The document discusses challenges in pharmacovigilance including developing common platforms across locations and groups, integrating multiple databases, and implementing workflow management. It outlines Elsevier solutions to these challenges like automated literature monitoring to avoid missing safety signals, literature triage tools to save time, and integration with case reporting systems to connect literature to the broader ecosystem. The solutions aim to make pharmacovigilance teams more efficient, compliant, and able to better mitigate risk.
Literature searches in Pharmacovigilancesamikshagupta
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Literature searches in Pharmacovigilancesamikshagupta
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Signal Management and Risk Assessment in PharmacovigilanceClinosolIndia
Signal management and risk assessment are critical components of pharmacovigilance, aimed at identifying and evaluating potential safety concerns associated with medicinal products. These processes help ensure the ongoing monitoring of product safety and the implementation of appropriate risk minimization strategies. Here's an overview of signal management and risk assessment in pharmacovigilance:
Signal Management:
A signal in pharmacovigilance refers to information that suggests a potential causal relationship between a medicinal product and an adverse event, either previously unrecognized or incompletely understood. Signal management involves the systematic detection, evaluation, and response to these potential safety signals. The goal is to determine whether further investigation is warranted and to take appropriate actions to mitigate risks if necessary.
Signal Management Process:
Signal Detection: Signals can be detected through various methods, including spontaneous reporting databases, literature review, data mining techniques, and cumulative analysis of safety data. Unusual patterns, unexpected associations, or an increase in the frequency of specific adverse events may trigger the need for further investigation.
Signal Evaluation: Once a signal is detected, it undergoes a comprehensive evaluation. This involves analyzing available data, conducting causality assessments, reviewing clinical trial results, and considering factors such as patient demographics, medical history, and concomitant medications.
Signal Validation: Validating a signal involves confirming its credibility and clinical relevance. This step may require additional data collection, case validation, and collaboration between various stakeholders, including regulatory authorities.
Signal Prioritization: Not all signals warrant the same level of attention. Signals are prioritized based on factors such as the severity of the adverse event, the strength of the association, and the potential impact on patient safety.
Risk-Benefit Assessment: A thorough benefit-risk assessment is conducted to weigh the potential risks associated with the signal against the known benefits of the medicinal product. This assessment informs regulatory decisions and the need for further actions.
Risk Minimization: If the signal is deemed credible and significant, risk minimization strategies may be implemented. These strategies could include changes to product labeling, communication to healthcare professionals and patients, and other measures to ensure the safe use of the product.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...László Árvai
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
This is an overview of the Literatures in Pharmacovigilance. This presentation might helpful for the beginners in literature stream. this is not a detailed explanation of the literature case processing,
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
A PSUR (Periodic Safety Update Report) is a pharmacovigilance document that provides an update on the safety profile of a drug product over a defined period of time. PSURs are submitted to regulatory authorities on a regular basis to ensure the continued safety and efficacy of the drug.
A PSUR SlideShare is a presentation that summarizes the key information contained within a PSUR report. It typically includes information such as adverse events, drug interactions, and any changes in the safety profile of the drug since the last report. The presentation may also include charts, graphs, and other visual aids to help illustrate the data.
The purpose of a PSUR SlideShare is to provide an easily digestible overview of the safety information contained within the PSUR report. This can be particularly useful for stakeholders who may not have the time or expertise to read through the full report, such as healthcare providers, patients, or investors.
In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
Privacy of patient data versus patient safety. HIMSS Europe, Nov 6, 2014Arjen Noordzij
(inter)national privacy regulations may have a negative impact on patient care, especially safety and efficiency. This presentation shows the measures taken by the Spaarne Hospital, Hoofddorp (NL)
Automate your literature monitoring for more effective pharmacovigilanceAnn-Marie Roche
Embase and QUOSA experts take you through a complete literature management workflow, demonstrating how Elsevier’s Pharmacovigilance solution enables efficient and comprehensive post-market surveillance.
