Benefit-Risk Assessment In Pharmacovigilance

Risk-Benefit Assessment in Pharmacovigilance, Benefit-Risk balance in Pharmacovigilance, Benefit-risk ratio, Value tree

What you'll learn

Benefit-Risk (BR) Landscape

Structured B/R Approach and Framework

BR Methodology considerations

Specificities of BR methods for special situations

Requirements

Laptop / PC/ Cellphone

Good Internet connection

Basic English

Description

This course of "Benefit-Risk [B/R] Assessment in Pharmacovigilance" is exclusively published for Pharmacovigilance professionals, Pharma students, Medical practitioners and Life science graduates. This course [Benefit-Risk Assessment in Pharmacovigilance] will be helpful to those who have experience in Pharmacovigilance domain and for those who wants to learn and pursue their career as Benefit-Risk Expert or Benefit-Risk Manager. This is one of the high paying Job Role in Pharmacovigilance. The roles and responsibilities of this role are complex and challenging.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:Benefit-Risk (BR) LandscapeInternational BR initiativesStructured B/R Approach and FrameworkSBRF, its components and its examplesRoutine and Additional Risk Minimization MeasuresBR Methodology considerationsKey components of overall BRAsQuantitative BRA methodsSpecificities of BR methods for special situationsBy completing this course, you will be able to know how Benefit-Risk Assessment in Pharmacovigilance is performed.So, what are you waiting for? Enroll and join us in this exciting course. See you soon in the class.Thanks & Regards,PV Drug Safety Academy

Overview

Section 1: Introduction of course

Lecture 1 Purpose of this course

Section 2: Benefit-Risk Landscape

Lecture 2 Introduction and new context

Lecture 3 New products, new data sources & new B/R methods

Lecture 4 International BR initiatives & Assessing BR methodologies

Section 3: Structured B/R Approach and Framework

Lecture 5 Introduction, definition and purpose of SBRF

Lecture 6 Examples of SBRFs

Lecture 7 Components of SBRF - Product opportunity

Lecture 8 Components of SBRF - Product profile

Lecture 9 Components of SBRF - Risk management

Lecture 10 Role of patient in SBRF

Lecture 11 Additional quantitative analysis

Section 4: BR Methodology considerations

Lecture 12 Introduction and Key components of overall BRAs

Lecture 13 Issues to consider in improving BRA

Lecture 14 Recommendations for integrating BR into clinical trial processes

Lecture 15 Quantitative BRA methods

Lecture 16 Methodological considerations to gain patient insights

Lecture 17 Approaches for visualization of BRA

Lecture 18 The multidisciplinary BRMT

Lecture 19 Company Benefit-Risk Assessment Document [BRAD]

Lecture 20 Demo of Benefit-Risk Assessment Document [BRAD]

Section 5: Specificities of BR Methods for Special situations

Lecture 21 Overview of special situations, key challenge and methods

Section 6: Congratulations and Thank you

Lecture 22 What to do after this training?

Pharmacovigilance professionals,Pharmacy, Medical and Life science students