Post graduation diploma course in CTD/eCTD

Raaj GPRAC
Distance

Rs 25,000
You can also call the Study Centre
98191... More

Important information

Typology Post Graduate Diploma
Methodology Distance learning
Duration 4 Months
Start Different dates available
Delivery of study materials Yes
  • Post Graduate Diploma
  • Distance learning
  • Duration:
    4 Months
  • Start:
    Different dates available
  • 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]

Venues

Where and when

Starts Location
Different dates available
Distance learning
Starts Different dates available
Location
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]

Students that were interested in this course also looked at...
See all