Our Embase expert, Ian Crowlesmith and PV expert Sherry Winter covered the following in this webinar:
- Reviewed the indexing and features and functionality in Embase, which support pharmacovigilence related workflows for drugs and devices
- Walked through integrated Embase and Pharmapendium practical examples, showing how easy it is to build comprehensive searches.
Pharmaceutical and medical device manufacturers are expected to capture all mentions of adverse events in the literature as soon as they are published. Failure to identify an event comes with high costs—including hefty fines from regulatory authorities and potential damage to the company’s reputation. Strategies for monitoring the ever-increasing amount of biomedical literature must be designed for huge volumes of data, and companies need to have a system in place to proactively identify reliable reports and accurately judge their importance.
Having the full range of necessary information also enables research teams to make thorough drug safety assessments, improve study design and regulatory applications and, ultimately, to make better-informed risk management and mitigation decisions.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Providing timely, evidence-based information on the safe and effective use of medicines, facilitating changes to healthcare practices, supporting risk minimization behavior.
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...KCR
Post-Authorisation Safety Studies (PASS)
Is the Ongoing Surveillance a Blessing Or a Curse?
28th DIA EuroMeeting
7 April 2016, Hamburg, Germany
Magdalena Matusiak, MPharm
Manager, Clinical Development
Pharmacovigilance Team Lead, KCR
Pharmaceutical and medical device manufacturers are expected to capture all mentions of adverse events in the literature as soon as they are published. Failure to identify an event comes with high costs—including hefty fines from regulatory authorities and potential damage to the company’s reputation. Strategies for monitoring the ever-increasing amount of biomedical literature must be designed for huge volumes of data, and companies need to have a system in place to proactively identify reliable reports and accurately judge their importance.
Having the full range of necessary information also enables research teams to make thorough drug safety assessments, improve study design and regulatory applications and, ultimately, to make better-informed risk management and mitigation decisions.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Providing timely, evidence-based information on the safe and effective use of medicines, facilitating changes to healthcare practices, supporting risk minimization behavior.
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...KCR
Post-Authorisation Safety Studies (PASS)
Is the Ongoing Surveillance a Blessing Or a Curse?
28th DIA EuroMeeting
7 April 2016, Hamburg, Germany
Magdalena Matusiak, MPharm
Manager, Clinical Development
Pharmacovigilance Team Lead, KCR
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
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
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
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
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
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Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
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 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.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
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
Semelhante a Embase webinar: Building searches for drug safety and post market device surveillance 26 Nov 2014 (20)
How predictive models help Medicinal Chemists design better drugs_webinarAnn-Marie Roche
All scientific disciplines, including medicinal chemistry, are experiencing a revolution in unprecedented rates of data being generated and the subsequent analysis and exploitation of this data is increasingly fundamental to innovation. Using data to design better compounds is a challenge for Medicinal and Computational chemists.
The design of small-molecule drug candidates, encompassing characteristics such as potency, selectivity and ADMET (absorption, distribution, metabolism, excretion and toxicity) is a key factor in the success of clinical trials and computer-aided drug discovery/design methods have played a major role in the development of therapeutically important small molecules for over three decades. These methods are broadly classified as either structure-based or ligand-based.
In this webinar our expert Dr. Olivier Barberan will discuss ligand-based methods and he will cover the following:
How to use only ligand information to predict activity depending on its similarity/dissimilarity to previously known active ligands.
- Discuss ligand-based pharmacophores, molecular descriptors, and quantitative structure-activity relationships and important tools such as target/ligand databases necessary for successful implementation of various computer-aided drug discovery/design methods in a drug discovery campaign.
Webinar: New RMC - Your lead_optimization Solution June082017Ann-Marie Roche
The drug discovery landscape is rapidly changing and drives the need to generate leads with lower attrition rates.
