Скачать или смотреть The Value of ECAs for Regulatory & HTA Evidence Needs

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As the industry grapples with the integration of real-world evidence (RWE) in drug development and commercialization, understanding when and how External Control Arms (ECAs) successfully contribute to regulatory, health technology assessment (HTA), and clinical decision-making has become increasingly important.

Articulate key considerations for investing in ECAs across regulatory and HTA environments including data quality, cost, and potential for expedited decision- making.

Examine variability in ECA acceptance and identify conditions in which ECAs meaningfully impact payer, regulatory and clinical decision-making.

Learn from shared examples and experience to maximize ROI of ECAs, and anticipate how evolving policies, such as EU JCA, may affect future evidence planning.

Moderator:

Alexandra Sosinsky, ScM
Senior Director, Genesis Research Group, Hoboken, NJ, USA

Speakers:

Frank-Ulrich Fricke, PhD
Dean, Technische Hochschule Nürnberg and Arbitration Board on Drug Prices, Nuremberg, Germany

Mira Pavlovic, MD
Director, Centre Sabouraud, Saint-Louis Hospital, Paris, France and Lisbon University, Lisbon, Portugal