Final answer:
Quality assurance programs in medical labs monitor patient care quality and worker safety; they employ biosafety principles and require documentation of safety training. Pharmacovigilance systems oversee postmarket drug safety, involving additional FDA-mandated studies or trials.
Step-by-step explanation:
A quality assurance program is designed to monitor the quality of patient care that a medical laboratory provides and helps to ensure the safety of laboratory workers. Such programs often include principles of biosafety evaluation and may require forms such as a Student Affirmation form to assess understanding and document training in biosafety. After implementation, these programs continue to play a critical role in safety surveillance.
In the context of pharmaceuticals, after a drug is approved and marketed, it must be subject to postmarket safety surveillance through a pharmacovigilance system. This continuous evaluation is critical due to exposure to a larger patient population and subgroups that may reveal long-term safety concerns not identified in clinical trials. The FDA may mandate postmarketing risk management strategies, including additional studies or Phase IV trials, to ensure patient safety and evaluate drug effectiveness in the broader population.