Regulatory-PV

Anticipation and understanding of the components that build the benefit-risk ratio are paramount. Regulatory affairs and Safety departments are instrumental in putting all these aspects together with the support of other departments and within the predefined standards and regulations. Although the efficacy aspect, which is the determinant of benefit, may look easy to measure, safety (the risk) issues are more sensitive and difficult to evaluate. Actually, a risk, by definition, is the probability that harm could occur, based on collected (or uncollected) data. The delicate work starts when one has to determine the level of acceptable risk (from a patient perspective) on spectrum between two extreme choices: one could be too conservative, causing the patient to miss a therapeutic chance; the other could be too aggressive exposing the patient to serious harm. This is to say that establishing the benefit-risk ratio should be a well thought-out endeavor with an in-depth analysis of all available collected data and a wise interpretation of the overall results.

Within a continuously changing regulatory environment, partner 4 health offers its support to regulatory and safety departments in:

  • Scientific and medical review of registration documents

 

  • Review of advertising documents/tools before it is used commercially

 

  • Periodic Safety Update Reports (PSURs) and similar documents

 

  • Writing narratives

 

  • Literature search to capture reports on safety

 

  • Risk-benefit assessment and design of Risk Minimization Plan

 

  • Responses to requests for information from regulatory authorities

 

  • Handling of urgent safety restrictions and safety variations
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