SDM Sharing | Drug Development in China, USA and Europe: Tips for Regulatory Communications and Consultations
Want to quickly penetrate the Chinese, American and European pharmaceutical markets? Registering for communication exchanges is the key!
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2025-02-14
2025-02-05
SDM Sharing | PM Stakeholder Management in Clinical Data Projects
This session focuses on Stakeholder Engagement: developing strategies for collaborative project decision-making and execution.
2025-01-11
SDM Interpretation | After 18 Years, FDA Issues Draft Guidance on Development of Weight-Loss Drugs and Biologics
The updated draft guidance involves a focus on clinical trial design, regulatory considerations, and whether these trials can demonstrate that the drugs can maintain weight loss as determined by BMI.
2024-11-12
SDM Sharing | Project Schedule management for Clinical Data Management “PM” Development Program
Let's take a look back at the previous two installments of the Clinical Data Management “PM” series: Scope Management, which clarifies the scope of responsibilities of all parties involved in a clinical trial, and Project Resource Management, which focuses on the utilization of company and personal resources to accomplish data management tasks. In this installment, we will focus on the most important part of project management - project schedule management - to share the timeline planning and progress follow-up of data management activities, so as to efficiently complete the data management work under the premise of ensuring the data quality and reaching the important milestones of the project.
2024-10-09
SDM Sharing | Project Resource Management for Clinical Data Management “PM” Development Program
In the last session, we learned about project scope management for data management work, identifying the scope of responsibilities for data cleansing and data management activities. After defining the scope of the data management work, in this session, we will learn how to mobilize the resources within the scope of work to carry out the data management work more efficiently and with higher quality.
