Raaj Pharma eLearning | GLOBAL Regulatory Affairs (GRA)

Course / Course Details

GLOBAL Regulatory Affairs (GRA)

Pharmaceutical

By - Rajashri Ojha
1 students
10 Min
(0)

Course Requirements

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

The course will cover role and responsibilities of RA, Drug development, formulation development, GMP/GLP/GCP, DMF/ASMF/CEP, Drug Regulations in USFDA, Europe, ROW countries, Canada, Regulation of OTC drugs, Medical Device Regulations, Biosimilar Regulations, Life cycle management of a Drug Product, Dossier preparation(eCTD, ACTD, Nees Format), CTD/eCTD Submission, ICH Quality Guidance and its importance, 21 CFR part 11 and its importance.

Course Curriculum

18 chapters
355 lectures
16 quizzes
10 Min total length

Toggle all chapters

1 SOP for Global RA course

15 Min

2 Step by Step Procedure

15 Min

3 Important guidance and articles

15 Min

1 Role and Responsibilities

15 Min

2 Regulatory Bodies

15 Min

3 Articles-1.1

15 Min

4 Articles-1.2

15 Min

5 Articles-1.3

15 Min

6 PPT

Preview

15 Min

7 Video

Preview

1 Min

8 Role and Responsibility Video

Preview

1 Min

9 Video-Lecture by Rajashri Ojha

Preview

1 Min

10 Regulatory bodies across the world and different markets and brief introduction of registration process videos - 1.1

Preview

1 Min

11 Regulatory bodies across the world and different markets and brief introduction of registration process Video -1.2

1 Min

12 Regulatory bodies across the world and different markets and brief introduction of registration process PPT

15 Min

13 MCQs 1 [Quiz]

10 Min

1 Drug Development Process

15 Min

2 Pharmacovigilance

15 Min

3 GVP, EVMPD & XEVMPD

15 Min

4 PPT

Preview

15 Min

5 Clinical Trial PPT

15 Min

6 Pharmacovigilance PPT

15 Min

7 Video

1 Min

8 Clinical Trial

1 Min

9 Mayur Kanchalwar Lecture Video on Clinical Trial - 1.1

1 Min

10 Mayur Kanchalwar Lecture Video on Clinical Trial - 1.2

1 Min

11 Mayur Kanchalwar Lecture Video on Clinical Trial - 1.3

1 Min

12 Mayur Kanchalwar Lecture Video on Pharmacovigilance-1.1

1 Min

13 Mayur Kanchalwar Lecture Video on Pharmacovigilance-1.2

1 Min

14 Mayur Kanchalwar Lecture Video on Pharmacovigilance-1.3

1 Min

15 Mayur Kanchalwar Lecture Video on Pharmacovigilance-1.4

1 Min

16 MCQs 2 [Quiz]

10 Min

1 Formulation Development

15 Min

2 Preformulation Studies

15 Min

3 PDR Writing as per ICH Q8

15 Min

4 Introduction, Formulation Development Objective and Process Improvement Approaches- Video Part1

1 Min

5 Introduction, Formulation Development Objective and Process Improvement Approaches- Video Part2

1 Min

6 Product Development PPT

15 Min

7 PDR video Part - 01

1 Min

8 PDR video Part - 02

1 Min

9 PDR video Part - 03

1 Min

10 PDR video Part - 04

1 Min

11 PDR video Part - 05

1 Min

12 PRODUCT DEVELOPMENT - A GUIDE [ORAL TABLETS DEVELOPMENT] PPT-Lecture by Rajashri Ojha

15 Min

13 Product Development-Oral Development -Rajashri Ojha-Lecture Video Part 01

