This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Kristiina Puusaari
eSubmission Programme Coordinator, eAF Product Owner at EMA
Speaker

Profile

Kristiina joined the European Medicines Agency in January 2002 and has been focusing on implementation of electronic submissions at the agency since 2006. Kristiina is responsible for the implementation, coordination and maintenance of the eSubmission systems and processes at the agency and is a product owner for the PLM Portal eAF which will deliver replacements for the pdf format eAFs for the EU network.

Kristiina is also a Product Owner and a subject matter expert for eCTD v3.2.2, eCDT v4.0, the electronic Application Forms (eAFs), the eSubmission Gateway and Web Client, the Common Repository, the PSUR Repository and the business processes related to the eSubmissions. Kristiina works closely with the business and technical colleagues and the development teams.

Kristiina works closely with colleagues from the European Medicines Network (EMRN) and the pharmaceutical industry. Kristiina represents the EMA in eSubmissions related stakeholder groups and represents the EU region as the Regulatory Chair at the ICH M8.

Agenda Sessions

  • eAF: The Current State of Play

    09:10