Pharmacovigilance in USA and Europe_Katalyst HLS
•Download as PPTX, PDF•
9 likes•2,078 views
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods. Contact: "Katalyst Healthcares & Life Sciences" South Plainfield, NJ, USA info@KatalystHLS.com
Report
Share
Report
Share
Recommended
Fda guidance for pharmaceutical post marketing reporting professor pirouzi
Fda guidance for pharmaceutical post marketing reporting professor pirouziPharmaceutical Compliance Inspection unit, Crown College of Canada
FDA Guidance for Pharmaceutical Post Marketing Reporting - Pharmaceuticals
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education Literature surveillance in pharmacovigilance
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.
Drug Safety Regulations In The Us And Eu
This document provides an overview of pharmacovigilance systems and regulations in the US and EU. It describes regulatory oversight bodies, key regulations governing pharmacovigilance, safety reporting requirements during pre-marketing and post-marketing periods, pediatric legislation differences, and risk management strategies between the regions.
SDEA Management in Pharmacovigilance
This document discusses safety data exchange agreements (SDEAs). It outlines the stakeholders involved in managing SDEAs, including legal, pharmacovigilance, sales, marketing, and business partners. SDEAs can be between two parties or involve more complex agreements between multiple affiliates, subsidiaries, vendors, and other partners. The key sections of an SDEA address legal matters, information exchange procedures, and safety responsibilities. Proper review and execution of SDEAs by authorized representatives helps ensure legal and company interests are protected.
Safety Reports: PBRER / PSUR
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.
Adverse Drug Reactions - Katalyst HLS
Introduction to Adverse Drug Reactions in Pharmacovigilance and Drug Safety in Pharma, Biotech, Medical Device, Cosmeceutical and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
An introduction to the EMA
The document discusses the role of patients, healthcare professionals, and academics in the European Medicines Agency's (EMA) process of approving medicines in the European Union. It describes how patients and patient organizations can provide input and expertise at various stages of the medicine development and review process. This includes involvement in scientific committees, evaluation of product information for patients, and review of safety communications. While patient participation has increased in recent years, challenges remain around representation, measuring impact, and ensuring comprehensive training. The EMA also facilitates collaboration with healthcare professionals and academics to enhance regulation and research.
Literature searches in Pharmacovigilance
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Recommended
Fda guidance for pharmaceutical post marketing reporting professor pirouzi
Fda guidance for pharmaceutical post marketing reporting professor pirouziPharmaceutical Compliance Inspection unit, Crown College of Canada
FDA Guidance for Pharmaceutical Post Marketing Reporting - Pharmaceuticals
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education Literature surveillance in pharmacovigilance
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.
Drug Safety Regulations In The Us And Eu
This document provides an overview of pharmacovigilance systems and regulations in the US and EU. It describes regulatory oversight bodies, key regulations governing pharmacovigilance, safety reporting requirements during pre-marketing and post-marketing periods, pediatric legislation differences, and risk management strategies between the regions.
SDEA Management in Pharmacovigilance
This document discusses safety data exchange agreements (SDEAs). It outlines the stakeholders involved in managing SDEAs, including legal, pharmacovigilance, sales, marketing, and business partners. SDEAs can be between two parties or involve more complex agreements between multiple affiliates, subsidiaries, vendors, and other partners. The key sections of an SDEA address legal matters, information exchange procedures, and safety responsibilities. Proper review and execution of SDEAs by authorized representatives helps ensure legal and company interests are protected.
Safety Reports: PBRER / PSUR
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.
Adverse Drug Reactions - Katalyst HLS
Introduction to Adverse Drug Reactions in Pharmacovigilance and Drug Safety in Pharma, Biotech, Medical Device, Cosmeceutical and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
An introduction to the EMA
The document discusses the role of patients, healthcare professionals, and academics in the European Medicines Agency's (EMA) process of approving medicines in the European Union. It describes how patients and patient organizations can provide input and expertise at various stages of the medicine development and review process. This includes involvement in scientific committees, evaluation of product information for patients, and review of safety communications. While patient participation has increased in recent years, challenges remain around representation, measuring impact, and ensuring comprehensive training. The EMA also facilitates collaboration with healthcare professionals and academics to enhance regulation and research.
Literature searches in Pharmacovigilance
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Fda med watch
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
Monitoring of medical literature(MLM)
Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (MLM Service)
An Introduction to the Pharmacovigilance System Master File
Presented at Arena's 9th Annual Pharmacovigilance, Drug Safety and Risk Management Conference in London in November 2013.
Post approval of drugs
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Literature monitoring for pharmacovigilance – outsourcing or in house solution
• 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.
