Post graduation diploma course in CTD/eCTD
Post Graduate Diploma
Distance
-
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Certificate OnlinePrice on request -
JRD Global EDU
Certificate Online₹ 35,000 -
Global Institute of Health Science
Post Graduate Diploma Distance learning₹ 28,000 -
POST GRADUATE DIPLOMA IN COUNSELLING
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Post Graduate Diploma Online₹ 45,000 -
JRD Global EDU
Post Graduate Diploma Online₹ 45,000 -
Advanced Post Graduate Diploma in Clinical Research
Cliniminds
Post Graduate Diploma Distance learning₹ 28,000 + VAT -
Vinayaka Missions University
Post Graduate Diploma Distance learningPrice on request
Description
-
Type
Post Graduate Diploma
-
Methodology
Distance learning
-
Duration
4 Months
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Start date
Different dates available
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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
Start date
Reviews
Subjects
- CTD
- ECTD
Teachers and trainers (1)
Rajashri Ojha
Teacher
Course programme
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
-
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Certificate OnlinePrice on request -
JRD Global EDU
Certificate Online₹ 35,000 -
Global Institute of Health Science
Post Graduate Diploma Distance learning₹ 28,000 -
POST GRADUATE DIPLOMA IN COUNSELLING
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Post Graduate Diploma Online₹ 45,000 -
JRD Global EDU
Post Graduate Diploma Online₹ 45,000 -
Advanced Post Graduate Diploma in Clinical Research
Cliniminds
Post Graduate Diploma Distance learning₹ 28,000 + VAT -
Vinayaka Missions University
Post Graduate Diploma Distance learningPrice on request