Pharmacovigilance plays a vital role in ensuring drug safety and efficacy throughout the entire lifecycle of a pharmaceutical product. Here are the key aspects of pharmacovigilance in safeguarding public health:
Early Detection of Adverse Drug Reactions (ADRs): Pharmacovigilance systems collect and analyze data on ADRs reported by healthcare professionals and patients. This enables the early detection of potential safety concerns associated with drugs, including known and previously unrecognized adverse effects.
Signal Detection and Evaluation: Pharmacovigilance activities involve the systematic identification and evaluation of safety signals, which are indications of potential risks associated with a drug. Signals are assessed by analyzing data from various sources, such as spontaneous reports, clinical trials, literature, and real-world evidence, to determine their clinical significance and inform regulatory action if necessary.
Risk Assessment and Benefit-Risk Evaluation: Pharmacovigilance assesses the balance between the benefits and risks of drugs. The collected data are evaluated to determine whether the benefits of a drug outweigh its risks or if any additional safety measures are required. This information guides regulatory decisions, such as labeling changes, restrictions, or even withdrawal of the drug from the market.
Post-Marketing Surveillance: Pharmacovigilance is crucial in monitoring the safety of drugs after they have been approved and marketed. It involves ongoing surveillance and analysis of real-world data, including ADR reports, electronic health records, and other sources, to identify new or rare adverse effects that may emerge in larger patient populations or specific subgroups.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
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Real-world data (RWD) has revolutionized the field of pharmacovigilance and regulatory decision-making. While clinical trials provide valuable insights into the safety and efficacy of medications, RWD offers a comprehensive view of a drug's performance in real-world settings. In this blog post, we will explore the significant impact of RWD in pharmacovigilance and how it has transformed the way regulatory decisions are made. We will discuss the benefits of utilizing RWD, the challenges associated with its implementation, and its potential to improve patient safety and healthcare outcomes.
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
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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. 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, URL: https://www.ijtsrd.com/papers/ijtsrd59690.pdf Paper Url:https://www.ijtsrd.com/pharmacy/other/59690/postmarketing-surveillance-and-pharmacoepidemiology/dr-farheen-yousuf
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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.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
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Pharmacovigilance, derived from the Greek words "pharmakon" (drug) and "vigilare" (to keep watch), is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It has a rich history that spans centuries, evolving in response to medical advancements, regulatory changes, and societal needs.
The roots of pharmacovigilance can be traced back to ancient civilizations where healers and physicians observed and documented the effects of various medicinal substances. However, the formalization of pharmacovigilance began in the 20th century with significant milestones shaping its development.
In the early 20th century, the introduction of potent drugs like digitalis and barbiturates highlighted the need for monitoring their safety. However, it wasn't until the thalidomide tragedy of the 1950s and 1960s, where thousands of babies were born with severe birth defects due to prenatal exposure to the drug, that pharmacovigilance gained widespread recognition. This catastrophic event underscored the importance of systematic surveillance and led to the establishment of regulatory frameworks to ensure drug safety.
The 1960s witnessed the creation of formal pharmacovigilance systems by regulatory agencies such as the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). These systems aimed to collect, analyze, and disseminate information on adverse drug reactions (ADRs) through spontaneous reporting systems.
The thalidomide tragedy also spurred the development of pharmacovigilance legislation worldwide. In 1961, the Kefauver-Harris Amendments in the United States mandated pre-market approval of drugs, rigorous testing, and post-marketing surveillance. Similar regulatory measures were adopted globally, emphasizing the importance of continuous monitoring of drugs throughout their lifecycle.
The 1970s and 1980s saw further advancements in pharmacovigilance methodologies and infrastructure. The WHO established the International Drug Monitoring Program (IDMP) in 1968, facilitating international collaboration in ADR reporting and analysis. Additionally, technological innovations, such as computerized databases and signal detection algorithms, enhanced the efficiency and accuracy of pharmacovigilance activities.
The 1990s marked a period of globalization and harmonization in pharmacovigilance. The International Conference on Harmonization (ICH) developed guidelines to standardize pharmacovigilance practices across regions, promoting consistency in data collection, analysis, and reporting. Furthermore, the emergence of the internet facilitated direct patient reporting of ADRs, empowering individuals to contribute to drug safety surveillance.
