JULY 2022LIFE SCIENCES REVIEW8t Avanir Pharmaceuticals, safety is our number one priority. We are committed to delivering innovative central nervous system (CNS) solutions that help improve the lives of patients and their care communities. To achieve our mission it's vital to maintain a diligent, robust and resourceful pharmacovigilance system. As a subsidiary of global healthcare company Otsuka Pharmaceutical Co., Ltd., we are able to draw upon global resources and expertise to enhance drug safety. While many pharmaceutical companies choose to outsource the development of their pharmacovigilance systems, Avanir's position in the Otsuka family of companies enables us to leverage shared knowledge and resources that can help enhance our drug-safety vigilance system. Whether small or large, drug development companies should always utilize every resource at their disposal to bring safe drugs to market. If your company happens to be part of a larger organization, you may find that you have more tools, resources and expertise available to you than initially thought. I'd like to share a few ways we've been able to take advantage of the global resources and tools to better ensure the safety of the patients we serve.Shared Database Pharmacovigilance is more than a functional area­it's a system that enables the pharmaceutical company to draw safety data from a variety of channels both internal and external to the organization. These channels include patients, physicians, manufacturers and service providers, among others. To ensure a robust pharmacovigilance system, companies must maintain a solid pharmacovigilance master file (PSMF) and adhere to their responsibilities. Avanir's position within the Otsuka family enables Avanir's PSMF to synchronize with Otsuka's pharmacovigilance master file. Because of its relationship with Otsuka, Avanir has access to a well-established pharmacovigilance database as By Mai Huang, M.D., Executive Director, Drug Safety and Pharmacovigilance, Avanir PharmaceuticalsMai Huang, M.D. is the Executive Director, Drug Safety and Pharmacovigilance at Avanir Pharmaceuticals. Mai received her M.D. at Capital University of Medical Sciences in Beijing, China, followed by a Master's Degree with a major in International Management from The University of California, San Diego. In addition, Mai is a certified regulatory affair professional (RAC) in the U.S. region.HOW SMALL PHARMA, WORKING WITHIN A GLOBAL PHARMA, CAN BENEFIT FROM ONE PHARMACOVIGILANCE SYSTEM IN MY OPINIONFederico Piutti
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