Clinical Trial Information System (CTIS) - Sponsor handbook
Submitted by Anonymous (not verified) on 7 August 2024 - 16:12
Clinical Trial Information System (CTIS) - Sponsor handbook
Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa
Submitted by Anonymous (not verified) on 7 August 2024 - 15:12
Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa
Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 22 April 2024 to 25 April 2024
Submitted by Anonymous (not verified) on 7 August 2024 - 12:00
Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 22 April 2024 to 25 April 2024
Human medicines European public assessment report (EPAR): Adzynma, rADAMTS13, Date of authorisation: 01/08/2024, Status: Authorised
Submitted by Anonymous (not verified) on 7 August 2024 - 12:00
Human medicines European public assessment report (EPAR): Adzynma, rADAMTS13, Date of authorisation: 01/08/2024, Status: Authorised
Healthcare Professionals' Working Party
Submitted by Anonymous (not verified) on 7 August 2024 - 10:45
Healthcare Professionals' Working Party
Minutes of the HMPC meeting 27-29 May 2024
Submitted by Anonymous (not verified) on 6 August 2024 - 10:54
Minutes of the HMPC meeting 27-29 May 2024
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
Submitted by Anonymous (not verified) on 5 August 2024 - 18:20
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)
Submitted by Anonymous (not verified) on 5 August 2024 - 16:30
Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)
Union list of critical medicines: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) / Product Management System (PMS) entries
Submitted by Anonymous (not verified) on 5 August 2024 - 15:55
Union list of critical medicines: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) / Product Management System (PMS) entries
Proposed invented name(s) request form for human medicinal products
Submitted by Anonymous (not verified) on 5 August 2024 - 15:22
Proposed invented name(s) request form for human medicinal products