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Industry Workshop: Specification 3.1 Processes
September 13 @ 9:00 am - 10:00 am
The South African Health Products Regulatory Authority (SAHPRA) hosted the third industry workshop in a series of informative sessions around eCTD. This webinar focused on Specification 3.1 processes.
The processes covered included:
- Baselines-Iterative
- TOA
- Splitting the eCTD
- Multiple applications (replicas, clones, and duplicates)
- Line Extensions
- Cancellations
- Withdrawals
Presentations
Watch Recording