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eCTD Submission

Apr 25 2014 9:00AM - Apr 26 2014 5:30PM | Sci-Tech Centre 7, Prabhatnagar Jogeshwari (W) MumbaiĀ 400102 MH India

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Overview 

Join us for this one-day hands-on training program. Please specify which date you would like to attend - either April 24 or 25 - on the registration form.

This workshop is focused on enabling the participants to compile, publish and validate eCTD submissions with insights on Life Cycle Management and STF compilations. Hands-on training also enables participants to understand regional differences and global submission strategies. Compilation of US M1 and EU M1 is discussed in detail to empower users with updated information on these major ICH regions. This course is designed for anyone pursuing or intending to pursue Regulatory Affairs, Regulatory Operations, Submission Management, and Electronic Publishing.

Who Should Attend 

Professionals in:

  • Regulatory Affairs
  • Regulatory Operations
  • Submission Management
  • Electronic Publishing

Learning Objectives 

At the conclusion of this workshop, participants will be able to:

  • Compile a technically validated eCTD for various regions
  • Maximize the reuse of compiled content
  • Understand eCTD publishing and technical validation
  • Understand the differences in the regional interpretations of electronic submissions
  • Consider the impact of various regional interpretations of eCTD specifications and guidelines on global submissions strategy

Contact Information 

Manoj Trivedi, Senior Manager Marketing and Program Development, DIA India
Mobile phone: +91-98-1977-7493
Phone: +91-22-6765-3226
Email: Manoj.Trivedi@diaindia.org

Registration Fees 

Other Fees

Government (Full Time)
Rs4000.00
Industry
Rs6000.00
Group Discounts

There are no group discounts for this event.


Join DIA now to qualify to save on future events and to receive all the benefits of membership.

A limited number of student registrations are available. A student is an undergraduate/graduate who can document enrollment in a Signature accredited, degree granting, academic program. Please send completed registration form, copy of student identification, and payment.


CANCELLATION POLICY: On or before APRIL 14, 2014

Cancellations must be in writing and received by April 14, 2014. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations.

DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

Upon cancellation, the administrative fee that will be withheld is 75% of the registration fee.

All refunds will be issued in the currency of original payment

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