Managing Safety Reporting in the Evolving Regulatory Environment of the Asia-Pacific Region

Si-Nae has almost 17 years of pharmaceutical industry experience and has worked in various pharmacovigilance roles in pre-/post-marketing pharmacovigilance, global audit/inspection readiness and post-marketing surveillance for 15 years. She set up the local safety reporting team in Korea and has managed a number of safety reporting projects for clients since joining ICON in January 2019. She was awarded her Bachelor’s Degree in Pharmacy from Ewha Womans University and holds a Master’s Degree in Pharmacy/Molecular Biology from the same university.

Mary is a Medical Writing Manager based in the UK who has worked in the CRO industry for over 15 years. She has experience writing numerous document types over a range of therapeutic areas and specialises in aggregate safety reports (clinical and post-marketing phases), leading the aggregate report writing group. She is the author and owner of many of the ICON SOPs and WPs (including the DSUR and PSUR WPs), develops aggregate report templates and is the primary trainer of ICON’s Medical Writers in aggregate report writing. Mary holds a first class honors BSc in Zoology from Swansea University and a PhD in Physiology from the University of Western Ontario.