Objective A variety of complementary approaches are needed to evaluate safety of medicine use in pregnancy. To evaluate safety in relation to teratogenicity (capacity to cause malformations), population-based congenital anomaly registers, which are already networked across Europe (EUROCAT) with a common database, can provide a cost-effective mechanism which is as yet underexploited. The enormous population coverage of registers when combined gives sufficient statistical power for the identification of associations between specific drugs and specific malformations. This project will develop and test an efficient pharmaco-vigilance system for safety of drugs during pregnancy in relation to teratogenicity by (i) enhancing the information regarding drug exposure in the EUROCAT database, covering a total population of 3 million births 1995-2010, through linkage to electronic databases containing prescription information, and by linkage to chronic disease cohorts (ii) analysing the enhanced EUROCAT database in relation to four drug groups of public health concern - new antiepileptics, insulin analogs, SSRI antidepressants, and antiasthmatics - exposure to all of which is increasing in the pregnant population (iii) interrogating health care databases to monitor the effectiveness of drug safety recommendations and pregnancy prevention programmes through drug utilisation studies, and to provide an exposure profile for pregnant women (iv) conducting a scoping study of the implications for drug safety of growing internet use by pregnant women, in terms of access to safety information about teratogenicity, and access to drugs with teratogenic potential. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacydrug safetymedical and health scienceshealth sciencespublic healthnatural sciencescomputer and information sciencesdatabases Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2010.4.2-3 - Adverse Drug Reaction Research. FP7-HEALTH-2010-single-stage Call for proposal FP7-HEALTH-2010-single-stage See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator UNIVERSITY OF ULSTER Address Cromore road BT52 1SA Coleraine United Kingdom See on map Region Northern Ireland Northern Ireland Causeway Coast and Glens Activity type Higher or Secondary Education Establishments Administrative Contact Anne Marie Patton (Dr.) Links Contact the organisation Opens in new window Website Opens in new window EU contribution € 1 093 379,95 Participants (8) Sort alphabetically Sort by EU Contribution Expand all Collapse all RIJKSUNIVERSITEIT GRONINGEN Netherlands EU contribution € 441 261,60 Address Broerstraat 5 9712CP Groningen See on map Region Noord-Nederland Groningen Overig Groningen Activity type Higher or Secondary Education Establishments Administrative Contact Jan Poutsma (Dr.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITY OF BATH United Kingdom EU contribution € 232 000,80 Address Claverton down BA2 7AY Bath See on map Region South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Bath and North East Somerset, North Somerset and South Gloucestershire Activity type Higher or Secondary Education Establishments Administrative Contact Fiona Wallis (Ms.) Links Contact the organisation Opens in new window Website Opens in new window ACADEMISCH ZIEKENHUIS GRONINGEN Netherlands EU contribution € 242 976,40 Address Hanzeplein 1 9713 GZ Groningen See on map Region Noord-Nederland Groningen Overig Groningen Activity type Higher or Secondary Education Establishments Administrative Contact J J Breeuwsma (Mr.) Links Contact the organisation Opens in new window Website Opens in new window REGION SYDDANMARK Denmark EU contribution € 333 975,75 Address Damhaven 12 7100 Vejle See on map Region Danmark Syddanmark Sydjylland Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Ester Garne (Dr.) Links Contact the organisation Opens in new window Website Opens in new window UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU Poland EU contribution € 237 821,25 Address Ul. fredry 10 61-701 Poznan See on map Region Makroregion północno-zachodni Wielkopolskie Miasto Poznań Activity type Higher or Secondary Education Establishments Administrative Contact Bozena Raducha (Dr.) Links Contact the organisation Opens in new window Website Opens in new window CONSIGLIO NAZIONALE DELLE RICERCHE Italy EU contribution € 155 823,00 Address Piazzale aldo moro 7 00185 Roma See on map Region Centro (IT) Lazio Roma Activity type Research Organisations Administrative Contact Marco Borbotti (Mr.) Links Contact the organisation Opens in new window Website Opens in new window SWANSEA UNIVERSITY United Kingdom EU contribution € 221 938,45 Address Singleton park SA2 8PP Swansea See on map Region Wales West Wales and The Valleys Swansea Activity type Higher or Secondary Education Establishments Administrative Contact Julie Williams (Ms.) Links Contact the organisation Opens in new window Website Opens in new window QUEEN MARY UNIVERSITY OF LONDON United Kingdom EU contribution € 36 922,80 Address 327 mile end road E1 4NS London See on map Region London Inner London — East Tower Hamlets Activity type Higher or Secondary Education Establishments Administrative Contact Szendeffy Tanya (Ms.) Links Contact the organisation Opens in new window Website Opens in new window
