Post graduation diploma course in CTD/eCTD

Post Graduate Diploma

Distance

₹ 25,000 VAT incl.

Description

  • Type

    Post Graduate Diploma

  • Methodology

    Distance learning

  • Duration

    4 Months

  • Start date

    Different dates available

  • Delivery of study materials

    Yes

Introduction to RA profession
ICH and CTD
Organization of CTD
Introduction to eCTD
European Union
Electronic Submissions [21 CFR Part 11]

Facilities

Location

Start date

Distance learning

Start date

Different dates availableNow taking bookings

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Reviews

Subjects

  • CTD
  • ECTD

Teachers and trainers (1)

Rajashri  Ojha

Rajashri Ojha

Teacher

Course programme

1)Introduction to RA profession
Regulatory Affairs Profession, role and its importance, overview of worldwideRegulatory agencies
2)ICH and CTD
Overview of ICH

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

Introduction to eCTD
Need to HarmonizeOrigin of CTDCTD ModulesIntroduction to eCTDDocument GranularityAdvantages of eCTDNeed of eCTD Builder SoftwareDTDIndex.xml FileRegional xml FileUSFDA Admin Information in US-regional.xml File Formats supported in eCTD for USFDA PDF Specification for USFDAFolder StructureSTF (Study Tagging File)RSN ConceptWay to submit the Final SubmissionThings to be taken care while preparing eCTD submissionEuropean Union
Electronic Submissions [21 CFR Part 11]

Post graduation diploma course in CTD/eCTD

₹ 25,000 VAT incl.