Refresher training webinar on post-authorisation procedure management in IRIS for marketing authorisation holders, ...

The aims of this webinar are to provide marketing authorisation holders with a refresher training session on post-authorisation procedure management, including: updates on future IRIS developments; showcasing the IRIS system; a questions and answers …

Proba receives conditional endorsement from ICROA

Proba receives conditional endorsement from ICROA, validating its fertilizer-focused carbon programme for credible Scope 3 insetting and impact. AMSTERDAM, NETHERLANDS, July 29, 2025 /⁨EINPresswire.com⁩/ -- Proba, a carbon project certifier …

European Platform for Regulatory Science Research meeting, Online, European Medicines Agency, Amsterdam, the Netherlands,...

The EMA/HMA European Platform for Regulatory Science Research was launched in March 2025. The Platform brings together academic and not-for-profit researchers and regulators, as well as other stakeholders, with the overall goal to advance research in …

EMA Information Day on submission predictability of initial marketing authorisation December 2025, Online, European ...

The European Medicines Agency facilitates the information day with the aim to enhance a common understanding, raise awareness of the challenges for EU regulatory network and to share best practices for planning and preparing submissions, as well as …

Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries ...

This joint hybrid HMA/EMA Patient Registries workshop aims to facilitate the long-term follow up of medicines for Alzheimer's Disease (AD), and enable the generation of meaningful safety and efficacy/effectiveness data using existing patient …

Unlocking PMS API potential: Edit functionality training for MAHs, Online, European Medicines Agency, Amsterdam, the ...

The PMS team will host a workshop to provide insights and training on the Application Programming Interface (API) edit functionalities for MAHs. This session will offer an overview of API edit functionalities' capabilities, along with guidance on …

PMS PUI Training: Product data submission & bulk edit made easy, Online, European Medicines Agency, Amsterdam, the ...

The PMS team will host a webinar to provide insights and training on the new bulk edit functionality for MAHs, including a recap of key features. This session will offer an overview of PUI bulk edit functionality's capabilities, along with guidance on …

First EMA-ACRO bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 September 2025

This meeting between European Medicines Agency (EMA) and ACRO 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 common …

Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, ...

Clinical Trials Information System (CTIS) Bitesize talk: Redesign of the CTIS training material for sponsor users, ...

CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it acts as a single entry point for clinical trial authorisation and supervision in the European Union (EU) and the European Economic Area (EEA).  This …