Latest updates on the go-live for eCTD in South Africa

October 11, 2017 10:00–11:00 Eastern Time (US & Canada)

In this webinar, Estelle Taute, Director Operations & Administration at Dept of Health, Medicines Control Council will provide and update on the implementation of eCTD at the South African agency.

Presentation overview:

- Registration process for eCTD
- Products in pilot phase
- eCTD roll-out & Update to guidelines & specifications
- Latest status of the go-live, NCEs & Generics (Expectations & common deficiencies)
- Presentation, validation & evaluation phases
- Conclusion and hints for industry for successful submissions

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