MBA in Drug Regulatory Affairs

Course Code : QERC-001
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Course Objective

To Develop Managerial and Administrative Skills with technical capabilities for managing higher regulatory affairs functions in Pharma Industry.

Course Features

1.      Executive MBA Program.
2.      Study Curriculum includes blend of Management and Technical Studies
3.      Management case studies and Practical regulatory projects will be offered.
4.      The faculties are Industrial managers and Management Gurus.
5.      This is Worlds first MBA Course with blend of management and technical aspects.
6.      Printed Book dispatched to correspondence address
7.      Presentations and PDF Study Material will be shared on our Website.
8.      Well established Classrooms with Audio video facilities.
9.      Trained Industrial Faculties.
10.  Exams after every 6 months. Exams will have online and classroom options.

Course Syllabus

First Semester

  • Code   Subject External
    Marks
    Internal   
    Marks    
  • Q001   Management Concept and Industrial behavior 80 20
  • Q002   Business Communication Skill 80 20
  • Q003   Managerial Psychology 80 20
  • Q004   Strategic Management 80 20
  • Second Semester

    • Code   Subject External
      Marks
      Internal   
      Marks    
    • Q005   Pharmaceutical Quality Management & Document Management 80 20
    • Q006   Innovation Management 80 20
    • Q007   Introduction to Worldwide Regulatory Guidelines 80 20
    • Q008   Pharma Management Marketing 80 20
    • Third Semester

      • Code   Subject External
        Marks
        Internal   
        Marks    
      • Q009   Regulatory Affairs registration requirements 80 20
      • Q010   Managing Regulatory Inspections 80 20
      • Q011   Organization of Dossiers and DMF 80 20
      • Q012   Interview & Networking Skills 80 20

      Course Eligibility

      B.Pharm/M.Pharm/B.Sc.M.Sc/Biotechnology/Industrial Professionals with minimum 18 Months Experience.
      M.Pharm/M.Sc Experience is not Required.

      Note

      * Service Tax will be charged extra as per current rates.