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Signal Management and Risk Assessment in PharmacovigilanceClinosolIndia
Signal management and risk assessment are critical components of pharmacovigilance, aimed at identifying and evaluating potential safety concerns associated with medicinal products. These processes help ensure the ongoing monitoring of product safety and the implementation of appropriate risk minimization strategies. Here's an overview of signal management and risk assessment in pharmacovigilance:
Signal Management:
A signal in pharmacovigilance refers to information that suggests a potential causal relationship between a medicinal product and an adverse event, either previously unrecognized or incompletely understood. Signal management involves the systematic detection, evaluation, and response to these potential safety signals. The goal is to determine whether further investigation is warranted and to take appropriate actions to mitigate risks if necessary.
Signal Management Process:
Signal Detection: Signals can be detected through various methods, including spontaneous reporting databases, literature review, data mining techniques, and cumulative analysis of safety data. Unusual patterns, unexpected associations, or an increase in the frequency of specific adverse events may trigger the need for further investigation.
Signal Evaluation: Once a signal is detected, it undergoes a comprehensive evaluation. This involves analyzing available data, conducting causality assessments, reviewing clinical trial results, and considering factors such as patient demographics, medical history, and concomitant medications.
Signal Validation: Validating a signal involves confirming its credibility and clinical relevance. This step may require additional data collection, case validation, and collaboration between various stakeholders, including regulatory authorities.
Signal Prioritization: Not all signals warrant the same level of attention. Signals are prioritized based on factors such as the severity of the adverse event, the strength of the association, and the potential impact on patient safety.
Risk-Benefit Assessment: A thorough benefit-risk assessment is conducted to weigh the potential risks associated with the signal against the known benefits of the medicinal product. This assessment informs regulatory decisions and the need for further actions.
Risk Minimization: If the signal is deemed credible and significant, risk minimization strategies may be implemented. These strategies could include changes to product labeling, communication to healthcare professionals and patients, and other measures to ensure the safe use of the product.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...László Árvai
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
This is an overview of the Literatures in Pharmacovigilance. This presentation might helpful for the beginners in literature stream. this is not a detailed explanation of the literature case processing,
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
A PSUR (Periodic Safety Update Report) is a pharmacovigilance document that provides an update on the safety profile of a drug product over a defined period of time. PSURs are submitted to regulatory authorities on a regular basis to ensure the continued safety and efficacy of the drug.
A PSUR SlideShare is a presentation that summarizes the key information contained within a PSUR report. It typically includes information such as adverse events, drug interactions, and any changes in the safety profile of the drug since the last report. The presentation may also include charts, graphs, and other visual aids to help illustrate the data.
The purpose of a PSUR SlideShare is to provide an easily digestible overview of the safety information contained within the PSUR report. This can be particularly useful for stakeholders who may not have the time or expertise to read through the full report, such as healthcare providers, patients, or investors.
In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
Privacy of patient data versus patient safety. HIMSS Europe, Nov 6, 2014Arjen Noordzij
(inter)national privacy regulations may have a negative impact on patient care, especially safety and efficiency. This presentation shows the measures taken by the Spaarne Hospital, Hoofddorp (NL)
Automate your literature monitoring for more effective pharmacovigilanceAnn-Marie Roche
Embase and QUOSA experts take you through a complete literature management workflow, demonstrating how Elsevier’s Pharmacovigilance solution enables efficient and comprehensive post-market surveillance.
A sample of our free eNewsletter, Adis in-touch. Each quarter we provide a round-up of news, content and events from the world of pharmacovigilance and send this to you for free! To sign up, visit http://goo.gl/ZGXMSq
This webinar provides an overview of:
- The regulatory landscape
- Territorial scope
- Remedies, liabilities and penalties
- Risk management and the GDPR
- Legal requirement for a DPIA
- Why and how to conduct a data flow mapping exercise
- What are the challenges?
- What is an information flow?
- The questions to ask
- Data flow mapping techniques.
A recording of this webinar is available here:
https://youtu.be/EZFgrmzmPYE
ICIC 2016: Improving the Pharmacovigilance Literature Screening Process. How ...Dr. Haxel Consult
Screening scientific literature for the purpose of detecting adverse side effects of drugs is burdensome, yet essential. The discovery and retrieval of full-text journal articles is a necessary part of this process. Cursory screening of abstracts has been used to determine which journal articles require full-text reviews. And transactional purchases have historically been the only option for accessing the full-text for non-subscribed content when cursory reviews lead to in-depth review requirements.
