Cell And Gene Therapy: Research, Development & Regulatory Guidance

 ICH E11, titled "Clinical Investigation of Medicinal Products in the Pediatric Population," with the reference number CPMP/ICH/2711/99, is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guideline provides recommendations and principles for conducting clinical trials involving pediatric patients to support the development and registration of medicinal products specifically intended for use in children. Here's an elaboration of ICH E11: 1. Purpose: The primary purpose of ICH E11 is to facilitate the development of safe and effective medicinal products for pediatric patients by providing guidance on the design, conduct, and ethical considerations of clinical trials in this population. 2. Applicability: ICH E11 is applicable to clinical trials conducted in pediatric populations across various therapeutic areas, including investigational drugs, biologics, and medical devices. It focus...