Pharmacovigilance

Product safety data comes from two main sources: clinical trials and pharmacovigilance.

Clinical trials are controlled scientific explorations seeking to answer specific questions or confirm hypotheses about how a medication will work in a specific patient population. These studies provide critical information for a company's regulatory filings for approval of a potential new medicine.

An even more complete understanding can emerge, over time, once a product is approved for marketing and becomes available to thousands or millions of patients around the world. Pharmacovigilance plays a key role in developing a deeper understanding of benefits and risks.

In each country, Novartis medical directors and patient safety teams are charged with tracking any reported adverse events, investigating their causes, and communicating that information to regulatory authorities, physicians and, where necessary, patients themselves. At times, we conduct specific studies after approval to address safety questions that could not be conclusively answered during the pre-approval clinical trial process.

Recently, Novartis has taken several steps to enhance our ability to identify and respond to potentially emerging risks.