1 Min

14 Product Development-Oral Development -Rajashri Ojha-Lecture Video Part 02

1 Min

15 MCQs 3 [Quiz]

10 Min

1 Good Manufacturing Practices

15 Min

2 Validation and Qualification

15 Min

3 PICs GMP

15 Min

4 GMP PPT - Part1

15 Min

5 GMP PPT - Part2

15 Min

6 GMP Lecture Video part 01

1 Min

7 GMP Lecture Video part 02

1 Min

8 Good Documentation Practice PPT

15 Min

9 Good Documentation Practice Video

1 Min

10 How to implement GxP Sytem in Pharma and Medical Device Industry PPT

15 Min

11 how to implement GxP System Lecture Video by Rajashri Ojha Part 01

1 Min

12 how to implement GxP System Lecture Video by Rajashri Ojha Part 02

1 Min

13 Lecture Video- Qualification and Validation part 01

1 Min

14 Lecture Video- Qualification and Validation part 02

1 Min

15 Lecture Video- Qualification and Validation part 03

1 Min

16 Qualification and Validation PPT

15 Min

17 PPT-GMP Lecture by Arvind Kadam

15 Min

18 Video-GMP Lecture by Arvind Kadam part 01

1 Min

19 Video-GMP Lecture by Arvind Kadam part 02

1 Min

20 Video-GMP Lecture by Arvind Kadam part 03

1 Min

21 cGMP Lecture Videos part 1

1 Min

22 cGMP Lecture Videos part 2

1 Min

1 GLP, GCP

15 Min

2 GOOD CLINICAL LABORATORY PRACTICE (GCLP)

15 Min

3 HVAC

15 Min

4 Deviations

15 Min

5 Clinical Study Report

15 Min

6 Importance of GCP

15 Min

7 ICH - E 3 Guidelines

15 Min

8 ICH - E 6 Guidelines

15 Min

9 GLP lecture video 1.1

1 Min

10 GLP lecture video 1.2

1 Min

11 GCP video

1 Min

12 GLP video

1 Min

13 GLP Video 2

1 Min

14 MCQs4 [Quiz]

10 Min

1 History of FDA and Related Regulatory Agencies

15 Min

2 FDA Organization

15 Min

3 INVESTIGATIONAL NEW DRUG

15 Min

4 New Drug Application (NDA)

15 Min

5 National Drug Code Directory

15 Min

6 Generic Drug Submissions

15 Min

7 Guidance for Industry

15 Min

8 Over-the-counter (OTC)

15 Min

9 Patents and Exclusivity

15 Min

10 Prescription Drug Labeling, Advertising and Promotion

15 Min

11 Injectable pharmaceuticals

15 Min

12 Importance of packaging and labeling

15 Min

13 Labeling Lecture Video by Sunil Bankar part 01

1 Min

14 Labeling Lecture Video by Sunil Bankar part 02

1 Min

15 Labeling Lecture Video by Sunil Bankar part 03

1 Min

16 para IV

1 Min

17 ANDA Lecture Video Rajashri Ojha

1 Min

18 USFDA Regulation PPT 1.1

15 Min

19 USFDA Regulation PPT 1.2

15 Min

20 ANDA lecture Video-Rajashri Ojha part 01

1 Min

21 ANDA Lecture Video Rajashri Ojha part 02

1 Min

22 FDA Inspection Part 01

1 Min

23 FDA Inspection PPT - 1.1

15 Min

24 FDA Inspection PPT - 1.2

15 Min

25 Lecture Video 01

1 Min

26 Lecture Video 02

1 Min

27 SUPAC Lecture Video -1.1

1 Min

28 SUPAC Lecture Video -1.2

1 Min

29 SUPAC PPT

15 Min

30 Drug Regulatory Submission- USFDA-Rajashri Ojha' Lecture -1.1

1 Min

31 Drug Regulatory Submission- USFDA-Rajashri Ojha' Lecture -1.2

1 Min

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32 Drug Regulatory Submission- USFDA-Rajashri Ojha' Lecture -1.3

