Regulatory intelligence, medical writing and operational efficiency through automation

Managing safety cases is becoming more complex due to the ever-increasing volume and variety of data.  In the Asia Pacific region specifically, regulatory and legal requirements vary from country to country and this is additionally layered by intricate country language requirements.

Over the last few years, pharmacovigilance requirements have evolved considerably and more changes are on the horizon. 

This webinar will provide an insight into safety regulations in Taiwan, China and Japan, delving deeper into the recent and upcoming safety regulations in Korea, to support understanding and compliance in pharmacovigilance. It will cover the latest regulatory intelligence, medical writing customisations and explore methods to achieve operational efficiency through system optimization.

Learning objectives:

  • Regulatory requirements in APAC region relating to:
    • E2B R3 regulatory requirements
    • Periodic reporting
  • Implementation approach for evolving requirements
  • DSUR/PSUR process and customisation requirements
  • Understanding of technology system to achieve safety reporting efficiency

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This program is intended for Vice Presidents, Executives, Directors, Managers, Associates responsible for oversight, Associates involved in:

  • Outsourcing
  • Procurement
  • Quality Assurance
  • Project Management
  • Pharmacovigilance
  • Safety Reporting
  • Medical Affairs
  • Regulatory Affairs
  • Medical Writing
  • Clinical Trials
  • Post Marketing



Si-Nae Lee

Senior Drug Safety Manager, Safety Reporting, ICON plc

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 Pilkington, PhD

Medical Writing Manager, ICON plc

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.

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