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

Course execution:

• Course will commence after completion of the admission formalities.
• Notes & CD containing relevant guidelines & formats will be couriered in 2 weeks’ time.
• Presentations and important questions will be emailed.
• Web-links on the topics mentioned in the syllabus will be provided to the students.
• Queries can be resolved through emails

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