Mastering Risk Management Plans (DRMPs) in Clinical Drug Development: Comprehensive Overview of Requirements in China

Risk Management Plans (RMPs) are a regulatory requirement for all marketed medicinal products. These documents aim to define a risk management system necessary to identify, characterize, and minimize a medicinal product's important risks. A Developmental Risk Management Plan (DRMP) is similar to an RMP but refers to the risk management system for medicinal products in the clinical trial stage. This evolving document changes during the clinical development of the medicinal product and can form the basis for future RMP development. Although DRMPs are usually not obligatory, some national regulatory authorities, such as those in China, require the submission of DRMPs for medicinal products in clinical development.

The goal of this webinar is to define the purpose and development of RMPs and DRMPs, with a special emphasis on the DRMP requirements for China. Join us to gain insights into the regulatory landscape, best practices for developing effective DRMPs, and how to navigate the specific requirements in China.