Periodic Benefit-Risk Evaluation Report PBRER -With Template

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1. Brushing Basics in Aggregate Safety Reports

1. Overview of Course Content.mp4

04:47

2. Introduction and Basic Terminologies.mp4

10:45

3. Types of Aggregate Safety Reports.mp4

03:28

4. Concept of Periodicity.mp4

09:38

5. Regulatory timelines & guidelines.mp4

07:10

6. Importance & Significance of Aggregate Safety Reports in PV.mp4

07:55

7. Learning Evaluation - 1.html

2. PBRER Theoretical Background

1. PBRER Key Objective.mp4

09:45

2. Principles of PBRER writing.mp4

05:17

3. PBRER Format & Template.mp4

05:58

4. PBRER Sections Overview.mp4

22:14

5. PBRER Appendices.mp4

07:32

6. PBRER vs PSUR.mp4

04:10

7. Learning evaluation - 2.html

3. PBRER- Sections Draft with Template

1. Section 1 Introduction.mp4

06:32

2. Section 2 Worldwide marketing authorization status.mp4

06:17

3. Section 3 Part I Actions taken in the reporting interval for safety reasons.mp4

11:08

4. Section 3 PART II Actions taken in the reporting interval for safety reasons.mp4

10:15

5. Section 4 Changes to reference safety information.mp4

07:28

6. Section 5 Estimated exposure and use patterns.mp4

09:54

7. Template- Section 5 Estimated exposure and use patterns.mp4

11:35

8. Section 6 Data in summary tabulations.mp4

08:00

9. Template, Appendix 2A, 2B for Section 6 Data in summary tabulations.mp4

08:44

10. Section 7 Summaries of significant findings from clinical trials.mp4

11:17

11. Template- Section 7 Summaries of significant findings from clinical trials.mp4

03:54

12. Section 8 Findings from non-interventional studies.mp4

05:15

13. Section 9 Information from other clinical trials and sources.mp4

15:25

14. Section 10 Non-clinical data.mp4

05:19

15. Section 11 Literature.mp4

10:52

16. Section 12 Other periodic reports.mp4

04:31

17. Section 13 Lack of efficacy in controlled clinical trials.mp4

04:59

18. Section 14 Late-breaking information.mp4

06:36

19. Signal Management Overview.mp4

18:01

20. Section 15 Overview of signals new, ongoing, or closed.mp4

20:21

21. Flow Chart - Signal & Risk Presentation.mp4

08:26

22. PBRER Template for draft guidance to Section 15 -Overview of Signals.mp4

10:15

23. Section 16 Signal and risk evaluation.mp4

03:31

24. 16.1 Summary of safety concerns.mp4

05:09

25. 16.2 Signal Evaluation.mp4

07:31

26. Section 16.3 Evaluation of risks and new information.mp4

10:34

27. Section 16.4 Risk Characterisation.mp4

12:07

28. Section 16.5 Effectiveness of risk management.mp4

05:02

29. PBRER Template for draft guidance to Section 16 Signal and Risk Evaluation.mp4

23:25

30. Section 17 Benefit Evaluation.mp4

07:43

31. PBRER Template for Section 17 Draft guidance.mp4

05:39

32. Section 18 Integrated benefit-risk analysis for authorised indications.mp4

13:51

33. PBRER Template guidance for Section 18.mp4

05:59

34. Section 19 Conclusions and actions.mp4

03:48

35. PBRER Template for Section 19 draft Guidance.mp4

03:20

36. References and Appendices.mp4

06:24

37. Learning Evaluation 3.html

4. PBRER - Assessment Reports

1. Introduction -Assessment reports in Aggregate Safety Reports.mp4

04:38

2. PSUSA Procedure in EMA & Types of AR.mp4

04:13

3. Post approval Regulatory requests.mp4

03:51

4. Template for PRAC Assessment Report.mp4

09:14

5. Learning Evaluation - 4.html

5. PBRER Project management Tips

1. Preparation for PBRER Production.mp4

03:43

2. Planning and Strategy.mp4

09:31

3. PBRER Authoring workflow.mp4

11:05

4. PBRER Review workflow.mp4

04:33

5. PBRER Submission.mp4

06:27

6. Learning Evaluation 5.html

Description

Learn Key concepts of PBRER writing and guidance for draft exposure using a PBRER template

What You'll Learn?

