Post Marketing Surveillance and Pharmacoepidemiology

International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 7 Issue 4, July-August 2023 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
@ IJTSRD | Unique Paper ID – IJTSRD59690 | Volume – 7 | Issue – 4 | Jul-Aug 2023 Page 397
Post-Marketing Surveillance and Pharmacoepidemiology
Dr. Farheen Yousuf
M.B.B.S, Student at ClinoSol Research, Hyderabad, India
ABSTRACT
Post-Marketing Surveillance (PMS) and pharmacoepidemiology are
essential components of drug safety monitoring and effectiveness
evaluation in real-world clinical settings. PMS involves the
continuous monitoring of pharmaceutical products after regulatory
approval to detect and assess adverse events and safety issues that
may not have surfaced during pre-marketing clinical trials.
Pharmacoepidemiology, on the other hand, employs epidemiological
methods to study the effects of drugs in large populations, utilizing
real-world data from various sources. This article explores the
significance of PMS and pharmacoepidemiology in ensuring patient
safety, highlights their mutual contributions in research, and
underscores the importance of collaborative efforts between
regulatory agencies, academia, and pharmaceutical companies. The
challenges related to data quality, privacy, and ethical considerations
are discussed, along with potential advancements in methodologies
and the integration of new technologies for future research and
vigilance in drug safety and public health.
KEYWORDS: Post-Marketing Surveillance, Pharmacoepidemiology,
Drug Safety, Real-World Data, Collaborative Efforts
How to cite this paper: Dr. Farheen
Yousuf "Post-Marketing Surveillance
and Pharmacoepidemiology" Published
in International
Journal of Trend in
Scientific Research
and Development
(ijtsrd), ISSN:
2456-6470,
Volume-7 | Issue-4,
August 2023,
pp.397-403, URL:
www.ijtsrd.com/papers/ijtsrd59690.pdf
Copyright © 2023 by author (s) and
International Journal of Trend in
Scientific Research and Development
Journal. This is an
Open Access article
distributed under the
terms of the Creative Commons
Attribution License (CC BY 4.0)
(http://creativecommons.org/licenses/by/4.0)
INTRODUCTION
Post-Marketing Surveillance (PMS) and
Pharmacoepidemiology play crucial roles in ensuring
drug safety and safeguarding public health. In the
pharmaceutical industry, the journey of a drug does
not end with its approval by regulatory agencies. In
fact, it marks the beginning of a new phase where the
drug is introduced to the general population,
potentially reaching millions of patients worldwide.
While clinical trials conducted during drug
development provide valuable information about a
drug's efficacy and safety in a controlled setting, they
often involve a limited number of participants and
have restricted durations. Post-marketing surveillance
and pharmacoepidemiology step in to monitor the
drug's performance in real-world settings, generating
vital evidence on its safety and effectiveness as it is
used by diverse patient populations over extended
periods. [1]
Post-Marketing Surveillance (PMS) refers to the
systematic and continuous monitoring of
pharmaceutical products once they have been
approved and made available in the market. It
involves the collection, analysis, and evaluation of
data related to adverse drug reactions (ADRs) and
other potential safety issues that may not have
surfaced during pre-marketing clinical trials. PMS
serves as a crucial mechanism to detect and assess
rare or long-term adverse effects, drug interactions,
and unexpected safety concerns that may not have
been apparent during the drug's initial testing.[1,2]
Pharmacoepidemiology, on the other hand, is a
branch of epidemiology that deals specifically with
the study of the utilization and effects of drugs in
large populations. It involves the application of
epidemiological methods to investigate the
relationship between drug exposure and health
outcomes. Pharmacoepidemiological studies utilize
real-world data from various sources, such as
electronic health records, claims databases, and
national health registries, to evaluate the safety and
effectiveness of drugs under routine clinical practice.
Importance of PMS and Pharmacoepidemiology in
drug safety and public health
The importance of Post-Marketing Surveillance and
Pharmacoepidemiology cannot be overstated. While
pre-marketing clinical trials are essential for
demonstrating a drug's safety and efficacy under
controlled conditions, they have limitations in terms
of sample size, study duration, and patient diversity.
IJTSRD59690

