PG DIPLOMA IN CTD-eCTD

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  • To provide an overview of Pharmaceutical industry in all aspects.
  • To Examine the various dossier formats in the region to simplify the registration process.
  • To overcome challenging regulatory procedures in the region, such as timelines, fees,   importing, GMP and pharmacovigilance.
  • Expand your understanding of local healthcare systems to maximize market access in the region.
  • 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.

Topic 1: Introduction to RA profession(Overview of worldwide Regulatory agencies & Pharmaceutical Industry)

  •  Regulatory Affairs Profession, role and its importance, overview of worldwide Regulatory agencies
  •  General Overview of the Pharmaceutical Industry, its functioning, role of various Departments like R & D, Production, RA, QA, Project Management, Supply  chain etc. Within the industry

Topic 2: ICH and CTD(Introduction and overview of ICH &CTD)

  • Overview of ICH.
  •  Introduction and overview of CTD.

Topic 3: Organization of CTD(Module 1, 2, 3, 4, & 5).

  •  Module 1. Administrative and Prescribing Information(Region specific).
  •  Module 2. Common Technical Document Summaries.
  •  Module 3: “QUALITY” – CMC section of the CTD.
  •  Module 4: Nonclinical study reports.
  •  Module 5: Clinical study reports.

Topic 4: Introduction to eCTD(USFDA, Origin of CTD, CTD Modules, Need of eCTD Builder Software)

  •  Need to Harmonize.
  •  Origin of CTD.
  •  CTD Modules.
  •  Introduction to eCTD.
  •  Document Granularity.
  •  Advantages of eCTD.
  •  Need of eCTD Builder Software.
  •  DTD.
  • Index.xml File.
  • Regional xml File.
  • USFDA
  • Admin Information in US-regional.xml
  • File Formats supported in eCTD for USFDA
  • PDF Specification for USFDA.
  • Folder Structure.
  • STF (Study Tagging File).
  • RSN Concept.
  • Way to submit the Final Submission.
  • Things to be taken care while preparing eCTD submission.
  • Leaf Title
  • TOC – Table Of Content
  • Reviewers Guide.
  • Bioequivalence tables
  • eCTD – To Do List.
  • eCTD – DO Not Do List.

Topic 5: European Union(Admin/envelop information in EU-regional.xml, Use of Node-extension,NeeS [Non-eCTD electronic submission])

  •  Admin/envelop information in EU-regional.xml.
  •  Procedures used in European Union for filing.
  •  National Procedure.
  •  Centralised Procedure.
  •  Decentralised Procedure.
  •  Mutual Recognition Procedure.
  •  Tracking Table in MRP and DCP.
  •  Things to be taken care while preparing eCTD submission.
  •   List of items in initial submission
  •   Handling of empty or missing eCTD sections
  •   Regional File Formats
  •   Section:m1 – Additional data
  •   Section:m1-1-form
  •   eCTD File Name
  •   eCTD Leaf Title
  •   Use of Node-extension.
  •   PDF Specifications for European Union.
  •   Transmission Media.
  •    Labeling Media.
  •    NeeS [Non-eCTD electronic submission].
  •    Areas of divergence between eCTD requirements for the US and the EU.

Topic 6: Electronic Submissions [21 CFR Part 11](Regulatory requirements & Electronic Submission Process).

  •   Introduction: Regulation.
  •   Planning for regulatory submission.
  •   Regulatory requirements.
  •   Electronic Submission Process.
  •   NeeS: Non eCTD electronic Submission.
  •   eCTD: electronic submissions with xml backbone files.
  • Graduate/Post graduate in Science or Pharmacy
  • Regulatory Affairs Department - Responsible for CTD /DMF Preparation & Submission
  • QC/QA Manager and Staff.
  • Production, Clinical, BPO, CRO, KPO Professionals.
  • Research Chemist, Quality Control Chemist, CRO's involved in Documentation
The course duration is Four Months & can be extended in special cases.
The admissions to the distance learning courses at Raaj GPRAC open throughout the year.
Fee structure of the courses will be given on request.
  • Elaborate course material, self-assessment assignments and project work details would be provided by the Raaj GPRAC from time to time. Details get updated on the webpage as well.
  • All the students are obliged to timely submit completed assignments (during the pendency of the course) and appear for an online exam at the end of the course.
  • After successful completion, the student will be awarded”Post Graduate Diploma in CTD/eCTD “by Raaj GPRAC.
  • Please browse through below link to know more about our clients…
  • http://www.rajgprac.com/industrial-clients/
  • We offer professional courses targeted to cater the industry need trained Regulatory affairs professionals. The information, guidance, practical training and PG Diploma course completion certificate will provide the Students with not “one” but “many” opportunities in the industry.
  • This would come true in form of job roles and positions in the field of Regulatory departments in reputed pharmaceutical companies, CRO ,BPO, KPO, Food and Food supplement manufacturers, biotechnology companies and consultancy firms.
  • We provide job assistance to all our registered candidates. We shall share your resume with all employers in our network and you will also receive all mails regarding jobs available across the globe along with all guidance!!