Certificate Course in Pharmacovigilance

Course Objectives:

Suitable for: Freshers, Pharmacy and Medical Students, trainers, academicians, Industry aspirants, and individuals who are new in the industry

To Learn the basics of Pharmacovigilance, Cosmetovigilance and Device Vigilance

 

  • History of Pharmacovigilance, and the importance
  • Introduction to concepts such as Day Zero, Four Minimum Criteria, Seriousness, Causality, and Dechallenge-Rechallenge, Adverse Event Vs Adverse Drug Reaction, causality, medical coding and Sources of Adverse Events
  • Case Processing and Aggregate Safety Reporting
  • Medical Information, Device Vigilance, EcoPharmacovigilance, Cosmetovigilance, and Hemovigilance
  • Vaccine Adverse Event Reporting System
  • Setting up a Pharmacovigilance Sytem
  • Quality Management System in Pharmacovigilance
  • Audits and Inspections
  • Pharmacovigilance Resources
  • Interview Questions
  • Career Opportunities
COURSE FEE: Rs 499 (US$11 for Overseas Participants)
(This includes all future updates and additional modules, Mock Interviews, etc.)
 
Mode: Self Learning + Live Webinar sessions with the Industry Experts for Doubt Solving
Course Hours: 25
Assessment – Yes
Certificate – YES
 
 

About the Course Designer: LINKEDIN PROFILE 

VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935)with a mission of Empowering Public Health by ensuring safe medicines and promoting a culture for reporting Adverse Drug Experiences and Side Effects. 

DONATE: https://www.vigiserve.com/donate

How will the Certificate look like?

Review of the Students from the courses conducted in the past:

 

Review 1

Review 2

Review 3

Review 4 (International Students)

Welcome

1
Welcome to the CCP Course
5 Minutes

Introduction and History

1
Introduction to Pharmacovigilance
15 Minutes

An introduction to the subject and more importantly, the need for Pharmacovigilance!


2
History of Pharmacovigilance
25 Minutes

Learn how Pharmacovigilance has evolved over a period of 160+ years!

3
Need for a Certification Course in Pharmacovigilance
3.5 Minutes
4
Take and Tell
2 Minutes
5
Introduction to Pharmacovigilance – Quiz
4 questions
6
Module 0 – Click on the links below – Additional Reading (Optional)
30 Minutes

Module 1 - Pharmacovigilance Basics

1
Four Minimum Criteria for Case-Report Validity
20 Minutes

Four Minimum Criteria:

Identifiable Patient

Identifiable Reporter

Suspected Drug

Adverse Event

2
Four Minimum Criteria – Quiz
4 questions
3
Day Zero
13 Minutes
4
Day Zero – Quiz
3 questions
5
Adverse Event Vs Adverse Drug Reactions
15 Minutes

Learn about the difference between an Adverse Event and an Adverse Drug Reaction

6
AE Vs ADR – Quiz
2 questions
7
Source of Adverse Event Reports
22 minutes
8
Sources of Adverse Events – Quiz
5 questions
9
Dechallenge and Rechallenge in Pharmacovigilance
13 Minutes

Learn about dechallenge and rechallenge in Pharmacovigilance

10
Dechallenge and Rechallenge – Quiz
3 questions
11
Basics – Assignment
20 Minutes
12
Module 1 – Click on the links below – Additional Reading (Optional)
30 Minutes

Module 2 - Case Processing

1
Seriousness Assessment in Pharmacovigilance
16 Minutes

Adverse Events can be Serious!

Important Medical Event List: https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview

2
Seriousness Criteria – Quiz
2 questions
3
The Triage Process
8 Minutes
4
Pharmacovigilance Triage
2 questions
5
Event outcome in Pharmacovigilance
3 Minutes

Learn about the fate of adverse events

6
Event outcome in Pharmacovigilance – Quiz
5 questions
7
Case-Narratives in Pharmacovigilance
20 Minutes
8
Narrative Writing – Quiz
5 questions
9
Medical Coding in Pharmacovigilance
33 Minutes

Medical Coding - MedDRA, VeDDRA, WHO DD, Snomed CT, CTCAE

Relevant Links:

CTCAE: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm

SNOMED CT: https://browser.ihtsdotools.org/

VeDDRA: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/combined-veterinary-dictionary-drug-regulatory-activities-veddra-list-clinical-terms-reporting_en.pdf

MedDRA: https://www.meddra.org/

10
Medical Coding in Pharmacovigilance – Quiz
7 questions
11
Causality Assessment in Pharmacovigilance
23 Minutes

Relatedness assessment - To evaluate the relationship between the suspect drug and the adverse event.