ICH - E2D Pharmacovigilance and Drug Safety - Professor Peivand Pirouzi
ICH - E2D Pharmacovigilance and Drug Safety - Professor Peivand PirouziPharmaceutical Compliance Inspection unit, Crown College of Canada
ICH - E2D Pharmacovigilance and Drug Safety - Pharmaceuticals
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education Regulatory requirements for orphan drugs delivery
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...
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 monitoring for pv what are we doing at galderma elsevier webinar
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.
New EU PV regulations
This document summarizes the major changes brought about by the new European Union pharmacovigilance legislation. It overviews the goals of improving safety monitoring and decision making. Key changes include new guidelines on pharmacovigilance systems and risk management, the establishment of the Pharmacovigilance Risk Assessment Committee, more stringent reporting rules, and increased transparency including public access to safety information. The legislation aims to modernize the EU pharmacovigilance system and better protect public health.
pharmacovigilance in INDIA,US,EUROPEAN UNION
The document discusses pharmacovigilance requirements and methods in India, the US, and the European Union. It outlines key pharmacovigilance methods like passive surveillance using spontaneous reports, stimulated reporting, and active surveillance. It also discusses additional requirements like periodic safety update reports, post-marketing trials, adverse event reporting to regulatory authorities, and considerations for vaccine pharmacovigilance including investigating serious rare adverse reactions and batch-related adverse reactions.
TGA Presentation: Pharmacovigilance inspections
An update on the Pharmacovigilance Inspection Program, practical tips for inspections and developing a Corrective And Preventive Plan
TMF PDF.pdf
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Aggregate Reporting_Pharmacovigilance_Katalyst HLS
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
Pharmaceutical Regulations in GCC countries
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
PSUR
The document provides information on periodic safety update reports (PSURs), including:
- PSURs are intended to evaluate the risk-benefit balance of a drug based on new or changing information during the post-approval phase.
- The objectives of a PSUR are to examine if new safety information aligns with previous knowledge, summarize relevant new safety data that could impact risk-benefit analysis, and provide an integrated risk-benefit evaluation.
- Guidelines for PSURs are provided in the ICH E2C guideline and EU's GVP Module VII, with the format and content changing to focus more on risk-benefit analyses and summary tables rather than individual case reports.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality system
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
Clinical Research Regulation in European Union
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
Expectedness/Unexpectedness Assessment_Katalyst HLS
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
European medicines agency
The European Medicines Agency (EMA) was founded in 1995 and is responsible for coordinating the evaluation and supervision of medicinal products in the European Union. Some key milestones include recommending authorization of 975 human medicines in its first 20 years and marking its 20th anniversary in 2015. The EMA operates through various committees that assess different drug types and ensures clinical trials and medicines meet EU standards of quality, safety and efficacy. There are centralized, mutual recognition and national procedures for marketing authorization, and the EMA plays an important role in reviewing applications and facilitating approval across EU states.
ICSR Workflow & Management_Katalyst HLS
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Reconciliation and Literature Review and Signal Detection_Katalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
More Related Content
What's hot
Fda med watch
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
Monitoring of medical literature(MLM)
Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (MLM Service)
An Introduction to the Pharmacovigilance System Master File
Presented at Arena's 9th Annual Pharmacovigilance, Drug Safety and Risk Management Conference in London in November 2013.
Post approval of drugs
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Literature monitoring for pharmacovigilance – outsourcing or in house solution
• 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.
ICH - E2D Pharmacovigilance and Drug Safety - Professor Peivand Pirouzi
ICH - E2D Pharmacovigilance and Drug Safety - Professor Peivand PirouziPharmaceutical Compliance Inspection unit, Crown College of Canada
ICH - E2D Pharmacovigilance and Drug Safety - Pharmaceuticals
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education Regulatory requirements for orphan drugs delivery
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...
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 monitoring for pv what are we doing at galderma elsevier webinar
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.
New EU PV regulations
This document summarizes the major changes brought about by the new European Union pharmacovigilance legislation. It overviews the goals of improving safety monitoring and decision making. Key changes include new guidelines on pharmacovigilance systems and risk management, the establishment of the Pharmacovigilance Risk Assessment Committee, more stringent reporting rules, and increased transparency including public access to safety information. The legislation aims to modernize the EU pharmacovigilance system and better protect public health.
pharmacovigilance in INDIA,US,EUROPEAN UNION
The document discusses pharmacovigilance requirements and methods in India, the US, and the European Union. It outlines key pharmacovigilance methods like passive surveillance using spontaneous reports, stimulated reporting, and active surveillance. It also discusses additional requirements like periodic safety update reports, post-marketing trials, adverse event reporting to regulatory authorities, and considerations for vaccine pharmacovigilance including investigating serious rare adverse reactions and batch-related adverse reactions.
