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PV & Risk Management Strategies in Asia: Updates from China, India, Japan
Published Date: Mar 01, 2020Regional harmonization initiatives heat up eLabeling as regional hot topic
Author(s)
E. Stewart Geary
MD, Global Safety Officer
Eisai Co., Ltd.
E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.
Rie Matsui
Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K.
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.
J Vijay Venkatraman
Managing Director and CEO
Oviya MedSafe
Dr J Vijay is the Founder, MD & CEO of Oviya MedSafe, a global Pharmacovigilance consulting & Drug Safety services providing company based in India and the United Kingdom. He is the first Indian to have received the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK. He has been the India Regional Editor of Global Forum, a DIA publication, since 2017. He served as Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR) since the Council’s inception in 2015 until 2019. He was the Chairman of the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance for 2021. He is a recipient of IMA’s Leadership Excellence Award.
Ms. Stella Xu
Senior Manager, Drug Safety and Pharmacovigilance
dMed
Stella Xu works as lead of safety operation & reporting function in dMed (a full service CRO), and takes the responsibility for providing professional pharmacovigilance service both in clinical trial and post-marketing drug safety. Before joining dMed, she had more than 6 years experience in pharmaceutical industry, worked in Pfizer (China) Research & Development Center drug safety unit. Experienced with pharmacovigilance activity including product acquisition, divestiture, migration in safety database, familiar with regulations in China, US and EU. She attended ICH E2B (R3) specification and implementation meeting organized by National Medical Products Administration (NMPA), and gave a speech on ICH E2B in Korea ICH training day.