eCTD Demystified – Mission3 Webinar

Date/Time
Date(s) - 30 Jul 2014 until 30 Jul 2014
10:00 AM - 11:00 AM

Location
Webinar


Mission3 Webinar: eCTD Demystified
Join Mission3 for a webinar:

​eCTD Demystified

 

The eCTD mandate is coming, are you ready?

 

Under PDFUA V, electronic submissions in eCTD v3.2.2 format will be mandatory for New Drug Applications (NDA), Biologic License Applications (BLA), and Abbreviated New Drug Applications (ANDA) as early as Q4 2016.

 

Register for our “eCTD Demystified” webinar to become an eCTD expert.

 

Topics include:

  • The basic components of the XML backbone and eCTD folder structure
  • The importance of metadata/attributes in establishing your XML backbone
  • An overview of the types of documents that are submitted in each module
  • The proper use of study tagging files to organize your clinical study reports
  • The correct procedure for submitting case report forms in eCTD format
  • Placement of datasets according to the FDA “Study Data Specifications” guidance
  • Suggestions for bookmarking and hyperlinking within and across documents
Who:
Pharmaceutical, biotechnology, medical device, regulatory affairs,

and clinical teams

When:
Wednesday

July 30, 2014

10:00-11:00 am Pacific /

1:00-2:00 PM Eastern
Where:
RSVP to join the webinar

and teleconference

 

Cost:

Free


Phone: 602.957.2150
Email: info@mission3.com  //  Website: http://www.mission3.com