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 Terminologies
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 Terminology
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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