What you'll learn

Brief history of Pharmacovigilance & Drug development process.
Terminologies in Pharmacovigilance.
Pharmacovigilance Regulations & Guidelines.
Sources of Adverse event & Assessing adverse event reports.
Reporting adverse events & Aggregate reports in pharmacovigillance.
Responsibilities of marketing authorization holder & Consequences of non compliance

Requirements

Basic level of English
Good quality of Internet connection
Desktop, Laptop or Smartphone

Description

Hello,Are you ready to enter the thriving field of pharmacovigilance and develop a rewarding career in drug safety? The Complete Pharmacovigilance Course: Become Professional" is your ultimate guide to mastering the science of drug safety monitoring. This comprehensive course is designed to provide you with a deep understanding of pharmacovigilance principles, practices, and regulations, making you a sought-after professional in the healthcare and pharmaceutical industry. With the increasing demand for skilled pharmacovigilance professionals, this course is your gateway to a high-paying, impactful career.This course is ideal for students, healthcare professionals, and career changers interested in drug safety and pharmacovigilance.This is a course that provides essential knowledge and skills in the field of pharmacovigilance, helping you advance your career with practical insights along with industry-relevant certification.The trainer of this course brings over 15 years of rich experience in the pharmacovigilance industry and academics, having worked with top multinational companies. With 10 books, 5 patents, and 70 research publications on pharmaceutical sciences to his name, he is an expert in ICSR, aggregate reports, signal detection, and risk management.This course covers the following topics:· About the course· What is pharmacovigillance· Brief history of pharmacovigilance· Drug development process· Terminologies and definitions· Pharmacovigilance Regulations & Guidelines· Responsibilities of marketing authorization holder· Consequences of non-compliance· Sources of Adverse event· Assessing adverse event reports· Reporting adverse events· De challenge / Re challenge concept· Aggregate reports in pharmacovigillance: PSUR, DSUR, PADER· Risk Management Plan (RMP )· Signal detectionI hope by the end of this course, you will be confident with skills to perform well in the field of pharmacovigilance and acquire all the desired career results. Wishing you great success on your journey—Good luck!

Overview

Section 1: Introduction to Pharmacovigilance
Lecture 1 About The Course
Lecture 2 What is Pharmacovigilance
Lecture 3 Brief History of Pharmacovigilance
Section 2: Foundations of Drug Safety
Lecture 4 Drug Development Process
Lecture 5 Terminologies and Definitions
Section 3: Regulatory Framework and Guidelines
Lecture 6 Pharmacovigilance Regulations & Guidelines
Lecture 7 Responsibilities of Marketing Authorization Holder
Lecture 8 Consequences of Non-Compliance
Section 4: Adverse Event Management
Lecture 9 Sources of Adverse Events
Lecture 10 Assessing Adverse Event Reports
Lecture 11 Reporting Adverse Events
Lecture 12 Dechallenge/Rechallenge Concept
Section 5: Advanced Pharmacovigilance Practices
Lecture 13 Aggregate Reports in Pharmacovigilance
Lecture 14 Risk Management Plan (RMP)
Lecture 15 Signal Detection
Graduate or postgraduate students in Pharmacy or Pharmaceutical Sciences and Pharm D.,Graduate or postgraduate students in Medicine and Life Sciences.,Healthcare professionals looking to enhance their knowledge of drug safety.,Professionals transitioning to pharmacovigilance roles.,Academicians wanting to integrate pharmacovigilance into their teaching.


Homepage:

https://www.udemy.com/course/the-complete-pharmacovigilance-course-become-professional/