The document discusses literature monitoring for pharmacovigilance. It describes weekly monitoring of individual case safety reports and periodic monitoring through development safety update reports and periodic benefit-risk evaluation reports. Key databases for literature searches are Medline and Embase. While Embase has more extensive drug coverage, searches on Medline via PubMed are more reliable due to the potential for loss of MeSH subheadings when mapping to Emtree and the risk of false negatives and positives when searching Embase alone. Literature searches support signal detection and periodic evaluation of a product's safety profile.
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.
Literature searches in Pharmacovigilancesamikshagupta
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
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.
Literature screening for pharmacovigilance 190818Marnix Wieffer
Biomedical literature is an important source of drug adverse event reporting and Pharmacovigilance. However, due to the high volume of literature, sub-optimal search strategies and regulatory pressure, pharmaceutical companies are struggling to screen biomedical literature in a compliant and cost-effective manner.
This slide deck describes how, through outsourcing, automation and prioritization technology, we can significantly improve efficiency and compliance of literature screening.
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
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.
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.
Literature searches in Pharmacovigilancesamikshagupta
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
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.
Literature screening for pharmacovigilance 190818Marnix Wieffer
Biomedical literature is an important source of drug adverse event reporting and Pharmacovigilance. However, due to the high volume of literature, sub-optimal search strategies and regulatory pressure, pharmaceutical companies are struggling to screen biomedical literature in a compliant and cost-effective manner.
This slide deck describes how, through outsourcing, automation and prioritization technology, we can significantly improve efficiency and compliance of literature screening.
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
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
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
“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.”
Automate your literature monitoring for more effective pharmacovigilanceAnn-Marie Roche
Embase and QUOSA experts take you through a complete literature management workflow, demonstrating how Elsevier’s Pharmacovigilance solution enables efficient and comprehensive post-market surveillance.
This is an overview of the Literatures in Pharmacovigilance. This presentation might helpful for the beginners in literature stream. this is not a detailed explanation of the literature case processing,
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
ICIC 2016: Improving the Pharmacovigilance Literature Screening Process. How ...Dr. Haxel Consult
Screening scientific literature for the purpose of detecting adverse side effects of drugs is burdensome, yet essential. The discovery and retrieval of full-text journal articles is a necessary part of this process. Cursory screening of abstracts has been used to determine which journal articles require full-text reviews. And transactional purchases have historically been the only option for accessing the full-text for non-subscribed content when cursory reviews lead to in-depth review requirements.
In February 2016, a new full-text article rental program was introduced to the drug safety market with the potential to enable a deeper screening of scientific journal content. In this session, Reprints Desk will present information related to new full-text article rentals, including an overview of how article rentals work and time-saving workflow options.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
“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.”
Automate your literature monitoring for more effective pharmacovigilanceAnn-Marie Roche
Embase and QUOSA experts take you through a complete literature management workflow, demonstrating how Elsevier’s Pharmacovigilance solution enables efficient and comprehensive post-market surveillance.
This is an overview of the Literatures in Pharmacovigilance. This presentation might helpful for the beginners in literature stream. this is not a detailed explanation of the literature case processing,
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
ICIC 2016: Improving the Pharmacovigilance Literature Screening Process. How ...Dr. Haxel Consult
Screening scientific literature for the purpose of detecting adverse side effects of drugs is burdensome, yet essential. The discovery and retrieval of full-text journal articles is a necessary part of this process. Cursory screening of abstracts has been used to determine which journal articles require full-text reviews. And transactional purchases have historically been the only option for accessing the full-text for non-subscribed content when cursory reviews lead to in-depth review requirements.
In February 2016, a new full-text article rental program was introduced to the drug safety market with the potential to enable a deeper screening of scientific journal content. In this session, Reprints Desk will present information related to new full-text article rentals, including an overview of how article rentals work and time-saving workflow options.
Founded in 2014, Revipharm is a consulting firm which provides guidance to pharmaceutical and Healthcare companies in the area of regulatory affairs and pharmacovigilance. We also provide related services, such as quality system implementation, business development and training.
