戻る Agenda
Session 1 - 1
Session Chair(s)
Heidi Janssen
Head, Endocrinology, Metabolism & Cardiovascular
European Medicines Agency, Netherlands
Irene Rager
Head of Service E, Procedure Management Department
European Medicines Agency, Netherlands
This session will provide a detailed update on the technical and procedural aspects in relation to PSUR submissions and the PSUR single assessment. It will start with an overview of the PSUR/PSUSA assessed so far including statistics, type of outcome and challenges encountered. Other key areas addressed will include procedural aspects related to periodicity, submissions and the maintenance of the EURD list. The PSUR repository functionalities to be audited will be also summarised.
Speaker(s)
An overview of the PSUR/PSUSA assessment experience so far
Maria Boulos
European Medicines Agency, Netherlands
Scientific Administrator
Application of the EU reference date list for PSUR submissions
Katerina-Christina Deli
European Medicines Agency, Netherlands
Submission requirements and procedural aspects of the PSUR single assessment procedure
Ana Zanoletty Perez
European Medicines Agency, Netherlands
Head of Clinical Trials Transformation Workstream