In February 2016, a new full-text article rental program was introduced to the drug safety market with the potential to enable a deeper screening of scientific journal content. In this session, Reprints Desk will present information related to new full-text article rentals, including an overview of how article rentals work and time-saving workflow options.
Professor Peivand Pirouzi Inc. - Pharmacovigilance Inspections: Representation of Pharmacovigilance System Master File
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
How Good Privacy Practices can help prepare for a Data Breach from TRUSTe TrustArc
Webinar on data privacy guidelines and best practices that will go a long way to prepare your company for a data breach.
Access the complete webinar from industry experts on how to be ready for a big data breach https://info.truste.com/On-Demand-Webinar-Reg-Page-V3.html?asset=IZC8I93X-553
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
What does the Proposed EU General Data Protection Regulation (GDPR) mean for ...TrustArc
We outline the proposed changes in the EU General Data Protection Regulation (GDPR) and its effect on the privacy of US-EU Data transfers.
Access the complete webinar on how the EU GDPR will affect your business https://info.truste.com/lp/truste/On-Demand-Webinar-Reg-Page.html?asset=J68IQUDK-565
Argus Patient Screen Tab Training - Katalyst HLSKatalyst HLS
Introduction to Argus Patient Screen Tab in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
TIMELINE
PHARMACOVIGILANCE STAKEHOLDERS
ERMS – RECOMMENDATIONS 2005 – KEY CHANGES
2006 CONSULTATIONS – 2008 PROPOSALS
NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
PHARMACOVIGILANCE OF HUMAN MPs
PHARMACOVIGILANCE OF VETERINARY MPS
MILESTONES 2011-2012
REGULATION (EU) 520/2012
ICH GUIDELINES
GPvP GUIDELINES
MILESTONES – FURTHER DEVELOPMENT
ARGUS Query Process Overview_Katalyst HLSKatalyst HLS
Introduction to ARGUS Query Process Overview in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Building an Effective Data Privacy Program – 6 Steps from TRUSTeTrustArc
Six practical steps to build an effective data privacy program from conducting an initial privacy risk assessment to implementing controls & ongoing maintenance.
Watch the complete webinar from leading privacy experts on 6 practical steps to build a data privacy program https://info.truste.com/lp/truste/On-Demand-Webinar-Reg-Page2.html?asset=KB5XQRQG-567
Literature screening for pharmacovigilance 190818Marnix Wieffer
Biomedical literature is an important source of drug adverse event reporting and Pharmacovigilance. However, due to the high volume of literature, sub-optimal search strategies and regulatory pressure, pharmaceutical companies are struggling to screen biomedical literature in a compliant and cost-effective manner.
This slide deck describes how, through outsourcing, automation and prioritization technology, we can significantly improve efficiency and compliance of literature screening.
Tools used in Pharmacovigilance (Clinical Research & Pharmacovigilance).pptxDureshahwar khan
Let’s take a look at some software used in Pharmacovigilance for the management and reporting of Adverse events.
Some software’s used in pharmacovigilance are:
-Oracle Argus Safety
-ArisG
-Oracle Adverse Event Reporting System (AERS)
-ClinTrace
-PvNET
-repClinical
-Vigilanz Dynamic Monitoring System
-WebVDME Pharmacovigilance Signal detection and Signal management software
-PV works
Preparing for a New Time in Medical Literature MonitoringCovance
In recent times, pharmacovigilance regulations have focused increasingly more on medical literature monitoring (MLM), a complex process whose scope continues to expand and deepen. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Integrated Safety and Risk Management Solutions - Addressing the Needs of Sma...Covance
Premarketing clinical safety and PV activities, and the technology infrastructure that supports it, are typically outsourced to multiple contract research organisations (CROs) as part of their clinical trial programmes. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
MEG + Clinical Pharmacy Use Cases - An OverviewEdel Churchill
In today's fast-paced hospital environment, clinical pharmacists are at the forefront of delivering critical care. Efficiency, safety, and quality are top priorities, and with MEG - your partner in digital quality management for healthcare - these goals are within easy reach. Purpose-built to support the unique needs of clinical pharmacy, MEG offers a suite of digital tools that streamline pharmacy operations and enhance patient care. Let's delve into specific use cases demonstrating how MEG's practical solutions can facilitate smoother, safer, and more effective management of your organisation’s pharmacy tasks.