Link to WHO-AEFI Causality Assessment: https://www.who.int/publications/i/item/9789241516990

Link to WHO-UMC Causality:https://www.who.int/publications/m/item/WHO-causality-assessment

12
Causality Assessment – Quiz
6 questions
13
Medical Review in Pharmacovigilance
13 Minutes

The role of medical reviewers and safety physicians in Pharmacovigilance

14
Medical Review in Pharmacovigilance – Quiz
5 questions
15
Labeledness Vs Listedness Vs Expectedness in Pharmacovigilance
11 Minutes

The terms Labeledness, Expectedness and Listedness are used interchangeably in Pharmacovigilance. Is this correct?

16
Expectedness, Labeledness and Listedness – Quiz
4 questions
17
Module 2 – Click on the links below – Additional Reading (Optional)
60 Minutes

Module 3 - Literature and Social Media Monitoring

1
Literature Safety Monitoring in Pharmacovigilance
32 Minutes

Learn about the literature search and review process in Pharmacovigilance.

www.pubmed.gov

Search String:

AND ('adverse drug reaction'/exp OR 'adverse drug reaction' OR 'drug overdose'/exp OR 'drug overdose' OR 'drug misuse'/exp OR 'drug misuse' OR 'drug abuse' OR 'substance abuse'/exp OR 'substance abuse' OR 'pregnancy'/exp OR 'pregnancy' OR 'drug efficacy'/exp OR 'drug efficacy' OR 'drug withdrawal'/exp OR 'drug withdrawal' OR 'drug tolerance'/exp OR 'drug tolerance' OR 'medication error'/exp OR 'medication error' OR 'death'/exp OR 'death' OR 'drug interaction'/exp OR 'drug interaction' OR 'carcinogenicity'/exp OR 'carcinogenicity' OR 'off label drug use'/exp OR 'off label drug use' OR 'occupational exposure'/exp OR 'occupational exposure' OR 'toxicity'/exp OR 'intoxication' OR 'drug contraindication'/exp OR 'drug contraindication' OR 'congenital disorder'/exp OR 'congenital disorder' OR 'drug treatment failure'/exp OR 'drug treatment failure' OR 'lactation'/exp OR 'lactation' OR 'case report'/exp OR 'case report' OR 'environmental exposure'/exp OR 'environmental exposure' OR 'treatment contraindication'/exp OR 'treatment contraindication')



2
Literature Safety Monitoring – Quiz
6 questions
3
Social Media Monitoring in Pharmacovigilance
21 Minutes

Adverse events can be received from the Social Media Platforms.

4
Social Media Monitoring in Pharmacovigilance – Quiz
5 questions
5
Module 3 – Click on the links below – Additional Reading (Optional)

Module 4 - Aggregate Safety Reporting and Benefit-Risk Management

1
Aggregate Safety Reporting – An Introduction
29 Minutes

PSURs, DSURs, PADERs, PBRERs, etc.

Template: https://www.ema.europa.eu/en/ich-e2c-r2-periodic-benefit-risk-evaluation-report

2
Aggregate Safety Reporting – An Introduction – Quiz
7 questions
3
Signal Management in Pharmacovigilance
31 Minutes

Learn about Signal management in Pharmacovigilance with a real-life example.

4
Basics of Signal Management – Quiz
5 questions
5
Black Triangle Products and Black Box Warnings
30 Minutes

Caution / Additional Monitoring

List of medicines under additional monitoring

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring

6
Black Triangle / Black Box – Quiz
4 questions
7
Module 4 – Click on the links below – Additional Reading (Optional)

Module 5 - SDEA and PSMF Management

1
Safety Data Exchange Agreement
22 minutes

SDEA or PVA

2
Need for a Safety Data Exchange Agreement
2.5 Minutes
3
Introduction to SDEA – Quiz
6 questions
4
Pharmacovigilance System Master File
31 Minutes

PSMF

5
PSMF – Intro – Quiz
6 questions
6
Module 5 – Click on the links below – Additional Reading (Optional)

Module 6 - Pharmacovigilance Quality

1
Quality Management System in Pharmacovigilance
27 min

Learn about the Quality Management System (QMS) in Pharmacovigilance; what all does it entail?

