ii4sm – The Safety of Medicines and the Added Value for Patients

The safety of medicines is increasingly a focus of attention for the public, regulatory agencies and reimbursement bodies. The pharmaceutical industry is faced with challenging expectations to deliver medicines that add value to patients’ lives with least potential for harm while assuring the best outcome. In an increasingly complex environment with industry consolidation, rising economic pressure and risk of litigation, the reputation and revenues of companies are placed at stake.

There is a growing expectation, clearly expressed by regulators, that safety and risk management should be a pro-active practice. To be pro-active however, companies and institutions must gain access to many sources of data that are not easily available, and analyze them accordingly. Regulators have already taken steps to develop methodologies to look across and interrogate sources of safety information, for example the Sentinel* and the Protect** initiatives, with the intent to validate drug performance in real life.

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*FDA's Sentinel Initiative: Transforming the way product safety is monitored; a USA electronic system that will transform FDA’s ability to track the safety of drugs, biologics, medical devices and ultimately all FDA regulated products once they reach the market
**EMEA’s PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium): Collaborative European project aiming to develop innovative methods in pharmacoepidemiology and pharmacovigilance