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ECTD Training

eCTD Submission Certification Training - Part Time/Distance learning

About Course

Many countries have started adopting the eCTD standard and are accepting eCTD submission. EMEA has started accepting eCTD Submission for all centralized procedure from 1st January 2010 as a step to mandate eCTD submission, paper submission for centralized procedure are no longer accepted.

The Course guides through various aspects of eCTD giving a complete understanding of what eCTD is and how companies can move from paper base to eCTD. The Program focuses on European and US eCTD Submission and help participants compile and submits and eCTD application. The Course is designed for students and Pharma professionals who have no or little knowledge in regards to eCTD and its submission.

ECTD-training

Learning Outcome

  • Basic Understanding of CTD & eCTD
  • Assisting in Compiling & filling and eCTD Application
  • Identifying EU & US Requirement for eCTD
  • Transiting from Paper based Submission to eCTD Submission
  • Review eCTD Application

Course Structure

  • Introduction & Overview of CTD
  • CTD Fundamentals ( Module 1 - 5)
  • eCTD Fundamentals & Details
  • Best Practice in Preparing eCTD
  • Submission using eCTD Format
  • Life Cycle Management for eCTD
  • eCTD Software for Compilation & Validation
  • Key Point for Successful eCTD Submission
  • 2 Days hands on TRAINING on eCTD Software

Course Duration

4 Months Distance learning Program.

Who will Benefit ???

  • QC/QA Managers & Staff
  • Documentation Department
  • Regulatory Affairs Department - Responsible for CTD /DMF Preparation & Submission
  • Research Chemist, Quality Control Chemist, CRO's involved in Documentation
  • harmacy Graduates with knowledge of CTD

Teaching Methodology

  • Participants will be provided with course & study material
  • Practical Training will be provided on eCTD.
  • Paritcipants can ask their query/questions to the instructor during the course.

Eligibility

  • Life Science Graduates with Experience or Knowledge of Regulatory Affairs

Program Fees

4 Months Distance learning Program - Rs 20,600-/-

Admission for Part Time

  • Get the Admission Prospectus from GIRA office in Pune by visiting personally or call us at 020-46704472 and email at info@regulatoryinstitute.com
  • Fill up and submit the same by prescribed date.
  • Pay the fees for admission before the prescribed date.

Apply Online

Students can download the admission form by clicking here, in PDF format print and fill the same, clearly mentioning Mobile No & Course Interested.The Filled form should be courried to us along with DD at the below mentioned address.

Address:
Global Institute of Regulatory Affairs
Prestige Classic BLD,
D Wing Off G4 & 5,
Chinchwad Station,
Near Dawabazar,
Chinchwad Pune - 19
Phone – 020-46704472

Apply Online

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Testimonials

    Nakul Pathak Says

    "Regulatory Affairs program at GIRA very effectively integrates industrial experiences with academics in the pharmaceutical field. It helps you to understand the Practicalities of the rules, regulations & guidelines ."

    Nikhil Pachpute Says

    “GIRA's training institute offers high quality courses. It gave me a much needed broader perspective and a multi- faceted view of regulatory affairs. I understood the department work in depth and got a breakthrough in Regulatory Sector."

    Arun Renukuntla Says

    "Faculty at GIRA has vast industrial experience, which has been very useful for me. The teaching methodology is very innovative as well as interactive. Dedicated sessions for query solving are also there.”

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