GVP Module 1: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-their-quality-systems_en.pdf

2
QMS in Pharmacovigilance – Quiz
6 questions
3
Pharmacovigilance Audit Vs Inspection
11 Minutes

The difference between an audit and an inspection

4
Pharmacovigilance Audit Vs Inspection – Quiz
5 questions
5
Qualified Person for Pharmacovigilance
30 Minutes

Roles and responsibilities of the QPPV

Country specific requirements

6
QPPV – Quiz
6 questions
7
WHO Pharmacovigilance Resources
13 Minutes

Free and useful Pharmacovigilance resources that are provided and facilitated by the World Health Organization.


Useful links:

https://whopvresources.org/

https://learning.who-umc.org/

https://who.csod.com/client/who/default.aspx

https://www.who-umc.org/media/1061/abbreviations.pdf

https://www.who.int/publications/i

8
Setting up a Pharmacovigilance System
22 minutes

What resources are required for setting up a Pharmacovigilance System?

www.whopvresources.org

https://www.meddra.org/about-meddra/organisation/msso

https://who-umc.org/whodrug/whodrug-global/

9
Variation in the Country-Specific Pharmacovigilance Requirements
21 Minutes

Learn how Pharmacovigilance requirements change across the countries. There may be regional or even country-specific variations.

10
Country Specific Pharmacovigilance – Quiz
4 questions
11
Module 6 – Click on the links below – Additional Reading (Optional)

Module 7 - Medical Information

1
Medical Information
37 Minutes

Medical Information deals with the collection, handling and dissemination of information on medicines, and their safe and correct use. The med info department acts as the link between the Marketing Authorisation Holder and the patient, caretaker or healthcare professional (HCP).

2
Global Medical Information – Quiz
12 questions
3
Module 7 – Click on the links below – Additional Reading (Optional)
30 Minutes

Module 8 - Product Complaints and Product Use Alterations

1
Product Quality Complaints
42 Minutes

The impact of product complaints on Patient Safety

2
Product Quality Complaints – Quiz
7 questions
3
Product Use Alterations
30 Minutes

Medication errors, off-label use, dependence, misuse, abuse, special supplies, compassionate use, etc.

4
Product use alterations – Quiz
8 questions
5
Module 8 – Click on the links below – Additional Reading (Optional)
30 Minutes

Module 9 - Vaccines' Safety

1
Vaccine Adverse Event Reporting System
18 Minutes

Adverse Event Reporting System for Vaccines, in the United States.

-Reporting Adverse Events following Immunization in the United States

-Downloading / Accessing data for free

-Other free resources


Relevant links:

https://vaers.hhs.gov/

https://vaers.hhs.gov/resources.html

View Data:

https://wonder.cdc.gov/vaers.html

Download Data:

https://vaers.hhs.gov/data/datasets.html


FDA eSubmitter:

https://www.fda.gov/industry/fda-esubmitter

2
Vaccines’ Safety Monitoring – Quiz
5 questions
3
Module 9 – Click on the links below – Additional Reading (Optional)
30 Minutes

Module 10 - Patient Safety - Beyond Pharmacovigilance

1
Medical Device Vigilance
22 minutes

Materiovigilance or Device Safety or Device Vigilance

2
Medical Device Vigilance – Quiz
6 questions
3
Cosmetovigilance
21 Minutes

Cosmetics can also cause undesirable effects, and one may need to report them to the regulatory agencies.

4
CosmetoVigilance – Quiz
5 questions
5
Hemovigilance (Blood Safety)
24 Minutes

Even blood donation or transfusion may be associated with Adverse Events

6
Hemovigilance – Quiz
4 questions
7
Veterinary Pharmacovigilance
21 Minutes

Learn about Pharmacovigilance for Veterinary Medicinal Products

8
Veterinary Pharmacovigilance – Quiz
12 questions
9
Ecopharmacovigilance or PharmEcoVigilance
34 Minutes

Ecopharmacovigilance is defined as science and activities concerning the detection, assessment, understanding, and prevention of adverse effects or other problems related to the presence of pharmaceuticals in the environment, which affect human and other animal species.

