Post-marketing surveillance, also known as post-marketing monitoring or pharmacovigilance, is a critical component of drug safety monitoring that occurs after a pharmaceutical product has been approved and is available on the market. It involves the systematic collection, analysis, and evaluation of real-world data to detect and assess any previously unrecognized adverse effects or other drug-related problems. Here are the key aspects of post-marketing surveillance and its role in monitoring drug safety after approval: Adverse Event Reporting: Post-marketing surveillance relies on the reporting of adverse events (AEs) by healthcare professionals, patients, and pharmaceutical companies. These reports, known as spontaneous or voluntary reports, provide valuable information about potential drug-related issues encountered in real-world clinical practice. Signal Detection: Post-marketing surveillance aims to detect signals, which are patterns or associations between a drug and an adverse event that may suggest a previously unrecognized safety concern. Signals are identified through various sources, including spontaneous reports, scientific literature, electronic health records, and other healthcare databases. Data Collection: Post-marketing surveillance collects data from diverse sources, such as individual case safety reports (ICSRs), observational studies, registries, clinical trials, and electronic health records. These sources provide a wealth of real-world data that can help identify safety signals and generate evidence regarding drug safety in broader patient populations. Risk Assessment: The collected data are analyzed and assessed to evaluate the potential risks associated with a drug. This involves analyzing the frequency, severity, and potential causal relationship between the drug and adverse events. Risk assessment helps determine the magnitude and significance of safety concerns and guides regulatory decisions and risk management strategies. Benefit-Risk Assessment: Post-marketing surveillance supports ongoing benefit-risk assessments of drugs. It involves weighing the potential benefits of the drug against the identified risks and any additional safety concerns that arise during the post-marketing phase. This assessment ensures that the overall benefit-risk profile of the drug remains favorable and justifies its continued use. Signal Validation: Signals detected through post-marketing surveillance undergo further investigation and validation to confirm their association with the drug. This may involve conducting additional studies, including observational studies, epidemiological research, and clinical trials, to gather more evidence and evaluate causality.

1. Welcome
Post-Marketing Surveillance Monitoring
Drug Safety After Approval
Student’s Name: Battina Gayathri
Student’s Qualification: msc biotechnology
Student ID : 091/052023
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2. Index
• INTRODUCTION
• HISTORY
• BENEFITS OF PMS
• SOURCE OF PMS
• PROCESS OF PMS
• METHODS OF PMS
• MANUFACTURE OF PMS
• REFERENCE
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3. Introduction
• Post marketing surveillance refers to any means of
obtaining information about a product after it has
been approved for public use.
• To market a drug , the manufacturer must provide
evidence of its efficacy and safety to the u.s food
and drug administration and specified regulatory
authorities
• Section 505(0)(3) authorizes FDA to require certain
post marketing studies and clinical trails for
prescription drugs approved under section 505(b)
and biological product approved under section 351.
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4. • Post marketing surveillance of drug therefore play an
important role to discover an undesirable effect that might
present at risk
PHASES OF CLINICAL TRAILS
• Phase o : Micro dosing
• Phase I : First in man - safety
• Phase II : First in patient - dose, dosage forms
• Phase III : Efficacy, Adrs
• POST MARKETING SURVEILLANCE or phase IV: Evaluation of
in the real clinical setting
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6. History
• The concept of post-marketing surveillance emerged in the 1960s as
concerns grew regarding the potential risks and side effects of
medications and medical devices. Regulatory authorities recognized the
need for continuous monitoring to ensure patient safety.
• .Thalidomide widely used drug in early 1960s a medication prescribed to
pregnant women for nausea
• In 1961 in germany, an astute pediatrician expressed concern about the
sudden large increase in the number of children referred to his clinic with
limb deformitis( phocomelia)
• The prevention of unwanted drug effects became matter of world wide.
• As a result , the joint commission on prescription drug use was
established in 1976, funded largely by the drug industry, with the
mandate to design a post marketing surveillance
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7. Benefits of PMS
• Detecting Adverse Drug Reactions (ADRs)
• Enhancing Patient Safety
• Identifying new drug interactions
• Evaluating risk-benefit profiles
• Improving product labeling and information
• Generating real-world evidence
• Supporting regulatory decisions
• Assessing real-world effectiveness
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8. Types and Source of PMS
A. Clinical data: 1)Electronic health records
2)case report forms
B. Patient generated data :1)health&treatment
history2)patient reported outcomes
C. Cost & utilization data : claims datasets
D. Public health data : government data source
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10. Methods of PMS
1.Spontaneous/voluntary reporting:
• Submitted voluntarily
• May be encouraged or stimulated by media reports or
article
• Communication from an individual to a company or
regulatory authority
• In many parts of the world AE reports are submitted
electronically using a defines message standard by
physicians and other health providers and hospitals which
may act to alert FDA and pharmaceutical firms
2.Control clinical trails:
• Directly monitor patients
• Often costly
• Evaluate rare suspected side-effect
• Retrospective Study
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11. 3.Cohort study:
• Prospective study
• Planned in advance and carried out over a future period of time
• Non-random
• Investigate the cause of disease
• Establish links between risk factors and health out comes
4. Case control study:
• identify patients with the adverse effects to be studied(the cases)
• Compare them with a sample(the controls)
• Both 'the cases' and 'the controls' are drawn from the same cohort
• Economical
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12. Manufacturer PMS system
These are some of the type of knowledge and
feedback which can achieved from a pms system
• Detection of some manufacturing problems
• Product quality improvement
• Conformation or risk analysis
• Knowledge of long term
• Performance or chronic complication
• Knowledge of performance in different user
population
• Feedback on indication of use
• Feedback on Instruction for use
• Feedback on customer satisfaction
• Feedback on Market viability
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14. References
• http://www.fda.gov/safety/MedWatch
• MedWatch safety Alerts
• http://www.fda.gov/safety/MedWatch/ucm287881.
htm
• http://www.fda.gov/Drugs/guidancecomplianceRegu
latoryInformation/surveillance/AdverseDrugEffects/u
cmo82196.htm#QuarterlyReports
• Food and drug administration,supplementary
reports to contrasts and grants committee on
Medicaid," from the division of Drugs
Experience,BUREAU OF DRUGS
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15. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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