Pharmacovigilance, derived from the Greek words "pharmakon" (drug) and "vigilare" (to keep watch), is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It has a rich history that spans centuries, evolving in response to medical advancements, regulatory changes, and societal needs. The roots of pharmacovigilance can be traced back to ancient civilizations where healers and physicians observed and documented the effects of various medicinal substances. However, the formalization of pharmacovigilance began in the 20th century with significant milestones shaping its development. In the early 20th century, the introduction of potent drugs like digitalis and barbiturates highlighted the need for monitoring their safety. However, it wasn't until the thalidomide tragedy of the 1950s and 1960s, where thousands of babies were born with severe birth defects due to prenatal exposure to the drug, that pharmacovigilance gained widespread recognition. This catastrophic event underscored the importance of systematic surveillance and led to the establishment of regulatory frameworks to ensure drug safety. The 1960s witnessed the creation of formal pharmacovigilance systems by regulatory agencies such as the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). These systems aimed to collect, analyze, and disseminate information on adverse drug reactions (ADRs) through spontaneous reporting systems. The thalidomide tragedy also spurred the development of pharmacovigilance legislation worldwide. In 1961, the Kefauver-Harris Amendments in the United States mandated pre-market approval of drugs, rigorous testing, and post-marketing surveillance. Similar regulatory measures were adopted globally, emphasizing the importance of continuous monitoring of drugs throughout their lifecycle. The 1970s and 1980s saw further advancements in pharmacovigilance methodologies and infrastructure. The WHO established the International Drug Monitoring Program (IDMP) in 1968, facilitating international collaboration in ADR reporting and analysis. Additionally, technological innovations, such as computerized databases and signal detection algorithms, enhanced the efficiency and accuracy of pharmacovigilance activities. The 1990s marked a period of globalization and harmonization in pharmacovigilance. The International Conference on Harmonization (ICH) developed guidelines to standardize pharmacovigilance practices across regions, promoting consistency in data collection, analysis, and reporting. Furthermore, the emergence of the internet facilitated direct patient reporting of ADRs, empowering individuals to contribute to drug safety surveillance. In the 21st century, pharmacovigilance has continued to evolve in response to emerging challenges and opportunities. The proliferation of biological therapies, personalized medicine, and pharmacogenomics has ne

1. History and Development of
Pharmacovigilance
Pharmacovigilance is a vital field that safeguards public health by monitoring the safety of
pharmaceutical drugs throughout their lifecycle. This presentation explores the pivotal moments, key
milestones, and ongoing advancements that have shaped the evolution of this critical discipline.
by Sasikiran Marri

2. Introduction to Pharmacovigilance
Pharmacovigilanceis the science and activitiesrelating to the detection, assessment, understanding, and
prevention of adverse effects or any other medicine-related problem. It is essential for ensuring the safe and
effectiveuse of drugs bycontinuously evaluating their benefits and risks. This overview will highlight the
importance of drug safety monitoring and provide a roadmap for the journey ahead.
1 Definition of
Pharmacovigilance
The systematic
collection, detection,
assessment, monitoring,
and prevention of
adverse effects with
pharmaceutical
products.
2 Importance of
Monitoring Drug
Safety
Identifying and
mitigating potential risks
associated with
medicines to protect
public health and
promote safe, effective
drug use.
3 Overview of
Presentation
Structure
Tracing the history,
development, and
advancements of
pharmacovigilance
systems and practices
over time.

3. The Thalidomide Tragedy
The Thalidomide disaster of the 1950s and 1960s was a watershed moment that catalyzed the establishment of modern
pharmacovigilance systems. This tragic event, where the drug Thalidomide caused severe birth defects in thousands of
children, exposed the urgent need for robust drug safety monitoring and regulation.
1 Thalidomide Disaster
The drug Thalidomide, promoted as a sedative and treatment for morning sickness in
pregnant women, was found to cause devastating birth defects in newborns.
2 Impact on Regulation
The Thalidomide tragedy led to major reforms in drug safety regulation, including the
introduction of rigorous pre-market testing and post-marketing surveillance requirements.
3 Catalyst for Pharmacovigilance
This pivotal event was the driving force behind the establishment of national and
international pharmacovigilance programs to systematically monitor and address drug
safety concerns.

4. Establishing Pharmacovigilance Systems
In the aftermath of the Thalidomide disaster, concerted efforts were made to develop comprehensive
pharmacovigilance systems at both the national and international levels. This section explores the key
milestones in the formation of these crucial drug safety monitoring frameworks.
National
Pharmacovigilance
Programs
Many countries established
dedicated national
pharmacovigilance centers to
collect, analyze, and respond
to adverse drug reaction
reports from healthcare
providers and the public.
Role of the World
Health Organization
(WHO)
The WHO played a pivotal role
in coordinating global
pharmacovigilance efforts,
including the creation of the
Uppsala Monitoring Centre
(UMC) to manage the WHO
Programme for International
Drug Monitoring.
Early Pharmacovigilance
Initiatives
In the 1960s and 1970s,
pharmaceutical companies,
regulatory authorities, and
healthcare professionals
began implementing
systematic processes for the
surveillance and reporting of
adverse drug reactions.

5. International Collaboration in
Pharmacovigilance
Recognizing the global nature of drug safety, the pharmacovigilance community has focused on fostering
international cooperation and coordination. This section highlights key initiatives and the importance of
cross-border collaboration in strengthening worldwide drug safety monitoring.
International Corporation
initiatives
The establishment of
organizations like the
International Conference on
Harmonisation (ICH) and the
International Society of
Pharmacovigilance (ISoP) have
facilitated the harmonization of
global standardsand best
practices.
Strengthening Global
Networks
The development of robust
international
pharmacovigilance networks
has enabled the sharing of data,
expertise, and resources,
leading to more efficient and
effective drug safety monitoring
worldwide.
Importance of Cross-
Border Cooperation
The globalization of the
pharmaceutical industry and the
need to addresssafety issues
that transcend national
boundaries have underscored
the critical role of international
collaboration in
pharmacovigilance.

