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April 18th, 2015, 10:49 AM
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Drug Regulatory Affairs Course In Mumbai University
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) Last edited by Neelurk; April 29th, 2020 at 11:36 AM. |
#2
February 28th, 2017, 03:41 PM
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Re: Drug Regulatory Affairs Course In Mumbai University
Hi I am interested in having the Syllabus for Post Graduate Diploma in Regulatory Affairs offered by University of Mumbai?
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