Pharmacovigilance

While a company’s goal is to move a drug through all phases of development in a timely and cost-efficient manner, the obligation to protect public safety remains paramount. Adequate monitoring and assessment of drug/vaccine safety during development and product lifecycle is a vital concern of both industry and regulatory authorities. These include the following activities, which are all supported by P95: * Benefit-risk assessment * Risk-management plans and pharmacovigilance strategy * Post-Authorisation Safety Study (PASS) protocols and studies * Individual adverse event management * Aggregate case reviews * Signal detection and evaluation * Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) support * Aggregate reports: Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) * Process development * Training Some examples of projects in this area are: * A quantitative benefit-risk assessment of a vaccine. * Full development and management of a risk management plan for a new vaccine in clinical development. * Protocol development and feasibility assessment of maternal and neonatal outcomes following maternal immunisation. * Rapid assessment of reactogenicity of a seasonal influenza vaccine.