6. Advancements in Pharmacovigilance
Systems
Over the decades,pharmacovigilancehas undergonesignificant technologicaland operational
advancementsthat have transformedthe way drug safetyinformationis collected,analyzed, and
disseminated.This sectionexploressomeof the keydevelopmentsthat have shaped the moderneraof
pharmacovigilance.
1
Electronic Reporting Systems
The introductionof electronic
databases,such as VigiBase,the WHO
global database of individual case
safetyreports,has revolutionizedthe
way adversedrug reactionsare
reportedand analyzed.
2 Advantages of Electronic
Reporting
Electronicreportingsystemshave
improveddata collection,enabled real-
timemonitoring,and facilitatedmore
efficientanalysis of safetysignals,
leading to quicker detectionand
responseto potentialdrug safety
issues.
3
Expanding Data Sources
Pharmacovigilancehas evolvedto
incorporatea broaderrange of data
sources,including electronichealth
records,patient registries,and social
media,providing a more
comprehensiveunderstandingof drug
safetyprofiles.

7. Regulatory Frameworks for
Pharmacovigilance
As pharmacovigilancehas becomemoreessentialto publichealth,regulatoryauthoritieshaveimplemented
increasinglycomprehensiveframeworksto governdrugsafetymonitoringandriskmanagement.This section
highlightssomeof thekeyregulatorydevelopmentsthathaveshapedthemodernpharmacovigilance
landscape.
EU Pharmacovigilance
Legislation
TheEuropeanUnionhas
establishedrobust
pharmacovigilance
regulations,includingtheEU
PharmacovigilanceDirective
andRegulation,which
mandatecomprehensivepost-
marketingsurveillanceand
riskmanagementplanningfor
marketedproducts.
FDA Amendments Act
In theUnitedStates,theFood
andDrugAdministration
AmendmentsAct(FDAAA)has
significantlyexpandedthe
pharmacovigilance
requirementsfordrug
manufacturers,including
mandatorypostmarketing
studiesandtheimplementation
of RiskEvaluationandMitigation
Strategies(REMS).
Integrating
Pharmacovigilance
Regulatoryframeworks
haveincreasingly
emphasizedthe
importanceof integrating
pharmacovigilance
throughouttheentiredrug
developmentlifecycle,from
pre-clinicaltrialsto post-
marketingsurveillance.

8. Pharmacovigilance in Drug Development
Pharmacovigilancehas becomean integral component of the drug development process, ensuring that safety
considerations are addressed at every stage. This section explores how pharmacovigilance has been
increasingly incorporated into the lifecycle of pharmaceutical products, from clinical trials to post-marketing
surveillance.
Pharmacovigilance in
Drug Lifecycle
Pharmacovigilanceactivities,
such as adverse event
reporting, safety signal
detection, and risk
management planning, are
now woven into the drug
development process, from
pre-clinical studies to post-
marketing surveillance.
Importance of Post-
Marketing Surveillance
Post-marketing surveillance
studies have becomecrucial
for identifying and addressing
potential safety issues that
may not have been detected
during clinical trials, which
often have limited sample sizes
and durations.
Risk Management
Planning
Comprehensive risk
management planning,
including the development of
Risk Evaluation and Mitigation
Strategies (REMS), has become
a standard requirement for
marketed products to
proactively address and
mitigateidentified safety risks.

9. Advancements in Pharmacovigilance
Analytics
The fieldof pharmacovigilancehas alsoseensignificantadvancementsin dataminingand signaldetection
techniques,leveragingemergingtechnologiestoenhancethe identificationand assessmentof potentialdrug
safetyissues.
Data Mining Techniques
Sophisticateddataminingalgorithmsand statisticalmethodsarebeingemployedtoanalyze
large,diversedatasetsand detectpotentialsafetysignalsmoreefficiently.
Artificial Intelligence and Machine Learning
The integrationof artificialintelligenceand machinelearningcapabilitieshas enabledthe
automationand optimizationof signaldetection,riskassessment,and decision-making
processesinpharmacovigilance.
Enhanced Signal Detection and Risk Assessment
Thesetechnologicaladvancementshave significantlyimprovedthe abilitytoidentify,
evaluate,and respondtopotentialdrugsafetyissuesin a moretimelyand effectivemanner,
ultimatelyenhancingpatientsafety.

10. The Future of Pharmacovigilance
As the field of pharmacovigilance continues to evolve, there are exciting opportunities and challenges on the
horizon. This final section highlights the key trends and future directions that will shape the future of drug
safety monitoring and promotion of public health.
Continued Innovation
Ongoing advancements in
data collection, analytics,
and technology will drive
further enhancements in
pharmacovigilance,
allowing for more
comprehensive, real-time
monitoring and rapid
response to emerging safety
concerns.
Enhancing Global
Collaboration
The importance of
international cooperation
and the sharing of data,
expertise, and best
practices will only grow, as
the pharmaceutical industry
and drug safety challenges
become increasingly global
in nature.
Addressing Future
Challenges
Emerging issues such as the rise
of biologics, personalized
medicine, and the increasing
prevalence of digital health
technologies will require the
pharmacovigilance community
to adapt and develop innovative
approaches to ensure the
continued safety of
pharmaceutical products.