Seminar: Points to note eCTD application and Practices in Tokyo - Japan

Point change and the utilization of internal processes and outsourcing for the creation of eCTD, the process of applying for eCTD real good explanation of experienced teachers?


Point of course

If the NDA went on eCTD, approval Attachment (CTD) eliminates the need for attachment of the third part of the fifth part in the big pharmaceutical companies have had the benefits, one can create an entirely eCTD One challenge that is. Point change and the utilization of internal processes and outsourcing for the creation of eCTD, doing commentary for the application process for the actual eCTD. Furthermore, QC is performed to explain and support eCTD ER / ES will need when applying for eCTD.

Knowledge can be learned

Such as the idea of ​​ER / ES Considerations when outsourcing considerations when creating eCTD eCTD application process to build house / outline of how to proceed · eCTD eCTD implementation project.

Program

1. NDA and the current review

(A) MHLW and PMDA
(B) of the examination and approval flow (c) query and response characteristics of the items (d) public information after approval

2. eCTD and is

(A) the history of the eCTD (b) Structure of eCTD (c) creating a flow of eCTD (d) Regulatory Considerations for eCTD applications

3. Preparing to apply for eCTD

(A) corresponds ER / ES (b) Considerations for the introduction of eCTD (c) implementation procedures eCTD (d) factors when deciding to outsource their creation and

4. apply quality assurance related to the eCTD

(A) QA and QC
(B) the selection of outside contractors (c) ensure the quality of the eCTD

5. Question and answer session

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