Safety signals
Within a pharmacovigilance system, timely identification and appropriate evaluation of possible signals of new adverse reactions and safety concerns for products are essential for the protection of patients, but also for protecting the company against litigation. By the same token, it is vital to evaluate safety concerns appropriately, if products are not to be unnecessarily damaged or even lost.
PrimeVigilance consultants include former regulators and industry experts who have long been at the forefront of this activity1,2. Not only are they adept at identifying and evaluating signals, they bring a common-sense approach to the methodology that can simplify the process and ultimately reduce costs.
If signals are evaluated and thought to represent real new concerns that may affect the balance of benefits and risks for a product, expert advice is essential. Again, PrimeVigilance has access to world-class pharmacovigilance experts who can carry out benefit-risk analysis, advise on strategy, and help to effectively communicate the message about new safety concerns both to top levels within a company and externally to regulatory authorities and to health professionals.
1Brown EG. Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART. Drug Safety 2002, 25(6), 445-452.
2Stahl M, Lindquist M, Edwards IR, Brown EG. Introducing Triage Logic as a New Strategy for the Detection of Signals in the WHO Drug Monitoring Database.Pharmacoepidemiol Drug Saf. 2004 Jun;13(6):355-63.
Signal Detection: Compliant and Protective
- just one of the pharmacovigilance services from PrimeVigilance
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