Certificate Course in Pharmacovigilance Aggregate Reporting

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PV Drug Safety Academy

3:09:21

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1 - General Information

1 - Introduction Purpose of this course and Topics to be covered.mp4

09:18

2 - Pharmacovigilance Its Objectives.mp4

02:18

3 - Aggregate Reports and Its Types.mp4

06:33

4 - Correlation between ICSR Aggregate Reports.mp4

05:44

5 - Difference between PSUR and PBRER.mp4

03:25

6 - Basic Terminologies.mp4

06:18

2 - PBRER Periodic BenefitRisk Evaluation Report

7 - Different Parts of PBRER Part I II III.mp4

08:35

8 - Section 1 Introduction.mp4

03:14

9 - Section 2 Worldwide Marketing Approval Status.mp4

02:24

10 - Section 3 Actions taken in Reporting interval for Safety reasons.mp4

05:27

11 - Section 4 Changes to RSI.mp4

03:30

12 - Section 5 Estimated Exposure and Use patterns.mp4

11:19

13 - Section 6 Data in Summary Tabulations.mp4

06:47

14 - Section 7 Summary of significant Safety findings from Clinical trials.mp4

06:57

15 - Section 8 Findings from Noninterventional studies.mp4

02:50

16 - Section 9 Information from other Clinical trials sources.mp4

03:00

17 - Section 10 Nonclinical data.mp4

01:44

18 - Section 11 Literature.mp4

02:57

19 - Section 12 Other periodic reports.mp4

02:05

20 - Section 13 LOE in controlled clinical trials.mp4

02:16

21 - Section 14 Late breaking information.mp4

03:11

22 - Section 15 Overview of signals New Ongoing or Closed.mp4

08:33

23 - Section 16 Signal and Risk Evaluation.mp4

14:51

24 - Section 17 Benefit Evaluation.mp4

04:48

25 - Section 18 Integrated BR Analysis for approved indications.mp4

05:13

26 - Section 19 Conclusions and Actions.mp4

01:40

27 - GVP-Module-VII-Periodic-safety-update-report.pdf

27 - ICH-guideline-E2C.pdf

27 - Section 20 References.mp4

02:35

3 - DSUR Development Safety Update Report

28 - Introduction Objectives and RSI.mp4

05:35

29 - General Terminology.mp4

05:12

30 - Relation of DSUR with PSUR.mp4

02:24

31 - Single DSUR for an active substance.mp4

01:41

32 - Periodicity and Data Lock Point.mp4

02:14

33 - DSURs for Multidrug therapies.mp4

02:00

34 - E2F-Guideline.pdf

34 - E2F-Presentation-DSUR.pdf

34 - Format and Presentation of DSUR.mp4

03:52

4 - PADER Periodic Adverse Drug Experience Report

35 - Introduction and Objectives.mp4

02:21

36 - Frequency and Waiver.mp4

01:27

37 - Table of Content.mp4

01:54

38 - Key points while drafting PADER.mp4

02:17

39 - Differences between PADER and PBRER.mp4

03:06

39 - uthoring a periodic adverse drug experience reportheres what you need to know.zip

5 - Additional Guidance

40 - Process Flow of Aggregate Reports.mp4

06:38

41 - How to Switch from ICSR to Aggregate Signal and Risk Management Role.mp4

08:21

6 - Congratulations

42 - What to do after this training.mp4

02:47

Description

Aggregate Report Writing, PSUR, PBRER, DSUR, PADER

What You'll Learn?

Pharmacovigilance Aggregate Reports and Process Flow
Periodic Benefit Risk Evaluation Report (PBRER)
Development Safety Update Report (DSUR)
Periodic Adverse Drug Experience Report (PADER)
Guidance Lecture on How to Switch from ICSR to Aggregate, Signal and Risk Management Role

Who is this for?

Pharmacovigilance ICSR experienced candidates

Graduate or postgraduate degree in Pharmacy (e.g. B Pharm, M Pharm, M S Pharm, Pharm D)

Graduate or postgraduate degree in Medicine (MBBS, MD, BAMS, BUMS, BHMS)

Graduate or postgraduate degree in Life Sciences (BSc, MSc, PhD)

More details

Description
This course is exclusively designed for Pharma students, Medical practitioners and Life science graduates. This course will be helpful to those who have ICSR experience in Pharmacovigilance domain and for those who wants to learn and excel their career in Aggregate reporting.
This Job Role (Pharmacovigilance Aggregate reporting) comes under Niche Skill, which means there is high demand and less resources available in the industry. This is one of the high paying Job Role in Pharmacovigilance/ Pharma domain.
The Trainer of this course has more than 10 years of Pharmacovigilance Industry Experience from different multinational companies (MNC). He has expertise in ICSR, Aggregate Reports, Signal and Risk Management.
In this course we have covered following topics:

Purpose of this Course
Pharmacovigilance and Its objectives
Aggregate Reports & its types
How ICSR & Aggregate Reports are interrelated
Difference between PSUR and PBRER
PBRERÂ and its different sections
DSUR and its different sections
PADER and its different sections
Additional Guidance Session - How to Switch from ICSR Role to Aggregate, Signal and Risk Management Role

By completing this course, you will be more confident to face your interview in Aggregate Reports. Along with main course, we have also shared Additional Guidance sessions on How to Switch from ICSR to Aggregate, Signal and Risk Management Role.

We hope you will find this course very helpful, and you will land your dream job in PV - Aggregate Reports very soon.

Good Luck!!!
Who this course is for:
Pharmacovigilance ICSR experienced candidates
Graduate or postgraduate degree in Pharmacy (e.g. B Pharm, M Pharm, M S Pharm, Pharm D)
Graduate or postgraduate degree in Medicine (MBBS, MD, BAMS, BUMS, BHMS)
Graduate or postgraduate degree in Life Sciences (BSc, MSc, PhD)

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We are here to help students from Pharma, Life sciences and Medical doctors to train them on Pharmacovigilance domain and make them job ready.Our PV faculty have more than 10 years of Pharmacovigilance Industry Experience and in-depth knowledge of ICSR, Aggregate Reports, Signal and Risk Management.We are sure that after you take these trainings, you will be more confident to face PV Interviews.

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