DIU-BLC
Pharmaceutical Regulatory Affairs (Fall 20)
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Course details
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Course outline
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Teaching strategy
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)
2. Drug controlling authority of Bangladesh and pharmacy council.
2. Drug regulatory authority in Bangladesh
Assignment
Assignment 425
3. International drug regulatory agencies
3. International drug regulatory agencies
ICH GUIDELINES IN BRIEF
QUIZ 1
QUIZ 1
Mid term examination
MID TERM EXAM_BPH425_FALL 20
4. QA and regulatory requirements in pharmaceuticals
4. QA and regulatory requirements in pharmaceuticals
Role of QA in pharma
QUIZ 2
QUIZ 2 BPH 425
5. Acts, rules, ordinance and laws regarding regulation of drugs in Bangladesh.
Lecture slide Acts, ordinance, policies regarding drug control in Bangladesh - Copy
6. Approval process, format and registration of pharmaceuticals in Bangladesh
6. Approval procedure for new pharmaceuticals in Bangladesh
QUIZ 3
QUIZ 3
Presentation
Presentation BPH 425
Final examination
BPH 425 FINAL EXAMINATION
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Course Information:
1
Course details
2
General news and announcements
Forum
Course curriculum
File
Lesson plan
File
Course outline
File
Assessment strategy
File
Teaching strategy
File
Recommended books
File
.1. Introduction to regulatory affairs and its scope.
3
Regulatory affairs basic intro
URL
Chapter 1: Introduction to regulatory affairs
File
Question & Answer Forum (Drug regulatory affairs intro)
4
Sharing knowledge & learning new things
Forum
Interactive quiz (RA intro)
Interactive Content
2. Drug controlling authority of Bangladesh and pharmacy council.
5
2. Drug regulatory authority in Bangladesh
File
Assignment
6
Assignment 425
3. International drug regulatory agencies
7
3. International drug regulatory agencies
File
ICH GUIDELINES IN BRIEF
URL
QUIZ 1
8
QUIZ 1
Mid term examination
9
MID TERM EXAM_BPH425_FALL 20
Quiz
4. QA and regulatory requirements in pharmaceuticals
10
4. QA and regulatory requirements in pharmaceuticals
File
Role of QA in pharma
URL
QUIZ 2
11
QUIZ 2 BPH 425
5. Acts, rules, ordinance and laws regarding regulation of drugs in Bangladesh.
12
Lecture slide Acts, ordinance, policies regarding drug control in Bangladesh - Copy
File
6. Approval process, format and registration of pharmaceuticals in Bangladesh
13
6. Approval procedure for new pharmaceuticals in Bangladesh
File
QUIZ 3
14
QUIZ 3
Presentation
15
Presentation BPH 425
Forum
Final examination
16
BPH 425 FINAL EXAMINATION
Quiz
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Pharmaceutical Regulatory Affairs (Fall 20)
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DIU
Faculty of Health and Life Sciences
Pharmacy
Pharmacy Fall 20
BPH 425 (MAH-203)
Course details
Lesson plan
Lesson plan
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Lesson plan.docx
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General news and announcements
Course curriculum
Course outline
Assessment strategy
Teaching strategy
Recommended books
Regulatory affairs basic intro
Chapter 1: Introduction to regulatory affairs
Sharing knowledge & learning new things
Interactive quiz (RA intro)
2. Drug regulatory authority in Bangladesh
Assignment 425
3. International drug regulatory agencies
ICH GUIDELINES IN BRIEF
QUIZ 1
MID TERM EXAM_BPH425_FALL 20
4. QA and regulatory requirements in pharmaceuticals
Role of QA in pharma
QUIZ 2 BPH 425
Lecture slide Acts, ordinance, policies regarding drug control in Bangladesh - Copy
6. Approval procedure for new pharmaceuticals in Bangladesh
QUIZ 3
Presentation BPH 425
BPH 425 FINAL EXAMINATION
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