Life sciences companies can avoid unnecessary risks and common sources of cost escalation by optimizing and centralizing the management of their promotional material references.
Big data, RWE and AI in Clinical Trials made simpleHadas Jacoby
Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands the desire to make clinical trials more patient centric.
In all of this, even though some of the technologies have yet to mature enough to meet the high quality standards necessary, it is important to know them and begin imagining the promise they hold for clinical trials.
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
HIPAA Compliance Testing In Software Applications.pdfZoe Gilbert
Read this article to gain a basic understanding of the significance of HIPPA compliance for the healthcare industry.
Our healthcare testing services acknowledges the challenges, consider ways to give patients more control over their health information, and implement security measures to guarantee that the privacy of patient information is safeguarded by healthcare practitioners and others.
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Reforming Medical Device approval processes especially in software requires careful consideration of shifting risks to patients without adequate protections.
Safety & Regulatory Solutions for Small and Medium-sized Life Science Organiz...Covance
A key issue for small and medium-sized enterprises is the optimal utilization of their limited resources for moving their product pipeline through clinical development, and launching and marketing their approved product(s). This is further heightened as both clinical trials and post-marketing activities continue to grow in complexity and scope due to stringent regulatory pressures, patient involvement and globalization. Yet companies face overwhelming pressure to get their product to market as quickly as possible.
Importance of systematic literature search for clinical evaluation (CE) the s...PEPGRA Healthcare
The Clinical Evaluation Report (CER) comprises of three major parts that present complete clinicalevaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of the medical device along with compliance and experience records. The third part of the CER deals with the literature review of the clinical evaluation published on equivalent devices.
Visit : www.pepgra.com
Similar to Minimizing Risk in Pharmacovigilance (20)
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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3. 3Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Challenge
• Development of a common platform
across different geographic locations,
functional groups, product lines.
• Integration of data — a single database to
include data across the entire product life
cycle (pre and post-market). Challenge:
multiple databases may contain similar
information but are not linked/linkable to
each other.
• Implementation of work flow
management technology — identify and
distribute information to stakeholders
according to a predetermined set of rules.
Ensure only the appropriate employees
receive the data required to inform the
decisions they are authorized to make.
How to Standardize Processes and Data Management
“We don’t view drug safety from a postmarket or
premarket perspective but, rather, as a continuum
from the time the compound is identified and the time
of animal studies on through when companies are
hoping to get approval...”
Alan Goldhammer, Associate vice president of regulatory
affairs for the Pharmaceutical Research and
Manufacturers of America (PhRMA) (source: PWC report)
4. 4Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Challenge
Implement Proactive Risk Management
• Development of a risk
management action plan
Establish risk scoring and
mitigation processes to
evaluate external risk
factors (regulatory,
reputation, product liability)
and internal (portfolio,
strategic and financial risk).
• Dashboard
Summarize safety
information across the
product portfolio in real
time. Identify the types
of data that should/should
not be used in drug safety
decision making.
• Implementation of data
mining techniques
Assess the patterns, time
trends and events
associated with drug-
drug interactions.
5. 5Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Challenge: Run PV Operations Cost Effectively
• Growing amount of data
causes important safety
signals to be missed — how
to deal with the data storm?
Embase, October 2014
• Savings from outsourcing PV
operations can be negated with
costs from the manual review of
records. Tools that better target
relevant literature can prevent
this.
• Signal identification must not
be lost due to segmentation of
the analysis by different parties.