In the 21st century, pharmacovigilance has continued to evolve in response to emerging challenges and opportunities. The proliferation of biological therapies, personalized medicine, and pharmacogenomics has ne
Post Marketing Surveillance and Drug Safety Monitoring Ensuring Patient Well ...ijtsrd
This comprehensive review explores the dynamic landscape of post marketing surveillance and drug safety monitoring, delving into key aspects from definitions to emerging trends. The discussion encompasses the importance of drug safety monitoring in ensuring patient well being, highlighting the significance of real world evidence, artificial intelligence, and patient centric approaches. Case studies provide valuable insights into both successful surveillance instances and lessons learned from challenges. Anticipated developments in the field are examined, underscoring the transformative impact on patient care and industry practices. The conclusion summarizes key takeaways and issues a call to action for stakeholders to embrace enhanced drug safety practices in this evolving landscape. Muhammad Afsana | G. Naga Malleshwari "Post-Marketing Surveillance and Drug Safety Monitoring: Ensuring Patient Well-Being" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-6 , December 2023, URL: https://www.ijtsrd.com/papers/ijtsrd61198.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/61198/postmarketing-surveillance-and-drug-safety-monitoring-ensuring-patient-wellbeing/muhammad-afsana
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Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. When it comes to special populations, such as pediatric and geriatric patients, there are specific considerations that need to be taken into account in pharmacovigilance efforts. Here are some key points regarding pharmacovigilance in these population
Pharmacovigilance planning is a systematic approach to ensuring the safety of pharmaceutical products, including drugs and medical devices, once they are approved and available in the market. It involves creating strategies, processes, and systems to monitor, detect, assess, and prevent adverse effects or other drug-related problems throughout the product's lifecycle. The ultimate goal of pharmacovigilance planning is to protect patient safety and public health by minimizing risks associated with the use of medical products.
Role of Pharmacovigilance in Drug Discovery and Post Marketing Surveillanceijtsrd
Pharmacovigilance is a cornerstone of both the pharmaceutical industry and the healthcare system. It is aimed to ensure guaranteed patient safety and is considered an arm of patient care. Pharmacovigilance is essential at many stages of the drug discovery and development process. Drug safety assures that a patients safety and well being are protected throughout the whole drug development lifecycle, including when the drug is easily available on the market. Pharmacovigilance comprises pre and post marketing surveillance. Pre clinical screening, which collects information on ADRs from phases I to III of clinical trials, and post marketing surveillance, which gathers data from the post approval stage and during the course of a drugs shelf life. During clinical trials pharmacovigilance mandates the timely submission of reports on adverse events during clinical trials to regulatory authorities, notification of such events to all investigators and ethics committees, and a safety review by independent Drug Safety Monitoring Boards DSMB . Predicting or evaluating potential ADRs at this early stage of the drug development pipeline is the focus of PV. Finding previously unrecognized adverse effects as well as good effects is the major goal of PMS research by utilizing various pharmacovigilance methodologies. K. Sravanathi Bai | V. Venu "Role of Pharmacovigilance in Drug Discovery & Post-Marketing Surveillance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-3 , June 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd57400.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/57400/role-of-pharmacovigilance-in-drug-discovery-and-postmarketing-surveillance/k-sravanathi-bai
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Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .ClinosolIndia
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
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The roots of pharmacovigilance can be traced back to ancient civilizations where healers and physicians observed and documented the effects of various medicinal substances. However, the formalization of pharmacovigilance began in the 20th century with significant milestones shaping its development.
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Collaborative initiatives involving patient advocacy groups play a crucial role in advancing the success of precision medicine. Precision medicine, also known as personalized medicine, tailors medical treatment and interventions to the characteristics of each patient, considering factors such as genetic makeup, lifestyle, and environment. Patient advocacy groups contribute to the success of precision medicine in several ways:
Raising Awareness and Education:
Patient advocacy groups are instrumental in raising awareness about precision medicine among their communities.
They provide education and resources to patients, caregivers, and the general public, promoting a better understanding of the benefits and implications of precision medicine.
Patient Empowerment:
Advocacy groups empower patients by providing them with information about their conditions and treatment options.