International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
Once a drug is approved and reaches a broader patient
population, it may be used by individuals with
different comorbidities, age groups, and genetic
backgrounds. PMS and pharmacoepidemiological
studies are invaluable in capturing real-world data
and identifying potential safety issues that may not
have been evident during the initial trials.
Early detection of adverse drug reactions through
PMS can lead to timely interventions, such as label
changes, contraindications, or even withdrawal of the
drug from the market if the risks outweigh the
benefits. This proactive approach helps protect
patients from harm and enhances drug safety. [2]
Moreover, Pharmacoepidemiology plays a vital role
in understanding drug effectiveness in various
subpopulations, helping healthcare providers make
informed treatment decisions tailored to individual
patient needs. By evaluating the effectiveness of
drugs in real-world settings, these studies contribute
to evidence-based medicine and the optimization of
treatment outcomes.
In terms of public health, PMS and
pharmacoepidemiology contribute to the surveillance
of drug-related issues at a population level. They aid
regulatory agencies in monitoring the overall safety
profile of drugs and identifying potential safety
signals that may not have been evident during clinical
trials. This information enables health authorities to
develop and implement targeted public health
interventions, thereby safeguarding the health of the
broader community. [3]
Overview of the article's content
This article aims to provide a comprehensive
overview of Post-Marketing Surveillance (PMS) and
Pharmacoepidemiology, highlighting their
significance in drug safety and public health. The
article will delve into the definitions of PMS and
pharmacoepidemiology, elucidating their roles in the
continuous monitoring of drugs and the evaluation of
their real-world impact.
The content will cover the distinct yet interconnected
aspects of PMS and pharmacoepidemiology,
beginning with an exploration of PMS and its
purpose. The differences between pre-marketing
clinical trials and post-marketing surveillance will be
emphasized to illustrate the necessityof both stages in
the drug development process.
The article will shed light on the pivotal role of
regulatory agencies in PMS and the methods and data
sources used in these surveillance efforts. Advantages
and limitations of PMS studies will be discussed to
provide a comprehensive view of their impact on drug
safety.
Subsequently, the focus will shift to
pharmacoepidemiology, encompassing its definition,
scope, and the significance of conducting
pharmacoepidemiological studies in evaluating drug
safety and effectiveness. Key principles and study
designs in pharmacoepidemiology will be elaborated
upon, with examples of common data sources and
methodologies used in such research.
The intersection between PMS and
pharmacoepidemiology will be explored to emphasize
how the two fields complement each other. Case
studies will be presented to demonstrate instances
where PMS data significantly contributed to
pharmacoepidemiological research and vice versa. [3]
Post-Marketing Surveillance (PMS)
Post-Marketing Surveillance (PMS) is the systematic
and ongoing process of monitoring pharmaceutical
products, medical devices, and vaccines after they
have been approved and made available to the general
public. The primary purpose of PMS is to detect,
assess, and evaluate the safety and effectiveness of
these products in real-world clinical settings. While
pre-marketing clinical trials provide essential data on
a drug's safety and efficacy under controlled
conditions, they often involve a limited number of
participants and have a relatively short duration. PMS
serves as a critical component of pharmacovigilance,
allowing for the identification of adverse drug
reactions (ADRs) and other safety issues that maynot
have been apparent during pre-approval testing. [4]
Distinction between pre-marketing clinical trials
and post-marketing surveillance
Pre-marketing clinical trials are conducted during the
early stages of drug development to evaluate a new
pharmaceutical product's safety and efficacy. These
trials involve controlled settings, carefully selected
patient populations, and close monitoring of
participants. In contrast, post-marketing surveillance
occurs after the drug is approved and enters the
market, allowing for its use by a much larger and
diverse population. The distinction lies in the study
environment and the number of participants involved.
Pre-marketing clinical trials are tightly regulated and
follow strict protocols to gather data under controlled
conditions. The focus is on proving the drug's safety
and efficacy to gain regulatory approval. In contrast,
PMS is less restrictive and aims to collect data from
real-world patients with varying characteristics, co-
morbidities, and treatment regimens. PMS is not
intended to replicate the conditions of clinical trials
but rather to monitor the drug's performance under
everyday clinical practice.[5]

