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
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?
Welcome
Introduction and History
An introduction to the subject and more importantly, the need for Pharmacovigilance!
Learn how Pharmacovigilance has evolved over a period of 160+ years!
Module 1 - Pharmacovigilance Basics
Four Minimum Criteria:
Identifiable Patient
Identifiable Reporter
Suspected Drug
Adverse Event
Learn about the difference between an Adverse Event and an Adverse Drug Reaction
Learn about dechallenge and rechallenge in Pharmacovigilance
Module 2 - Case Processing
Adverse Events can be Serious!
Important Medical Event List: https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview
Learn about the fate of adverse events
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/
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
The role of medical reviewers and safety physicians in Pharmacovigilance
The terms Labeledness, Expectedness and Listedness are used interchangeably in Pharmacovigilance. Is this correct?
Module 3 - Literature and Social Media Monitoring
Learn about the literature search and review process in Pharmacovigilance.
www.pubmed.gov
Search String:
<DRUG NAME> 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')
Adverse events can be received from the Social Media Platforms.
Module 4 - Aggregate Safety Reporting and Benefit-Risk Management
PSURs, DSURs, PADERs, PBRERs, etc.
Template: https://www.ema.europa.eu/en/ich-e2c-r2-periodic-benefit-risk-evaluation-report
Learn about Signal management in Pharmacovigilance with a real-life example.
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
Module 5 - SDEA and PSMF Management
SDEA or PVA
PSMF
Module 6 - Pharmacovigilance Quality
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
The difference between an audit and an inspection
Roles and responsibilities of the QPPV
Country specific requirements
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
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/
Learn how Pharmacovigilance requirements change across the countries. There may be regional or even country-specific variations.
Module 7 - Medical Information
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).
Module 8 - Product Complaints and Product Use Alterations
The impact of product complaints on Patient Safety
Medication errors, off-label use, dependence, misuse, abuse, special supplies, compassionate use, etc.
Module 9 - Vaccines' Safety
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
Module 10 - Patient Safety - Beyond Pharmacovigilance
Materiovigilance or Device Safety or Device Vigilance
Cosmetics can also cause undesirable effects, and one may need to report them to the regulatory agencies.
Even blood donation or transfusion may be associated with Adverse Events
Learn about Pharmacovigilance for Veterinary Medicinal Products
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.
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.
Module 11 - Role of Allied Functions in Pharmacovigilance
The Information Technology team plays a very important role in the smooth functioning of the Pharmacovigilance department. It is also a lucrative career option.
The Regulatory Affairs department plays a vital role in the smooth functioning of the Pharmacovigilance activities
How can the legal team support the smooth functioning of the Pharmacovigilance department?
Module 12 - A Successful Career in the field of Pharmacovigilance and Patient Safety
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
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
Artificial Intelligence / Machine Learning for Screening relevant Pharmacovigilance CVs. The use of the right keywords is essential to ensure that your CV gets shortlisted.
Learn how the career can evolve in the Pharmacovigilance Industry
Final Assessment
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