1 Min

33 Regulation for OTC PPT

15 Min

34 Guidance/Articles for OTC - 1.1

15 Min

35 Guidance/Articles for OTC - 1.2

15 Min

36 Video-Regulation for OTC- Lecture by Rajashri Ojha

1 Min

37 Drug Regulation In US Lecture Video 1.1

1 Min

38 Drug Regulation In US Lecture Video 1.2

1 Min

39 Drug Regulation In US Lecture Video 1.3

1 Min

40 Drug Regulation In US Lecture Video 1.4

1 Min

41 MCQs 5 [Quiz]

10 Min

1 Medical Device

15 Min

2 EU MDR

15 Min

3 EU MDR PPT

15 Min

4 EU MDR lecture Video 1.1

1 Min

5 EU MDR lecture Video 1.2

1 Min

6 EU MDR lecture Video 1.3

1 Min

7 EU MDR lecture Video 1.4

1 Min

8 EU MDR lecture Video 1.5

1 Min

9 Medical Device Classification Video

1 Min

10 USFDA Regulation Lecture Video 1.1

1 Min

11 USFDA Regulation Lecture Video 1.2

1 Min

12 USFDA Regulation Lecture Video 1.3

1 Min

13 USFDA PPT

15 Min

14 FDA Regulation Video

1 Min

15 Global Classification lecture Video 1.1

1 Min

16 Global Classification lecture Video 1.2

1 Min

17 Global Classification lecture Video 1.3

1 Min

18 global medical device classification

15 Min

19 MDD to MDR Difference

1 Min

20 MDD to MDR Difference PPT

15 Min

21 Sugam Portal PPT

15 Min

22 Sugam Portal Video1.1

1 Min

23 Sugam Portal Video1.2

1 Min

24 MEDICAL DEVICE REGULATIONS-Global overview and guiding principles-WHO

N/A

25 Medical Device Regulation USFDA 1.1

1 Min

26 Medical Device Regulation USFDA 1.2

1 Min

27 Medical device regulation: USFDA, EU, India

15 Min

28 Medical Device Submission in EU

1 Min

29 Articles - Medical Device Safety Action Plan Protecting Patients Promoting Public Health

15 Min

30 Articles - Introduction FDA Regulation of Medical Devices slides

15 Min

31 Articles - Frequently Asked Questions About Medical Devices Information Sheet

15 Min

32 Articles - USFDA MD Regulations 2023

15 Min

33 Articles - Labeling Regulatory Requirements for Medical Devices (FDA-89-4203)

15 Min

34 Articles - Medical Devices Product Classification Guide

15 Min

35 Articles - Design Control

15 Min

36 Articles - Visit Eudamed.com - Everything EUDAMED software training

15 Min

37 Articles - CELEX

15 Min

38 Articles - Medical Devices Labelling – Instructions for Use

15 Min

39 Articles - Tata Elxsi Whitepaper Impact of EU MDR on Medical Device Labeling

15 Min

40 Articles - European MDR IFU Regulatory Compliance

15 Min

41 Articles - Indian MDR 2017

15 Min

42 Articles - Indian Amendment Rule 2020

15 Min

43 Articles - Medical Device labeling- ISO 15223-1:2016

15 Min

44 Articles - Medical Device labeling- ISO 15223-2021 Draft Copy

15 Min

45 MCQs 6 [Quiz]

10 Min

1 Biosimilar Submission

15 Min

2 Guidance - 1.1

15 Min

3 Guidance - 1.2

15 Min

4 Guidance - 1.3

15 Min

5 Guidance - 2.1

15 Min

6 Guidance - 2.2

15 Min

7 Guidance - 2.3

15 Min

8 Biosimilar Video

1 Min

9 MCQs 7 [Quiz]

10 Min

1 DMF

15 Min

2 DMF in CTD format

15 Min

3 ASMF

15 Min

4 DMF in Canada/ Japan/ Australia submission

15 Min

5 DMF Video

1 Min

6 Global Drug Master File

15 Min

7 Writing and Review Skills - CMC

15 Min

8 CEP

15 Min

9 DMF Lecture Video 1.1

1 Min

10 DMF Lecture Video 1.2

1 Min

11 DMF Lecture Video 1.3

1 Min

12 DMF Lecture Video 1.4

1 Min

13 DMF Lecture Video 1.5

1 Min

14 MCQs 8 [Quiz]

10 Min

1 Product lifecycle management (PLM)

15 Min

2 SUPAC

15 Min

3 FDA Inspection and Enforcement Act

15 Min

4 FDA form 483 and FDA warning letter

1 Min

5 FDA 483 inspection

1 Min

6 Guidance/Articles - Post-Approval Changes to an NDA or ANDA

15 Min

7 Guidance/Articles - Annual Report 1.1

15 Min

8 Guidance/Articles - Annual Report 1.2

15 Min

9 Guidance/Articles - Post approval Changes best practices and strategies

15 Min

10 PPT

15 Min

11 Labeling as per India, US, EU Video-lecture by Rajashri Ojha 1.1

1 Min

12 Labeling as per India, US, EU Video-lecture by Rajashri Ojha 1.2

1 Min

13 Labeling as per India, US, EU Video-lecture by Rajashri Ojha 1.3

1 Min

14 Labeling as per India, US and Eu PPT-Lecture by Rajashri Ojha

15 Min

15 MCQs 9 [Quiz]

9 Min

1 Health Canada

15 Min

2 How are drugs reviewed in Canada?

15 Min

3 Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs)