Role of regulatory agencies in PMS (e.g., FDA,
EMA)
Regulatory agencies, such as the Food and Drug
Administration (FDA) in the United States and the
European Medicines Agency (EMA) in Europe, play
a central role in overseeing post-marketing
surveillance activities. They require pharmaceutical
companies to implement PMS programs as a
condition of drug approval to ensure ongoing safety
monitoring once the product reaches the market.
These agencies collaborate with pharmaceutical
companies, healthcare professionals, and the general
public to collect and analyze safety data from various
sources, such as spontaneous reporting systems,
electronic health records, and medical literature. They
use this data to assess the risk-benefit profile of drugs
continuously and take appropriate actions to
safeguard public health. These actions may include
issuing safety communications, updating drug labels,
implementing Risk Evaluation and Mitigation
Strategies (REMS), or, in extreme cases, removing
drugs from the market if serious safety concerns arise.
Methods and data sources used in PMS
Several methods and data sources are employed in
Post-Marketing Surveillance to monitor the safety and
effectiveness of pharmaceutical products:
Spontaneous Reporting Systems: Healthcare
professionals and patients can voluntarily report
adverse reactions to regulatory agencies or drug
manufacturers. These reports contribute to the
detection of potential safety signals.
Electronic Health Records (EHRs): Real-world
data from EHRs provide valuable information on
drug utilization and patient outcomes in routine
clinical practice.
Pharmacoepidemiological Studies: These
observational studies use large databases to analyze
the association between drug exposure and adverse
events in the general population.
Active Surveillance Systems: These systems involve
proactive monitoring of specific patient populations
to detect adverse events, especially in cases of high-
risk medications or vulnerable patient groups.
Patient Registries: Registries collect data from
patients with specific medical conditions or those
prescribed certain drugs to gain insights into long-
term safety and effectiveness.
Advantages and limitations of PMS studies
Advantages:
Early Detection of Adverse Events: PMS allows
for the detection of rare or long-term adverse
events that may not have been apparent during
pre-marketing clinical trials due to the larger and
more diverse patient population.
Real-World Data: PMS studies utilize real-world
data, providing insights into a drug's performance
under routine clinical practice and patient
variability.
Continuous Monitoring: PMS provides ongoing
safety surveillance, enabling timely interventions
if safety concerns arise, ensuring patient safety.
Pharmacovigilance Feedback Loop: Data from
PMS contribute to the feedback loop for
pharmacovigilance, enabling regulatory agencies
to update drug labels with new safety information.
[6]
Limitations:
Underreporting: Spontaneous reporting systems
are subject to underreporting, as not all adverse
events are reported by healthcare professionals or
patients.
Data Quality and Completeness: The reliability
and completeness of data from various sources
can vary, impacting the accuracy of PMS
findings.
Confounding Factors: Observational nature of
PMS studies may lead to potential biases due to
confounding factors that are difficult to control
for.
Generalizability: PMS studies may not fully
represent all patient populations, as certain groups
may be underrepresented in the data.
The Intersection of PMS and
Pharmacoepidemiology
The intersection of Post-Marketing Surveillance
(PMS) and Pharmacoepidemiology brings together
two powerful sources of data to enhance our
understanding of drug safety and effectiveness in
real-world settings. PMS data contributes
significantly to pharmacoepidemiological research in
the following ways:
Early Signal Detection: PMS data allows for the
early detection of potential safety concerns, which
can then be further investigated using
pharmacoepidemiological methods. Adverse
events reported through spontaneous reporting
systems or identified in active surveillance can
trigger epidemiological studies to assess causality
and risk.
Generating Hypotheses: PMS data often provides
valuable insights into unexpected drug outcomes
or associations. These observations can lead to the
formulation of research hypotheses that can be