In this webinar, our expert Dr. Olivier Barberan discussed how NEW Reaxys Medicinal chemistry in NEW Reaxys allows better discovery and exploration of structure activity relationship and also supports a more efficient property-based drug design approach. He covered the following:
• How has RMC being transformed into a more accessible tool for all users, allowing complex searches and workflows to be easily carried out.
• A demonstration of how more than ever RMC is the only lead-optimization solution you will need.
Oil&Gas Thought Leader Webinar - New Plays for Old Ideas - Dr.Gabor TariAnn-Marie Roche
In our April 2017 webinar, three industry experts shared their research and demonstrated the importance of focusing on fundamental geologic and geophysical research approaches that integrate variety of data, information and concepts from disparate sources and related disciplines.
This back-to-fundamentals research can both inspire and accelerate exploration teams’ thinking about petroleum systems and lead to a path to success.
Dr Gabor Tari is currently the Group Chief Geologist at OMV. He has over 20 years’ experience working in upstream oil & gas and has worked for Amoco, BP, and Vanco, before joining OMV in 2007. Gabor has worked on exploration projects in basins around the globe, including Romania, Angola, North Africa, and the Middle East. He has authored over 50 scientific publications, presented papers at dozens of conferences, and most recently co-authored the book Permo-Triassic Salt Provinces of Europe, North Africa and the Atlantic Margins, with Dr Joan Flinch (Repsol) and Juan Soto, Professor of Geodynamics in the Granada University and in the Instituto Andaluz de Ciencias de la Tierra, Spain, which is currently available from Elsevier for pre-order online.
Gabor discussed and shared some examples of how new plays can be built on a solid foundation of petroleum system development and research, and how new ideas can be garnered from building on published research of oil & gas companies, academia, service providers and consultants.
Oil&Gas Thought-Leader Webinar - New Plays for Old Ideas - Dr. Rob ForknerAnn-Marie Roche
In our April 2017 webinar, three industry experts shared their research and demonstrated the importance of focusing on fundamental geologic and geophysical research approaches that integrate variety of data, information and concepts from disparate sources and related disciplines. This back-to-fundamentals research can both inspire and accelerate exploration teams’ thinking about petroleum systems and lead to a path to success.
Dr Rob Forkner is a carbonate geologist at Statoil, working in the carbonate plays and reservoirs research group in Austin, Texas, focusing on carbonate play prediction in Atlantic margin systems. Prior to Statoil, Rob worked at Maersk and Shell in onshore and offshore in well planning, geosteering, high-resolution sequence stratigraphy and facies prediction, carbonate sedimentology in unconventional assets, evaporite classification and prediction, rock typing, and more recently, carbonate system suppression and recovery during Oceanic Anoxic Events.
Oil&Gas Thought-Leader Webinar - New Plays for Old Ideas - Dr. Sander HoubenAnn-Marie Roche
In our April 2017 webinar, three industry experts shared their research and demonstrated the importance of focusing on fundamental geologic and geophysical research approaches that integrate variety of data, information and concepts from disparate sources and related disciplines.
This back-to-fundamentals research can both inspire and accelerate exploration teams’ thinking about petroleum systems and lead to a path to success.
Dr. Sander Houben is a biostratrapher and researcher within the Basin Analysis team at TNO, Netherlands Organisation for Applied Scientific Research, and the leading research institute for applied sciences in the Netherlands. As part of the Basin Analysis Team, Sander provides scientific and technical expertise regarding stratigraphic and paleo-environmental constraints for multidisciplinary projects. In addition to conducting research, he leads TNO’s biostratigraphic consultancy research programs.
Embase for pharmacovigilance: Search and validation March 22 2017Ann-Marie Roche
Scientific literature plays a critical role in Pharmacovigilance and Drug Safety workflows. Monitoring literature for mentions of adverse drug reactions (ADRs) is mandated by regulatory bodies, and marketing authorization holders (MAHs) that do not properly report ADRs can be subject to heavy fines. With an increasing volume of unstructured content to cover, along with rising labor costs, MAHs are looking for ways to make their literature monitoring more effective and efficient.
