DIU-BLC
Pharmaceutical Regulatory Affairs (Spring 21)
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Recommended books
.1. Introduction to regulatory affairs and its scope.
Regulatory affairs basic intro
Chapter 1: Introduction to regulatory affairs
Question & Answer Forum (Drug regulatory affairs intro)
Sharing knowledge & learning new things
Interactive quiz (RA intro)
Assignment
Assignment 425
2. Drug controlling authority of Bangladesh and pharmacy council.
2. Drug regulatory authority in Bangladesh
DRUG ORDINANCE 1976
QUIZ 1
QUIZ 1
3. International drug regulatory agencies
3. International drug regulatory agencies
ICH GUIDELINES IN BRIEF
QUIZ 2
QUIZ 2 19PCA
QUIZ 2 18th
Mid term examination
MID TERM EXAM_BPH425_Spring 21
MID TERM Supplimentary EXAM_BPH425_Spring 21
4. QA and regulatory requirements in pharmaceuticals
4. QA and regulatory requirements in pharmaceuticals
Role of QA in pharma
5. Acts, rules, ordinance and laws regarding regulation of drugs in Bangladesh.
Lecture slide Acts, ordinance, policies regarding drug control in Bangladesh - Copy
Class feedback
QUIZ 3
QUIZ 3 18th
QUIZ 3 19th
QUIZ 4 19th copy
6. Approval process, format and registration of pharmaceuticals in Bangladesh
6. Approval procedure for new pharmaceuticals in Bangladesh
Knowledge sharing
QUIZ 4 18th
Presentation
Presentation BPH 425
Final examination
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BPH 425 (MAH-211)
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DIU
Faculty of Health and Life Sciences
Pharmacy
Pharmacy Spring 21
BPH 425 (MAH-211)
Summary
Pharmaceutical Regulatory Affairs (Spring 21)
Teacher:
Md. Anamul Haque
Skill Level
:
Beginner