With over twenty years of pharmacovigilance experience to draw from, the staff at CCSL have acquired much knowledge from a series of major safety issues and product crises. In each case, these were satisfactorily resolved and in one example a product withdrawal was reversed with no damage to the product or its original label. Read some of their following (anonymised) case histories:

• An antidiarrhoeal was shown to be inappropriately promoted in a third world environment in a major TV documentary. While the sister company's product was being pilloried by the media, the sponsor company quietly performed a risk assessment, corrected and realigned its promotional campaign in an ethical approach and was able to continue to market its product range with no adverse publicity
  
• A major Western authority requested a Benefit Risk Assessment for a product. Challenging enough, but in this instance the product was a device with an unusual use, and limited clinical data to support it. During an intense two month period, drawing on epidemiologcal data and clinical models, the manufacturer prepared what is purported to be the first such benefit risk assessment in Europe. This was accepted by the regulator and the issue was resolved.
  
• A major implementation fault in a clinical trial resulted in a significant avoidable injury to a patient. An effective crisis management team took control and managed the evaluation of the issue including cause and effect, internal and external press communications, rectification of the process defects, and manitained the ethical integrity of the involved company.
  
• A major Western authority withdrew a company's leading product on safety concerns. While confidence in the product was actively maintained in other leading markets, a full evaluation of the issues was performed including significant pharmacoepidemiological, scientific, and medical analyses, and led to a successful defence and withdraw of the regulator's actions. Sales were minimally affected during the crisis and rapidly recovered after the resolution of the crisis.