Shionogi Group Drug Safety Policy
The safety of patients and study subjects is our topmost priority when we perform drug safety management activities.
In order to contribute to the quality of life of patients and study subjects as well as their families, we perform global risk management of Shionogi products by conducting proper pharmacovigilance activities and enacting measures to minimize risks that may emerge. We strive to optimize the benefit/risk profile of our products.
As members of Shionogi Drug Safety, whether at Headquarters or in the regions, we are committed to conducting pharmacovigilance by performing uniform and consistent collection, detection, assessment, monitoring, communication and prevention of adverse effects.
Shionogi Drug Safety Management System
The “Shionogi Drug Safety Management System” was established in order to conduct drug safety management, which consists of the following:
- Drug safety management from clinical development to post-marketing product lifecycle management;
- Predictive and prevention-oriented risk management to enable estimation of the occurrence of adverse drug reactions and minimization of risk;
- Scientific risk management;
- Appropriate communication to the regulators, healthcare professionals, and patients of Shionogi product risk information and tools to minimize risks throughout the lifecycle of Shionogi products;
- Education and training of all personnel engaged in Shionogi Drug Safety Management, to assure understanding of drug safety and facilitate work practices.
By properly performing these activities at high quality standards and in a timely manner, we will contribute to the lifecycle management of Shionogi products and fulfil our corporate social responsibility from the standpoint of safety.
According to this policy, we contribute to maximizing the value of Shionogi products to our patients. We will monitor our performance and review this policy regularly in order to ensure that it fits our purpose.
(Established on April 1st, 2015)