Pharmacovigilance Risk Management Plan: Step By Step Guide

Pharmacovigilance, Risk Management Plan, RMP

What you'll learn

Introduction and Objectives of RMP

Terminologies in RMP

Principles of RMP

Responsibilities of MAH in RMP

Format, Content and Template of the RMP

Common sections in RMP and PSUR

Template of RMP

Risk minimization measures & Safety communications

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, Aggregate Reporting or Signal management experience in Pharmacovigilance domain and for those who wants to learn and excel their career in Pharmacovigilance Risk Management Plan (RMP). This Job role (Risk Management Expert) 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:Introduction and Objectives of RMPPrinciples of RMPResponsibilities of MAH in RMPFormat, Content and Template of RMPRMP parts and modulesCommon sections in RMP and PSURRisk minimization measures and Safety communicationsBy completing this course, you will be more confident to face your interview in Pharmacovigilance Risk Management. You will learn new aspects of pharmacovigilance Risk Management. We hope you will find this course very helpful, and you will land your dream job in Pharmacovigilance Risk Management very soon. Good Luck!!!

Overview

Section 1: Basics of Risk Management Plan (RMP)

Lecture 1 Introduction and Objectives of RMP

Lecture 2 Terminologies in RMP

Lecture 3 Principles of RMP

Lecture 4 Responsibilities of MAH in RMP

Section 2: Format and Content of Risk Management Plan

Lecture 5 Overview of the RMP Parts and Modules

Lecture 6 RMP Part I - Product(s) overview

Lecture 7 RMP Part II - Safety specification

Lecture 8 RMP Part III - Pharmacovigilance plan

Lecture 9 RMP Part IV: Plans for Post-authorisation Efficacy Studies

Lecture 10 RMP Part V: Risk minimisation measures

Lecture 11 RMP Part VI: Summary of the Risk Management Plan

Lecture 12 RMP Part VII: Annexes to the Risk Management Plan

Section 3: Risk minimization measures & Safety communications

Lecture 13 Selection of tools, Effectiveness Indicators and aRMM

Lecture 14 Effectiveness evaluation of risk minimisation measures

Lecture 15 Safety communications

Section 4: RMP template and other information

Lecture 16 Template of RMP

Lecture 17 Common Sections in RMP and PSUR

Section 5: What to do after this training

Lecture 18 What to do after this training

Pharmacovigilance 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)