Utrecht Centre for
Pharmaceutical Policy and Regulation
Sini Eskola
Class of:
2019
Current affiliation:
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Contact:
s.m.eskola@uu.nl
Motivation:
Improving the way medicines are researched, developed, used and regulated is my passion. I want to explore and extend my practical experience from regulatory affairs and regulatory policy making into endeavouring academic research in the field of regulatory sciences. I am excited to use my energy in improving the regulatory frameworks globally and bringing value for the society and different stakeholders.
Education and experience:
Sini Eskola is a professional PhD candidate with the Utrecht Centre for Pharmaceutical Policy and Regulation. She has 20 years professional experience in the field of pharmacy; working for Finnish Pharmacists Society (2005-2008), holding positions of Global Regulatory Submission Manager and Regulatory Project Manager in AstraZeneca R&D site in Mölndal Sweden (2008-2014) and lastly working as Director Regulatory, Drug development and Manufacturing in European industry trade association EFPIA (2014-now).
Sini holds Bachelor (2003) and Masters Degree (2005) of Pharmaceutical Sciences from University of Helsinki. During her studies (2000-2005) she was working in multiple community pharmacies, gained experience in whole sales and did study internships in Zürich, CH and London, UK.
Title PhD project:
Use of Real World Data/Evidence in Medicines Development and Regulatory Decision Making
PhD project description:
The clinical evidence collected for the marketing authorisation of a new medicine is traditionally generated from randomized controlled clinical trials (RCTs). It is recognised that RCT data have limitations including tightly controlled conditions of clinical care, highly selected populations and in some scenarios small population sizes. It is suggested that Real World Data (RWD) can provide additional insights on the benefits and risks of a medicine. RWD is increasingly proposed and used as a source of evidence to support medicines development and regulatory decision making. RWD becomes evidence (Real World Evidence=RWE) when applicable tools and methods are applied to analyse the RWD. This research aims to evaluate and strengthen the evidence base of the level of RWD/E use in medicines development and regulatory decision making focusing on Europe as a region.
Team members and other people involved: