asean - ICH
asean - ICH
asean - ICH
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ASEAN-PPWG<br />
ACTD <strong>ICH</strong>-CTD<br />
Module 1<br />
Regional<br />
Admin.Info.<br />
1<br />
Non-CTD<br />
Part I<br />
11.1 Submission<br />
T o C<br />
* = upon request<br />
Part II<br />
Quality<br />
Overall Summary<br />
& Report<br />
TOC<br />
Admin.data / Product Info.<br />
Part III<br />
Non-Clinical<br />
Overview,<br />
Summary,<br />
& Study Report*<br />
Part IV<br />
Clinical<br />
Overview,<br />
Summary,<br />
& Study Report*<br />
Quality<br />
Overall<br />
Summary<br />
2.3<br />
Module 3<br />
Quality<br />
3<br />
2.1 - CTD T o C<br />
2.2 - CTD Introduction<br />
Non-clinical<br />
Overview<br />
2.4<br />
Non-clinical<br />
Written and Tabulated Summaries<br />
2.6<br />
Module 4<br />
Non-clinical<br />
Study Report<br />
4<br />
Clinical<br />
Overview<br />
2.5<br />
Clinical<br />
Summary<br />
2.7<br />
Module 5<br />
Clinical<br />
Study Report<br />
5<br />
Module 2<br />
Yuppadee – 8Jun2010, Tallinn, Estonia<br />
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