The senior management team views this aspect of the business as fundamental to the integrity of its day-to-day activities. It promotes a culture of product innovation and quality which it views as critical to the maintenance of trust with regulators, healthcare professionals and patients.
Indivior maintains and constantly evolves its pharmacovigilance management system in partnership with its manufacturing suppliers. These processes monitor the safety of Indivior’s products in a comprehensive and a thorough manner. Indivior’s management systems include the US FDA required Risk Evaluation and Mitigation Strategies (“REMS”) program to mitigate the risk of accidental overdose, misuse and abuse of sub-lingual film and to inform healthcare professionals and patients of the risks associated with the product. Indivior also has and maintains an FDA-required REMS program for SUBLOCADE in the US to mitigate the risk of serious harm or death that could results from intravenous self-administrations.
Globally, an ongoing program of enhancement of Indivior’s product risk management plans is in place to minimize these risks in other countries.