Aggregate Safety Reports in Pharmacovigilance: PBRER as a major aggregate report type, Using Template to learn PBRER drafting
Periodic Benefit Risk Evaluation Report (PBRER): Understanding concepts all PBRER sections with emphasis on Safety Sections
Understanding the process of authoring an Aggregate Safety report
EMA PSUSA Procedures: Handling PBRER Assessment reports [AR]
Project management for PBRER production: Workflows of authoring, review, strategy meetings, stakeholder interactions

Who is this for?

Working Professionals in Pharmacovigilance with experience in Case processing, literature

Graduate or postgraduate degree in Medical sciences, Pharmaceutical sciences or Life sciences.

Beginners in PV training to explore concepts of aggregate safety reports[like PBRER] in Pharmacovigilance

What You Need to Know?

Understanding of Pharmacovigilance Fundamentals

Experience in PV ICSR Operations

Good quality of Internet connection

Basic level of English

More details

Description
This course is designed exclusively for professionals working in Pharmacovigilance ICSR Case management, aspiring to learn and explore other domains of PV, especially to shift their careers within PV from ICSR to writing aggregate safety reports.
In Pharmacovigilance, Periodic Benefit-Risk Evaluation Report [PBRER] is a major aggregate safety report type which is accepted worldwide for periodic assessment of benefit risk profiles for the medicinal products that are in market.
Each section of PBRER is explained with required fundamental content and utilised our PBRER Template to teach the drafting principles of PBRER.
One of the experts in our community is a lead-trainer for the aggregate safety reports who has significant experience in drafting various kind of safety reports in pharmacovigilance, including project management. Our SME in this domain will take you through the PBRER concepts using template for your better understanding.
You will learn following concepts in this course:

We will brush you with the basics of aggregate safety reports before starting PBRER concepts
We will provide theoretical background to PBRER [objectives, principles, report sections etc] to have a high-level overview before deep diving into each section of the report.
Now, you will enter into core section of the course, where you will learn each section and subsections of PBRER, including the key content and drafting concepts of PBRER.
After completion of our main part of course, we will explain what are PBRER - Assessment Reports and key concepts of PSUSA procedure in providing feedback to the PBRERs submitted by MAHs to the EMA.
At the end, we will provide bonus lectures by giving some project management tips that are essential for production of a PBRER which included general workflows of authoring, review, submissions, strategy meetings with key stakeholders etc.
After completion of this course, you will gain new skill in fundamental concepts of aggregate safety reports including the key objectives and principles of drafting a PBRER. With that you can be confident to shift your career into this domain by facing interviews in Aggregate Safety Reports.
Our Best Wishes to all learners to realise their professional dreams in their career!
Who this course is for:
Working Professionals in Pharmacovigilance with experience in Case processing, literature
Graduate or postgraduate degree in Medical sciences, Pharmaceutical sciences or Life sciences.
Beginners in PV training to explore concepts of aggregate safety reports[like PBRER] in Pharmacovigilance

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Instructor's Courses

Hello!Warm Greetings from PV Experts Community!We are a group of professionals having expertise in Pharmacovigilance Sciences with over a decade of experience in various sub-domains of PV like ICSR operations, Literature Surveillance in Safety Sciences, Aggregate Safety Reports writing, Signal Management, Risk Management, Benefit-risk Assessments, product labelling, Insights on latest technology integrations using ML and AI technologies for increasing efficiencies in PV operations and deliverables.We strive to contribute for the PV community which helps in providing a better patient safety.Safety Sciences, especially post-marketing safety activities that we refer as Pharmacovigilance is a significant discipline for the wellbeing of humanity by making sure all patients receive medicines that are safe with no or little harm that can be mitigated easily. Students, Graduates, Post-graduates from medical, life sciences and pharmaceutical sciences have this Pharmacovigilance as relevant career option. Career in PV is corporate in nature with high pay for skills in demand like aggregate safety reports or signal / risk management.Trainings are structured specific to learners ranging from beginners to experienced working professionals to help in gaining relevant skills and knowledge in PV to flourish in their career by cracking job in PV easily and also by shifting internally to various domain within PV.Our group of experts in PV wishes every curious learner to have a successful career in Pharmacovigilance.Our Key Skills: PV Operations including ICSR- Case Management, Literature screening, Aggregate Safety Reports writing, Signal Management, Risk Management, Product Labelling, Handling Health Authority Enquiries, Referral Procedures, Agreements in PV, Third Party Audits & Health Authority Inspections, Pharmacovigilance System Master File [PSMF], Benefit-Risk Assessments, Setting Up Project in PV.

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