Real-world data (RWD) has revolutionized the field of pharmacovigilance and regulatory decision-making. While clinical trials provide valuable insights into the safety and efficacy of medications, RWD offers a comprehensive view of a drug's performance in real-world settings. In this blog post, we will explore the significant impact of RWD in pharmacovigilance and how it has transformed the way regulatory decisions are made. We will discuss the benefits of utilizing RWD, the challenges associated with its implementation, and its potential to improve patient safety and healthcare outcomes.

1. Welcome
THE IMPACT OF REAL-WORLD DATA IN
PHARMACOVIGILANCE AND REGULATORY
DECISION-MAKING
K. Pavani
B. Pharmacy
Student ID : CLS_0103/052023
10/18/2022
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2. Index
• Definition of real world data
• Sources of real world data
• Real world data
• Impact of real world data in pharmacovigilance and
regulatory decision making
• Conclusion
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3. DEFINITION
REAL WORLD DATA
Real word data is a data relating to patients health status
or patients outcome that are collected from a variety of sources.
PHARMACOVIGILANCE
Pharmacovigilance refers to the science and activities
relating to the detection, assessment, understanding, and
prevention of adverse effects and other drug-related safety
problems.
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4. SOURCES OF REAL WORLD DATA
• Electronic Health Records
• Administrative claims
• Patient reported outcomes
• Patient registries
• Specific disease registries
• Social media and online forums
• Environmental factors and social determinants of health
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5. REAL WORLD DATA IN
PHARMACOVIGILANCE AND
REGULATORY DECISION MAKING
 The real world data has become more and more important in fields
of pharmacovigilance and regulatory decision making in recent
years.
 This RWD provides information of drug safety and effectiveness
from the data collected from real world sources.
 This is the data that is collected beyond the clinical trials.
 Regulatory agencies such as FDA ad EMA have recognized the
importance of RWD in supplementing clinical data and informing
regulatory decisions.
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6.  It is different from the data that is collected from
clinical trials as it collects the data from daily basis in
real world.
 It helps to identify the rare and long term adverse
effects and evaluates drug safety profiles.
 By identifying all the data it takes appropriate
regulatory decisions.
 It is more important in public health surveillance and
outbreak of adverse events detection.
 It mainly challenges the data quality issues, missing
or incomplete information and takes appropriate
protective measures for the real world population.
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7. IMPACTS OF REAL WORLD DATA IN
PHARMACOVIGILANCE AND
REGULATORY DECISION MAKING
• Post-marketing Surveillance
• Signal Detection
• Comparative Effectiveness Research
• Pharmacovigilance System Improvement
• Regulatory Decision Making
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8. 10/18/2022
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Post-
marketing
surveillance
Signal
detection
Comparative
effectiveness
research
Regulatory
decision
making
Pharmaco
-vigilance
system
improve-
ment

9. 1.POST-MARKETING SURVEILLANCE
• The real world data helps to monitor continuously the
adverse effects and safety of drug after the release of
product into market.
• Adverse drug reactions and safety are detected by
analyzing the data from the sources for safety concern
of population.
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10. SIGNAL DETECTION
• Real world data helps to identify the safety signals that
have not been identified during the process of clinical
trials.
• This real world data signals the safety issues and
detects and helps the pharmaceutical companies to
take appropriate actions with respect to the isssues.
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11. COMPARATIVE EFFECTIVENESS
RESEARCH
• By RWD the regulators can assess the impact of drugs
in routine clinical practice and compare different
treatment options and makes some regulatory decisions.
• It helps to compare the risks and benefits of a drug
among populations.
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12. PHARMACOVIGILANCE IMPROVEMENT
SYSTEM
• The RWD plays a key role in pharmacovigilance
system that monitors the safety of drugs when they are
in the market for sale.
• The main aim is to detect, analyze, understanding and
prevention of adverse events.
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13. REGULATORY DECISION MAKING
• The RWD has been more used by the regulatory
agencies to support decision making processes.
• By this data, the regulators assess the safety and
efficacy, risk management and support drug drug
approval and post approval.
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14. CONCLUSION
From this we conclude that, the RWD mainly collects the
data from electronic health records, administrative claims, patient
registries, specific disease registries and other sources. This mainly
focusses on the drug safety profile, its effectiveness, comparative
treatment operations and evaluation, detection and prevention of
adverse events when on the market. It helps the regulators to take a
proper decision making regarding the drug’s safety.
it is important to know that the RWD in pharmacovigilance and
regulatory decision making also come with some challenges
regarding the quality, safety and prevention.
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15. Thank You!
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