Published 1/2023MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHzLanguage: English | Size: 1.44 GB | Duration: 3h 9m

Aggregate Report Writing (PSUR/PBRER, DUSR, 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)

Addendum to Clinical Overview (ACO)

Guidance Lecture on How to Switch from ICSR to Aggregate, Signal and Risk Management Role

Requirements

Basic level of English

Good quality of Internet connection

Desktop, Laptop or Smartphone

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 11 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 CoursePharmacovigilance and Its objectivesAggregate Reports & its typesHow ICSR & Aggregate Reports are interrelatedDifference between PSUR and PBRERPBRER and its different sectionsDSUR and its different sectionsPADER and its different sectionsAdditional Guidance Session - How to Switch from ICSR Role to Aggregate, Signal and Risk Management RoleBy 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 !!!

Overview

Section 1: General Information

Lecture 1 Introduction, Purpose of this course and Topics to be covered

Lecture 2 Pharmacovigilance & Its Objectives

Lecture 3 Aggregate Reports and Its Types

Lecture 4 Correlation between ICSR & Aggregate Reports

Lecture 5 Difference between PSUR and PBRER

Lecture 6 Basic Teologies

Section 2: PBRER (Periodic Benefit-Risk Evaluation Report)

Lecture 7 Different Parts of PBRER (Part I, II, III)

Lecture 8 Section 1 - Introduction

Lecture 9 Section 2 - Worldwide Marketing Approval Status

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

Lecture 11 Section 4 - Changes to RSI

Lecture 12 Section 5 - Estimated Exposure and Use patterns

Lecture 13 Section 6 - Data in Summary Tabulations

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

Lecture 15 Section 8 - Findings from Non-interventional studies

Lecture 16 Section 9 - Information from other Clinical trials & sources

Lecture 17 Section 10 - Non-clinical data

Lecture 18 Section 11 - Literature

Lecture 19 Section 12 - Other periodic reports

Lecture 20 Section 13 - LOE in controlled clinical trials

Lecture 21 Section 14 - Late breaking information

Lecture 22 Section 15 - Overview of signals: New, Ongoing or Closed

Lecture 23 Section 16 - Signal and Risk Evaluation

Lecture 24 Section 17 - Benefit Evaluation

Lecture 25 Section 18 - Integrated B/R Analysis for approved indications

Lecture 26 Section 19 - Conclusions and Actions

Lecture 27 Section 20 - References

Section 3: DSUR (Development Safety Update Report)

Lecture 28 Introduction, Objectives and RSI

Lecture 29 General Teology

Lecture 30 Relation of DSUR with PSUR

Lecture 31 Single DSUR for an active substance

Lecture 32 Periodicity and Data Lock Point

Lecture 33 DSURs for Multi-drug therapies

Lecture 34 Format and Presentation of DSUR

Section 4: PADER (Periodic Adverse Drug Experience Report)

Lecture 35 Introduction and Objectives

Lecture 36 Frequency and Waiver

Lecture 37 Table of Content

Lecture 38 Key points while drafting PADER

Lecture 39 Differences between PADER and PBRER

Section 5: Additional Guidance

Lecture 40 Process Flow of Aggregate Reports

Lecture 41 How to Switch from ICSR to Aggregate, Signal and Risk Management Role

Section 6: Congratulations

Lecture 42 What to do after this training?

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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