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M. Pharm. (Pharm. Mgmt. & Regulatory Affairs Semester III Syllabus)

SCHEME OF TEACHING

Subject Code Name of Subject Contact Hours
Per Week
Credits
T P T P
631 Management concepts –III 4 - 4 -
632 Good Clinical Practices 3 - 3 -
633 Preclinical safety and efficacy studies 2 - 2 -
634 Regulatory aspects of Cosmetics, Nutraceuticals, Biotech products and Medical devices 3 - 3 -
635 Regulatory Submissions - National and International 3 - 3 -
636 Regulatory Affairs practical-II - 18 - 6
637 Assignments/Seminars/Presentations 3 - 3 -
  Total 18 18 18 6

SCHEME OF EXAMINATION

Subject Code Name of Subject Duration of
exam(Hrs)
Marks
T P
University level evaluation Institute level evaluation University level evaluation Institute level evaluation
631 Management concepts –III 3 80 20 - -
632 Good clinical practices 3 80 20 - -
633 Preclinical safety and efficacy studies 3 80 20 - -
634 Regulatory aspects of Cosmetics, Nutraceuticals, Biotech products and Medical devices 3 80 20 - -
635 Regulatory submissions-National and International 3 80 20 - -
636 Regulatory Affairs Practical-II 6 - - 80 20
637 Assignments/Seminars/Presentations 6 - - - 100
  Total 27 400 100 80 120