eCTD Submission Certification Program - Part Time/Distance learning

Learning outcome >> Who Will Benefit >> Eligibility >> Program Fees

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.

 

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 StructureTop

• 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

Course DurationTop

• 3 Months Part Time Class Room Program.
• 4 Months Distance learning Program.

Who will Benefit ???Top

• 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
• Pharmacy Graduates with knowledge of CTD

Teaching MethodologyTop

• 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 Top

• Life Science Graduates with Experience or Knowledge of Regulatory Affairs

Program Fees Top

• 3 Months Part Time Program - Rs 20,000-/-
• 4 Months Distance learning Program - Rs 15,000-/-

Admission for Part Time Top

• 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 Top

Students can register online by clicking here, please mention your mobile number and course interested . A representative will get in touch with you within 48 hours.