Across
- 1. A __________, an adverse drug event/ event, a reporter, a suspected company product are the 4 minimum criteria for a valid adverse drug reaction.
- 4. Patient experienced any side effect /adverse event mentioned in _________ after using company product should be reported to as adverse event.
- 6. Reporting of safety information / adverse event to PV team is ______________ for all Santen employees regardless of your role in the company.
- 8. The science and activities relating to detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems.
- 11. Employees might receive _______________ from healthcare professionals regarding safety information of Santen products and this information need to be reported as adverse event.
- 12. __________ during pregnancy can have serious consequences (temporary or permanent effects) for the fetus.
- 14. The term "_____________" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
Down
- 2. __________, a sedative prescribed to pregnant women to alleviate symptoms of morning sickness caused severe birth defects of the arms and legs in thousands of babies born in Western Europe (1960's).
- 3. The main professional goal of healthcare professionals is to provide and improve human health. _________ are among the most common health threatening mistakes that affect patient care.
- 5. Any unfavorable and unintended sign, symptom, or disease associated with the use of a medicinal product or medical device, whether or not considered related to the medicinal product.
- 7. Some patient populations are not being studied during _________, hence it is very important for pharmaceutical company to collect safety information during post-marketing, and have better understanding on company products.
- 9. Patient / consumers might report product ____________ associated with adverse event regarding Santen products to any Santen employees.
- 10. _________ reporting of safety information / adverse events if the key to assuring the safe use of drugs.
- 13. As a pharmaceutical company, we need to ensure our marketed products are _______.
