Forum Institut für Management GmbH

eCTD in the Middle East - CTD content and eCTD submission requirements in Middle Eastern countries in cooperation with SIPS

Forum Institut für Management GmbH
Online

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Wichtige informationen

Tipologie Seminar
Methodologie Online
  • Seminar
  • Online
Beschreibung

Do you need to acquire expertise in CTD dossier development and the mandatory submission in the eCTD format? Then this
online training programme comprising one e-learning course and four live webcasts will be your fast track to becoming knowledgeable
in this field. Experts in regulatory operations, IT and the Middle East will share their knowledge with you and guide you
through the programme.


You will receive the access data for the e-learning two weeks before the first live webcast to give you enough time to gain
knowledge about the CTD structure, content and CMC requirements.


At our live webcasts, you will meet our experts in a virtual conference room. Each meeting will be a two-hour live webcast,
delivering the information with supporting slides (also for your personal download). Your practical questions will be addressed
directly via the chat function coordinated by the meeting chairperson.

Zu berücksichtigen

· An wen richtet sich dieser Kurs?

Do you need to acquire expertise in the CTD and eCTD? Then this online training programme is your fast track to becoming knowledgeable in this field. It will be of benefit to all those working in regulatory and medical affairs. No prior dossier experience is required.

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e-Learning

Themenkreis

- E-learning course on the CTD structure, content and CMC requirements - Webcast on dossier requirements in the GCC office, Saudi Arabia, Oman, UAE and Jordan - Webcast on eCTD document authoring and technical preparation - Webcast on the baseline submission - Webcast on dossier compilation, submission and review

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