Anna Litsiou
Senior Director, Regulatory Policy & Intelligence, International Region AstraZeneca
Anna Litsiou is Senior Director, Regulatory Policy & Intelligence – International Region at AstraZeneca, with extensive experience shaping global regulatory strategy across biopharmaceuticals, cell and gene therapy, oncology, and emerging markets. Having held regulatory leadership roles at AstraZeneca, Biogen, Shire, and Astellas Pharma, she has led regulatory policy and intelligence initiatives spanning China, EMEA, LATAM, APAC, and over 50 international markets. Anna is particularly focused on regulatory affairs, policy intelligence, cell and gene therapy, global registrations, CMC, and evolving international regulatory frameworks, helping advance innovative therapies across diverse global regions.
Seminars
- Navigating FDA, EMA, and NMPA expectations early to align development plans and enable smoother clinical progression
- Leveraging IND, CTA and IIT pathways to optimise streamline approvals, and reduce patient enrolment timelines
- Learning from successful global development programmes to identify regulatory strategies that have accelerated approvals, site activation, and clinical execution across major markets
- Assessing the advantages and trade-offs of Chinese development and manufacturing, to determine the optimal balance between speed, cost, quality, effort, and long-term clinical strategy
- Navigating IIT pathways and regulatory requirements to support future clinical and regulatory success in Asia, the US and Europe
- Examining the investment and commercial implications of conducting trials and manufacturing in China, to accelerate asset interest and global market opportunities
