Whitepaper: Detection and Management of Safety Signals

What defines a signal? Why do we need to do signal detection and what steps are involved? ​Although signal detection can take many forms, there are basics to the process no matter where you market your products.

The FDA Guidance for Industry entitled Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (from March 2005) is the reference most commonly used by companies marketing pharmaceutical products in the U.S. This guidance evolved from one of three papers delivered by the FDA as part of PDUFA III which resulted from public comment on risk management for regulated drugs. As stated, the guidance is not intended for all products but focuses on products which may pose a clinically important and / or unusual type or level of risk. The guidance is also geared towards the post-approval period of a product. The FDA defines a safety signal as a concern about an excess of adverse events compared to what would be expected to be associated with a product’s use. The FDA is clear that the topics presented in the guidance are in-line with international discussions as well ...

Read more in the downloadable whitepaper by Robin Williams, B.S., CMC, Senior Safety Scientist, Ashfield Pharmacovigilance.

Detection and Management of Safety Signals

In case you are interested, find out more useful information in case studies.

North America Pharma

3rd Annual Pharmacovigilance & Risk Management Strategies Summit

Visit event website

Interested in this topic?

More articles