An Overview of Pharmacovigilance

An Overview of Pharmacovigilance, available at $64.99, has an average rating of 4.55, with 62 lectures, 5 quizzes, based on 100 reviews, and has 385 subscribers.

You will learn about Understand the Basics of Pharmacovigilance Domain Get a clear knowledge of the Drug Safety Activities Understand Pharmacovigilance Organization and Operations Explore the importance of Pharmacovigilance for a pharma Company This course is ideal for individuals who are Anyone in Pharmaceutical or Healthcare Industry or Professionals in Patient Safety or Drug Safety Organization or IT Professionals working in Patient Safety or Pharmacovigilance domain projects or Pharmacy Students It is particularly useful for Anyone in Pharmaceutical or Healthcare Industry or Professionals in Patient Safety or Drug Safety Organization or IT Professionals working in Patient Safety or Pharmacovigilance domain projects or Pharmacy Students.

Enroll now: An Overview of Pharmacovigilance

Summary

Title: An Overview of Pharmacovigilance

Price: $64.99

Average Rating: 4.55

Number of Lectures: 62

Number of Quizzes: 5

Number of Published Lectures: 62

Number of Published Quizzes: 5

Number of Curriculum Items: 68

Number of Published Curriculum Objects: 68

Original Price: ₹799

Quality Status: approved

Status: Live

What You Will Learn

Understand the Basics of Pharmacovigilance Domain
Get a clear knowledge of the Drug Safety Activities
Understand Pharmacovigilance Organization and Operations
Explore the importance of Pharmacovigilance for a pharma Company

Who Should Attend

Anyone in Pharmaceutical or Healthcare Industry
Professionals in Patient Safety or Drug Safety Organization
IT Professionals working in Patient Safety or Pharmacovigilance domain projects
Pharmacy Students

Target Audiences

Anyone in Pharmaceutical or Healthcare Industry
Professionals in Patient Safety or Drug Safety Organization
IT Professionals working in Patient Safety or Pharmacovigilance domain projects
Pharmacy Students

This course is designed to teach an Overview of Pharmacovigilance. Pharmacovigilance activities are critical to safety of patients by detecting, assessing, understanding and preventing adverse reactions. Implementation of technology and building systems that can simplify the Pharmacovigilance operations, bring productivity gains and save costs for the companies.

This course starts with historical aspects of Pharmacovigilance, the role of Regulatory Organizations various terms and definitions related to an Adverse Event and Adverse Reaction.

The core part of the course is the entire chain of activities for a Pharmacovigilance Organization. This starts with Case Intake, Case Processing (Data Entry) Signal Management, Aggregate Reporting and Risk Management aspects.

The concluding part of the course talks about all those enabling and disrupting elements of the industry like Strategy, External environment, Technology etc.

Overall, the course attempts to provide the learner an opportunity to learn the very basics of Pharmacovigilance and expand thereafter. Exercises, Quiz questions are designed to test the learner’s learning progress. This course can be taken up by

· PV Professionals interested to learn Technology and Systems in PV domain

· IT Professionals building software for PV Operations

· Anyone in Life Sciences domain and looking for a career shift technology in PV

· Pharmacy students to expand their knowledge base

Please note that this course is theoretical in nature and for educational purpose only. This provides a path for you to explore the subject further. The real time scenarios in your Organization can be very much different. Kindly take cognizance and perform due diligence while applying any of the concepts. directly in your workplace.

Course Curriculum

Chapter 1: First things first

Lecture 1: Why are we here?

Lecture 2: Your Instructor – Bharadwaja Choudhury

Lecture 3: Careers in Pharmacovigilance

Lecture 4: The Course Design – Why you should enrol for it?

Lecture 5: Walkthrough of Course on the Udemy Platform

Lecture 6: Journey of a Drug

Lecture 7: Side Effects of a Drug – Why do they occur in first place?

Chapter 2: Introduction to Drug Safety and Important Concepts

Lecture 1: Why Pharmacovigilance – Not so glorious past

Lecture 2: Why Pharmacovigilance – Numbers those were expensive

Lecture 3: Why Pharmacovigilance

Lecture 4: What is Pharmacovigilance

Lecture 5: Concepts of Adverse Drug Reaction

Lecture 6: Concepts of Adverse Drug Reaction : De-challenge and Re-challenge

Lecture 7: Be Curious with Curio-CIty

Lecture 8: Concepts of Adverse Drug Reaction – Concomitance of Drugs

Lecture 9: Take Your Career To The Next Level

Chapter 3: Regulatory Aspects of Pharmacovigilance

Lecture 1: Role of Regulatory Organizations

Lecture 2: FDA Regulations – Code of Federal Regulations

Lecture 3: Be Curious with Curio-City

Lecture 4: GDPR – General Data Protection Regulation

Lecture 5: HIPAA Regulations

Lecture 6: HIPAA Vs GDPR

Lecture 7: Other Organizations: ICH – Harmonisation for better health

Lecture 8: Be Curious with Curio-City

Lecture 9: Other Organizations: Uppsala Monitoring Centre (UMC)

Lecture 10: Other Organizations : CIOMS

Lecture 11: Take the Challenge – Maximize Your Learning

Chapter 4: Core Pharmacovigilance Activities

Lecture 1: Source of Adverse Events

Lecture 2: What goes into a Case or ICSR

Lecture 3: Case Triage

Lecture 4: Key Concepts – Case Processing

Lecture 5: WHODD for Drug Name Coding

Lecture 6: Case Processing

Lecture 7: Suggested Reading – Case Processing

Lecture 8: Aggregate Reporting

Lecture 9: Expedited Reporting

Lecture 10: Signal Management

Lecture 11: Suggested Reading

Lecture 12: Risk Management

Lecture 13: Exchange of Safety Data

Lecture 14: Drug Labeling for Pharmacovigilance

Lecture 15: Take the Challenge – Maximize your Learning

Chapter 5: The Supporting Ecosystem

Lecture 1: Drug Safety within Pharma Organization

Lecture 2: Top Pharma Companies

Lecture 3: Pharmacovigilance Organization

Lecture 4: Audits and Inspections

Lecture 5: Challenges in Pharmacovigilance

Lecture 6: Be Curious with Curio-City

Lecture 7: Computer Systems in Pharmacovigilance

Lecture 8: Technology in Pharmacovigilance

Lecture 9: The PSMF

Lecture 10: From Instructor's Desk – The Learning Path

Chapter 6: Advanced Topics

Lecture 1: The Future of Pharmacovigilance

Lecture 2: Safety in Clinical Trial Phases

Lecture 3: Real World Evidence

Lecture 4: Drug Quality Issues

Lecture 5: Take the Challenge – Maximize your Learning

Chapter 7: Concluding Sessions

Lecture 1: Interview Questions – Basic Level

Lecture 2: Interview Questions – Behavioral

Lecture 3: From Instructor's Desk – Preparing for Interview

Lecture 4: PROMOTION – Generative AI in Pharmacovigilance

Lecture 5: Thank You

Instructors

Bharadwaja Choudhury
Bringing Digital Transformation in Pharmaceutical Industry

Rating Distribution

1 stars: 0 votes
2 stars: 1 votes
3 stars: 7 votes
4 stars: 36 votes
5 stars: 56 votes

Frequently Asked Questions

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You can view and review the lecture materials indefinitely, like an on-demand channel.

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