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The eCTD summit: Expert Commentary for Electronic Regulatory Submissions

Expert Commentary for Electronic Regulatory Submissions

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The eCTD summit: Expert Commentary for Electronic Regulatory Submissions | theectdsummit.com Reviews
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Expert Commentary for Electronic Regulatory Submissions
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Expert Commentary for Electronic Regulatory Submissions

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1

eCTD 2010 Conference and Talking to the Speakers | The eCTD Summit

http://theectdsummit.com/eCTD/ectd

ECTD 2010 Conference and Talking to the Speakers. ECTD 2010 Conference and Talking to the Speakers. On Feb 12, 2010 in eCTD. I have often noticed that people attending conferences would like a chance to talk to the speakers that they have found to be interesting. Of course, you can ask questions at the end of the session, but often what you would really like to do is to pick someone’s brain talk to them about your ideas and challenges. That’s why you often see the speakers mobbed during the cocktail hour!

2

FDA Module 1 Grouped Submissions Q&A | The eCTD Summit

http://theectdsummit.com/2015/06/grouped-submissions-qa-part-i

FDA Module 1 Grouped Submissions Q&A. FDA Module 1 Grouped Submissions Q&A. Posted By Brandon Underwood. On Jun 26, 2015 in eCTD. Editor’s Note: Below are responses to the questions submitted by members of industry during GlobalSubmit’s Module 1 Education Series – Grouped Submissions Webinar on June 23, 2015. For the sake of comprehension and as a nod to the M1 fatigue you may be feeling after this month’s crash course, we’ve split our responses into Part I and Part II. Sequence number was not done away ...

3

Brandon Underwood, Author at The eCTD Summit

http://theectdsummit.com/author/bunderwood

Health Canada Hints at 2018 eCTD Mandate. Posted By Brandon Underwood. On Jul 21, 2016 in Agencies and Regulations. In a notice posted to its website, Health Canada gave advance warning that the agency is considering an eCTD filing requirement, or eCTD mandate, that would take effect as early as January 1, 2018. Health Canada is asking for stakeholders to submit comments by August 31, 2016. Comments can be sent to ereview@hc-sc.gc.ca. Posted By Brandon Underwood. On Apr 8, 2016 in Agencies and Regulations.

4

Module 1 Grouped Submissions Explained | The eCTD Summit

http://theectdsummit.com/eCTD/module-1

Module 1 Grouped Submissions Explained. Module 1 Grouped Submissions Explained. Posted By Brandon Underwood. On Jun 19, 2015 in Agencies and Regulations. Editor’s Note: This post is the final of three coinciding with GlobalSubmit’s 3-part Module 1 Education webinar series. Register for Module 1 Education June 23 – Grouped Submissions. Figure 1: The grouped submission concept is similar to an email Cc. A grouped submission eliminates the need to submit multiple, identical submissions to different applicat...

5

Best Practices Archives | The eCTD Summit

http://theectdsummit.com/eCTD/ectdbp

Leveraging eCTD Templates at the Early Stage of Drug Development. Posted By Rob Labriola. On Jul 13, 2016 in Best Practices. ECTD templates set the tone at the early stage of drug development for a smooth, standardized presentation of information in future regulatory submissions. Templates are favorable when compared to creating documents from scratch. Authoring templates make it easier to write summary documents and easily repurpose information from multiple reports without worrying about reform...Rathe...

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The eCTD summit: Expert Commentary for Electronic Regulatory Submissions

Expert Commentary for Electronic Regulatory Submissions. Grouped Submissions Q&A Part I. June 26, 2015. June 19, 2015. Q&A – Ad Promo Submissions. Published by Rob Connelly. June 18, 2015. Editor’s Note: Below are responses to the questions submitted by members of industry during GlobalSubmit’s Module 1 Education Series M1 Effect on Ad Promo Submissions Webinar on June 16, 2015. 1. Now that industry is able to submit OPDP submissions in eCTD format, can you foresee any issues/challenges whe...Editor’s No...

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