Abstract and indexing (A&I) databases play an important role in Literature Monitoring – due to the vast amount of scientific literature published daily – in order for MAH’s to locate specific articles or conference presentations that may be relevant for their products (for both benefit/risk analysis and ADR detection). Rather than reading all the literature, MAH’s create search strategies that identify the relevant records in A&I databases and execute the searches regularly. GVP module VI mandates that searches are done at least weekly, but many companies maintain a daily monitoring and review cycle.
In this webinar, Senior Product Development Manager Embase, Dr. Ivan Krstic discussed best practices for saving time, staying current, validating search strategies and mitigating risk in the face of these increasingly complex processes in literature monitoring
Literature Management for Pharmacovigilance: Outsource or in-house solution? ...Ann-Marie Roche
Pharmaceutical companies are required to screen scientific literature on a regular basis and this comes with many challenges, such as handling large amounts of data, building search strings and integrating EMA MLM results. Out-sourcing literature screening to service providers reduces the workload for the PV-team, but how does it impact the literature management process overall? Maybe it results in decreased oversight and additional activities like audits and reconciliation? And what about building the search strategy?
During this webinar our PV expert, Dr. Joyce De Langen spoke about the following:
• The importance of literature management in Pharmacovigilance and the challenges.
• An evaluation of the benefits and risks of outsourcing literature management versus alternative solutions.
About the speaker:
Joyce de Langen, Ph.D has more than 10 years of experience in the domain of pharmacovigilance and drug safety. Through her work in the pharmaceutical industry, academia and regulatory authorities, Joyce has developed a broad perspective and knowledge in pharmacovigilance and drug safety.
The All-New 2016 Engineering Academic Challenge - developed by students for students
The Engineering Academic Challenge (formerly as the Knovel Academic Challenge) is an immersive, 5-week interactive problem-set competition, featuring weekly thematic engineering challenges built around five transdisciplinary themes inspired by the National Academy of Engineering Grand Challenges.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Embase webinar: Building searches for drug safety and post market device surveillance 26 Nov 2014
1. Building searches for drug safety and
device postmarket surveillance
Presented by Sherry Winter
and Ian Crowlesmith
26 November 2014
s.winter.1@elsevier.com
i.crowlesmith@elsevier.com
Embase® is a registered trademark of Elsevier BV.
2. Building searches for drug safety and
device postmarket surveillance
AGENDA
1. Introduction
2. Finding adverse reactions for drugs
3. Post marketing surveillance for
medical devices
4. Drug safety and risk
5. Conclusion
Embase® is a registered trademark of Elsevier BV.
3. 3
Pharmacovigilance
• 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.
• Increasingly important in
today’s world of big data
analysis and regulation
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
4. 4
What Are Governments Doing?
Growing regulatory pressure and focus on literature monitoring in EU & US
VI.B.1.1.2. Literature reports
The scientific and medical literature is a significant source of
information for the monitoring of the safety profile and of the risk
benefit balance of medicinal products, particularly in relation to the
detection of new safety signals or emerging safety issues. Marketing
authorization holders are therefore expected to maintain awareness of
possible publications through a systematic literature review of widely
used reference databases (e.g. Medline, Excerpta Medica or Embase)
no less frequently than once a week. The marketing authorization
holder should ensure that the literature review includes the use of
reference databases that contain the largest reference of articles in
relation to the medicinal product properties
A. Good reporting Practice
Spontaneous case reports of adverse events submitted to the sponsor
and FDA, and reports from other sources, such as the medical
literature or clinical studies, may generate signals of adverse effects of
drugs. The quality of the reports is critical for appropriate evaluation
of the relationship between the product and adverse events. FDA
recommends that sponsors make a reasonable attempt to obtain
complete information for case assessment during initial contacts and
subsequent follow-up, especially for serious events, and encourages
sponsors to used train…
Marketing authorization holders are therefore
expected to maintain awareness of possible
publications through a systematic literature
review of widely used reference databases
(e.g. Medline, Excerpta Medica or Embase)
no less frequently than once a week.
