eCTD specifications?, Requirements of different regulatory authority.

Question

Accepted Answer

eCTD specifications and regulatory authority requirements for Research Associate role.

eCTD stands for electronic Common Technical Document and is a standard format for submitting regulatory documents electronically.
Different regulatory authorities have their own specific requirements for eCTD submissions, such as the FDA in the US, EMA in Europe, and PMDA in Japan.
These requirements can include specific file formats, naming conventions, and submission timelines.
Research Associates may be responsible for ensuring that eCTD submissions meet the requirements of the relevant regulatory authorities.
Familiarity with eCTD software and regulatory guidelines is important for success in this role.

Accepted Answer

The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).

eCTD specifications?, Requirements of different regulatory authority.

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