ERN input to ACT-EU priorities- Survey!

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ACT-EU* – Accelerating Clinical Trials in the EU

Please contribute to ACT-EU survey

Target group: Academic Stakeholders

The aim of the survey is to identify needs and priorities of academic stakeholders involved in clinical trials, integrating them into the work of ACT EU. It seeks to address challenges in conducting clinical trials in the EU faced by ERNs and academics, highlight topics needing further clarification or discussion, and propose solutions for improving and accelerating clinical trials. Academic stakeholders are encouraged to contribute ideas for improvement across various aspects of clinical trial governance and implementation, clinical trial methodologies [...]



EMA/ACT EU Training: Transitioning trials to the CTR (CTIS) for non-commercial sponsors

ACT EU Training

ACT EU Training for non-commercial sponsors: Transitioning trials to CTIS

9 February 2024 10:00-13:00 CET

Location: Online/ European Medicines Agency, Amsterdam, the Netherlands, Live Broadcast

Event summary

This training event aims to support non-commercial sponsors of clinical trials in transitioning their clinical trials that are expected to continue after 30 January 2025 from the Clinical Trials Directive to the EU Clinical Trials Regulation (Regulation (EU) No 536/2014). Moreover, the event will provide useful training in preparing new clinical trials following the Clinical Trial Regulation (CTR).

From 31 January 2025 onwards only the CTR and its Delegated Acts will [...]



EMA Webinar on Rare World Diseases Day

EMA RD Day webinar

Orphan Medicines Development – ask the European regulator

Thursday, 29 February 2024 Virtual meeting via WebEx / EMA, Amsterdam

The EMA’s Orphan Medicines Office is hosting an interactive webinar on Rare Disease Day on 29 February 2024, to answer questions that developers of products for rare diseases or researchers in this field might have on orphan designations and rare disease development. The webinar will feature:

short presentations on the background of orphan designation and the benefits it has brought to patients; a live question-and-answer session enabling participants to ask their questions on orphan medicines development to a panel of regulatory [...]