Key Points

The obligation to protect the well-being of patients does not end when a product receives the marketing authorization. At the time of a medicine’s authorization, the product has been tested in a relatively small number of selected patients for a limited length of time.

The interests of patients must be safeguarded at all times— and by all involved parties—throughout the products’ lifecycle, as other side effects may emerge in real-life circumstances.

It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.

Pharmaceutical and medical device companies may encounter considerable challenges in meeting specific requirements (e.g., having a local contact person for PV, a deputy/back-up local contact person, or additional supporting staff during periods of increased work volume; ensuring the quality control of translations and transcriptions of safety-related information; intake and follow-up of AE cases, the performance of safety intelligence)

Monthly reconciliation is critical, as is the input provided to our customers’ PSMF (updates and assistance with implementing risk management plans and risk minimization measures).