vigi Unit 4

Introduction The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a globally recognized and influential organization that plays a central role in the harmonization of pharmaceutical regulations and standards across different regions. Founded in 1990, the ICH was created as a collaborative effort among the regulatory authorities and the…

Safety Data Generation in Drug Development: Ensuring the safety of pharmaceutical products is a foundational objective in drug development. Drug safety, also known as pharmacovigilance, refers to the science and activities concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Safety data are generated across a continuum of…