This meeting between European Medicines Agency (EMA) and Vaccines 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 and...
EMA is hosting the thirteenth industry stakeholder platform on the operation of the centralised procedure for human medicines. This will be the thirteenth in a series of regular meetings between regulators and representatives of industry...
In January 2025, the following EMA-led procedures will transition to IRIS for all Centrally Authorised Products (CAPs) (and involved non-CAPs): Periodic Safety Update Reports, Post-Authorisation Measures, Line Extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Studies/Post-Marketing Surveillance...
This meeting between European Medicines Agency (EMA), IPFA and PPTA 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...
European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are hosting a workshop on AI. The workshop will provide updates on: the state-of-the-art of AI developments with keynote speakers; policy and legislative environment and...
This report on mobile health (mHealth) data is available to explore the opportunities of using data from mobile technologies and digital interventions in regulatory decision-making. This report focuses on mHealth data use in real-world settings,...
The 10 October 2024 was held at the EMA a Symposium on Advanced Therapy Medicinal Products focusing on the regulatory, developmental, and future challenges of ATMPs in Europe. Discussions on the role of the Committee...
On 25 September 2024, the EMA and the HMA held a joint workshop on submission predictability, bringing together representatives from the national competent authorities, industry, and EMA, to focus on submission predictability and how it...
The European Medicines Agency (EMA) organised a hybrid SME (small and medium-sized enterprises) info day on 18 October 2024. The SME info day is a training event dedicated to small and medium-sized enterprises in the...
On 22 April 2024, EMA organised a workshop to present and discuss to Notified Bodies (NBs) the current activities being developed by the Expert Panels. The secretariat presented an overview of the consultation procedures – Clinical Evaluation Consultation Procedure (CECP) and Performance...
