Minimizing risks
The Novartis Product Stewardship Board proactively assesses all risk-benefit issues related to marketed products, including any risks that products pose to the company's reputation or legal position. Closely linked to this effort is the Medical Safety Review Board, set up in September 2006 to provide an independent review of product safety along the entire life cycle from the earliest stages of exploratory development, through clinical development and continuing after the product goes to market.
How do the two boards operate? The Product Stewardship Board ensures proactive risk management by identifying, assessing and prioritizing risks - including safety, regulatory, reputational and legal concerns - for all Novartis marketed products. The board reports to the senior management of the Pharmaceuticals division. The reviews are regular and ongoing for every marketed product, subject to a standard review each year for the first five years on the market and then every five years thereafter.
Separately, the Medical Safety Review Board reviews each product in development or on the market at least once a year. Chaired by our chief safety officer, the board meets every other week and brings together senior-level expertise that includes clinical development and medical affairs, integrated medical safety, biostatistics and statistical research, safety epidemiology, drug regulatory affairs, safety profiling and assessment, early clinical development, drug metabolism, pharmacokinetics and legal affairs.
In addition to looking at any safety signals that may arise for specific products, the board also reviews the safety profiling plan, an internal document that tracks the safety of a drug throughout its life cycle, as well as risk management plan proposals.
While ensuring safety is part of the development process - and reporting and investigating every adverse event of marketed products is an ongoing effort across Novartis - both boards seek to preempt any problems that may arise. They proactively identify potential issues and seek out any specific safety signals that may be identified by adverse events or other activities. Common to both groups are their independence from any specific project team, representation of senior leaders and cross-functional expertise.