rigorously examined through
pharmacoepidemiological studies using large-
scale, real-world data.
Identifying High-Risk Subgroups: PMS data can
highlight patient subgroups that may be at higher
risk for certain adverse events.
Pharmacoepidemiological studies can delve
deeper into these subgroups to understand the
underlying factors contributing to the risks and
tailor interventions accordingly.
Comparative Effectiveness Research: PMS data
can shed light on the real-world effectiveness of
drugs in comparison to other treatment options.
Pharmacoepidemiological studies can then use
these comparative data to evaluate the relative
benefits and risks of different medications and
treatment strategies.
Rare Events Detection: PMS, being conducted on
a larger scale, allows for the identification of rare
adverse events that may not have been observable
in pre-marketing clinical trials.
Pharmacoepidemiology can further validate and
quantify the risks associated with these events. [7]
Utilization of pharmacoepidemiological methods
in PMS studies
Pharmacoepidemiological methods are increasingly
integrated into Post-Marketing Surveillance studies to
enhance the analysis and interpretation of safety and
effectiveness data. Some of the key ways in which
these methods are utilized in PMS studies include:
Cohort Studies: Pharmacoepidemiological cohort
studies are often employed to assess the safety
and effectiveness of a drug in a specific patient
population. PMS data can be used to create and
follow cohorts over time to understand the long-
term outcomes associated with drug use.
Case-Control Studies: In situations where certain
adverse events are rare, case-control studies can
be conducted using PMS data to compare the
exposure to a particular drug among patients with
and without the adverse event, helping identify
potential associations.
Propensity Score Matching: PMS data often
contains confounding variables, and propensity
score matching is a method used to control for
these confounders when comparing treatment
groups, allowing for more reliable estimates of
treatment effects.
Time-Series Analysis: Pharmacoepidemiological
time-series analysis can be applied to PMS data to
examine trends in drug utilization and adverse
event occurrences over time, enabling the
detection of potential safety signals.
Meta-Analysis: When PMS data from multiple
sources are available, pharmacoepidemiological
meta-analyses can be conducted to combine and
synthesize data, providing more robust evidence
on drug safety and effectiveness.
Case studies demonstrating the synergy between
PMS and pharmacoepidemiology
Case Study: Vioxx (Rofecoxib)
Vioxx, a nonsteroidal anti-inflammatory drug
(NSAID), was withdrawn from the market due to
an increased risk of cardiovascular events. PMS
data initially raised concerns about this risk,
leading to further pharmacoepidemiological
studies that confirmed the association and
quantified the risks. The integration of PMS data
and pharmacoepidemiological methods played a
pivotal role in the drug's withdrawal, preventing
potential harm to millions of patients.
Case Study: Pandemrix (H1N1 Influenza
Vaccine)
The H1N1 influenza vaccine Pandemrix was
associated with an increased risk of narcolepsy in
certain patient groups, particularly children and
adolescents. PMS data provided initial signals of
this safety concern, prompting
pharmacoepidemiological investigations to
confirm the association and assess the risk in
different age groups. This synergy between PMS
and pharmacoepidemiology highlighted the need
for careful consideration of vaccine safety,
especially during mass vaccination campaigns.
Case Study: Statins and Myopathy
Post-Marketing Surveillance data for statin use
raised questions about the risk of myopathy, a
muscle-related adverse event.
Pharmacoepidemiological studies were conducted
to assess the risk in different statin users and
identify contributing factors. The combination of
PMS data and pharmacoepidemiological analyses
helped healthcare providers make informed
decisions regarding statin use, considering both
their effectiveness in reducing cardiovascular risk
and the potential risk of myopathy. [8]
Challenges and Ethical Considerations
Challenges in conducting PMS and
pharmacoepidemiological studies
Data Availability and Quality: One of the primary
challenges is the availability and quality of data.
PMS and pharmacoepidemiological studies rely
on real-world data from various sources, and the
data may be incomplete, inaccurate, or lacking
crucial information.

Bias and Confounding: Observational nature of
both PMS and pharmacoepidemiological studies
makes them susceptible to biases and
confounding variables that can influence study
outcomes. It is challenging to control for all
potential confounders, leading to potential
limitations in the study's validity.
Sample Size and Rare Events: Some adverse
events may be rare and require large sample sizes
to detect, making it challenging to study these
events effectively, especially when relying solely
on PMS data.
Time and Resource Constraints: PMS and
pharmacoepidemiological studies are time-
consuming and resource-intensive endeavors.
Gathering and analyzing real-world data can be
complex and demanding, requiring significant
financial and human resources.
Generalizability: Results from PMS and
pharmacoepidemiological studies maynot always
be directly applicable to the entire population due
to inherent differences in patient characteristics
and healthcare practices across various regions.
Issues related to data quality and access
Data Privacy and Security: PMS and
pharmacoepidemiological research often involve
accessing sensitive patient information, raising
concerns about data privacy and security.
Safeguarding patient identities and protecting data
from unauthorized access is essential.
Data Fragmentation: Real-world data used in
PMS and pharmacoepidemiological studies may
be fragmented across multiple healthcare systems
and databases, making it challenging to aggregate
and standardize the information for analysis.
Data Interoperability: Different healthcare
systems may use varying formats and data
standards, hindering data interoperability and
complicating data integration for research
purposes.
Data Ownership and Sharing: Ownership and
control of real-world data can be complex,
involving multiple stakeholders, such as
healthcare providers, electronic health record
vendors, and regulatory agencies. Negotiating
data sharing agreements can be challenging.
Bias in Data Collection: Bias in data collection
can arise due to differences in healthcare-seeking
behavior, diagnostic practices, and reporting
practices, affecting the accuracy and
completeness of the data. [9]
Ethical considerations and patient privacy in PMS
and pharmacoepidemiological research
Informed Consent: Ethical considerations
surrounding informed consent can be challenging
in PMS and pharmacoepidemiological studies, as
they often involve the use of existing medical
records without direct patient consent. Balancing
the need for data access with patient autonomy is
critical.
Anonymization and De-identification: Ensuring
patient privacy is crucial in these studies.
Researchers must take appropriate measures to
anonymize and de-identify data to protect patient
identities.
Risk-Benefit Analysis: Ethical considerations
arise when evaluating the risks and benefits of
continuing a drug's use in the face of potential
safety concerns identified through PMS and
pharmacoepidemiological research.
Vulnerable Populations: Special attention must be
given to ethical considerations when studying
vulnerable populations, such as children, pregnant
women, and the elderly, to ensure their protection
and well-being.
Transparency and Data Sharing: Ethical
principles demand transparency in research
methods and findings. There is increasing
emphasis on data sharing to promote scientific
collaboration and independent validation of
results.
Institutional Review Board (IRB) Approval: PMS
and pharmacoepidemiological studies involving
human subjects require approval from an IRB to
ensure that the research adheres to ethical
guidelines and protects participants' rights.
Reporting of Results: Ethical considerations
extend to the timely and accurate reporting of
study results. Negative findings and safety
concerns must be communicated to regulatory
agencies, healthcare professionals, and the public
to prevent potential harm.
Future Directions
The future of Post-Marketing Surveillance (PMS) and
pharmacoepidemiological research holds tremendous
potential for advancements in methodologies to
further enhance drug safety monitoring and
effectiveness evaluation. Some key future directions
include:
Advanced Data Analytics: The integration of
machine learning, artificial intelligence, and
natural language processing can expedite the
analysis of large-scale data from various sources,