We have many years of experience of working with and in the pharmaceutical industry and other such industries (cosmetics, medical devices).
Revipharm is your company’s multicultural partner with a global presence through our various partnerships within Europe. The company’s quality services and results forge solid and long-term relationships with its stakeholders.
"Renaissance in Signal Management" highlights recently published studies and their insights regarding opportunities to refine signal management processes and leverage different data sources including electronic health records for signal detection. The talk discusses the published work of many teams including CIOMS, EMA, IMI UMC, FDA and others and what the results of those studies offer regarding the relative strengths of various data sources and statistical methods for signal detection. This talk was presented at the 2016 World Drug Safety Congress by Commonwealth Informatics.
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.
This was a presentation given at the European Patent Office's annual Patent Information Conference in Madrid, Spain on November 10th, 2016.
In it, we give an overview of how machine translation works, latest advances in neural MT, and how this can be applied to patents and intellectual property content, not only for translations but also information extraction and other NLP applications.
Embase: Adverse Drug Reactions - webinar September 25 2013Ann-Marie Roche
Ian Crowlesmith, our Embase expert reviewed the following in this webinar:
- Drugs and adverse drug reaction in Embase vs MEDLINE
- Searching for Adverse events and side effects in Embase
- Using keywords when searching for adverse events
- Adverse events of devices
Learn how to use Embase for all your biomedical searches
• Which workflows are supported by Embase and why
• An overview of content and indexing compared to Medline
• A demo in Embase of some introductory searches
• Answers to the most frequently asked questions by new users
• Where to find materials to support trainers
Importance of systematic literature search for clinical evaluation (CE) the s...PEPGRA Healthcare
The Clinical Evaluation Report (CER) comprises of three major parts that present complete clinicalevaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of the medical device along with compliance and experience records. The third part of the CER deals with the literature review of the clinical evaluation published on equivalent devices.
Visit : www.pepgra.com
A literature review may form the major source of clinical evidence
to validate the safety and performance of the established devices
in their commercialization approval process, where it may not be
feasible to conduct new clinical investigations on the device.
Preparing for a New Time in Medical Literature MonitoringCovance
In recent times, pharmacovigilance regulations have focused increasingly more on medical literature monitoring (MLM), a complex process whose scope continues to expand and deepen. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
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.
Dr. Su Golder, NIHR Research Fellow at the University of York, presents findings from her recent publication: “Systematic review on the prevalence, frequency and comparative value of adverse events data in social media”.
Learn how to use Pathway Studio to explore biomarkers and brain regions. With the addition of highly sophisticated visualization tools, users can interactively explore the vast number of connections created to help unravel disease biology. In addition, an innovative new taxonomy based on brain region identifications will be presented. Together, these innovations can be applied to rapidly increase the knowledge of diseases based on published findings.
Cell centered database for immunology and cancer research feb252016Ann-Marie Roche
Determining the cellular mechanisms of diseases is a crucial requirement for understanding the causes and progression of diseases, predicting outcomes, and developing new treatments. Often relevant information, e.g. what cells are involved in a disease or what effects does a drug have on cells, is scattered across many papers and journals, which makes it difficult for researchers to be sure they have a complete picture. Using Elsevier’s automated text mining technology, we have created a new cell-centered database consisting of 850 000 facts captured from more than 24 million PubMed abstracts and 3.5 million full text articles for use in Pathway Studio. This database focused primarily on cellular aspects of immunology and immuno-oncology can be used to summarize and visualize published research, and to analyze experimental data.
Are you using phenotypic screening as a way to discover new drugs or would you like to know more about this approach?
• Outline the steps to take when building this approach in Reaxys.
• Demonstrate how pharmacological targets involved in cell based assay can be easily identified in Reaxys with their mechanisms of action
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
3. 3 / CONFIDENTIAL
Weekly monitoring: Individual case safety report
• The reporting of an adverse reaction requires 4 criteria :
At least one
identifiable reporter
One single identifiable
patient
At least one suspect
medicinal product
At least one suspect
adverse reaction
Day zero is the date on which the applicant or its foreign affiliate
has received the 4 basic elements.