The quality of the reports is critical for
appropriate evaluation of the relationship
between the product and adverse events.
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
5. 5
The Increasing Volume of Literature Is Making Adverse
Event Monitoring a More Difficult Challenge
2013
2012
2011
2010
2005
2000
1995
1990
1985
1980
1975
0 5 10 15 20 25
30
Millions
• Reliable tools for finding adverse events are needed
Embase, October 2014
• Complex search strategies need to be employed to find the most relevant articles among the
thousands that are published each year
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
6. 6
Our Framework
Elsevier provides the capabilities necessary for Pharmacovigilance and Drug
Safety groups to be more efficient, stay compliant and mitigate risk
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
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
7. EMBASE FOCUSES ON DETECTING ADVERSE
EVENTS IN THE SCIENTIFIC LITERATURE
Every year >1,000,000 biomedical articles and
300,000 conference papers are published
7
Of all adverse events reported, 14%
comes from the literature
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
8. Building searches for drug safety and
device postmarket surveillance
AGENDA
1. Introduction
2. Finding adverse reactions for drugs
3. Post marketing surveillance for
medical devices
4. Drug safety and risk
5. Conclusion
Embase® is a registered trademark of Elsevier BV.
9. FINDING ADVERSE REACTIONS FOR DRUGS
TOPICS COVERED
9
• Searching with drug subheadings
Used for: fully indexed records
• Searching with free text (keywords)
Used for: automatically indexed records
• Saving search strategies
• Setting up Email alerts
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
10. POSTMARKET SURVEILLANCE FOR MEDICAL DEVICES
SEARCH OPTIONS
10
• Searching with device subheadings
Used for: fully indexed records from 2014
• Searching with keywords and other terms
Used for: automatically indexed AND older records
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
11. Building searches for drug safety and
device postmarket surveillance
AGENDA
1. Introduction
2. Finding adverse reactions for drugs
3. Post marketing surveillance for
medical devices
4. Drug safety and risk
5. Conclusion
Embase® is a registered trademark of Elsevier BV.
12. 12
Output Analysis: Risk Mitigation
Key Challenges
• 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?
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
13. EMBASE & PHARMAPENDIUM
IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING
13
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
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
14. EMBASE & PHARMAPENDIUM
IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING
By accessing regulatory data as well as published literature, you can:
14
• Link critical post marketing findings to the drug and validate its relevance in the
context of the studies that were performed as part of the drug approval process
• Look at post marketing findings and understand how they could be relevant
across different drugs and drug classes
• Go directly to a study that was done to find ways in which study designs could be
optimized in order to reduce the chance of seeing those same events take place
with a drug that you are currently developing
• Develop risk mitigation strategies that establish inclusion and exclusion criteria
for patients who wish to participate in trials (for example by predicting the
effect of drug-drug interactions with medications they are already on)
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
15. IDENTIFY AE REPORTED IN LITERATURE
FIND AE ON ROFECOXIB IN EMBASE (SHOWN BY IAN)
15
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
16. ACCESS INFORMATION FROM REGULATORY DATA
DELVE INTO MORE DETAILS WITH THE FDA APPROVAL PACKAGE
16
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
17. FIND DRUG-DRUG INTERACTIONS
17
E.g., search for drug interactions
to find those identified with
existing drugs.
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
18. FIND ADVERSE EVENTS REPORTED IN FDA/EMA
PACKAGE
18
Search the FDA package
for mentions of reported
adverse events
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
19. ACCESS AE DATA AND AERS REPORTS
19
Access Preclinical and
Clinical data on adverse
events and Post-marketing
(AERS reports)
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
20. 20
• Post-market surveillance of drugs
• Post-market surveillance of medical devices
• For drug safety/risk mitigation during drug development
• Other
POLL – WHAT IS YOUR MAIN REASON FOR
SEARCHING FOR ADVERSE EVENTS IN EMBASE?
