Fiona Maini

Biography

Fiona is a Director with around nineteen years' experience within the Pharmaceutical and Chemicals industries. Fiona currently leads the Centre for Regulatory Excellence for Life Sciences. Fiona commenced her career as a scientist working in a research and development based environment. Over the last fifteen years with Intrasphere Technologies and Deloitte Fiona has primarily been working in the Life Sciences industry working on multiple projects relating to the management, oversight and strategic direction with regards to Pharmaceutical business processes and systems implementation. Fiona has performed multiple roles from advisory, programme/project management, CSV validation, quality and compliance management

Research Interest

 Fiona's focus and specialisation over the past few years has been on the changing regulations and supporting pharmaceutical and regulatory organisations through planning and preparation with particular respect to the new European pharmacovigilance legislation, GVP, GCP and ICSR, XEVMPD, IDMPeSubmissions, eCTD formats.