Eirini Kaskani

Background

About Eirini Kaskani

Planning, managing, preparing and submission process for out-licensing EU, Non- EU & US applications. e-CTD dossier preparation and coordination (initial submissions, variations, renewals) for EU (MRPs, DCPs, national). Preparing and submitting New Drug Applications through Decentralize Procedure (DCP), Mutual Recognition Procedures (MRP) and National Procedures (MAA) for EU countries. Preparing and submitting New Drug Applications through National Procedures (MAA) for non-EU countries. Maintenance of Marketing Authorization Applications (Variations and Renewals) abiding to post approval commitments, as well as handling of withdrawals and transfers of Marketing Authorizations in EU & non-EU countries. Maintaining required annual licenses, registrations, and listings to support the Company’s commercial strategy (GDUFA fees, establishment registration, product listing etc.). Providing regulatory / M1 expertise during negotiations and interactions with regulatory agencies 8. Communicating with internal and external parties to obtain required supporting documents data for compilation of CTD dossier, supplements/variations, responses to authorities’ questions etc, maintaining timelines of projects and solve any issues raised. Communicating/liaising with Competent Authorities for handling any conflicts. Adaptation and translation of Product Information (SmPC, labelling & PIL) in compliance with the EU and local legislation. Registration of medical devices to the National/European database and reparation/maintenance of technical dossier for CE mark. Responsible for worldwide tenders 13. Submitting OTC Notifications 14. Training staff in regulatory policies and procedures.