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
21. IN CONCLUSION…
21
Embase supports your pharmacovigilance workflow by:
Finding adverse events in the literature
Comprehensive content, deep drug, device and disease indexing and dedicated
search tools mean you will avoid missing critical information
Unique access to regulatory data
Manage the risk of late stage failure by making more informed risk
management/mitigation decisions with information reported in the literature as
well as adverse events and drug-drug interactions reported in FDA/EMA documents
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
22. 22
• Q&A will be sent to you by email and for more information and
questions please contact your regional office
• Our next Embase webinar will take place January 2015 and will focus
on Systematic Reviews.
• Please click on at Embase.com for all Embase training materials
and a webinar overview
THANK YOU
SEE YOU NEXT TIME!
Please fill out the survey that appears on your
screen after leaving the webinar.
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
23. THANK YOU
ANY QUESTIONS?
23
Sherry Winter
Product Marketing Manager
s.winter.1@elsevier.com
Ian Crowlesmith
Sr Product Manager, Content Development
i.crowlesmith@elsevier.com
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
Notas do Editor
Welcome to our Embase webinar, my name is Sherry Winter. I’m the Product Marketing Manager for Embase and I will be one of your speakers today. I am here with our Embase expert Ian Crowlesmith. Ian will be familiar to regular Embase webinar attendees, but for those of you who don’t know him, Ian has been with Embase for over 30 years and he is currently Senior Product Manager for Content Development, playing a key role in managing the content and coverage of Embase. Ian has carried out several roles in his time at Elsevier, including leading the team that set up the Emtree thesaurus in the late 1980s and early 90’s.
Today, Ian and I will discuss the key things to think about searching for adverse drug events and for drug safety, and Ian will also demonstrate how you can do post-market surveillance for medical devices in Embase. This webinar is aimed at users with some Embase experience, but we also offer introductory webinars regularly and will share more details on upcoming webinars at the end.
We will share the slides and recording directly after this webinar, so you can review or share with your colleagues. During the session you can send us your questions by using the chat or Ask a Question function on the webinar control panel and we will answer as many of your questions as possible during the webinar. All questions will be answered and included in a Q&A email that will be sent to you after the webinar.
If you wish to have a full screen view, please click on the red arrow. Your control panel will be hidden. Click again on the red arrow to see your control panel.
Today we’ll be discussing important considerations for your pharmacovigilance workflows and how Embase is a key resource for post-market surveillance of adverse drug or device events, and also for drug safety, or risk mitigation.
Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, and thorough PV strategies are key to protect patients from drugs that are unsafe or ineffective and also to comply with increasingly strict reporting requirements. Not performing adequate pharmacovigilance can result in heavy fines and can also damage the company’s reputation.
There is growing regulatory pressure and focus on literature monitoring in EU & US. Embase is mentioned as a source for biomedical literature in European Medical Association guidelines: (Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week)
The FDA notes that the quality of reports generated from sources, such as the medical literature, is critical for appropriate evaluation of the relationship between the product and adverse events.
The increasing volume of literature makes finding adverse events more challenging every year.
This graph demonstrated just how many more records have been added to Embase each year from 1974. With such an increase in information, the search strategies and tools that are used to find adverse events are critical to ensure that the most relevant information is found and that nothing is missed.
More adverse events are also being reported due to our aging population that results in more chronic conditions (meaning that more people are on drugs and they are on more than one drug, which can lead to harmful drug-drug interactions).
With these challenges in mind, Elsevier has developed the capabilities necessary for Pharmacovigilance and Drug Safety groups to be more efficient, stay compliant and mitigate risk. Although these capabilities extend into case processing and output with the use of Quosa, in today’s Embase-focused webinar, we will take a closer look at Case Input – searching the literature for reported adverse events and Risk Mitigation, or managing the risk of late-stage failure during drug development by using Embase to search for information found in the literature and in the regulatory information from PharmaPendium.
