CIOMS definition

CIOMS means the Council for International Organisations of Medical Sciences.
View Source
CIOMS means: the Council for International Organizations of Medical Sciences pursuant to the World Health Organization or the United States equivalent thereof.
View Source

Examples of CIOMS in a sentence

  • Safety information on serious adverse events shall be provided in CIOMS format and safety information on non-serious adverse events shall be provided in English Line Listing format.

  • Such notice shall be provided in English in the form of a processed CIOMS I within [***] days of such Party receiving such information where such potential Adverse Events is a SAE and associated with the clinical uses, Clinical Studies, investigations, tests or marketing of such Collaboration Product for such Program.

  • After the Closing, Seller shall promptly provide Purchaser an electronic copy of the CIOMS I form for all legacy data of Adverse Events with respect to any Seller Product that is within Seller’s (or its Affiliate’s, as appropriate) possession, for inclusion in Purchaser’s safety database for the Product.

  • While exposure via pregnancy itself is not a serious adverse event, Aptalis and Strakan will exchange all reports of exposure via pregnancy by Calendar Day 7 from Receipt Date preferably using on FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via designated e-mail.

  • Kyowa Kirin will be responsible, at its sole cost and expense, for: (a) collecting all pharmacovigilance and other drug safety data for Licensed Product in the Territory as required by Applicable Laws; and (b) reporting any such data, including Adverse Events in the Territory, to the applicable Regulatory Authorities in the Territory, as appropriate to be in compliance with all Applicable Laws, including entry into the global safety database in CIOMS format (in English).

  • ICSRs with all available information shall be submitted by NORGINE to the CMS using CIOMS I format and xml (ICH E2B) format no later than TWELVE (12) Calendar Days after receipt Day Zero.

  • At the time of the expected due date CMS shall seek follow up from the reporting source on the outcome of pregnancy and complete CIOMS I format as per the timelines identified in this section 16.

  • All reports will be forwarded using the CIOMS I format, and per the timelines identified in this section 16.

  • The CIOMS 1 Report form will reflect the source data comprehensively and accurately without interpretation of reported information.

  • The transmission will normally be by email, using the CIOMS I format for medicinal products as well as in xml file.

Related to CIOMS

  • Dataset means the data specified in Appendix 1 (Environmental Information) to Schedule 11.2 (Management Information) as the same may be amended from time to time by the Secretary of State (acting reasonably);

  • ODMHSAS means the Oklahoma Department of Mental Health and Substance Abuse Services.

  • Sample means a sample of blood, tissue or other biological material.

  • QA means Quality Assurance.

  • HCD means the California Department of Housing and Community Development.