I want to do Post Graduate Diploma in Drug Regulatory Affairs from the Mumbai University so can you please tell me is this University offers this course? What is the eligibility criteria required to get admission in this course? Give me the list of some other Colleges which offer this course?

The Syllabus for Post Graduate Diploma in Regulatory Affairs offered by University of Mumbai is as given below.

Syllabus for Post Graduate Diploma in Regulatory Affairs

Important to Regulatory Affairs in Pharma Industry

Basic regulatory framework with respect to Regulated and Non-regulated market practices and procedures.
Global Pharmaceutical Industry Scenario.

Paper I 24 Credits

Basic ICH Requirement
ICH Topics
Q1 -Stability
Q2 -Analytical Validation
Q3 –Impurities
Q4 –Pharmacopoeia
Q6 –Specifications
Q7 –GMP API
Q8 –Pharmaceutical Development
Q9 –Quality Risk Management
Q10 –Pharmaceutical Quality System
Q11 –Development and manufacture of drug

Regulatory Filing systems for Active Pharmaceutical Ingredients in different countries.
EU - ASMF, CEP, EU DMF
US – DMF application, preparation and annual report.
Semiregulated Markets- Requirement of API.
Genotoxic Impurities, Elemental Impurities, Polymorphic form and characterization.
Various types of DMF
CTD –Module 1,2,3
Quality Overall Summary (QOS)
Quality by design concept applicable to API
Post approval changes and handling deficiencies

Regulatory Filing systems in Europe.
EMEA Procedures –Centralized, Decentralized, Mutual recognition and
national procedure.
CTD-Module 1, 2, 3, 4, 5 (including QOS, quality design concept and bioequivalence).
Variation and Renewals
Query-Response .
Paper II 24 Credits

Regulatory Filing systems in US.
Various Types of application - IND, NDA and ANDA.
CTD- Module1, 2, 3 and CTD Overall summary -Module1, 2, 3 including quality overall
summary and Quality by design CTD module. Module 4 and 5 (including
Bioequivalence).
Post approval changes.
.
Registration procedures in various countries:
Australia
New Zealand
Canada
South Africa/Africa
Latum
DCGI(India)
Asia
Russia/CIS

Pharmacovigilance in EU/US
Interviews for Regulatory Opening.
Case study for both US and EU

Audit Checklist
Prior Approval Inspections (PAI)
Out of Specifications (OOS), Inspection and Audits, Deviations and Change Controls
Annual Product Reviews (APRs) for Pharmaceuticals

References:
Stability Testing of New Drug Substances and Products Q1A(R2)
Validation of Analytical Procedures: Text and Methodology Q2(R1)
Impurities in new drug substance Q3A(R2)
Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Q6A )
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7)
Organization of the Common Technical Document For the Registration of
Pharmaceuticals for Human Use M4
DISSOLUTION Guidance (USP pharmacopoeia Chapter 711)