Master PharmacoVigilance from A to Z .

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About Course

Alwyas comes to you from prcatice ! and Updates!

You are ete next QPPV/LSR !

You are the next PV Auditor !

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.

In this course, you will:

  • Understand the Essentials: Learn the key principles of pharmacovigilance, drug safety regulations, and the global framework that governs adverse event reporting.

  • Master Real-World PV Processes: Gain hands-on knowledge in signal detection, risk management, case processing, and regulatory submissions.

  • Navigate Regulatory Landscapes: Explore the latest requirements in the FDA, EMA, ICH, and other global health authorities.

  • Boost Your Career: Acquire the skills that top pharmaceutical companies and CROs are seeking in PV specialists, drug safety officers, and regulatory affairs professionals.

Topics you will master?

  • Definition of the PV

  • The need for the PV

  • The PV History

  • The Emergance of the PV in the Pharma industry

  • Structure of the PV

  • PV process

  • ICSR

  • Case Managmnet

  • CASES

  • PSMF/PSSF

  • Common Arab Guidleines for PV

  • PSUR

  • PV Audit

  • PV Signals

  • PV PASS

  • PV RMP

  • PV Communication

  • PV CAPA

  • PVImpact

  • PV Tracking and Tracing

  • AI Closing

Why this course is different:

  • Practical, real-world examples from the pharmaceutical industry

  • Step-by-step guidance on navigating complex PV databases and reporting systems

  • Insights into global regulatory updates that impact your daily work

  • Engaging content designed for fast comprehension, even if you are new to PV

By the end of this course, you’ll be confident in your ability to handle pharmacovigilance tasks with accuracy and professionalism, making you a valuable asset in any healthcare or pharmaceutical setting.

Enroll now and start your journey to becoming a skilled pharmacovigilance professional — because patient safety isn’t just a requirement, it’s a responsibility.

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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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