They help patients understand the importance of participating in precision medicine initiatives, including clinical trials and genetic testing.
Supporting Research and Development:
Patient advocacy groups often collaborate with researchers and industry stakeholders to support the development of targeted therapies and diagnostics.
By actively participating in research initiatives, advocacy groups contribute to the identification of genetic markers, biomarkers, and other factors that influence treatment response.
Influencing Policy and Regulation:
Advocacy groups advocate for policies that support the advancement of precision medicine.
They work to ensure that regulations promote patient access to personalized treatments and protect patient rights, privacy, and data security.
Fostering Collaboration:
Patient advocacy groups facilitate collaboration among patients, researchers, healthcare providers, and industry partners.
They create platforms for sharing information, experiences, and best practices, fostering a collaborative environment that accelerates progress in precision medicine.
Clinical Trial Recruitment:
Advocacy groups play a crucial role in recruiting patients for clinical trials related to precision medicine.
Their engagement helps ensure diverse and representative participant populations, leading to more robust and applicable research outcomes.
Feedback and Patient-Centric Approaches:
Advocacy groups provide valuable feedback on the patient experience, preferences, and priorities.
This patient-centric approach helps researchers and healthcare professionals tailor precision medicine strategies to better meet the needs and expectations of the individuals they serve.
Championing Access to Treatments:
Patient advocacy groups work to improve patient access to precision medicine treatments.
They advocate for affordable and equitable access to innovative therapies, ensuring that the benefits of precision medicine are accessible to a broader population.
In summary, patient advocacy groups play a multifaceted role in advancing precision medicine by fostering awareness,
Ethical Dilemmas in Precision Medicine: Navigating the Intersection of Scienc...ClinosolIndia
The Ethical dilemmas in precision medicine arise from balancing the potential benefits of tailored treatments with concerns about privacy, consent, equity, and the implications of genetic information. These Dilemmas include issues around informed consent for data sharing, ensuring equitable access to precision medicine technologies, and safeguarding against discrimination based on Information. The potential for misuse or unintended consequences further complicate the ethical landscape of precision medicine. The Precision medicine widely used in Data Integration, Biomarkers, Targeted Therapies, predictive modeling, Clinical Decision Support. Precision Medicine improves the Patient outcomes, enhancing treatment efficacy, and reducing healthcare costs by minimizing trial and error in treatment selection. The precision medicine also raises Ethical legal and social complications related to data privacy, consent and equitable access and the potential for Discrimination based on information.
Regulatory Considerations in Precision Medicine: Navigating the Approval ProcessClinosolIndia
Precision medicine, with its focus on tailoring medical treatments to individual characteristics, presents unique regulatory challenges in the drug development and approval process. This ppt delves into the regulatory considerations associated with precision medicine, exploring the key aspects that pharmaceutical and biotechnology companies need to navigate
Emerging Technologies and Tools in Precision Medicine ResearchClinosolIndia
Precision medicine has witnessed significant advancements with the integration of emerging technologies and innovative tools. This abstract explores the current landscape of precision medicine research, focusing on the role of cutting-edge technologies and tools in revolutionizing healthcare approaches.
Precision Medicine in Action: Case Studies and Success StoriesClinosolIndia
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Harnessing Big Data and Artificial Intelligence for Pharmacovigilance in Prec...ClinosolIndia
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Integration of Clinical Trial Systems: Enhancing Collaboration and EfficiencyClinosolIndia
Clinical trials are complex endeavors that involve numerous stakeholders, vast datasets, and intricate processes. To streamline operations, enhance collaboration, and improve efficiency, the integration of clinical trial systems has emerged as a pivotal solution. This strategic approach involves connecting various components, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHR), fostering a cohesive ecosystem that accelerates the pace of research and ensures data accuracy.
Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...ClinosolIndia
Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.
Adoptive Design: Optimizing Clinical Trial Strategies for Precision MedicineClinosolIndia
Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.
Artificial Intelligence In Clinical TrialClinosolIndia
Clinical trials are a cornerstone of medical research, paving the way for new treatments and advancements in healthcare. In recent years, Artificial Intelligence (AI) has emerged as a transformative force, reshaping the landscape of clinical trials. This article explores the various ways in which AI is revolutionizing the design, execution, and analysis of clinical trials.
