Sponsor companies are now expected to submit globally as quickly as possible. Successful achievement of this combination of speed and complexity requires extensive regulatory knowledge and planning. The first half of this webcast will cover how to plan for simultaneous global submissions, including aspects the team can control and aspects that are out of the team’s control. The second half of this webcast will cover the strategic planning and practices necessary for efficiently publishing and assembling the thousands of documents and data files required for submission.
Learning Objectives
- Factors to be addressed to achieve simultaneous global submissions.
- What factors are typically within a team’s control, which are not, and how to mitigate the potential impacts of those factors not in the team’s control.
- Which activities can be aligned across application types to expedite the publishing of simultaneous submissions and prevent unnecessary re-work.
- How to leverage re-usability and commonality for efficiency in eCTD publishing.
Who Should Watch?
- All regulatory affairs professionals
- Product and submission team leads
- 监管运营
- Project Managers
- Regulatory and Medical Writers
