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Safety signals

Business-Critical Responses – Your Processing of Safety Signals

All drugs safety monitoring activities involve the collection and processing of tremendous amounts of drug safety data. When it comes to processing data related to Adverse Reactions, your work must demonstrably meet with both EU regulations and best practice guidelines. Patterns that could suggest new safety information must be swiftly and accurately identified – without exception.
Within your 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
  • Protecting your company against litigation and action taken by regulators

By the same token, it is vital to evaluate safety concerns appropriately, if products are not to be unnecessarily damaged or even lost.
This area of practice is subject to stringently defined expectations as far as drug safety laws are concerned across the EU. Formal guidelines on Signal Detection can be found in GVP Module IX which also refers to CIOMS VIII.

Why Choose PrimeVigilance for Safety Signals Management Services?

Our consultants include former regulators and industry experts who have long been at the forefront of this activity1,2. Not only are we adept at identifying and evaluating signals, we bring a common-sense approach to the methodology that can simplify the process and ultimately reduce your costs.

If your 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 your company and any necessary regulatory authorities.

Why Can Safety Signals Management Become So Complex?

Signals can indicate the potential for new risks associated with a particular medicinal product or the potential for the expected risks to have changed. The data which informs the signal detection process can come from a truly diverse range of sources, including but not limited to:

  • The Spontaneous Reporting System
  • Clinical Trials – pre or post marketing
  • Pharmacovigilance Literature Screening
  • Other types of non-clinical non-interventional studies
  • Systemic reviews and meta analyses
  • Other forms of active monitoring including risk-benefit monitoring
  • Databases such as EudraVigilance
  • Periodic Safety Update Reports (PSURs) 
  • Media reports carrying information not channelled through the Spontaneous Reporting system for some reason

In addition, the regulations which address this vital drug safety activity are highly specific, necessarily complex to reflect the nature of the work – and subject to periodic review and change over time. You need to demonstrably work within the regulations not only for detection, but also for the:

  • Prioritisation of tasks and responses
  • Robust and timely analysis of all potentially and actually relevant data
  • Validation and confirmation processes for signalling
  • Assessment of findings
  • Recommendations for next steps – consistently compliant with both EU regulations and best practice guidelines

PrimeVigilance pharmacovigilance services consultants ensure your Safety Signals Management activities are consistently comprehensive and your responsive action always timely, sensitive, accurate and compliant.

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