15 Min

4 Drug regulation in Canada video 1.1

1 Min

5 Drug regulation in Canada video 1.2

1 Min

6 Regulatory System In Canada LectureVideo1.1

1 Min

7 Regulatory System In Canada LectureVideo1.2

1 Min

8 Health Canada PPT

15 Min

9 MCQs 10 [Quiz]

10 Min

1 Pharmaceuticals in the European Union

15 Min

2 EUDRALEX: EU Pharmaceutical Legislation

15 Min

3 Regulation of medicines in the European Union

15 Min

4 Marketing Authorization

15 Min

5 VARIATIONS

15 Min

6 IDMP and SPOR

15 Min

7 EU Drug Regulatory System basic video

1 Min

8 EU Marketing Authorization Video

1 Min

9 Product life cycle mangement

15 Min

10 EU Variation Video 1.1

1 Min

11 EU Variation Video 1.2

1 Min

12 EU Variation Video 1.3

1 Min

13 EU-Regulatory System by Surekha Amrutkar- Lecture Video 1.1

1 Min

14 EU-Regulatory System by Surekha Amrutkar- Lecture Video 1.2

1 Min

15 Regulatory System in Norway Lecture Video

1 Min

16 EU PPT 1.1

15 Min

17 EU PPT 1.2

15 Min

18 Drug Regulation in EU Lecture Video 1.1

1 Min

19 Drug Regulation in EU Lecture Video 1.2

1 Min

20 MCQs 11 [Quiz]

10 Min

1 Regulation in ROW

15 Min

2 Regulation in Asean Countries

15 Min

3 Regulation in Middle East Countries

15 Min

4 Regulation in Latin America

15 Min

5 Registration in Emerging market (India, Russia, China, Japan, South Africa)

15 Min

6 Lecture Video ROW 1.1

1 Min

7 Lecture Video ROW 1.2

1 Min

8 Lecture Video ROW 1.3

1 Min

9 Lecture Video ROW 1.4

1 Min

10 ROW PPT

15 Min

11 Roadmap to Africa 1.1

1 Min

12 Roadmap to Africa 1.2

1 Min

13 Roadmap to Africa 1.3

1 Min

14 Vietnam Regulatory System

1 Min

15 Australian Regulation lecture Video 1.1

1 Min

16 Australian Regulation lecture Video 1.2

1 Min

17 Australian Regulation lecture Video 1.3

1 Min

18 Australian Regulation lecture Video 1.4

1 Min

19 Australian Regulation lecture Video 1.5

1 Min

20 TGA Regulation PPT

15 Min

21 New Zealand Drug Regulation PPT

15 Min

22 Regulation in Brazil PPT

15 Min

23 Regulation in Brazil Video 1.1

1 Min

24 Regulation in Brazil Video 1.2

1 Min

25 Regulation in Brazil Video 1.3

1 Min

26 Regulation in Brazil Video 1.4

1 Min

27 MCQs 12 [Quiz]

10 Min

1 Dossier Preparation

15 Min

2 Dossier Preparation in pCTD and eCTD format

15 Min

3 Guidance 1.1

15 Min

4 Guidance 1.2

15 Min

5 Guidance 1.3

15 Min

6 Guidance 1.4

15 Min

7 Guidance for quality modules Part 3S-drug substance

15 Min

8 Guidance for quality modules Part 3P-drug product

15 Min

9 ICH Guidance for M4-common technical document (CTD) for the registration of pharmaceuticals for human use

