Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
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.
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.
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.
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.
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.
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 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
Learn more about signal management, the process of detecting, prioritizing and evaluating determined signals in a data population. This infographic also mentions signal detection, signal prioritization, and signal evaluation.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
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.
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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 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
Learn more about signal management, the process of detecting, prioritizing and evaluating determined signals in a data population. This infographic also mentions signal detection, signal prioritization, and signal evaluation.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
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info@KatalystHLS.com
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
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The Growing Role of Signal Management in the Product Life Cycle and How Optim...Covance
A safety signal suggests a possible causal relationship between an adverse event (AE) and a drug, or a new aspect of a known AE and a drug, which requires some type of further investigation. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Signal detection is a process used in pharmacovigilance to identify potential safety issues or new safety information associated with a medicinal product. The goal of signal detection is to detect signals, or potential safety concerns, as early as possible in order to allow for timely risk management and safety interventions.
Signal detection typically involves analyzing large amounts of safety data, including adverse event reports, clinical trial data, post-marketing surveillance data, and other sources of safety information. The data is analyzed using statistical methods and algorithms to identify any patterns or trends that may suggest a potential safety concern.
Once a potential safety concern is identified, further investigation is typically required to confirm the signal and assess the magnitude of the risk. This may involve conducting additional studies, analyzing the available data in more detail, or consulting with regulatory agencies and other stakeholders.
Signal detection is an ongoing process that continues throughout the life cycle of a medicinal product. The process is critical for ensuring the ongoing safety and effectiveness of medicinal products, and is an important component of pharmacovigilance activities.
How Big Data Transforms Reactive Drug Safety to Proactive PharmacovigilanceClinosolIndia
he advent of big data has ushered in a transformative era in the field of pharmacovigilance, shifting the focus from reactive drug safety monitoring to proactive, data-driven approaches. This paradigm shift is revolutionizing the way pharmaceutical companies and regulatory agencies detect, assess, and respond to adverse events and potential safety concerns associated with medications.
The World Health Organization defines pharmacovigilance as the science and actions connected to the detection, evaluation, understanding, and prevention of adverse effects or any other drug related problem. Pharmacovigilance is critical in ensuring that patients receive safe pharmaceuticals. We can learn more about a drugs side effects through a variety of methods, including spontaneous reporting, diligent monitoring, and database research. Novel mechanisms are being established at both the regulatory and scientific levels to increase pharmacovigilance. They include conditional approval and risk management strategies on a regulatory level, and openness and increasing patient engagement on a scientific one. OBJECTIVE To review and discuss various aspects of pharmacovigilance, including new methodological developments. V Sai Kruthika | Sarvani Ekathmika | Prathamesh Golapkar "Advanced Methodologies in Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55052.pdf Paper URL: https://www.ijtsrd.com.com/other-scientific-research-area/other/55052/advanced-methodologies-in-pharmacovigilance/v-sai-kruthika
Signal Detection and Their Assessment in Clinical Trial.ClinosolIndia
Signal detection in clinical trials refers to the process of identifying potential safety signals or new and potentially important information regarding adverse events associated with a drug or intervention. It involves analyzing data collected during the trial to detect any unexpected patterns, trends, or associations that may indicate a safety concern. Here are the key steps involved in signal detection and their assessment in clinical trials:
Data Collection:
Accurate and comprehensive data collection is essential for signal detection. This includes the collection of adverse event data, including the nature of the event, severity, timing, duration, and any associated factors. Other relevant data, such as patient demographics, concomitant medications, and medical history, may also be collected.
Data Cleaning and Preparation:
Data cleaning and preparation involve reviewing and validating the collected data to ensure accuracy, completeness, and consistency. This includes identifying and resolving missing, inconsistent, or erroneous data. Data coding and standardization may also be performed to facilitate analysis.
Data Exploration and Descriptive Analysis:
Initial exploratory data analysis is conducted to identify patterns, trends, or outliers in the collected data. This may involve the calculation of descriptive statistics, such as frequencies, proportions, and measures of central tendency, to summarize the adverse event data. Data visualization techniques, such as plots, graphs, or charts, may be used to aid in the identification of potential signals.
Statistical Methods:
Various statistical methods can be applied to detect potential signals in clinical trial data. These methods include:
Disproportionality Analysis: This method examines the frequency of specific adverse events in relation to the exposure to the drug or intervention compared to other drugs or interventions. Common disproportionality measures include reporting odds ratios (ROR) or information component (IC).
Time-to-Event Analysis: This analysis focuses on the time between drug exposure and the occurrence of adverse events. Methods such as Kaplan-Meier survival analysis or Cox proportional hazards models can be used to assess if there are any significant differences in event rates between treatment groups.
Comparative Analysis: Comparing adverse event rates between treatment groups or different patient populations can help identify potential signals. This may involve calculating incidence rates, relative risks, or odds ratios.
Sequential Monitoring: Sequential monitoring methods, such as the Poisson distribution or Bayesian approaches, can be employed to detect signals in ongoing trials by monitoring accumulating data over time.