enabling the identification of safety signals and
associations more efficiently.
Real-Time Surveillance: Future PMS systems
may incorporate real-time monitoring of drug
safety data, allowing for immediate detection and
response to adverse events, which can lead to
more rapid regulatory interventions.
Longitudinal Studies: Longer follow-up periods
in pharmacoepidemiological studies can provide
insights into the long-term safety and
effectiveness of drugs, especially for chronic
conditions or medications taken over extended
periods.
Bayesian Methods: Bayesian statistical methods
can be applied to better handle complex data,
uncertainties, and prior information, leading to
more precise estimates of drug safety and
effectiveness.
Pharmacogenomics: Advancements in
pharmacogenomics can personalize drug therapy
based on an individual's genetic profile, leading to
more effective and safer treatment regimens.
Integration of new technologies and big data in
surveillance and research
Wearable Devices and Mobile Health Apps: The
integration of data from wearable devices and
mobile health apps can provide real-time data on
patient health, medication adherence, and
treatment outcomes, offering valuable inputs for
PMS and pharmacoepidemiological studies.
Electronic Health Records (EHRs): Improved
interoperability and standardization of EHR data
can facilitate data integration, enabling seamless
analysis across different healthcare systems and
enhancing the quality of real-world evidence.
Big Data Analytics: The utilization of big data
from diverse sources, such as social media, online
patient forums, and claims databases, can provide
a comprehensive understanding of drug safety and
effectiveness on a population level.
Blockchain Technology: Blockchain technology
can enhance data security, integrity, and
traceability in PMS and pharmacoepidemiological
studies, addressing concerns related to data
privacy and ownership.
Real-World Randomized Trials: Innovative trial
designs, such as pragmatic or adaptive
randomized trials, can bridge the gap between
traditional clinical trials and real-world evidence,
enabling more robust evaluations of drug
effectiveness in routine clinical practice.
Collaborative efforts between regulatory agencies,
academia, and pharmaceutical companies
Data Sharing Initiatives: Collaborative efforts
involving regulatory agencies, academia, and
pharmaceutical companies can promote data
sharing and data pooling to create more
comprehensive and diverse datasets for research.
Research Consortia: Establishing research
consortia can foster cooperation between
stakeholders, encouraging the exchange of
expertise, resources, and knowledge in the field of
PMS and pharmacoepidemiology.
Post-Approval Monitoring: Closer collaboration
between regulatory agencies and pharmaceutical
companies can facilitate more robust post-
approval monitoring plans, ensuring timely
detection and evaluation of drug safety concerns.
Public-Private Partnerships: Partnerships between
government entities, academic institutions, and
industry can accelerate research efforts, share best
practices, and leverage each other's strengths in
drug safety and effectiveness research.
Real-Time Data Sharing for Rapid Response:
Collaborative efforts can enable real-time data
sharing between stakeholders to respond promptly
to potential safety signals and take appropriate
actions to protect public health. [9, 10]
Conclusion
Post-Marketing Surveillance (PMS) and
pharmacoepidemiology are vital pillars in the realm
of drug safety and public health. While pre-marketing
clinical trials provide essential data for drug approval,
PMS fills the critical gap by monitoring drugs in real-
world settings, detecting adverse events, and
evaluating long-term safety and effectiveness.
Pharmacoepidemiology complements PMS by
employing rigorous research methods to analyze
large-scale real-world data and generate evidence on
drug outcomes. Together, these two disciplines form
a robust approach to continuously monitor drug
safety, identify potential risks, and make informed
decisions that protect patients and enhance healthcare
outcomes.
PMS and pharmacoepidemiology play pivotal roles in
the detection of rare adverse events, identification of
high-risk subgroups, and assessment of drug
effectiveness in diverse patient populations. By
integrating PMS data with pharmacoepidemiological
methods, researchers and regulatory agencies can
gain valuable insights into a drug's real-world
performance, enabling timely interventions and
improving patient care. Post-Marketing Surveillance
and pharmacoepidemiology serve as the cornerstone