1/ 2/ 3/ 4/
4. 4 / CONFIDENTIAL
Regulatory requirements for the weekly monitoring
ICH EMA FDA
Guideline ICH E2D Module VI of GVP 21CFR314.80
Monitoring frequency At least every 2 weeks Weekly Not specified
Where to look? Widely used systematic
literature reviews or
reference databases
Systematic literature
review of two widely
used reference
databases that contain
the largest number of
articles in relation to the
medicinal product
properties
Applicants can use
literature search services
(ex : Weekly Reactions)
Submission criteria - The product of the
applicant is clearly
suspected
- The product source,
brand, or trade name is
not specified
- If multiple products are
mentioned in the article,
a report should be
submitted only by the
applicant whose product
is suspected.
- The product of the
applicant is clearly
suspected
- The product source,
brand, or trade name is
not specified
- If multiple products are
mentioned in the article,
a report should be
submitted only by the
applicant whose product
is suspected.
- Same active substance as a
product marketed in the US
(even if the excipient,
dosage forms, strengths,
routes of administraction,
and indications vary)
- If multiple products are
mentioned in the article, a
report should be submitted
only by the applicant whose
product is suspected.
5. 5 / CONFIDENTIAL
Regulatory requirements for the weekly monitoring
ICH EMA FDA
Exclusions Brand or trade name of
another company can
exclude
- Brand or trade name of another
company can exclude
- The ICSR originates in a country where
the company holds a marketing
autorisation but has never
commercialised the product
- Literature ICSRs based on an analysis
from a competent authority database
or from publicly available databases
- Literature articles which summarise
results from post-autorisation studies
Brand or trade name of
another company can
exclude
Local monitoring Subsidiaries
Comments « There is no acceptable loss of recall
when searching published literature for
pharmacovigilance. » (Module VI – GVP
EMA)
6. 6 / CONFIDENTIAL
Periodic monitoring: DSUR
• DSUR = Development Safety Update Report
- Annual reporting on drugs under development
- Review and evaluation of pertinent safety information collected during the
reporting period
- Examines if the new safety information is in line with previous knowledge
• Contribution of the literature
- New and significant safety finding during the reporting period
- Non-clinical and clinical studies
- + information on drugs of the same class if relevant
7. 7 / CONFIDENTIAL
Periodic monitoring: PBRER
• PBRER = Periodic Benefit-Risk Evaluation Report
- Annual periodic report on marketed products
- Objective: enable an appraisal of the product’s benefit-risk profile by analyzing:
New safety information that could have an impact on the benefit-risk profile
(and if so, conduct an integrated B-R evaluation for approved indications)
New efficacy information
- Examines if the new safety information is in line with previous knowledge
• Contribution of the literature
- New and significant safety finding during the reporting period
- Non-clinical and clinical studies
- Wider than searches for ICSRs : studies reporting, safety outcomes in groups of
subjects…
- + information on drugs of the same class if relevant
8. 8 / CONFIDENTIAL
Periodic monitoring: NDA Annual Report Bibliography
• New Drug Application Annual Report
- Submission to the FDA within 60 days of the anniversary date of US approval of the application
- Includes:
A brief summary of significant new information from the previous year that might affect the safety,
effectiveness, or labeling of the drug product
Currently used labeling for patients and professionnals
Distribution data and authorized generic drugs
Chemistry, manufacturing and controls changes
Nonclinical laboratory studies
Clinical data
• Contribution of the literature
- Clinical information (any indications):
• Safety and effectiveness, clinical trials, clinical trial on new uses
• Biopharmaceutic, pharmacokinetic, clinical pharmacology studies;
• Epidemiologic studies or analyses of experience in a monitored serie of patients
- Nonclinical information: published reports of new toxicological findings in animal studies and in vitro
studies
10. 10 / CONFIDENTIAL
Where to look for relevant articles for pharmacovigilance?
