Pharmacovigilance and Risk Management in 2020: A Global Perspective

With the development of expedited regulatory frameworks in the US, EU, and Japan to address unmet medical needs, traditional clinical safety and pharmacovigilance methods must adapt. The ability to apply best practices in current daily operations while anticipating coming changes associated with new therapies and technologies - against an ever-changing regulatory, political and environmental backdrop - is key to putting safe products on the market and optimizing benefits to patients. Learn more about international and regional initiatives impacting Pharmacovigilance in 2020.

Highlights

International Initiatives

Voluntary guidances, accepted as worldwide best practices, as well as guidelines that are translated into regulation by regional health authorities, continue to play a key role in the advancement of public health.

Regional Considerations

From all corners of the globe, the focus on and accounting of the risks inherent in the development of therapeutic medical products sharpens – aided by new technologies and a desire for standardized practices, even amidst regulatory complexity, resource allocations, and regional distinctions.

Risk Management in 2020

From updates on shared system REMS to the Harmonisation of RMP Project (HaRP), regulatory authorities continue the work to address and minimize inconsistencies and address safety concerns.
20002-ebook-lp-dia-logo-150x82.png   © 2020 DIA. All rights reserved.