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… GA Jennifer Luebke, JD, is Vice President for Legal & Regulatory Affairs at RTI-HS. Ms. Luebke oversees the … guidance and project support, primarily related to data protection. Ms. Luebke works closely with the research, finance, quality assurance, proposal, and project management teams to …
… treatment drugs, focuses on key differences between the 2 regulatory agencies. Popular myths will be debunked, oncology … • What are the emerging oncology labeling trends in the regulatory environment? …
… studies of clinical effectiveness. Her previous work as a data analyst for the Boston Public Health Commission’s … interpretation, and dissemination of local public health data. Ms. Saltus has been responsible for managing the daily … the preparation of orphan drug applications and other key regulatory submissions in the US and Europe, targeted and …
… study execution, analyzing quantitative and qualitative data, drafting manuscripts, and aligning publication strategies with market and regulatory aims. Key therapeutic areas of expertise include … publication strategies and provided research support for regulatory submissions in the US, Canada, the EU and India …
… conducting systematic literature reviews for a range of purposes including publications. Sydney has experience in a range of therapeutic …
… testing target product profile, pricing assumptions, regulatory environments, horizon scanning, and early access considerations. He also has a background in respiratory …
… cancer illnesses. Recent projects have included: Chairing data monitoring committees Cost-utility models … of disease Exploratory analyses of clinical trial data Global and country-specific value dossiers Health-related quality-of-life analyses Inclusion of health economics and …
… in health research, managing daily operations for data collection, data flow and timelines, quality control procedures, budgeting and resource …
… India Saurabh Nagar, BPharm, MS, is a Director in the Real World Data and Analytics group at RTI-HS. In his current … effectiveness research, chart reviews, and scientific publications. His responsibilities include designing studies …
… vast experience leading studies using existing health care data to evaluate the use, safety, and effectiveness of … in the field of pharmacoepidemiology. His experience and publications span a wide range of substantive areas, …