15 Min

10 PPT 1.1

15 Min

11 PPT 1.2

15 Min

12 PPT 1.3

15 Min

13 CTD Triangle Video

1 Min

14 Core Concept of eCTD video 1.1

1 Min

15 Core Concept of eCTD video 1.2

1 Min

16 Core Concept of eCTD video 1.3

1 Min

17 eCTD Software Lecture by Shiv Somani 1.1

1 Min

18 eCTD Software Lecture by Shiv Somani 1.2

1 Min

19 eCTD Software Lecture by Shiv Somani 1.3

1 Min

20 Video-Overview and Organization of eCTD by Rajashri Ojha

1 Min

21 Video-CMC Writing in Detail 1.1

1 Min

22 Video-CMC Writing in Detail 1.2

1 Min

23 eCTD Overview by Sairam Reddy 1.1

1 Min

24 eCTD Overview by Sairam Reddy 1.2

1 Min

25 Organization of CTD video 1.1

1 Min

26 Organization of CTD video 1.2

1 Min

27 Organization of CTD video 1.3

1 Min

28 Technical Writing Skills and International Standard Video

1 Min

29 Basic of CMC and Scientific and Regulatory Writing 1.1

1 Min

30 Basic of CMC and Scientific and Regulatory Writing 1.2

1 Min

31 Basic of CMC and Scientific and Regulatory Writing 1.3

1 Min

32 MCQs [Quiz]

10 Min

1 ICH

15 Min

2 ICH Q 1 Video part 1

1 Min

3 ICH Q 1 Video part 2

1 Min

4 ICH Q2 Video by Suhas Yewale part 1

1 Min

5 ICH Q2 Video by Suhas Yewale part 2

1 Min

6 ICH Q 3 Lecture video by Suhas Yewale part1

1 Min

7 ICH Q 3 Lecture video by Suhas Yewale part2

1 Min

8 ICH Q2 Lecture Video by Dr Sripad Naik part1

1 Min

9 ICH Q2 Lecture Video by Dr Sripad Naik part2

1 Min

10 ICH Q3 Lecture Video by Dr Sripad Naik 1.1

1 Min

11 ICH Q3 Lecture Video by Dr Sripad Naik 1.2

1 Min

12 ICH Q6 Video - 1.1

1 Min

13 ICH Q6 Video - 1.2

1 Min

14 ICH Q9 Video - 1.1

1 Min

15 ICH Q9 Video - 1.2

1 Min

16 ICH Q10 Video - 1.1

1 Min

17 ICH Q10 Video - 1.2

1 Min

18 ICH Guidelines Overview PPT

15 Min

19 ICH Q 1-Stability Studies Lecture PPT

15 Min

20 ICH Q6- Specification Lecture PPT

15 Min

21 Genotoxic Impurities-Lecture Video by Shripad naik

1 Min

22 ICH Lecture by Arvind Kadam PPT

15 Min

23 ICH Guidance by Arvind Kadam - Lecture Video -1.1

1 Min

24 ICH Guidance by Arvind Kadam - Lecture Video -1.2

1 Min

25 ICH Guidance by Arvind Kadam - Lecture Video -1.3

1 Min

26 Analytical Validation PPT by Arvind Kadam

15 Min

27 Video-Analytical Validation Lecture-Arvind Kadam - 1.1

1 Min

28 Video-Analytical Validation Lecture-Arvind Kadam - 1.2

1 Min

29 Video-Analytical Validation Lecture-Arvind Kadam - 1.3

1 Min

30 Video-Analytical Validation Lecture-Arvind Kadam - 1.4

1 Min

31 ICH Guidelines - Q1A_R2_Guideline

15 Min

32 ICH Guidelines-Q1B_Guideline

15 Min

33 ICH Guidelines-Q1C_Guideline

