risk

By distributor, we mean the business partners who support the commercialization of the company products in the concerned territories. We won’t discuss the non-compliance areas but provide considerations for the marketing authorization holder (MAH) for ensuring compliance. Every MAH can’t have commercial operations in every country in which it holds licenses. This may even apply […]

Common questions asked by the Pharmacovigilance Inspector, with regards to Pharmacovigilance vendors

The primary objective of Pharmacovigilance is to ensure that safe and effective medicines are available for Public Health. In August 2020, the FDA removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin, based on the review of new data from three clinical trials. This boxed warning was imposed in May 2017. Thanks […]