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M. Pharm. Pharm. Mgmt. & Regulatory Affairs Semester II Syllabus

SCHEME OF TEACHING

Subject Code Name of Subject Contact Hours
Per Week
Credits
T P T P
621 Management concepts –II 4 - 4 -
622 Good Manufacturing Practices 3 - 3 -
623 Pharmaceutical validation 3 - 3 -
624 QGood Laboratory Practices 3 - 3 -
625 Regulatory Affairs Practical-I - 18 - 6
626 Drug development process -Outline 2 - 2 -
627 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
621 Management concepts –II 3 80 20 - -
622 Good Manufacturing practices 3 80 20 - -
623 Pharmaceutical validation 3 80 20 - -
624 Good laboratory practices 3 80 20 - -
625 Regulatory affairs practical-I 6 - - 80 20
626 Drug development process - Outline 3 80 20 - -
627 Assignments/Seminars/Presentati ons 6 - - - 100
  Total 27 400 100 80 120