Pharmaceutical Safety and Risk-Management

This class explored  the  technical  and  regulatory  safety  aspects  of pharmaceutical  products,  including  premarket  testing  and  development,  recognition  of  safety  signals,  post-approval experience, drug production, risk mitigation, and administration of pharmaceuticals. A case-study approach was presented to demonstrate real-life applications of these concepts. 
  • Articulate basic concepts of drug action. 
  • Describe the steps involved in developing a drug and obtaining FDA approval. 
  • Identify  key  components  of  a  safety  analysis  for  pharmaceuticals  during  clinical  trials  (phase  I,  phase II, and phase III in most cases) and factors that limit the likelihood of detecting serious adverse 
    drug reactions in the clinical trial setting.
  • Discuss the process by which adverse effects of drugs are detected and reported in the US and the safety impact of drug interactions.
  • Elucidate the factors leading up to, and related processes associated with, recalls, warnings, and adverse effect reporting requirements.  
  • Determine risk-benefit ratio given clinical trial information, and analyze the data. 
  • Evaluate the quality of advertising and labeling safety messages for pharmaceutical agents targeted 
    to various levels of health literacy. 
  • Describe off-label use of drugs and appropriate regulatory responses to off label safety concerns. 
  • Discuss the safety and effectiveness issues related to counterfeit drugs. 
  • Define the impact of differing patient populations and pharmacogenomics on drug safety. 
  • Discuss the impact of globalization on clinical trials and the effects of drugs.
  • Formulate a risk-mitigation plan. 
  • Compare and contrast perceived and real conflicts of interest and ethical concerns associated with marketing of pharmaceutical products and pharmacovigilance initiatives. 

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