Signal Assessment:
Once potential signals are identified, further assessment is conducted to evaluate the clinical relevance and validity of the signals.
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
TRI was founded as a subsidiary of Triumph Consultancy Services in 2013, following 12 years of consulting to the clinical trial industry. TRI has been evaluating the specific challenges facing the industry when implementing a risk-based monitoring strategy and the various approaches and products being utilized by organizations as they move into the RBM arena. This paper aims to summarize our findings and provide guidance as to how the main challenges can be overcome.
Signal Detection and Their Assessment in Clinical Trial.ClinosolIndia
Signal detection in clinical trials is the process of identifying potential safety concerns related to a medicinal product during the clinical development phase. It is a critical component of pharmacovigilance activities for clinical trials and is important for ensuring the safety of study participants.
Signal detection in clinical trials involves analyzing safety data from a variety of sources, including adverse event reports, laboratory data, and clinical trial data. The data is analyzed using statistical methods and algorithms to identify any patterns or trends that may suggest a potential safety concern. This process typically involves comparing the incidence of adverse events in the study population to that of a control group or to the expected incidence based on previous studies or other data sources.
If a potential safety concern is identified, further investigation is typically required to confirm the signal and assess the magnitude of the risk. This may involve conducting additional studies or analyses, consulting with regulatory agencies and other stakeholders, and implementing risk management strategies to mitigate the potential risk.
The assessment of a signal in a clinical trial is typically based on a variety of factors, including the severity and frequency of the adverse event, the potential impact on study participants, and the potential impact on the overall benefit-risk profile of the product. The assessment is typically conducted by a multidisciplinary team that includes medical and scientific experts, regulatory authorities, and other stakeholders.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEWS & Its PREPARATIONSJonaid Ali
FREQUENTLY asked questions about pharmacovigilance in an interview. Pharmacovigilance is fastest growing career in these days in the healthcare sector specially for pharmacy students although some corporates allow non pharm candidates also
leewayhertz.com-How to build an AI-based anomaly detection system for fraud p...alexjohnson7307
In the rapidly evolving landscape of the insurance industry, the integration of artificial intelligence (AI) is proving to be a game-changer. AI is reshaping the way insurance companies operate, from customer service to risk assessment, underwriting, and claims processing. This article delves into the transformative impact of AI for insurance, exploring its key applications and the benefits it brings to both insurers and policyholders.
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Attached is a view on the importance of Automation & appropriate technology in the collection of Adverse Event data, and how this data can be used to the benefit of the patient population.
Using Digital Innovation to Establish Authentic Reporter DialogueSophia Ahrel FCIM
Digital solutions that put patients at forefront of safety processes
Capture relevant, essential and complete data at first interaction
Maximise the value of initial contact and reduce low value follow up
Solutions that ensure REMS and RMP commitments are met and are future proofed
Signal detection and their assessment in clinical trialsClinosolIndia
Signal detection in clinical trials is a crucial aspect of pharmacovigilance that involves identifying potential safety concerns or signals associated with the use of investigational drugs. The process of signal detection is ongoing throughout the life cycle of a drug, from early-phase trials to post-marketing surveillance. Here's an overview of signal detection and the assessment process in clinical trials
This presentation will present topics such as "What is Anomaly Detection? What are the different types of Data that may be used? What are the popular techniques may be used to identify anomalies. What are the best practices in anomaly detection? What is the Value of Anomaly Detection?
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1. Detect the safety signals
Signal Detection & Management Strategies
29th September - 30th September 2016, in Frankfurt
1 Signal management process
The signal management process shall
include all steps from initial signal
detection; through their validation and
confirmation; analysis and prioritisation;
and signal assessment to recommending
action, as well as the tracking of the
steps taken and of any
recommendations made.
SignalDetection
Signal
Prioritization
Signal
Evaluation
2 Challenges in data mining
Data mining posing challenges which must be taken
into consideration.
One particular challenge is selection bias, when the
reporters are in control of what actually gets
reported. This could lead to an over-representation
or under-representation of the true data. Reporting
can also be influenced by social media attention that
may or may not be a true representation of a drug
event association.
The source data is sometimes unverified and
consumers self-diagnosing can also skew the data.
True or false?
3
Qualitative vs. quantitative
assessment of ICSRs
Case-by-case manual review of individual case reports (a single
case, in some rare instances, may constitute a signal). A human
assessor reviews line listings or individual CIOMS forms for a
given period.
Statistical methods to identify drug-event pairs (or frequent
combinations of a drug and an event) that occur with disproportionately
high frequency in large spontaneous report databases.
Typical methodologies used include the Proportional Reporting Ratio
(PRR) or the Empirical Bayesian Geometric Mean (EBGM).
Qualitative method
Quantitative method
Sources:
https://www.ashfieldhealthcare.com/en/post/role-data-mining-signal-detection/
http://www.pipaonline.org/write/MediaManager/Members Area/Pharmacovigilance/Signal
Detection/PIPA_UK_Guidelines_Signal_Management_May_2012.pdf
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