Safety Reporting. Institution and Investigator will report all serious adverse events, Special Situation Reports (defined below), and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC. For the avoidance of doubt, each of the Investigator and the Institution will provide all reasonable assistance to Gilead to allow Gilead to comply with all applicable requirements. “Special Situation Reports” means: a) pregnancy reports; b) reports of medication error, abuse, misuse, or overdose; c) lack of effect reports, d) reports of adverse reactions in infants following exposure from breastfeeding; e) reports of adverse reactions associated with product complaints; and f) reports arising from occupational exposure. 1.9
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Samples: smlouvy.gov.cz, smlouvy.gov.cz, smlouvy.gov.cz
