(ICHe2c); syn. international prescribing information, "virtual SPC", core data sheet (CDS); central document that may be prepared by the marketing authorisation holder concerning a medicinal product covering material relating to safety, indications, dosing, pharmacology, and other information as a ...
community based trials As part of an expedited drug develop-ment program simple, large, low-tech trials can be planned that collect less stringent data, generally on patients not eligible for standard trials.Company Core Data Sheet (CCDS) ICH: “A document prepared by the marketing authorisation...
COMPANYCOREDATASHEETndashCCDS40 系统标签: ccdscoresheetfibrinogencompanybehring CSLBehringPage1of11 Haemocomplettan_CCDS_22-MAY-2014_blank_0a9f25 COMPANYCOREDATASHEET–CCDS(EDS/CORE/ENGLISH) HAEMOCOMPLETTAN ® P1G/2G Rev.:22-MAY-2014/4.2correction Supersedespreviousversions Rev.:30-AUG-2013/Ada...
Core Data Sheet Basics (7)The CCDS Format (13)Updating an Existing CCDS (19)Developing Company Core Safety Information (CCSI) (27)SBR Use Encouraged to Lighten Product Safety Paperwork (41)Conclusion (43)Appendices (can be found on the CD in the back of this report)A. CIOMS I ...
aandjaneisthisyourrule andjaneisthisyourrule[translate] aPreparation and Maintenance of Company Core Data Sheet (CCDS) 正在翻译,请等待...[translate]
Das Company Core Data Sheet (CCDS)-SystemDr. Ralf Zerban