Connecting to the Agency ESTRI Gateway using an AS2 compatible product
Submitted by Anonymous (not verified) on 7 March 2024 - 16:00
Connecting to the Agency ESTRI Gateway using an AS2 compatible product
EudraVigilance - EVWEB user manual
Submitted by Anonymous (not verified) on 7 March 2024 - 15:15
EudraVigilance - EVWEB user manual
EudraVigilance support guide
Submitted by Anonymous (not verified) on 7 March 2024 - 15:10
EudraVigilance support guide
Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0098/2023
Submitted by Anonymous (not verified) on 7 March 2024 - 14:42
Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0098/2023
Vaccine Monitoring Platform: List of EMA-funded studies
Submitted by Anonymous (not verified) on 7 March 2024 - 14:40
Vaccine Monitoring Platform: List of EMA-funded studies
Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 March 2024, 10:00 (CET) to 4 March 2024, 12:00 (CET)
Submitted by Anonymous (not verified) on 7 March 2024 - 14:10
Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 4 March 2024, 10:00 (CET) to 4 March 2024, 12:00 (CET)
Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0087/2023
Submitted by Anonymous (not verified) on 7 March 2024 - 14:00
Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0087/2023
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025
Submitted by Anonymous (not verified) on 7 March 2024 - 13:17
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2024-2025
Meeting Report of the second Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG)
Submitted by Anonymous (not verified) on 7 March 2024 - 11:10
Meeting Report of the second Listen and Learn Focus Group (LLFG) meeting of the Quality Innovation Group (QIG)
Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 30 January 2024
Submitted by Anonymous (not verified) on 7 March 2024 - 10:57
Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 30 January 2024