Emerging Technologies Shaping the Future of Precision MedicineClinosolIndia
Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.
Innovations in Liquid Biopsies for Precision Cancer DiagnosisClinosolIndia
Precision medicine, with its focus on tailoring medical interventions to individual characteristics, benefits significantly from the integration of machine learning (ML) algorithms for predictive analytics. These algorithms analyze complex datasets, identify patterns, and generate predictions that inform personalized treatment strategies. This article explores the diverse applications of ML in precision medicine, highlighting the key algorithms driving predictive analytics in this transformative field.
Machine Learning Algorithms for Predictive Analytics in Precision MedicineClinosolIndia
The integration of machine learning algorithms for predictive analytics in precision medicine represents a powerful tool for extracting meaningful insights from diverse and complex datasets. As the field continues to evolve, these algorithms play a crucial role in advancing our understanding of individualized treatment strategies, improving patient outcomes, and ultimately shaping the future of personalized healthcare.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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.
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.
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.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
The Role of Pharmacovigilance in Ensuring Drug Safety and Efficacy
1. Welcome
THE ROLE OF PHARMACOVIGILANE IN
DRUG SAFETY AND EFFICACY
JAYA SHEELA KOMBATHULA
B. PHARMACY
CSRPL_STD_IND_HYD_ONL/
CLS_080/042023
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2. Index
• INTRODUCTION
• HISTORICAL PRESPECTIVE OF WHO –
DRUG MONITORING
• WORLDWIDE CENTERS OF PHARMACOVIGILANCE
• DRUG SAFETY REGULATION.
• CONCLUSION
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3. INTRODUCTION
Drug safety and pharmacovigilance remains a dynamic clinical and scientific discipline.
Pharmacovigilance is defined by the World Health Organization (WHO) as ’the science and
activities relating to the detection, assessment, understanding and prevention of adverse effects
or any other drug-related problem’ it plays a vital role in ensuring that doctors, together with
the patient, have enough information to make a decision when it comes to choosing a drug for
treatment.
Pharmacovigilance also known as drug safety - is a broad term that describes the collection,
analysis, monitoring and prevention of adverse effects in drugs and therapies. It is a completely
scientific and process-driven area within pharma.
Pharmacovigilance is arguably the most essential function within a life science company. To
develop, manufacture and commercialize a drug a company must adhere to strict regulations.
Many of these regulations will focus on the patient’s safety and the added benefit to the patient
derived from the drug. This, in a nutshell, is the mission of drug safety and highlights why this
discipline plays such a central and important role within pharmaceuticals.
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4. INTRODUCTION
Patient safety and continuous vigilance
By definition, drug safety ensures that a patient’s safety and wellbeing is safeguarded
throughout the entire drug development lifecycle, including when the drug is readily
available on the market. Indeed, drugs are continuously monitored for other side effects
on patients, and any new data is collected and reported to health authorities on a regular
basis. While other areas focus on improving patient lives in everything that they do, no
other department has such a sharp focus on patient safety as an end-point.
Power and authority
This continuous vigilance does mean that, alongside others in the business, senior leaders
within a drug safety team have the responsibility and authority to recommend that a
development process is stopped, or that an approved drug is pulled from the market. EU
QPPVs are especially important in this process, and again this goes to demonstrate the
importance and central role of drug safety.
Keeping it moving
In many ways, drug safety helps to keep the wheels of a pharmaceutical company moving.
The nature of drug safety means that it works on a very cross-functional basis. Therefore,
the influence and value which the division can add to other aspects of the business is
tremendous
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5. HISTORICAL PRESPECTIVE OF
WHO – DRUG MONITORING
In 2002, more than 65 countries have their own pharmacovigilance centers. Membership
of the WHO for International Drug Monitoring is coordinated by the WHO Collaborating
Centre for International Drug Monitoring, known as the Uppsala Monitoring Centre
(UMC). Pharmacovigilance is now firmly based on sound scientific principles and is
integral to effective clinical practice. The discipline needs to develop further to meet
public expectations and the demands of modern public health. The Sixteenth World
Health Assembly adopted a resolution, that reaffirmed the need for early action in regard
to rapid dissemination of information on adverse drug reactions and led later to creation
of the WHO Pilot Research Project for International Drug Monitoring. The purpose of this
was to develop a system, applicable internationally, for detecting previously unknown or
poorly understood adverse effects of medicines.
