Global Regulatory Policy Group in F. Hoffmann-La Roche
Nevena Miletic is a pharmacist, with postgraduate studies in pharmacoeconomics, regulatory affairs and quality assurance, and certified QP. She has over seventeen years of broad and deep experience in pharmaceutical industry, with the topics covering both clinical and cmc development. She worked in the areas of Policy, Regulatory Affairs, Quality Assurance and Market Access, on local, regional and global level, covering developed and developing markets.
Currently she works within global Regulatory Policy Group in F. Hoffmann-La Roche, Switzerland, among else as a global topic lead for regulatory reliance and work sharing.
She is a co-chair of IFPMA Africa Regulatory Network and IFPMA CPP Network, member of IFPMA Regulatory Science Committee, EFPIA ERAO PI Working Group, EFPIA Russia Network and EFPIA International PV group, DIA Middle East & Africa Advisory Board, involved in numerous meetings, workshops and projects with regulators and cross-industry collaborative platforms (e.g. Pre-ICDRA, IMI etc.).
Nevena is a strong advocate for regulatory convergence and harmonization, with main interest in innovative development and review/approval pathways, good review practices, as well as in innovative approaches such as digital dynamic labelling, dynamic regulatory assessment and with special focus on biotherapeutics and ATMP.