Total marks: 100 Total credits: 3
Breakdown of marks
Assessment types
Number of assessments
Marks in each assessment
Total marks
Class test
3 class tests
10 marks
10 marks (Average)
Assignment
1 assignment
5 marks
Presentation
1 presentation
Attendance
Base on class attendance
Midterm exam
25 marks (Question types: MCQ,T/F,SQ)
25 marks
Final exam
In two slots(Question types: MCQ,T/F,SQ)
50 marks
Total marks:
100
SUBMIT YOUR ASSIGNMENT BY 05 MARCH 2021
Mid-Term Exam:
Total Marks:20
Total Time: 25 minutes
Chapter :
1. Introduction to RA
2. Drugs controlling authority in Bangladesh
3. International drug regulatory agencies.
Assessment strategy:
MCQ:20 marks
Online activity & class performance: 5 marks
Level 1: Five questions relating to subjects topic and general idea.
Level 2: Ten questions to judge understand ability of particular topics.
Level 3: Three questions relating to elucidation of some pharmacological facts.
Level 4: Two questions to assess students critical thinking.
Complete by 24 May 2021
Topics
FDA
MHRA
TGA
ICH
Dossier
Drug Master File
CTD
DGDA
QAD in pharmaceuticals
Stability study
QCD
GMP
Drug policy 1982
Drug policy 2016
Total marks: 50
Online Exam at BLC: 25 Marks Time 30 minutes
MCQ 20 marks, True/False 10 marks
Oral Assessment 15 Marks
Online activity 10 marks
Syllabus
Quality management system in pharmaceuticals
Act, laws and drug policies, Drug ordinance 1982
Approval process of pharmaceutical in Bangladesh
Question types
Level 1: 12 questions relating to subjects topic and general idea.
Level 2: 6 questions to judge understand ability of particular topics.
Level 3: 4 questions relating to elucidation of some pharmacological facts.
Level 4: 3 question to assess students critical thinking.