10
Diclofenac and Vultures
2 Minutes
11
EcoPharmacovigilance – Quiz
6 questions
12
Pharmacogenomics in Patient Safety
38 Minutes

Pharmacogenomics is an important example of precision medicine, which aims to tailor medical treatment to each person or a group of people. Pharmacogenomics looks at how your genetic profile affects the way you respond to drugs.

13
Pharmacogenomics in Patient Safety – Quiz
5 questions
14
Module 10 – Click on the links below – Additional Reading (Optional)
30 Minutes

Module 11 - Role of Allied Functions in Pharmacovigilance

1
Role of IT in Pharmacovigilance
11 Minutes

The Information Technology team plays a very important role in the smooth functioning of the Pharmacovigilance department. It is also a lucrative career option.

2
Role of IT
4 questions
3
Role of Regulatory Affairs in Pharmacovigilance
16 Minutes

The Regulatory Affairs department plays a vital role in the smooth functioning of the Pharmacovigilance activities

4
Role of Legal department in Pharmacovigilance
8 Minutes

How can the legal team support the smooth functioning of the Pharmacovigilance department?

5
Role of Legal and Regulatory
4 questions

Module 12 - A Successful Career in the field of Pharmacovigilance and Patient Safety

1
Effective Networking on LinkedIn
19 Minutes

Make use of LinkedIn to the fullest!

https://www.linkedin.com/learning

https://www.linkedin.com/jobs/

https://www.linkedin.com/groups/

For Banner / Background: www.canva.com

2
Designing a good CV or Resume for getting a dream job in Pharmacovigilance
27 min

Having a good resume or CV is very important for getting the dream job in Pharmacovigilance.

Is it CV or resume?

How many pages?

Should I include my Foto or signature?

Tool: www.canva.com

Other links:

https://youtu.be/d7D1p5Y5X8g

3
Using the right keywords in your Resume
3.5 Minutes

Artificial Intelligence / Machine Learning for Screening relevant Pharmacovigilance CVs. The use of the right keywords is essential to ensure that your CV gets shortlisted.

4
Preparing for a Pharmacovigilance Job Interview
20 Minutes
5
A Career in the Pharmacovigilance Industry
28 Minutes

Learn how the career can evolve in the Pharmacovigilance Industry

6
Career in Pharmacovigilance – Quiz
4 questions
7
Module 11 – Click on the links below -Additional Reading (Optional)

Final Assessment

1
Certificate Course in Pharmacovigilance – Final Assessment
16 questions
Graduates in Medicine, Pharmacy, Science, Nursing, etc. Undergraduate Students in Medicine, Pharmacy, Science, Nursing, etc. Academicians, Industry personnel, etc.
Only that you should have access to YouTube and www.vigiservefoundation.org
-Some students/academicians genuinely wish to learn Pharmacovigilance. -Most of the Pharmacovigilance courses available today have a commercial motive. -The industry professionals too get limited exposure to the various topics in Patient Safety To address all these requirements, VigiServe Foundation has come up with this initiative, where quality content will be available at nominal rates.
Yes; we can arrange on-demand Microsoft Teams meetings with the industry experts for the course participants, over the weekends.
Yes, this is a full-fledged course that will take 25 hours to complete VigiServe Foundation is a registered not-for-profit organization. Funds are required for the day-to-day operations and for maintaining the learning management systems, company website, and also for coming up with new learning modules.
Yes; you can check https://www.vigiservefoundation.org/courses/ for more details. More than 4000 students globally have been benefited
VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935)with a mission of Empowering Public Health by ensuring safe medicines and promoting culture for reporting Adverse Drug Experiences and Side Effects.
We will provide relevant links to the course materials. Most of these materials have been prepared by VigiServe Foundation. Besides, we will also share the links to the necessary websites
Yes, we have a student and course reference number published on the top of the certificate. This makes it unique
Yes, you can generate it on your own. It is recommended to use a PC/Laptop for downloading the certificate.
You can find them on https://www.vigiservefoundation.org/activities/

A fully online, self-learning certification course in Pharmacovigilance from the VigiServe Academy for Patient Safety.

Learn at your own pace!

VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935) with a mission of Empowering Public Health by ensuring safe medicines and promoting a culture for reporting Adverse Drug Experiences and Side Effects.

