Post graduation diploma course in CTD/eCTD

Raaj GPRAC
Distance

Rs 25,000
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98191... More
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Important information

  • Post Graduate Diploma
  • Distance learning
  • Duration:
    4 Months
  • When:
    Flexible
  • Credits:
  • Delivery of study materials
Description

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

Important information
Venues

Where and when

Starts Location Timetable
Flexible
Distance learning

What you'll learn on the course

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]

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