Regulatory Affairs Project Management
This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.Learning ObjectivesSetting tasks focused on project objectivesCreating a project timeline and task trackerAssigning managing resourcesLeading effective project team meetingsTracking progress on tasks and overall projectUsing available tools to assist in project completionEnsuring effective team communicationRe-evaluating resource needs and time constraintIdentifying and mitigating risks to project completionCommunicating progress to managementWho Should AttendRegulatory Affairs, Regulatory Operations, Project Team Members across Disciplines.This presentation is targeted toward the following organizational positions and discage understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative and would be valuable for experience levels ranging from seasoned veterans to those newly assigned roles related to regulatory project management.Why Should You AttendThis program will address aspects of traditional project management with consideration of tailoring for regulatory affairs projects as well as tips for leading the team to completion and maintaining established timelines.
This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.
Learning Objectives
- Setting tasks focused on project objectives
- Creating a project timeline and task tracker
- Assigning managing resources
- Leading effective project team meetings
- Tracking progress on tasks and overall project
- Using available tools to assist in project completion
- Ensuring effective team communication
- Re-evaluating resource needs and time constraint
- Identifying and mitigating risks to project completion
- Communicating progress to management
Who Should Attend
Regulatory Affairs, Regulatory Operations, Project Team Members across Disciplines.
This presentation is targeted toward the following organizational positions and discage understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative and would be valuable for experience levels ranging from seasoned veterans to those newly assigned roles related to regulatory project management.
Why Should You Attend
This program will address aspects of traditional project management with consideration of tailoring for regulatory affairs projects as well as tips for leading the team to completion and maintaining established timelines.
