Real-world data (RWD) has emerged as a transformative force in the field of pharmacovigilance, significantly influencing regulatory decision-making processes. Unlike data generated in controlled clinical trials, RWD reflects the everyday clinical experiences and outcomes of patients in real-world settings. The impact of integrating RWD into pharmacovigilance and regulatory decision-making is multifaceted and has profound implications for patient safety, drug development, and healthcare policymaking

1. Welcome
THE IMPACT OF REAL WORLD DATA IN
PHARMACOVIGILANCE AND REGULATORY DECISION
MAKING
Student’s Name- K.Manogna
B. Pharmacy
Student ID – CLS_219/112023
10/18/2022
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2. Introduction
• Real world data and real world evidence are drawing ever increasing attention in
the pharmaceutical and dug regulatory authorities.
• This is due to their paramount role in supporting the Drug development and
regulatory decision making.
• However there is a little systematic way for the use of RWE by the regulatory
authorities in evaluating new treatment approaches.
• Different strategies have been applied by the FDA, EMA, and NMPA for the
development of the RWD
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3. Real World Data
• Data relating to the patient health status and the delivery of health acre
routinely collected from a variety of sources.
• It can also be described as the data collected during routine clinical
practice in the real-world or by the patients going about their daily lives.
• Clinical evidence regarding the usuage and potential benefits and risks of a
medical product derived from analysis of real world data(RWD)
• RWE can be generated through randomized clinical trials or observational
studies
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4. Sources for RWD
• Electronic health records
• Claims data
• Prescription data
• Patient registries
• Wearables
• Medical health apps
• Environmental data includes data on social status and other
lifestyle factors.
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5. Why we need RWD
The majority of the current literature on RWD mainly focuses on the
following aspects :
• Drug clinical development and evaluation
• Assisting drug regulatory decision making
• Pharmacovigilance
• Post marketing research
• Evaluating clinical treatment effects
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6. Comparision with Randomized
clinical trails (RCTs)
• Traditionally, regulatory approvals of of new drugs have always
been largely based on the randomized clinical trails(RCTs).
• There are some drawbacks with RCTs when compared with the
RWD.
1. Multiple comorbid conditions can be easily compromised
with the exclusion of population subsets in RCTs.
2. Developing the evidence base for the proper use of treatment
or drug is limited.
• Therefore RWD play an complementary role to RCTs with
much needed information from real life practices to support
regulatory decision making.
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7. Conclusion
• The digitalization of the health care and increasingly lifestyle data brings new
opportunities to complement and enhance the data traditionally utilized in the
regulatory decision making, the combination of scientific and technological
advances, the quality of evidence generated and the consistency of regulatory
decision making can be optimized.
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8. ThankYou!
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