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6. WORLDWIDE CENTERS OF
PHARMACOVIGILANCE
A complex and vital relationship exists between wide ranges of partners in the practice
of drug safety monitoring. These partners must jointly anticipate, understand and
respond to the continually increasing demands and expectations of the public, health
administrators, policy officials, politicians and health professionals.
The Quality Assurance and Safety: The team is a part of the Department of Essential
Drugs and Medicines Policy, within the WHO Health Technology and Pharmaceuticals
cluster. The purpose of the department is to help save lives and improve health by
closing the huge gap between the potential that essential drugs have to offer and the
reality that for millions of people, particularly the poor and disadvantaged, medicines
are unavailable, unaffordable, unsafe or improperly used.
The Uppsala Monitoring Centre: The principal function of the Uppsala Monitoring
Centre is to manage the international database of ADR reports received from National
Centers. The UMC has established standardized reporting by all National Centers and
has facilitated communication between countries to promote rapid identification of
signals.
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7. WORLDWIDE CENTERS OF
PHARMACOVIGILANCE
The National Pharmacovigilance Centers: National Centers have played a significant
role in increasing public awareness of drug safety. This development is partly
attributable to the fact that many national and regional centers are housed within
hospitals, medical schools or poison and drug information centers, rather than within the
confines of a drug regulatory authority. Major centers in developed countries have
established active surveillance programs using record linkage and prescription event
monitoring systems (PEM) to collect epidemiological information on adverse reactions to
specific drugs. Such systems have already been implemented in New Zealand, the
United Kingdom, Sweden and the United States of America. The entire cost of a
pharmacovigilance system, compared with the national expenditure on medicines or the
cost of ADRs to the nation is very small indeed.
Hospitals and Academia: A number of medical institutions have developed adverse
reaction and medication error close watch systems in their clinics, wards and emergency
rooms. Case-control studies and other pharmacoepidemiologic methods have
increasingly been used to estimate the harm associated with medicines once they have
been marketed. Academic centers of pharmacology and pharmacy have played an
important role through teaching, training, research, policy development, clinical
research, ethics committees (institutional review boards) and the clinical services they
provide.
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8. WORLDWIDE CENTERS OF
PHARMACOVIGILANCE
Health Professionals: Originally physicians were the only professionals invited to report
as judging whether disease or medicine causes a certain symptom by exercising the skill
of differential diagnosis. Today, different categories of health professionals will observe
different kinds of drug related problems.
Patients: Only a patient knows the actual benefit and harm of a medicine taken. Direct
patient participation in the reporting of drug related problems will increase the
efficiency of the pharmacovigilance system and compensate for some of the
shortcomings of systems based on reports from health professionals only.
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9. DRUG SAFETY REGULATION
Pharmacovigilance programs made strong by links with regulators. Regulators
understand that pharmacovigilance plays a specialized and pivotal role in ensuring
ongoing safety of medicinal products.
Clinical trial regulation: In recent years there has been a substantial increase in the
number of clinical trials in developed and developing countries. In their approval of
clinical trials, regulatory bodies look at safety and efficacy of new products under
investigation. Safety monitoring of medicines in common use should be an integral part
of clinical practice. Education and training of health professionals in medicine safety,
exchange of information between national pharmacovigilance centers, the coordination
of such exchange, and the linking of clinical experience of medicine safety with research
and health policy, all serve to enhance effective patient care.
.
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10. DRUG SAFETY REGULATION
Post marketing safety drug monitoring: These includes detection of drug interactions,
measuring the environmental burden of medicines used in large populations, assessing
the contribution of ’inactive’ ingredients to the safety profile, systems for comparing
safety profiles of similar medicines, surveillance of the adverse effects on human health
of drug residues in animals, e.g. antibiotics and hormones. The Council for International
Organizations of Medical Sciences (CIOMS) report on benefit-risk assessment of
medicines after marketing has contributed to a more systematic approach to
determining the merit of available medicines.
