戻る Agenda
Session 1: Technical and procedural aspects of PSUR submissions and the PSUR single assessment
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)
PSURs for Nationally Authorised Products – Transitional and Future arrangements
Anne M Ambrose, MPHARM, MSC, RPH, RAC
Medicines & Healthcare Products Regulatory Agency, United Kingdom
Specialist in Post Authorisation Operations and Safety Issues
PSUR Repository and functionalities to be audited
Kristiina Puusaari, MBA, PMP
European Medicines Agency, Netherlands
Digital Business Transformation Programme eSubmission Senior Coordinator