Mumbai University offers Post Graduate Diploma in Drug Regulatory Affairs of duration 1 year.

Post Graduate Diploma in Drug Regulatory Affairs

Duration of the Course : 1 Year

Fee Structure : Rs. 20,000/-

Intake Capacity : 40 Students

Eligibility-

B.Pharm, B.Sc (Botany, Zoology, Chemistry, Biochemsitry, Biotechnology, Microbiology, Life Sciences), PhD’s and Pharmaceutical Professionals

Syllabus-

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 .

For more details here is the attachment




Contact-

University of Mumbai
Kalina, Santacruz East, Mumbai, Maharashtra 400098

Attached Files

MU Post Graduate Diploma in Drug Regulatory Affairs.pdf (91.0 KB, 166 views)

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