Pharmacovigilance in national drug Policy: The provision of good quality, safe and
effective medicines and their appropriate use is the responsibility of national
governments. Multidisciplinary collaboration is of great importance in particular, links
need to be forged between various departments of the ministry of health and also with
other stakeholders, such as the pharmaceutical industry, universities, nongovernmental
organizations (NGOs) and those professional associations having responsibility for
education on rational use of medicines and pharmacotherapy monitoring.
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11. DRUG SAFETY REGULATION
Pharmacovigilance in Disease Control Public Health Programmed: The monitoring of
medicine safety in countries where there is no regulatory or safety monitoring system in
place, or in remote areas with little or no health care surveillance or infrastructure, has
been identified as a matter for concern. The problems are especially apparent in
situations that involve the use of medicines in specific communities, for example, for the
treatment of tropical diseases such as malaria, leishmaniasis and schistosomiasis, and for
the treatment of HIV/AIDS and tuberculosis. Pharmacovigilance should be a priority for
every country with a public health disease control programs.
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12. CONCLUSION
Pharmacovigilance continues to play a crucial role in meeting the challenges posed by
the ever increasing range and potency of medicines, all of which carry an inevitable and
some- times unpredictable potential for harm. When adverse effects and toxicity do
appear, especially when previously unknown, it is essential that these are reported,
analyzed and their significance is communicated effectively to the audience having
knowledge to interpret the information. For all medicines, there is a trade-off between
the benefits and the potential for harm. The harm can be minimized by ensuring that
medicines of good quality, safety and efficacy are used rationally, and that the
expectations and concerns of the patient are taken into account when therapeutic
decisions are made. To achieve this is to serve public health, and to foster a sense of trust
among patients in the medicines they use that would extend the confidence in the health
service in general, ensure that risks in drug use are anticipated and managed, provide
regulators with the necessary information to amend the recommendations on the use of
the medicines, improve communication between the health professionals and the public
and educate health professionals to understand the effectiveness or risk of medicines
that they prescribe.
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13. REFERENCES
1. WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Geneva: World
Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of
medicines. Available
from: http://www.whqlibdoc.who.int/hq/2004/WHO_EDM_2004.8.pdf
2. Harmark L, van Grootheest AC. Pharmacovigilance: Methods, recent
developments and future perspectives. Eur J Clin Pharmacol. 2008;64:743–52
3. Biswas P, Biswas A. Setting standards for proactive pharmacovigilance in India:
The way forward. Indian J Pharmacol. 2007;39:124–8.
4. The Importance of pharmacovigilance Safety monitoring of medicinal
products. WHO Lib Catalog. 2002. Available
from: http://www.apps.who.int/medicinedocs/en/d/Js4893e/
5. whqlibdoc.who.int [homepage on the Internet]. Geneva: World Health
Organization. 1973. Handbook of resolutions and decisions of the World Health
Assembly and Executive Board. Available
from: http://whqlibdoc.who.int/wha_eb_handbooks/9241652063_Vol2.pdf
6. Lared NL. Pharmacists’ role in reporting adverse drug reactions in an
international perspective. 2003. Available
from: http://www.lareb.nl/documents/pds2004_1291.pdf
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14. REFERENCES
7. WHO Medicines Strategy: Framework for Action in Essential Drugs and
Medicines Policy 2000-2003. Available
from: http://www.apps.who.int/medicinedocs/en/d/Jwhozip16e/8.html
8. Olsson S. The role of the WHO Programme for International Drug
Monitoring in coordinating worldwide drug safety efforts. Drug
Saf. 1998;19:1–10.
9. Coulter DM. The New Zealand intensive medicines monitoring programme
in proactive safety surveillance. Pharmacoepidemiol Drug Saf. 2000;9:273–80.
10. Mackay FJ. Post-marketing studies: The work of the drug safety research
unit. Drug Saf. 1998;19:343–53.
11. Folb PI, ten Ham M. Drug monitoring in developing countries: A drug
regulator’s perspective. Drug Inf J. 1995;29:303–5.
12. Talbot JC, Nilsson BS. Pharmacovigilance in the pharmaceutical
industry. Br J Clin Pharmacol. 1998;45:427–31.
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15. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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