• EMA guidelines: at least 2 databases must be searched
• Databases used by the Galderma’s Competitive and Scientific Intelligence
service:
Embase.com
Which includes the references from:
11. 11 / CONFIDENTIAL
Medline/Embase
Database Medline Embase
Focus Biomedicine and health
Broad biomedical scope with in-depth coverage of
drugs and pharmacology
Date of creation 1879 1947
Time coverage 1946 to the present 1947 to the present
Produced by US National Library of Medicine Elsevier (Netherlands)
Access Available free of charge via PubMed Through institutional subscription
Content
Journal articles, mostly from peer-reviewed
journals
Journal articles, mostly from peer-reviewed journals
+ conference abstracts since 2009
Number of records Over 23 million records from 5600 journals
published in 70 countries in about 40
languages
Over 21 million records from 6100 journals
published in 70 countries in about 40 languages.
Embase.com includes all Medline records and
reaches 32 million records from 8517 journals.
Updates Daily from Tuesday to Saturday (2000-4000
records per update)
Daily from Tuesday to Saturday (6000 records per
update)
Thesaurus MeSH Emtree
Uses
- For clinical queries and biological,
genetics topics
- Similar articles are suggested (formerly
« related articles »)
- For easy keyword search
- For drug/pharmacy topics (coverage plus
subheading options)
- To pick up recent articles and conference papers
- For great basic, natural language search
- Allows proximity operators
12. 12 / CONFIDENTIAL
A focus on Embase
• Content
- In-depth coverage of pharmacology, toxicology, pharmaceutical
science and clinical research
• Geographic coverage
- More European journals are indexed
- A special attention is given to journals published outside
the main area (USA, Canada and Western Europe)
- But Medline has more journals indexed from the USA than Embase
• Conference abstracts
- Added on Embase, nonexistent on Medline
13. 13 / CONFIDENTIAL
MeSH / Emtree : key figures
Thesaurus MeSH Emtree
Database Medline Embase
Number of terms 27,883 73,000 (of which more than 30,000 are drugs
and chemicals)
Number of terms per
article
10-20 3-4 major terms, and up to 50 minor terms
_______
Medline-derived articles are not directly
indexed with Emtree terms. However MeSH
terms are mapped to Emtree terms to provide
indexing compatible with Embase indexing.
Description of terms Most terms come with a short
description or definition.
No definitions used for indexing because
according to Elsevier, « natural language
terminology means that you don’t need to
know « how » terms are defined in Emtree ».
However, Emtree contains definitions from
Dorlands dictionary for most of terms.
Synonyms 213 000 310 000 (including over 190 000 drug
synonyms)
Supplementary concept
record
232 000 0
Updates Once per year Three times per year
14. 14 / CONFIDENTIAL
MeSH / Emtree : indexing process
Medline/MeSH Embase/Emtree
Automatic indexing Nonexistent Since 2009, 3 types of articles are indexed
automatically:
- Conference abstracts
- Articles in Press
- In-Process records
Manual indexing - Federal employees or employees of
firms that have contracts with NLM
for biomedical indexing.
- An indexer must have no less than a
bachelor's degree in a biomedical
science.
- Performed by trained indexers with a
biomedical background.
- Indexers read and analyze the full text of
articles in order to identify relevant concepts,
and index them with the most specific Emtree
terms
15. 15 / CONFIDENTIAL
A focus on Emtree
Strength Weakness
Extensive pharmaceutical coverage:
- Drugs: Emtree includes chemical names, trade
names, and laboratory/research codes as well as
generic names for more than 31,000 drugs and
chemicals, including all generic names recognised by
FDA, EMA and WHO (from 2000)
- Medical devices: over 3000 specific terms
- Large number of drug subheadings (64), including
47 routes of drug administration
For each new modified descriptor: no history of
previous indexing of this concept
- The history of a term before coming to the actual
term is unknown.
It can be problematic to find old articles if the
way of indexing before is unknown.
