This document discusses vaccine safety surveillance systems. It describes post-marketing surveillance systems like VAERS in the US and EudraVigilance in Europe that monitor adverse events. International organizations like WHO and programs like EPI work to strengthen safety surveillance globally and help low-income countries monitor vaccines. Harmonized reporting systems, guidelines, and data sharing aim to ensure vaccine safety worldwide.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time.
Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period.
A vaccine is a biological preparation that improves immunity to a particular Disease.
No vaccine is completely safe or completely effective, while all known vaccine adverse events are minor and self limited, some vaccine have been associated with rare but serious health effects.
Signal Validation and Causality Assessment in Adverse Event ReportingClinosolIndia
Signal validation and causality assessment are essential components of pharmacovigilance, which is the science and activities related to monitoring, assessing, and preventing adverse effects or any other drug-related problems. Pharmacovigilance plays a crucial role in ensuring the safety of drugs and medical products after they have been approved and are available on the market.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Ayurvedic Formulation: Asava, Arishta, Avaleha, Ghrita, Taila, Gutika
Concept of Detoxification: Panchkarma
Final Year B.Pharm (Sem-VIII) Pharmacognosy-III (Mumbai University Syllabus
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
2. Introduction
• Clinical trials To evaluate efficacy and not safety,
can’t detect RARE adverse events
• Post marketing surveillance is To ensure safety is
continually monitored
• Vaccine, given to healthy people including infants,
children
• Effective & safe vaccine ensures public health
disease prevention
3. • 1986: The national childhood vaccine injury act in USA
• Act mandates:
• To check vaccine liabilities & other concerns
• Safe infrastructure
• VAERS: Vaccine Adverse Events Reporting Systems
USFDA+ CDC
• Report submission by vaccine manufacturer, physicians,
public health clinic, vaccine recipients, parents, care givers
• Reporting to VAERS must within 15 days for serious
unexpected events within US + outside US
4. • Vaccine injury table: list of medical conditions
presumed to be caused by certain vaccines
• Medical officer to review:
• Death & serious ADR after vaccination
• Hospital discharge summaries
• Laboratory result
• Autopsy report
• 30k reports/annum, 14% serious reports, 90% for
blood products
• Half reports, from < 18 years of age patients
5. VAERS
• To generate signals of potential problems
• To evaluate new vaccine for unexpected ADR,
report of death & serious AE
• To prevent ADR
• E.g. Intussusception after live Rotavirus vaccine in
infants
• Thrombocytopenia, alopecia after vaccination
6. VAERS
• Strength
• Detection of rare AEs
• Timely compilation of data
• National & International coverage ability to generate hypotheses
• Limitations:
• Uncertainty about denominators (difference between no. of vaccine
distributed to no. of vaccine administered)
• Under reporting
• Incomplete inaccurate reporting
• Biased/ stimulating reporting
• Limited resources for follow up
• Lack of unbiased comparison
7. VAERS
• Range of potential vaccine safety effects
• Post marketing evaluation after 18 months of approval of
product OR used by 10k individuals whatever is late
Physicians:
• To review relevant data, summarize findings, when
necessary develop plan to investigate new safety issue
• To evaluate whether new serious AD not previously
identified, known S/e with unusually high frequency,
potential new safety concern when introduced to general
population
• To make transparency of information about drugs &
biologicals
8. FDA
To assess information from
• Preapproval safety data
• To review VAERS reports, periodic safety reports by
manufacturers
• To check medical literature
• To check product utilization database
• To check data from post approval clinical trials
• To provide safety summary to pediatrics
• E.g. Diptheria, TT, inactivated poliovirus, Rota virus,
HPV
9. REMS
• Risk Evaluation and Mitigation Strategy
• To manage known/potential serious risk associated
with drug/biological product
• To check medication guide, patient package,
communication plan, elements to assure safe
insert, implementation system, timetable for
assessment
• Post Marketing Requirement (PMR) to assess the
risk of spontaneous abortion in who became
pregnant around time of vaccination
10. • Integration of vaccine adverse events reporting system
and safety data from other sources
• Post licensure rapid immunization safety monitoring
system (PRISM)
• Mini-Sentinel Network
• To check key gaps in existing vaccine safety monitoring
capabilities
• VSD: Vaccine Safety Data link
• CISA: The Clinical Immunization Safety Assessment
• Role of individual variation in susceptibility to adverse events
• To provide clinicians with vaccine based counselling
• To empower individuals to make informed immunization
11. Global vaccine safety surveillance
• National Immunization Program
• Reporting form
• Terminology
• Case definition
• Database
• Methods for assessing causalities
12. NRA & NIP
National Regulatory Authority
• Marketing authorization
• Licensing activities
• Post marketing surveillance
National Immunization Program
• Safe, storage, handling, delivery, administration of
vaccine
• Safe injection practice, detection, correction,
prevention of program error
13. NIP
• If AE is sought, assessing, treating, reporting,
participating in investigation
• Vaccines, introduced into high income countries
(Hepatitis B), because low income country has
limited resources to conduct post marketing safety
surveillance
• Vaccine for infectious disease burden would be
introduced at high income countries but not in
large scale.
14. WHO
• 48% world’s population is from non functional
vaccine safety and from poor countries
• Marketing safe and efficacious vaccine available
and in strengthening and harmonizing post
marketing safety surveillance
• Immunization program
• To decide prequalification of vaccine
• Global advisory committee
16. Programmatic Error
• June 2013, 3 infants, aged 9-11 months, died
following routine measles immunization
• Suxamethonium (muscle relaxant) instead of
regular diluent
• Suxamethonium and Synthetic oxytocin
17. • Prequalification of vaccine
• Global standards of quality, safety, efficacy
• To optimize use of resources
• To improve health outcomes
• To review dossier
• To check consistency testing/performance
evaluation
• To site visit to manufacturer
18. • Safety + Effectiveness of vaccine for WHO
recommends
• Potency
• Thermostability
• Presentation
• Labelling
• Shipping condition
• Prequalified vaccine, to distribute to UNICEF
• NRA: To monitor production, QC methods, to check
compliance of GMP
19. Global Advisory Committee for
Vaccine Safety
• Establishment: 1999
• To provide prompt scientific, evidence based
responses to vaccine safety issue
• Epidemiology, Statistics, Paediatrics, Internal
Medicine, Pharmacology & Toxicology, Infectious
disease, Public health, Immunology, Auto immunity,
Drug regulation safety
• To assess specific vaccine AEs
• To frame global policies
20. International Database
• VigiBase (UMC): 1968
• Global database of individual case safety reports (ICSRs). It is
the largest database of its kind in the world, with over 20
million reports of suspected adverse effects
• Not mandatory but national centres asked to send reports
quarterly
• EudraVigilance:
• System for managing and analysing information on
suspected adverse reactions to medicines which have been
authorised or being studied in clinical trials in the European
Economic Area.
• Pharma companies & NRA to provide data on Adverse
Events following Immunization
21. • Prequalified vaccine:
• To establish standardized post marketing surveillance of
safety of vaccine
• 12 countries including China & India to pilot strategy
and tools for post marketing surveillance of vaccine
• Global vaccine safety blue print:
• To define indicator of minimal capacity for ensuring
vaccine safety
• To propose strategic plan for enhancing global safety
• To share safety information globally