15 Min

34 ICH Guidelines-Q1D_Guideline

15 Min

35 ICH Guidelines-Q1E_Guideline

15 Min

36 ICH Guidelines-Q2_R1__Guideline

15 Min

37 ICH Guidelines-Q3A_R2__Guideline

15 Min

38 ICH Guidelines-Q3B_R2__Guideline

15 Min

39 ICH Guidelines-Q3C-R7_Document_Guideline

15 Min

40 ICH Guidelines-Q4B_Guideline

15 Min

41 ICH Guidelines-Q5A_R1__Guideline

15 Min

42 ICH Guidelines-Q5B_Guideline

15 Min

43 ICH Guidelines-Q6B_Guideline

15 Min

44 ICH Guidelines-Q6A

15 Min

45 ICH Guidelines-Q7_Guideline

15 Min

46 ICH Guidelines-Q9_Guideline

15 Min

47 ICH Guidelines-Q10_Guideline

15 Min

48 ICH Guidelines-Q12_Draft_Guideline_Step2

15 Min

49 MCQ 16 [Quiz]

10 Min

1 21 CFR part 11

15 Min

2 21 CFR part 11 guidance

15 Min

3 Data Integrity

15 Min

4 Data Integrity guidance

15 Min

5 Data Integrity Lecture video -1.1

1 Min

6 Data Integrity Lecture video -1.2

1 Min

7 Data Integrity Lecture video -1.3

1 Min

8 Data Integrity Lecture video -1.4

1 Min

9 Data Integrity Lecture video -1.5

1 Min

10 MCQs 17 [Quiz]

10 Min

1 Final GRA Exam Paper [Quiz]

1 Hour 40 Min

Instructor

Rajashri Ojha

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Duration 10 Min
Lectures 355 lessons
Enrolled 1 students
Category: Pharmaceutical
16 Quizzes
Language: English
Skill Level Regular Courses
Certificate of Completion
180 Days Access

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GLOBAL Regulatory Affairs (GRA)

Course Requirements

Course Description

Course Curriculum

Instructor

Rajashri Ojha

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GLOBAL Regulatory Affairs (GRA)

Course Requirements

Course Description

Course Curriculum

Introduction 3 Lectures 45 Min

RA Profession 13 Lectures 2 Hours

Drug Development Process 16 Lectures 1 Hour 49 Min

Formulation or Product Development 15 Lectures 1 Hour 34 Min

GMP 22 Lectures 2 Hours 28 Min

GLP, GCP 14 Lectures 2 Hours 15 Min

Regulatory System in US 41 Lectures 5 Hours 30 Min

Medical Device Submission 45 Lectures 6 Hours 29 Min

Biosimilar Submission 9 Lectures 1 Hour 56 Min

Drug Master File 14 Lectures 2 Hours 1 Min

Life Cycle of Drug Product 15 Lectures 2 Hours 29 Min

Health Canada 9 Lectures 1 Hour 14 Min

Regulatory System in EU 20 Lectures 2 Hours 35 Min

Drug registration in ROW 27 Lectures 2 Hours 42 Min

Dossier Preparation 32 Lectures 3 Hours 29 Min

ICH Guidelines 49 Lectures 6 Hours 34 Min

21 CFR Part 11 10 Lectures 1 Hour 15 Min

Final Exam Paper 1 Lectures 1 Hour 40 Min

Instructor

Rajashri Ojha

Course Full Rating

0

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