Scopes notes seem to be less systematic than in the
MeSH
Limited use of subheadings
- The subheadings cannot be used for every kind of
descriptors. Subheadings can qualify drugs, diseases
or medical devices only, contrary to the MeSH with
which the descriptors can almost always be
associated to subheadings
17. 17 / CONFIDENTIAL
Comparison Embase/Medline
• Several tests performed on Embase.com and PubMed
• Problematic: shall we search for Medline articles on PubMed with the MeSH or can we keep
searching for Medline articles on Embase.com with the Emtree?
• Findings:
1. Loss of subheadings during the automatic mapping of articles from Medline on
Embase.com
2. The use of some terms differs between the MeSH and the Emtree
3. False negatives on Embase.com
- Some articles weren’t indexed with adverse effects terms whereas the articles were about
adverse effects.
4. False positives on PubMed
- Some drugs were indexed with the « adverse drug reaction » subheading whereas the article did
not mention any adverse event caused by the drug in question.
Conclusion : it would be more reliable to search for Medline on PubMed with the MeSH
20. 20 / CONFIDENTIAL
Comparison Embase/Medline : example
• Several tests performed on Embase.com and PubMed
• Problematic: shall we search for Medline articles on PubMed with the MeSH or can we keep
searching for Medline articles on Embase.com with the Emtree?
• Findings:
1. Loss of subheadings during the automatic mapping of articles from Medline on
Embase.com
2. The use of some terms differs between the MeSH and the Emtree
3. False negatives on Embase.com
- Some articles weren’t indexed with adverse effects terms whereas the articles were about
adverse effects.
4. False positives on PubMed
- Some drugs were indexed with the « adverse drug reaction » subheading whereas the article did
not mention any adverse event caused by the drug in question.
Conclusion : it would be more reliable to search for Medline on PubMed with the MeSH
21. 21 / CONFIDENTIAL
Comparison Embase/Medline
Subheading Emtree definition MeSH definition
« Adverse effects » dd_ae: “Adverse drug reaction” :
Used as a drug subheading to identify a
drug for which an undesired side effect is
reported (when used at therapeutic dose
ranges in humans)
AE : Used with drugs, chemicals, or biological agents in
accepted dosage - or with physical agents or manufactured
products in normal usage - when intended for diagnostic,
therapeutic, prophylactic, or anesthetic purposes.
It is used also for adverse effects or complications of
diagnostic, therapeutic, prophylactic, anesthetic, surgical, or
other procedures, but excludes contraindications for which
"contraindications" is used.
« Toxicity » dd_to: “Drug toxicity” :
Used as a drug subheading to identify a
drug or chemical that is toxic in animals
(including LD50 tests), in animal or human
cells and tissues, and in other toxicity
studies.
In humans, used to signal toxicity at non-
therapeutic dose ranges, or when lasting
damage is caused at therapeutic dose
ranges.
TO : Used with drugs and chemicals for experimental human
and animal studies of their ill effects. It includes studies to
determine the margin of safety or the reactions
accompanying administration at various dose levels. It is
used also for exposure to environmental agents. Poisoning
should be considered for life-threatening exposure to
environmental agents.
24. 24 / CONFIDENTIAL
Comparison Embase/Medline
• Several tests performed on Embase.com and PubMed
• Problematic: shall we search for Medline articles on PubMed with the MeSH or can we keep
searching for Medline articles on Embase.com with the Emtree?
• Findings:
1. Loss of subheadings during the automatic mapping of articles from Medline on
Embase.com
2. The use of some terms differs between the MeSH and the Emtree
3. False negatives on Embase.com
- Some articles weren’t indexed with adverse effects terms whereas the articles were about
adverse effects.
4. False positives on PubMed
- Some drugs were indexed with the « adverse drug reaction » subheading whereas the article did
not mention any adverse event caused by the drug in question.
Conclusion : it would be more reliable to search for Medline on PubMed with the MeSH
27. 27 / CONFIDENTIAL
Comparison Embase/Medline
• Several tests performed on Embase.com and PubMed
• Problematic: shall we search for Medline articles on PubMed with the MeSH or can we keep
searching for Medline articles on Embase.com with the Emtree?
