Pharmacovigilance Risk Management Plan: Step By Step Guide
Pharmacovigilance Risk Management Plan: Step By Step Guide
Published 5/2023
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 2.03 GB | Duration: 1h 56m
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)
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