Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
In pharmacovigilance, effective search strings are key
Posted on February 9th, 2018 by Xuanyan Xu in Pharmacovigilance
A key component of any pharmacovigilance strategy is building search strings that successfully identify potential adverse events, which must be reported to regulatory agencies. If the query returns too narrow a result set, adverse events may be missed. (more…)
Why a reliable FAERS searching capability is essential for pharma companies
Posted on October 27th, 2017 by Sherry Winter in Pharmacovigilance
In the description of the FDA Adverse Event Reporting System (FAERS), the agency states that “voluntary and mandatory reporting plays an important role in the FDA’s post-market safety monitoring.” (more…)
Big Data and Proactive Pharmacovigilance
Posted on September 20th, 2017 by Christy J. Wilson in Pharmacovigilance
Traditionally thought of as a post-market process, pharmacovigilance is how pharmaceutical companies monitor and address any safety issues that arise once a drug becomes available commercially. However, some companies are now thinking ahead about these potential safety concerns with what is known as “proactive PV”. (more…)
The Challenges of Signal Detection in Spontaneous Reporting
Posted on September 13th, 2017 by Sherry Winter in Pharmacovigilance
Pharmacovigilance is essential to pharmaceutical businesses. It facilitates the correct use of a drug, safeguarding the drug as a meaningful treatment option when the benefits it offers outweigh known risks, or measures can be taken to mitigate those risks. (more…)