1975
1980
1985
1990
1995
2000
2005
2010
2011
2012
2013
0 5 10 15 20 25 30
Millions of Records
Increasing number of records added to Embase
6. 6Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Once Articles Are Captured, the Review and Triage
Process Has Additional Challenges
Too much time is wasted
looking at the same article
multiple times
Challenges Needs
Some outsourced systems
are unable to meet the rigid
regulatory demands
Existing in-house systems are
becoming outdated, and
maintenance & replacement
costs are high
Need to be sure all articles are
captured and reviewed
A coordinated workflow to
manage the article pipeline
Capture metrics behind article
reviews in case of audits
7. 7Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Elsevier Can Create a Unifying Structure that Can Be
Used to Promote Best Practices
Adapted from Zhengwu Lu, Information technology in pharmacovigilance: Benefits, challenges, and
future directions from industry perspectives, Drug Health Patient Saf. 2009; 1: 35–45.
Tested and Proven Cloud-Based Tools
Set up a
coordinated
workflow to
manage the
article pipeline
Be sure all
articles are
captured
and reviewed
Capture metrics
behind article
reviews in case
of audits
Ensure
accessibility
of safety
information
Organizational
Alignment
Operations
Management
Data
Management
Risk
Management
8. 8Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Cloud Based
Solution
Pharma company was using a combination
of a cloud-based solution and SharePoint
to monitor literature for adverse events.
Pharma company reviewed captured
articles and submitted serious cases to
regulatory agencies
However, not all articles were appearing in
SharePoint, and important articles are missed,
resulting in a warning from the regulatory agency
Regulatory
Agency
Issues
Warning
Pharma
Company
What Can Go Wrong in Large Pharma
A Gap in Literature Monitoring
Published Literature
Literature
Monitoring
System
9. 9Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Published Literature
Literature
Monitoring
System
Elsevier implemented a complex search
strategy into its biomedical literature
database [Embase] to ensure that relevant
information was captured.
Elsevier also provided a tool that alerted the
customer about unread articles to make
sure all materials were reviewed.
Seamless
Literature
Triage
Largest Journal
and Conference Coverage
+
Specialist-Developed
Search Strategy
Regulatory
Agency
ICSRs
Pharma
Company
What Can Go Wrong in Large Pharma
A Gap in Literature Monitoring
10. 10Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Additional Sub-optimal Processes in Pharma Companies…
• Under-staffed literature screening teams
– Some global pharma companies have as few as one person screening literature for
adverse events.
– This is a tremendous workload that results in too much time being taken to discover
serious ADRs, or possibly missing them entirely.
• Use of Reference Management tools to manage literature
– Reference Management tools do not allow searching of full text articles.
– This results in a highly manual process that requires additional time to read the
article for mentions of adverse events.
12. 12Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Our Mission in Pharmacovigilance
Elsevier provides the capabilities necessary for
Pharmacovigilance and Drug Safety groups to be:
more efficient
stay compliant
and mitigate risk
13. 13Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
1. Avoid missing critical
information
2. Save time with better
article pipeline
management
3. Connect literature
to broader ecosystem
4. Manage risk of
late-stage failure
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
Integration with case
reporting systems
and audit trails
Our Framework
14. 14Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Case Input: Literature Monitoring
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
Integration with case
reporting systems
and audit trails
• How thorough is your existing
literature monitoring process?
Are you at risk of missing
articles that report AEs?
• Are you wasting valuable
time sifting through
duplicate articles?
• Are you increasing cost by
purchasing the full-text articles
multiple times?
15. 15Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Centralized
Document
Repository for
Drug Safety
Published
Literature
Avoid missing critical information
Case Input: Literature Monitoring
More confidently
find adverse
events in the
literature
Find information
not available in
other tools
Increase the
likelihood of early
signal detection
Save time reviewing,
reduce the risk of
double-counting
Most
comprehensive
journal coverage
and indexing
available
Most
comprehensive
coverage of
conference
proceedings
Custom
development of
complex
searches
Automatic
deduplication of
articles
16. 16Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Case Processing: Literature Triage
• Are the appropriate employees
receiving the required data to inform
the decisions they are authorized
to make?
• Are you working with multiple
databases that contain similar
information but are not linked/linkable
to each other?
• Are you wasting valuable time sifting
through duplicate articles?
• Are you increasing cost by purchasing
the full-text articles multiple times?
