BPH 425 (MAH-203): CTD dossier

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Presentation BPH 425

CTD dossier

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https://drive.google.com/file/d/1VgMLTEgwykv6qkJKvSeQ25KyxbsCAf9w/view?usp=sharing

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General news and announcements

Course curriculum

Lesson plan

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

Pharmaceutical Regulatory Affairs (Fall 20)

Presentation BPH 425

CTD dossier

CTD dossier

Course Information:

Course details

General news and announcements

Course curriculum

Lesson plan

Course outline

Assessment strategy

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 &amp; 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

Presentation BPH 425

CTD dossier

Sharing knowledge & learning new things