of drug safety monitoring and effectiveness
evaluation. Their significance lies in their ability to
detect, assess, and respond to drug-related safety
concerns, ultimately safeguarding public health.
Continued research, collaborative efforts, and the
integration of new technologies are vital for
advancing these fields, promoting evidence-based
medicine, and ensuring the well-being of patients
worldwide. By embracing these principles, we can
build a safer and more effective healthcare landscape
for future generations.
References
[1] Kesselheim AS, Avorn J. Post-marketing
Surveillance-Lack of Vigilance, Lack of
Trust. JAMA Intern Med. 2015;175(6):861–
862. doi:10.1001/jamainternmed.2015.1106
[2] Suissa S. Immortal Time Bias in
Pharmacoepidemiology. Am J Epidemiol.
2008;167(4):492–499.
doi:10.1093/aje/kwm324
[3] European Medicines Agency. Post-
Authorisation Safety Studies (PASS).
Retrieved from
https://www.ema.europa.eu/en/human-
regulatory/post-authorisation/post-
authorisation-safety-studies-pass
[4] Food and Drug Administration (FDA). Post-
marketing Requirements and Commitments:
Reports. Retrieved from
https://www.fda.gov/drugs/postmarket-drug-
safety-information-patients-and-
providers/postmarketing-requirements-and-
commitments-reports
[5] Schneeweiss S, Avorn J. A review of uses of
health care utilization databases for
epidemiologic research on therapeutics. J Clin
Epidemiol. 2005; 58(4):323–337.
doi:10.1016/j.jclinepi.2004.10.012
[6] Wang SV, Verpillat P, Rassen JA, et al.
Transparency and Reproducibility of
Observational Cohort Studies Using Large
Healthcare Databases. Clin Pharmacol Ther.
2016;99(3):325–332. doi:10.1002/cpt.290
[7] European Network of Centres for
Pharmacoepidemiology and
Pharmacovigilance (ENCePP). Guidance on
Conducting Post-Authorisation Safety Studies
(PASS). Retrieved from
http://www.encepp.eu/standards_and_guidanc
es/guidance.cfm
[8] Food and Drug Administration (FDA). Real-
World Evidence. Retrieved from
https://www.fda.gov/science-
research/science-and-research-special-
topics/real-world-evidence
[9] Lapi F, Piccinni C, Simonetti M, et al. Future
directions for Pharmacoepidemiology in the
era of Big Data: Linking electronic health
records and claims data. Drug Saf.
2016;39(8):719–721. doi:10.1007/s40264-
016-0442-2
[10] Goldacre B, Lane S, Mahtani KR, et al.
Pharmaceutical companies’ policies on access
to trial data, results, and methods: audit study.
BMJ. 2017; 358: j3334.
doi:10.1136/bmj.j3334

Post Marketing Surveillance and Pharmacoepidemiology

Recommended

Recommended

More Related Content

Similar to Post Marketing Surveillance and Pharmacoepidemiology

Similar to Post Marketing Surveillance and Pharmacoepidemiology (20)

More from ijtsrd

More from ijtsrd (20)

Recently uploaded

Recently uploaded (20)

Post Marketing Surveillance and Pharmacoepidemiology