Adverse Drug Experience Clause Samples
Adverse Drug Experience. Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; any failure of expected pharmacological action; a Medication Error; or Other Reportable Information.
Adverse Drug Experience. If Innovex and/or the Clinical Research Personnel become aware of any adverse drug experience reports involving use of any Client product they shall immediately inform the Client in accordance with Innovex or the Client's standard operating procedures, as appropriate, and shall comply with any legal or regulatory reporting requirements with respect to such matters. When Client communicates information concerning adverse drug experience reports to its own employees, investigators or in compliance with any legal or regulatory requirements, such information shall be communicated to Innovex and the Clinical Research Personnel in a manner consistent with Client standard operating procedures. 13 Innovex Standard Terms for Clinical Services 13 Innovex #5378
Adverse Drug Experience. (a) OraVax shall conduct post marketing surveillance of adverse events as required by the FDA. If OraVax receives any report of a serious adverse drug experience (as described in Schedule 3) allegedly caused by the Product, OraVax shall report the matter to the relevant regulatory authorities in compliance with the laws and regulations of the Product Territory covering licensed products and OraVax shall report to Evan▇ ▇▇ a manner consistent with the spontaneous adverse drug event (ADE) reporting procedure developed by Evan▇ ▇▇▇ use by its distributors forthwith by telephone or facsimile transmission (immediately confirmed in writing). Evan▇ ▇▇▇ll have responsibility for the notification of regulatory authorities in the United Kingdom and in other countries in which the Product is distributed, according to the statutory requirements in such countries.
(b) If Evan▇ ▇▇▇eives any report of a serious adverse drug experience allegedly caused by the Product in any country of the world other than the Product Territory, Evan▇ ▇▇▇ll immediately advise OraVax accordingly.
(c) Evan▇ ▇▇▇ll provide OraVax on a biannual basis with written summaries of reports of adverse drug experiences that are not serious but are allegedly caused by the Product in any country of the world other than the Product Territory.
(d) OraVax shall provide Evan▇ ▇▇ a biannual basis with written summaries of reports of adverse drug experiences that are not serious but allegedly caused by the Product in the Product Territory.
Adverse Drug Experience. Consistent with its internal SOPs, Pharmacy will promptly inform Celgene’s Drug Safety Group of any information regarding adverse drug experiences suspected to be associated with the use of Product and all cases of special situations it receives, with the appropriate information, as set forth in more detail on Schedule 8.1, to the address set forth therein.
Adverse Drug Experience