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
Integration with case
reporting systems
and audit trails
17. 17Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Case Processing: Literature Triage
Regulatory
Reports
Centralized
Document
Repository
Save time with better article pipeline management
Seamless
centralized
triage tool
Text mining of
articles
Alerts about
unread articles
Triage articles
faster
Find AEs faster by
reviewing the most
relevant articles
Be more confident
that information
isn’t missed
18. 18Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Case Output: Integration With Case Reporting System
• Can you effortlessly export your
data to existing
analysis/reporting tools?
• Are you wasting valuable
resources on manual
processing of data?
• In the event of an audit, will you
be able to clearly demonstrate
that the review process was
done correctly?
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
Integration with case
reporting systems
and audit trails
19. 19Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Case Output: Integration With Case Reporting System
Connect literature process to the broader ecosystem
Pharmacovigil
ance Signal
Detection and
Reporting
Ecosystem
Centralized
Document
Repository
Review process
tracked for
reporting
Literature
pre-formatted
for case reports
Automated
exporting of
data to case
management
systems
Be better prepared
for audits
Save time and effort
Reduce manual steps
when integrating
triage results
20. 20Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Output Analysis: Risk Mitigation
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
Integration with case
reporting systems
and audit trails
• How can we better manage risk?
• Are we gathering all available
safety/AE data about a drug/
class of drugs?
• Are we leveraging best practices
from precedent preclinical/
clinical studies?
• Have all the potential and
unanticipated risks been captured?
21. 21Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Output Analysis: Risk Mitigation
Make better informed risk management and mitigation decisions
Reduce
regulatory
cycling
Improve REMS
planning and
approval
processes
Detect emerging
risks not observed
in the clinic
Identify key areas of
surveillance
Understand how to tailor
standards to specific risks
Find best practices in
designing and
implementing REMS
intervention
Comparative drug
safety data across
preclinical, clinical
and post market
Precedent REMS
plans and
regulatory context
Precedent
standards and
regulatory context
for patient and
HCP
communication
plans
Post market
data from
regulatory
documents and
literature
Searchable
FDA/EMA drug
approval
documents,
biomedical
literature and
FDA AERS
22. 22Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
The Elsevier Life Science Solutions (ELSS) Portfolio
• Workflow specific decision tools that
support key use cases and
research outcomes in Life
Sciences
• Working as a portfolio — Evolving
from ‘point solutions’ to tools that
work together to support integrated,
cross-domain workflows
• Using our capabilities to provide
services that address ‘custom’ use
cases, changing how organizations
manage R&D data
Text Mining &
Data Integration
23. 23Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Embase & Pharmapendium
A single drug search in Embase seamlessly
links to PharmaPendium to deliver:
• Comprehensive information that better
informs a risk management /
pharmacovigilance strategy
• Drug safety information reported
in the literature
• FDA/EMA approval and drug review
reports that provides insights into
historical regulatory precedents
• A direct link to preclinical and clinical
observations and reported adverse
events (AERs) to better monitor and
anticipate safety risks
23
Improving biomedical literature search and risk monitoring
24. 24Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
QUOSA
A combination of software and services that
allows customers to reduce risk, remain
compliant and ensure that workgroups have
the latest scientific literature
•Pharmacovigilance — Monitor literature for
adverse drug events
•Medical Affairs — Collect and share the
latest information for Key Opinion Leaders
and healthcare providers
•Medical Devices — Conduct post-market
surveillance for adverse events reporting and
pre-market approval
•Information Management — Collect,
organize and share key documents for your
stakeholders
24
Improving biomedical literature search and risk monitoring
25. 25Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
To Summarize…
• Key trends in Pharmacovigilance include:
–greater standardization of processes and data management
–implementation of proactive risk management
–reduction/management of costs
• Elsevier provides the capabilities necessary for Pharmacovigilance and Drug
Safety groups to be more efficient, stay compliant and mitigate risk
–Automated literature monitoring — avoid missing critical information
–Fast and effective literature triage — save time with better article
pipeline management
–Seamless integration with existing case reporting systems — connect
literature to a broader ecosystem
–Unique access to regulatory data — manage the risk of late stage failure
by making more informed risk management/mitigation decisions