• Findings:
1. Loss of subheadings during the automatic mapping of articles from Medline on
Embase.com
2. The use of some terms differs between the MeSH and the Emtree
3. False negatives on Embase.com
- Some articles weren’t indexed with adverse effects terms whereas the articles were about
adverse effects.
4. False positives on PubMed
- Some drugs were indexed with the « adverse drug reaction » subheading whereas the article did
not mention any adverse event caused by the drug in question.
Conclusion : it would be more reliable to search for Medline on PubMed with the MeSH
32. 32 / CONFIDENTIAL
Comparison Embase/Medline
• Several tests performed on Embase.com and PubMed
• Problematic: shall we search for Medline articles on PubMed with the MeSH or can we keep
searching for Medline articles on Embase.com with the Emtree?
• Findings:
1. Loss of subheadings during the automatic mapping of articles from Medline on
Embase.com
2. The use of some terms differs between the MeSH and the Emtree
3. False negatives on Embase.com
- Some articles weren’t indexed with adverse effects terms whereas the articles were about
adverse effects.
4. False positives on PubMed
- Some drugs were indexed with the « adverse drug reaction » subheading whereas the article did
not mention any adverse event caused by the drug in question.
Conclusion: it would be more reliable to search for Medline articles on PubMed with the MeSH
34. 34 / CONFIDENTIAL
Weekly literature monitoring
• Search strategy for the weekly monitoring:
- INN (free-text + corresponding Emtree term)
- Brand names and trade names in all languages (free-text)
+ Pre-selection:
- Active ingredient corresponding
- Galenic form corresponding
- Human
35. 35 / CONFIDENTIAL
Periodic literature monitoring
• Search strategy for the periodic monitoring:
1. Safety query: ‘product’/exp/dd_ae,dd_to
‘drug class’/exp/dd_ae,dd_to
2. Interactions query: ‘product’/dd_it
‘drug class’/dd_it
3. Benefit-risk query: product query AND benefit-risk query
drug class query AND benefit-risk query
Bold = suggestions for additions
36. 36 / CONFIDENTIAL
Periodic literature monitoring SOP
• Search strategy for the periodic monitoring :
- Benefit-risk query (1) :
EMA guidelines
(GVP)
Concepts Terms currently used in the query Terms that could be added
Generalities General terms on the
benefit/risk
Risk benefit analysis
Drug surveillance program
Pharmacoepidemiology
Treatment effect Therapy effect
Drug effect
Treatment outcome
Benefit Efficacy Clinical effectiveness
Patient satisfaction
Risk Inefficacy Treatment failure Drug substitution
Drug withdrawal
Drug resistance
Free-text :
Ineff*
Lack of efficacy
Drug effect decreased
Nonresponse, unresponse
37. 37 / CONFIDENTIAL
Periodic literature monitoring SOP
• Search strategy for the periodic monitoring :
- Benefit-risk query (2) :
EMA guidelines
(GVP)
Concepts Terms currently used in the query Terms that could be added
Risk Adverse effect Adverse drug reaction
Side effect OR ‘Side effect’/lnk
Risk/safety data Risk
Safety
Drug safety
Risk assessment
Patient safety
Iatrogenic disease
Intoxication, toxicity and
fatality
Drug toxicity and intoxication
(this term includes « drug fatality,
« drug intoxication » and « drug
toxicity »)
Death
Suicide
Abuse Drug abuse
Drug overdose
Medication error Medication error
Misuse Drug misuse
Hypersensitivity Drug hypersensitivity
Tolerance Drug tolerance Drug tolerability
38. 38 / CONFIDENTIAL
Periodic literature monitoring SOP
• Search strategy for the periodic monitoring :
- Benefit-risk query (3) :
EMA guidelines
(GVP)
Concepts Terms currently used in the query Terms that could be added
Interaction Drug interaction
Clinical studies (with
