FREE WEBINAR TOPIC

“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.

 

Join us to gain insights into the regulatory landscape, best practices for developing effective DRMPs, and how to navigate the specific requirements in China.

 

Choose between one of 3 sessions available for this webinar on March 26th:

• Session 1:Thu 27 Jun, 6am ET | 12pm CET | 6pm CST
• Session 2:Thu 27 Jun, 10am ET | 4pm CET | 10pm CST
• Session 3:Thu 27 Jun, 2pm ET | 8pm CET | 2am CST

 

Agenda:

• Definition and Purpose of Risk Management Plans (RMPs) for Medicinal Products (MPs)
• Requirements for RMPs for MPs with Marketing Authorization and Developmental RMPs (DRMPs) for MPs in Clinical Development Stage
• Guidelines and Requirements for DRMPs in China
• Approach to Designing DRMPs in China

At the end of the webinar, you will have the opportunity to ask our expert any questions you may have.

 

About our expert speaker:

Vjera Bilušić Vundać, PhD Pharm
Senior Director of Medical Writing

 

If you have any questions about our webinar please feel free to contact us.