Kristiina Puusaari

eSubmissions Programme Management at EMA

Speaker

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 DADI project which will deliver replacements for the pdf format eAFs for the EU network.

Kristiina is 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.