The Course Modules

Introduction and History

•                    Introduction to Pharmacovigilance

•                    History of Pharmacovigilance

•                    Need for a Certification Course in Pharmacovigilance

•                    Take and Tell

•                    Introduction to Pharmacovigilance – Quiz

Module 1 - Pharmacovigilance Basics

•                    Four Minimum Criteria for Case-Report Validity

•                    Four Minimum Criteria – Quiz

•                    Day Zero

•                    Day Zero – Quiz

•                    Adverse Event Vs Adverse Drug Reactions

•                    AE Vs ADR – Quiz

•                    Source of Adverse Event Reports

•                    Sources of Adverse Events – Quiz

•                    Dechallenge and Rechallenge in Pharmacovigilance

•                    Dechallenge and Rechallenge – Quiz

•                    Basics – Assignment

Module 2 - Case Processing

•                    Seriousness Assessment in Pharmacovigilance

•                    Seriousness Criteria – Quiz

•                    Event outcome in Pharmacovigilance

•                    Event outcome in Pharmacovigilance – Quiz

•                    Case-Narratives in Pharmacovigilance

•                    Narrative Writing – Quiz

•                    Medical Coding in Pharmacovigilance

•                    Medical Coding in Pharmacovigilance – Quiz

•                    Causality Assessment in Pharmacovigilance

•                    Causality Assessment – Quiz

•                    Medical Review in Pharmacovigilance

•                    Medical Review in Pharmacovigilance – Quiz

•                    Labeledness Vs Listedness Vs Expectedness in

•                    Expectedness, Labeledness and Listedness – Quiz

Module 3 - Literature and Social Media Monitoring

•                    Literature Safety Monitoring in Pharmacovigilance

•                    Literature Safety Monitoring – Quiz

•                    Social Media Monitoring in Pharmacovigilance

•                    Social Media Monitoring in Pharmacovigilance – Quiz

Module 4 - Aggregate Safety Reporting and Benefit-Risk Management

•                    Aggregate Safety Reporting – An Introduction

•                    Aggregate Safety Reporting – Quiz

•                    Signal Management

•                    Signal Management – Quiz

•                    Black Triangle and Black box Warnings

•                    Black Triangle and Black box Warnings - Quiz

Module 5 - SDEA and PSMF Management

•                    Safety Data Exchange Agreement

•                    Need for a Safety Data Exchange Agreement

•                    Introduction to SDEA – Quiz

•                    Pharmacovigilance System Master File

•                    PSMF – Intro – Quiz

Module 6 - Pharmacovigilance Quality

•                    Quality Management System in Pharmacovigilance

•                    QMS in Pharmacovigilance – Quiz

•                    Audit Vs Inspection

•                    Audit Vs Inspection -Quiz

•                    QPPV

•                    QPPV-Quiz

•                    WHO PHV Resources

•                    Setting up a PHV System

•                    Variation in Country Specific Requirements

•                    Country Specific Requirements – Quiz

Module 7 - Medical Information

•                    Medical Information

•                    Global Medical Information – Quiz

Module 8 - Product Complaints

•                    Product Quality Complaints

•                    Product Quality Complaints – Quiz

•                    Product use alterations

•                    Product use alterations – Quiz

Module 9 - Vaccines' Safety

•                    Vaccine Adverse Event Reporting System

•                    Vaccines’ Safety Monitoring – Quiz

Module 10 - Patient Safety - Beyond Pharmacovigilance

•                    Medical Device Vigilance

•                    Medical Device Vigilance – Quiz

•                    Cosmetovigilance

•                    CosmetoVigilance – Quiz

•                    Hemovigilance (Blood Safety)

•                    Hemovigilance – Quiz

•                    Veterinary Pharmacovigilance

•                    Veterinary Pharmacovigilance – Quiz

•                    EcoPharmacovigilance

•                    EcoPharmacovigilance – Quiz

•                    Pharmacogenomics in Pharmacovigilance

•                    Pharmacogenomics - Quiz

Module 11 - A Successful Career in the field of Pharmacovigilance

•                    Designing a good CV or Resume for getting a dream job in Pharmacovigilance

•                    Using the right keywords in your Resume

•                    Preparing for a Pharmacovigilance Job Interview

•                    Effective Networking on LinkedIn

•                    A Career in the Pharmacovigilance Industry

•                    Career in Pharmacovigilance – Quiz

•                    Final Assessment

 

Final Assessment

 

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Enrolled: 17 students
Duration: 25 Hours
Lectures: 64
Video: 18 Hours
Level: Intermediate

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