Patient safety largely depends not only upon safe products but also on appropriate (safe) use of these products after they’re approved for the market. “Safe use” is generally defined by identifying and communicating the benefits and risks of that product. Post-market safety monitoring keeps patients safe. Read how simplification, harmonization, and risk communication are effective tools for safe use.
The FDA Sentinel System started as a congressional mandate in the FDA Amendments Act of 2007 and has given rise to one of the world’s premier evidence generation platforms. Read how this system is continuing to be invaluable and is a test bed for future projects.
Pharmacovigilance in 2020 is a global activity that takes place against an ever changing regulatory, political, and environmental backdrop. To combat inequalities in resources and inconsistencies in policy as science and technology evolve, collaboration and harmonization are key to maintaining patient safety and holistically raising the standards of global health.
China joined the International Council for Harmonisation (ICH) in 2017, and the country's subsequent announcement to follow relevant ICH guidelines such as E2, M1, and M4, in 2018, is continuing to change the conduct of pharmacovigilance in China. Read more about the aspects of these regulatory changes and resulting industry needs.
Dr. Petra Doerr, deputy executive director of Swissmedic, and Dr. Murray Lumpkin, deputy director of regulatory affairs and lead for global regulatory systems initiatives for the Bill and Melinda Gates Foundation, explain the World Health Organization’s Essential Medicines and Health Products Strategic Framework for 2016 to 2030.
This track provides an overview of the global regulatory environment in the field of clinical safety and pharmacovigilance for medical products (biopharmaceutical products, advanced therapies, and medical devices), with a focus on pragmatic approaches to protecting patient safety and incorporating the patient voice into the complex and evolving pharmacovigilance ecosystem.