Effective pharmacovigilance and risk management practices are critical to ensuring that medical products are safe and their risks are balanced with benefits in a way that best meets the needs of the patients who use them.
With the development of expedited regulatory frameworks such as the breakthrough therapy designation (US), PRIME (EU), and Sakigake (Japan), to address unmet medical needs, traditional clinical safety and pharmacovigilance methods must adapt. Additionally, advanced therapeutic products, such as cell and gene therapies, tissue-engineered products, and combination products, are evolving in a complex and dynamic scientific and regulatory environment. Professionals must build on their knowledge of safety and pharmacovigilance for small molecule and biologic-based medicines to understand special safety considerations for these unique new products.
Today’s safety and pharmacovigilance professionals assess and manage risk of a broad and changing scope of therapeutic products. Their ability to apply best practices in current daily operations while anticipating coming changes associated with new therapies and technologies is key to putting safe products on the market and optimizing benefits to patients.
These applications of best practices do not exist in isolation. Pharmacovigilance in 2020 is a global activity which 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 in a new decade and beyond.