Certificate Course in Pharmacovigilance

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

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

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

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?

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.

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

SDEA or PVA

PSMF

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.

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).

The impact of product complaints on Patient Safety

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

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

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.

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?

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