Identified Risk

Definition according to GVP Annex I (Rev 3):
An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest. Explanatory wording provided in GVP module V (Rev 2): Undesirable clinical outcomes for which there is sufficient scientific evidence that they are caused by the medicinal product.


Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.