a number of
subjects high
enough)
Major clinical study
Multicenter study
Off-label use Off label drug use Case report (may be very broad)
Particular
populations
Pregnant women Pregnancy
Drug exposure
Pregnancy outcome
Pregnancy disorder
Lactation
Breast feeding
(Compassionate use) (Not useful for current Galderma products) (compassionate use)
39. 39 / CONFIDENTIAL
Periodic literature monitoring SOP
• Search strategy for the periodic monitoring :
- Benefit-risk query : 'risk benefit analysis'/de OR 'drug surveillance program’/exp OR
'pharmacoepidemiology'/exp OR 'therapy effect'/exp OR 'drug effect'/exp OR
'treatment outcome'/exp OR 'patient satisfaction'/exp OR 'clinical effectiveness'/exp
OR ‘adverse drug reaction’/exp OR ‘side effect’/exp OR ‘side effect’/lnk OR 'treatment
failure'/exp OR 'drug substitution'/exp OR ‘drug withdrawal’/exp OR ‘drug
resistance’/exp OR ineff* OR ‘lack of efficacy’ OR nonresponse OR ‘non response’ OR
‘no response’ OR unresponse OR ‘drug effect decreased’/exp OR 'risk'/exp OR
'safety'/de OR 'drug safety'/de OR 'risk assessment'/de OR ‘patient safety’/exp OR
‘iatrogenic disease’/exp OR 'drug toxicity and intoxication'/exp OR 'death'/exp OR
'suicide'/exp OR 'drug abuse'/exp OR 'drug overdose'/exp OR 'withdrawal
syndrome'/exp OR 'vitamin D intoxication'/exp OR ‘retinol intoxication’/exp OR
'toxic epidermal necrolysis'/exp OR 'toxicity'/exp OR 'medication error'/exp OR ‘drug
misuse’/exp OR 'drug hypersensitivity'/exp OR 'drug tolerance'/exp OR ‘drug
tolerability’/exp OR ‘drug interaction’/exp OR ‘major clinical study’/exp OR
‘multicenter study’/exp OR 'case report'/exp OR 'off label drug use'/exp OR
'pregnancy'/exp OR 'drug exposure'/exp OR 'pregnancy outcome'/exp OR ‘pregnancy
disorder'/exp OR 'lactation'/exp OR 'breast feeding'/exp
Bold = suggestions for additions
40. 40 / CONFIDENTIAL
Periodic literature monitoring
• Search strategy for the periodic monitoring:
- Benefit-risk query: tests were performed to evaluate the new query
• The new query was tested in association to the adapalene query
• Old query: 825 results ; New query: 1,100 results (+25%)
• Analyze of the relevance of the articles found with the new query:
Among the 275 articles found with the new query and that were not found with the old
query, 67% of the articles are relevant for the benefit/risk assessment
8%
17%
34%
4%
4%
29%
4%
Pediatric population
Clinical study
Off-label use
Interaction
Inefficacy
Not pertinent for the B/R
General article
41. 41 / CONFIDENTIAL
Free-text/thesaurus
• Problematic: Would it be useful to search for the keywords in free-text, in
addition to the descriptors corresponding to the keywords on the thesaurus?
The tests performed showed that the search with free-text was not useful
(noise). Keep in mind that we gather the literature twice: once during the
weekly monitoring and once during the periodic monitoring.
• The free-text is only useful when the concept does not exist in the thesaurus
(example: « lack of efficacy » can be used with free-text)
42. 42 / CONFIDENTIAL
Quality key elements to document
• Useful for the weekly monitoring:
- List of products to monitor and associated queries
- Changements tracking with :
• Modification type (addition/modification/withdrawal)
• Date of request
• Date of implementation
• New query
• Execution of the weekly or periodic literature monitoring:
- Type of request (weekly monitoring/DSUR/PSUR/PBRER)
- Reference of the search
- Date of execution
- Name of the documentalist who performed the monitoring
- Period covered by the search
- Queries used
- Number of results found (including the products for which 0 result was found)*
- Number of results kept
*for the weekly search only