Adverse events are reported in a variety of forums; the majority are reported directly to a health professional (these will then be reported to the FDA or other regulatory body and (for example) will be entered into the FDA Adverse Event Reporting System, which I’ll describe later on in the webinar).
Although only 14% of adverse events are reported in the scientific literature, it’s critical to not miss any mentions of these, and this is where Embase comes in. Every year, more than 1,000,000 non-conference records and 300,000 conference abstracts are added to Embase.
At this point, I’ll hand the presenter rights over to Ian, who will demonstrate in detail how to find adverse reactions for drugs and how you can also do post-market surveillance for medical devices using Embase. It may just take a minute or 2 while we change presenters…
Switch presentation to Ian
In addition to post-market surveillance, risk mitigation is another important aspect of pharmacovigilance, and is critical for any drug development/post-market surveillance plan.
Typical questions that you might consider when thinking about a risk mitigation strategy are:
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?
To answer these questions, it’s important to have all the information possible, which means accessing published biomedical literature as well as the vast amount of information that’s reported to the FDA or EMA during and after drug development.
This is where Embase and PharmaPendium work together to provide the information that allows you to develop a better risk management or pharmacovigilance strategy. A single drug search in Embase will search PharmaPendium at the same time. If there is information in PP on that particular drug, then an information panel in Embase appears with links to drug safety information reported in FDA or EMA approval documents and to preclinical and clinical adverse events.
Together, Embase and PharmaPendium provide more information and insights into historical regulatory precedents and allow you to better monitor and anticipate safety risks.
Read slide
As Ian showed you earlier, you can identify adverse events for rofecoxib that have been reported in the literature. Here I’ve done a search for any adverse events reported for rofecoxib. At the same time, PharmaPendium was automatically being searched for information on rofecoxib. You can see the results in this panel on the right-hand side of the screen that shows information including the chemical structure, brand and chemical names, and links to FDA and EMA regulatory documents.
Access regulatory data found in the medical, chemistry, statistical and clinical pharmacology /biopharmaceutics reviews sections of the FDA’s drug approval packages, and similar input from the European Medicines Agency.
In the case of Rofecoxib, PharmaPendium includes FDA approval package information. For example, a closer look at the Medical/Clinical Review section shows results of clinical trials and includes dosage, efficacy and safety information.
You can search for specific information in the approval package - for example, for any reported drug-drug interactions. This allows you to anticipate drug-drug interactions that might be observed during the development of a similar drug, and to develop risk mitigation strategies with this in mind (for example, by excluding study participants who are on drugs that might interact, or by finding alternate drugs for them to be on)
You can also search the FDA approval package for mentions of adverse events that were reported during the approval process for the drug
And you can access adverse events directly from the PharmaPendium information window in Embase. From here, you can access preclinical Adverse events (e.g., those seen in preclinical animal models), or from clinical trials or post-clinical reports (these are the Adverse Events Reporting System reports I mentioned earlier, which may be generated when an adverse event is reported directly to a healthcare professional).
An example of such a report for rofecoxib is shown here.
At this point, I’d like to ask our audience if they’d mind sharing with us their main reason for looking for adverse events in Embase?
Please select the reason that best applies to you from the poll now appearing on your screens.
Thank you for your response. According to the poll, the majority of our uses look for AEs to …..
Read slide
We have come to the end of our Embase webinar. On behalf of Ian, I would like to thank you very much for attending and I hope you enjoyed the webinar.
When you leave the session, a survey will pop up. We hope you have a few additional minutes to share your much appreciated feedback with us. As already mentioned, we will complete all questions and send to you by email and the slides and the recording will be shared with you today.
Thanks again and good luck with further exploring Embase. We hope to meet you again soon.