using real-world … postapproval studies. This final release represents the FDA’s current thinking and recommendations on this topic. …
… FDA’s Sentinel Initiative Driving Sound Research Practices … on: November 11, 2021 RTI-HS is collaborating with the FDA to ensure that rigorous, valid methods are used to … RTI-HS, shares, “We are honored to be working with the FDA and their network of research collaborators committed to …