Title 21 of the Code of Federal Regulations (CFR) 314.80, defines an Adverse Drug Experience (ADE) as: Any undesirable event that is associated with the use of a drug in humans, whether or not considered drug-related.
Events occurring in the course of the use of a drug product in professional practice
Any failure of expected pharmacologic action.
As a pharmaceutical company, Dompé collects safety information arising from the use of its medicinal products pertaining to special conditions, even in the absence of an adverse event, such as:
Medication error or any problem related to the use of the product,
Exposure during pregnancy or during breastfeeding,
Suspected transmission of an infectious agent via medicinal product,
Falsified medicinal product.
Dompé Pharmacovigilance Department will notify the Regulatory Authorities about any ADE in line with applicable law requirements.
What is an adverse event to a medical device?
An adverse event can refer to any unfavorable occurrence involving a medical device in the market.
