Post graduate diploma in Regulatory Affairs [API & Formulation]
Salient features are:
- Admissions open for all 365 days
- Seminars are recorded by Subject matter experts on the entire syllabus mentioned below
- Explanation with case-studies
- User-friendly notes based on current guidelines
- Time flexibility for attending assessments
- Question bank based on common interview questions
- Certification after course completion
Introduction to RA profession
Registration requirements of USFDA
- Introduction of FDA and CDER
- FEI, DUNS, NDC
- Drug Establishment Registration
- GDUFA, Self-Identification
- Drug Listing
Introduction to ICH M4 Q CTD &eCTD
DMF preparation
- Module 2 – Quality Overall Summary
- Module 3 – Drug Substance [with deficiencies]
DMF submission to US
- Introduction of DMF
- DMF submission and review
DMF submission to Europe
- Introduction of EDQM and CEP approval
- Module 1, 2 and 3
- Process of CEP approval
- Revisions & renewal procedure
- Suspension, Withdrawal, closure and restoration of CEP
- EDMF/ASMF filing procedure
Dossier preparation in CTD format
- Module 2 – Summaries
- Module 3 – Drug Substance & Drug Product [with deficiencies]
- Module 4 – Non Clinical Study
- Module 5 – Clinical Trials/ Bioequivalence studies
ANDA submission
- Types of drug applications to US
- Hatch-Waxman Law & Patent certification rules
- Module 1
- Module 2
- ANDA review process
Dossier submission to Europe
- Introduction
- Marketing Authorisation procedures
- Centralised procedure
- Mutual Recognition procedure
- Decentralised procedure
- National application
- Module 1 & 2