This guideline provides guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation. The guideline provides general guidance on stability testing for type IA and...
European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) were hosting the first EMA/HMA multi-stakeholder forum on EudraVigilance and signal Detection. The Forum’s main objectives were to inform stakeholders on ongoing and forthcoming developments...
The 20th meeting of the industry stakeholder platform on the operation of EU pharmacovigilance aimed to inform, get feedback and foster dialogue between industry and the EU regulators. Topics included: Real World Evidence update Guidance...
Enpr-EMA’s annual meeting is a unique opportunity for networks and other stakeholders of paediatric clinical trials, such as health care professionals, parents, carers, patient representatives as well as medicine developers and regulators, to learn about...
The 2025 annual meeting of the members of the European network of paediatric research at the EMA (Enpr-EMA) and its Coordinating Group focused on recent Enpr-EMA developments, collaboration with ACT EU, and future strategic priorities....
This was the fifteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addressed all areas of evidence generation along the medicine’s life-cycle and related to development support activities,...
The EMA recently issued an Explanatory note on the withdrawal of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. The interim guidance focused on the requirements for annual enhanced...
The 6th EMA-AESGP bilateral meeting is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and promote dialogue on topics of...
The seventh EMA-EUROPABIO bilateral meeting is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and promote dialogue on topics of...
This meeting between European Medicines Agency (EMA) and Medicines for Europe is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views...
