E Stewart GearyChief Medical Officer, Vice President and General Manager
Eisai Co., Ltd.
E. Stewart Geary, M.D, has worked at Eisai since 1996 in pharmacovigilance, clinical safety and regulatory science. He was a member of the CIOMS IX Working Group on Medicinal Product Risk Management, the Executive Committee of the Japanese Association of Pharmaceutical Medicine, the DIA Advisory Committee Japan and serves on the Editorial Advisory Boards for the publications Applied Clinical Trials and IFAPP World. He previously served on the CIOMS VIII Working Group on Signal Detection, the CIOMS VII Working Group on the Development Safety Update Report and the CIOMS Working Group on Standardized MedDRA Queries.
Dr Geary graduated from Harvard College summa cum laude with a bachelor’s degree in chemistry in 1985. He spent a year doing basic research on insulin-like growth factor receptors at Harvard Medical School before attending Stanford Medical School from which he earned an MD degree in 1990. He went on to complete a residency in Urology at the Stanford University Medical Center in 1996. He has published on the Japanese pharmaceutical industry and lectured on global pharmaceutical regulations.
Adherence to Pharmacovigilance Risk Assessment Committee guidelines
Understanding rationale, format and content for writing PSURs/PBRERs
Developing a “Benefit Maximisation Plan” toolbox for approved medicines
Reporting, evaluating and summarising safety data and signals
Incorporating communication within and across agencies to patient support programmes (PSP)
Collating patient and healthcare provider inputs from various social and digital channels
Managing variations in safety restrictions, license suspension and withdrawal
16:30 Panel Discussion: Ensuring Compliance in Patient Support Programmes (PSP): Leveraging Multi-Stakeholder Collaboration to Enhance Data Capture
• How do you realistically ensure patient adherence and prevent off-label use with the assistance of digital technologies?
• Interfacing both local and global markets research programmes to maximize data collection
• Effectively capturing all opportunities of patient interaction with pharmacists and healthcare providers to improve systematic inputs of information
• Ensuring quality standards in conduct of PSPs and Market Research Programmes (MRPs) in real-time