ACT EU has developed the guideline to simplify the clinical trials application package for use during PHEs. The package consists of:
1️⃣ A guidance document on the simplified application package for clinical trials targeting a PHE
2️⃣ Annex I: Part I language requirements
3️⃣ Annex II: Part II national requirements
4️⃣ A site suitability template
In preparation for publication, stakeholders are invited to review the documents and provide targeted feedback only on any critical issues identified on:
➡️ Clarity and usability of the guidance and templates;
➡️ Issues that may affect the practical applicability of the documents
🔴 HOW TO SUBMIT: Please submit any comments by 24 June COB to “romee.reijsenbachdehaan@ema.europa.eu“, copying “acteu@ema.europa.eu“