Glossary

Potential Risk

Definition according to GVP Annex I (Rev 3):
An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this association has not been confirmed.

Explanatory wording provided in GVP module V (Rev 2):
Undesirable clinical outcomes for which there is scientific evidence to suspect the possibility of a causal relationship with the medicinal product, but where there is currently insufficient evidence to conclude that this association is causal.

Resources

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.