PHARMA-
COVIGILANCE
MENTORSHIP
WHAT IS
PHARMA-
COVIGILANCE
Pharmacovigilance is a crucial aspect of the healthcare system that involves the science
and activities related to the adverse effects or any other drug-related problems.
Detection Assessment Understanding Prevention
The primary goal of pharmacovigilance is to :
Improve patient safety
Ensure the rational and effective use of
medications.
COURSE
EXPLAINED
Imagine a superhero is keeping everyone safe from the bad side effects of
medicines! That's what Pharmacovigilance is all about. .
It's like being a medicine detective, always on the lookout for
any trouble drugs might cause
They're like the first line of defense, noticing
DOCTORS AND NURSES any unusual reactions patients might have
after taking a medicine.
They're the detectives, collecting reports from
PCV EXPERTS doctors and nurses to understand if there's a
pattern of bad side effects.
They're the brains of the operation, figuring
SCIENTISTS out why these side effects happen and how
to prevent them in the future.
They're the enforcers, making sure medicine
REGULATORY AGENCIES companies are honest about potential side
effects and take action if any serious issues arise.
COURSE TIMELINE
Drug Discovery &
Developmental Safety & Risk Periodic Safety
Research Process Analysis Update Reports
2 4 6
1 3 5
Aim & Principles in Causality Ethics & Regulations
Pharmacovigilance Assessment & ADRs
6
Modules Time 2
- -
Covered Alloted Months
MODULE ONE
Adverse Events (AE): Think of AEs as any unexpected, unfavorable event that occurs
during a patient's treatment. This could be anything from a minor headache to a life-
threatening allergic reaction.
Adverse Drug Reactions (ADR): ADRs are a subset of AEs that are suspected to be
caused by the medication.
ORIGIN OF MODERN PV : Thalidomide and the emergence of ADR reporting
and Drug Legislation
Principle of ICH-GCP : International Council for Harmonisation (ICH) Good Clinical
Practice (GCP) is a set of ethical and scientific principles that guide the design, conduct,
performance, monitoring, auditing, of clinical trials involving human subjects.
REGULATORY BODIES : Institutional Review Board and Institutional Ethics Committee
MODULE TWO
Drug Discoveries & Usage (1774-1998) : Edward Jenner's smallpox vaccine (1796)
and morphine isolation (1804)
History of Clinical Research : Nuremberg Code (1947), Declaration of Helsinki (1964),
Belmont Report (1979), Indian Council of Medical Research (1980)
Research Process as per GCP : Single Ascending Dose ; Maximum Tolerated Dose
Multiple Ascending Dose ; Food Effects ; Toxic Effects ; Efficacy ; Safety (Post
Marketing Surveillance)
STUDY DESIGNS in Clinical Trials : Controlled Trials ; Crossover Trials ; Parallel Trials
Blinded Trials ; Double Blinded Trials ; Randomised Trials ; Prevention Trials ;
Treatment Trials
MODULE THREE
This module dives deep into the heart of Pharmacovigilance – understanding and
assessing Adverse Drug Reactions (ADRs).
MedDRA: This standardized medical dictionary provides consistent terminology for
describing ADRs across different languages and databases, facilitating global
communication and data sharing.
Expectedness of Adverse Events: Known vs. Unknown: Expected ADRs are listed in
the drug's label, while unknown ADRs require further investigation and reporting.
Dechallenge: Stopping the suspected drug and observing if the ADR resolves
Rechallenge: Re-administering the drug under controlled conditions to
confirm the ADR's recurrence
MODULE FOUR
Module 4 dives into the practical aspects of ensuring medication and medical
device safety through the following mechanism.
Safety Data Preventive Risk
Measures Recording Strategy Analysis
MODULE FIVE
Module 5 delves into the crucial aspects of ethical conduct and regulatory
frameworks governing Pharmacovigilance across various regions.
International Drug Monitoring: World Health Organization (WHO) Programme on
International Drug Monitoring. International Council for Harmonisation (ICH)
Guidelines. Pharmacovigilance Working Group of the International Pharmaceutical
Manufacturers Association (IPPMA)
National Pharmacovigilance Regulations : India: Central Drugs Standard Control
Organization (CDSCO); USA: Food and Drug Administration (FDA) ; EU: European
Medicines Agency (EMA) ; UK: Medicines and Healthcare products Regulatory Agency
(MHRA) ; Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
Reporting Guidelines : CIOMS (Council for International Organizations of Medical
Sciences), CIOMS-I (India), MedWatch (FDA), and Yellow Card (UK)
MODULE SIX
Module 6 delves into the crucial realm of post-marketing surveillance and Periodic
Safety Update Reports (PSURs) in India, ensuring continued monitoring of
medication safety after market authorization.
PSUR - Comprehensive safety reports: Compiled by pharmaceutical companies at
regular intervals (usually every 6 months for the first 3 years), summarizing all
available safety data on a drug.
Types of Reports in India : Individual Case Safety Reports (ICSRs) ; Serious Adverse
Event Reports (SAErs) ; Periodic Safety Reports (PSURs)
YELLOW CARD : A well-established scheme where patients and healthcare
professionals can directly report ADRs. CDSCO's Pharmacovigilance Programme of
India (PvPI) website provides an online platform for reporting ADRs
