Moving Beyond Spontaneous Surveillance
Drug Safety: A Holistic View
While individual case reports will always have an important role to play in ensuring drug safety, pharmacovigilance professionals are moving towards an aggregate analysis of real-world data in their effort to understand how drugs and vaccines affect patients.
This “is a huge shift for pharmacovigilance,” asserts Stewart Geary, MD, Chief Medical Officer at Eisai Co., Ltd.
Dr. Geary joins the podcast for a dynamic discussion about gaining a more holistic view of drug safety in both the clinical development and post marketing environments.
In this episode of Safety Signals, we discuss:
– New requirements and techniques for looking at the complete data picture – How media can influence adverse event reporting – Why scientists need to know what they want from their data before they analyze it – Why pharmacovigilance professionals must work with technologists to understand what new tools can really do
The Saama Safety Signals podcast provides a stage for pharmacovigilance and drug safety leaders and innovators to tell their stories and perspectives on adopting modern technologies for pharmacovigilance, benefit-risk management, and epidemiology.
* The views of the hosts and guests featured on Safety Signals are their own and do not necessarily reflect the views of Saama or the individual companies for which the guests may work.About Saama Safety Signals
Introducing Safety Signals, the show for pharmacovigilance professionals, benefit risk managers, epidemiologists, and other patient safety stakeholders. From pharma leaders to academics and scientists, we provide expert perspectives on the challenges, opportunities, and technologies that are shaping the future of the safety sciences. Get ready to be inspired and energized as you work to reduce the risk of life-changing–and life SAVING–medical treatments.
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Meet Your Hosts & Guests
Stewart Geary
Senior Vice President, Chief Medical Officer Director, Corporate Medical Affairs Headquarters, Eisai Co., Ltd. E. Stewart Geary, M.D, has worked at Eisai since 1996 in pharmacovigilance, clinical safety and regulatory science. He is currently a member of the Executive Committee of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Boards for the publications Applied Clinical Trials and Pharmaceutical Medicine. He recently joined the CIOMS Working Group on Drug-Induced Liver Injury and served on the CIOMS VII Working Group on the Development Safety Update Report, the CIOMS VIII Working Group on Signal Detection, the CIOMS Working Group on Standardized MedDRA Queries and the CIOMS IX Working Group on Medicinal Product Risk Management.
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 lectures at several universities on Pharmaceutical Medicine and has published on the Japanese pharmaceutical industry and on global pharmaceutical regulations.
Stewart
Geary
SVP, Global Safety Officer
Eisai Co., Ltd.