Master PharmacoVigilance from A to Z .

About Course

Pharmacovigilance Master the Economics Behind Smarter Healthcare Decisions Are you ready to take your career in pharmaceuticals and healthcare to the next level? Pharmacovigilance (PV) is the cornerstone of drug safety, ensuring that medications are not only effective but safe for patients worldwide. This comprehensive course is designed for professionals, students, and anyone passionate about drug safety, offering both foundational knowledge and practical, industry-ready skills.

Course Content

Module 1: Introduction
Get introduced to the world of the PharmacoVigilance Master Pharmacovigilance Be the next QPV or LSR Be the next PV Audit

Introduction

02:22

Module 2: PV definition
Get introduced to the definition of the PV, the basics on which you will build up your experience, approach, and practice

Module 3: WHO Definition
WHO Definition, Key Aspects, Regulatory plus PV, The need for PV

Module 4: PV History PART 1
PV History PART 1

Module 5: PV History PART 2
PV History PART 2, Thalidomide disaster, Formalization and Globalization of the PV

Module 6: PV In the META region/GVP
PV In the META region/GVP module structure

Module 7: PV GVP Responsibilities/PV Agreements
PV GVP Responsibilities, tasks, subcontractors tasks, MAH tasks, PV Agreements

Module 8: PSMF/PSSF
PSMF/PSSF Structure/Annexes/Regulations/Accessibility/Submission/LSR and Delegation

Module 9: Let’s Practice PV Process
Let's Practice PV Process, quality submissions, timeframe, performance, reporting, reporting sources, cases collection, MAH role in cases collection, ADR, ICSR

Module 10: ICSR Case Management
ICSR Case Management, MAH role in handling and submission

Module 11: ICSR Cases
ICSR Cases

Module 12: PSUR PART 1
Introduction to PSUR content and submission

Module 13: PSUR PART 2
PSUR PART 2

Module 14: Complaints
Complains Handling

Module 15: Casualty Assessment
Casualty Assessment

Module 16: Signal Management
Signal Management

Module 17: PASS
PASS

Module 18: RMP 1
RMP 1

Module 19: RMP 2
RMP 2

Module 20: RMP 3
RMP 3

Module 21: PV Communication
PV Communication

Module 22: PV Inspection
PV Inspection

Module 23: PV Audit PART 1
PV Audit PART 1

Module 24: PV Audit PART 2
PV Audit PART 2

Module 25: PV Tracking and Tracing
PV Tracking and Tracing

Module 26: Role of AI with PV Practice
Role of AI with PV Practice

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About Course

Course Content

Module 1: Introduction Get introduced to the world of the PharmacoVigilance Master Pharmacovigilance Be the next QPV or LSR Be the next PV Audit

Introduction

Module 2: PV definition Get introduced to the definition of the PV, the basics on which you will build up your experience, approach, and practice

PV definition

Module 3: WHO Definition WHO Definition, Key Aspects, Regulatory plus PV, The need for PV

WHO Definition

Module 4: PV History PART 1 PV History PART 1

PV History Part 1

Module 5: PV History PART 2 PV History PART 2, Thalidomide disaster, Formalization and Globalization of the PV

PV History PART 2

Module 6: PV In the META region/GVP PV In the META region/GVP module structure

PV In the META region/GVP

Module 7: PV GVP Responsibilities/PV Agreements PV GVP Responsibilities, tasks, subcontractors tasks, MAH tasks, PV Agreements

PV GVP Responsibilities/PV Agreements

Quiz 1

Module 8: PSMF/PSSF PSMF/PSSF Structure/Annexes/Regulations/Accessibility/Submission/LSR and Delegation

PSMF/PSSF

Quiz 2

Module 9: Let’s Practice PV Process Let's Practice PV Process, quality submissions, timeframe, performance, reporting, reporting sources, cases collection, MAH role in cases collection, ADR, ICSR

Let’s Practice PV Process

Module 10: ICSR Case Management ICSR Case Management, MAH role in handling and submission

ICSR Case Management

Module 11: ICSR Cases ICSR Cases

ICSR Cases

Quiz 3

Module 12: PSUR PART 1 Introduction to PSUR content and submission

PSUR PART 1

Module 13: PSUR PART 2 PSUR PART 2

PSUR PART 2

Module 14: Complaints Complains Handling

Complaints

Module 15: Casualty Assessment Casualty Assessment

Casualty Assessment

Module 16: Signal Management Signal Management

Signal Management

Module 17: PASS PASS

PASS

Module 18: RMP 1 RMP 1

RMP 1

Module 19: RMP 2 RMP 2

RMP 2

Module 20: RMP 3 RMP 3

RMP 3

Quiz 4

Module 21: PV Communication PV Communication

PV Communication

Module 22: PV Inspection PV Inspection

PV Inspection

Module 23: PV Audit PART 1 PV Audit PART 1

PV Audit PART 1

Module 24: PV Audit PART 2 PV Audit PART 2

PV Audit PART 2

Module 25: PV Tracking and Tracing PV Tracking and Tracing

PV Tracking and Tracing

Quiz 5

Module 26: Role of AI with PV Practice Role of AI with PV Practice

Role of AI with PV Practice

Final

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