TGA Presentation: Pharmacovigilance inspections
An update on the Pharmacovigilance Inspection Program, practical tips for inspections and developing a Corrective And Preventive Plan
TMF PDF.pdf
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Aggregate Reporting_Pharmacovigilance_Katalyst HLS
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
Pharmaceutical Regulations in GCC countries
The Gulf Cooperation Council (GCC) regulatory authorities approved a centralized drug registration system located in Riyadh, Saudi Arabia in 1999. The system aims to improve patient access to safe and effective medicines across GCC countries. The GCC Central Drug Registration Committee is composed of two members from each GCC state. Applications are reviewed by two selected states alphabetically, but all states are responsible for evaluating quality, safety and efficacy. States meet regularly to discuss applications and make approval decisions by agreement. Registration requirements and procedures are generally harmonized across GCC states but some variation remains. Further harmonization efforts are still needed.
PSUR
The document provides information on periodic safety update reports (PSURs), including:
- PSURs are intended to evaluate the risk-benefit balance of a drug based on new or changing information during the post-approval phase.
- The objectives of a PSUR are to examine if new safety information aligns with previous knowledge, summarize relevant new safety data that could impact risk-benefit analysis, and provide an integrated risk-benefit evaluation.
- Guidelines for PSURs are provided in the ICH E2C guideline and EU's GVP Module VII, with the format and content changing to focus more on risk-benefit analyses and summary tables rather than individual case reports.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality system
This Module contains guidance for the establishment and maintenance of quality assured Pharmacovigilance systems for marketing authorization holders (MAHs) and national medicine authorities (NMAs).
Reference:- Guideline on good pharmacovigilance practices (GVP) version no.3
Clinical Research Regulation in European Union
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
Expectedness/Unexpectedness Assessment_Katalyst HLS
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
European medicines agency
The European Medicines Agency (EMA) was founded in 1995 and is responsible for coordinating the evaluation and supervision of medicinal products in the European Union. Some key milestones include recommending authorization of 975 human medicines in its first 20 years and marking its 20th anniversary in 2015. The EMA operates through various committees that assess different drug types and ensures clinical trials and medicines meet EU standards of quality, safety and efficacy. There are centralized, mutual recognition and national procedures for marketing authorization, and the EMA plays an important role in reviewing applications and facilitating approval across EU states.
What's hot (20)
An Introduction to the Pharmacovigilance System Master File
An Introduction to the Pharmacovigilance System Master File
Literature monitoring for pharmacovigilance – outsourcing or in house solution
Literature monitoring for pharmacovigilance – outsourcing or in house solution
ICH - E2D Pharmacovigilance and Drug Safety - Professor Peivand Pirouzi
ICH - E2D Pharmacovigilance and Drug Safety - Professor Peivand Pirouzi
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...
Literature monitoring for pv what are we doing at galderma elsevier webinar
Literature monitoring for pv what are we doing at galderma elsevier webinar
Aggregate Reporting_Pharmacovigilance_Katalyst HLS
Aggregate Reporting_Pharmacovigilance_Katalyst HLS
Pharmacovigilance "Module I" Pharmacovigilance system & their quality system
Pharmacovigilance "Module I" Pharmacovigilance system & their quality system
Expectedness/Unexpectedness Assessment_Katalyst HLS
Expectedness/Unexpectedness Assessment_Katalyst HLS
Viewers also liked
ICSR Workflow & Management_Katalyst HLS
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Reconciliation and Literature Review and Signal Detection_Katalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Argus Aggregrate Reporting_Katalyst HLS
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
Argus Patient Screen Tab Training - Katalyst HLS
This document provides instructions for entering patient information, medical history, and laboratory data into the ARGUS patient screening system. It describes how to enter initials only for patient name, date of birth using hyphens for missing parts, and age manually if date of birth is partial. Relevant medical history, including conditions, historical drugs, and family history should be included. Laboratory results should be entered in the coded field if abnormal and relevant to events, and normal tests or those not codable go in the free text field. Dates and details like units should be included.
Argus Screen Shots General Tab - Katalyst HLS
Introduction to Argus Screen Shots General Tab - Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Argus Analysis Tab Screen - Katalyst HLS
Introduction to Argus Analysis Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
ICSR Narrative Writing_Katalyst HLS
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
ARGUS Query Process Overview_Katalyst HLS
This document provides an overview of the query process in the Argus system. It describes how to enter individual query action items, generate query letters containing all open queries, follow up on query responses, and reissue query letters if responses are not received by the due date. The goal is to track queries and responses to allow useful metrics to be produced regarding open and closed queries.
Viewers also liked (8)
Reconciliation and Literature Review and Signal Detection_Katalyst HLS
Reconciliation and Literature Review and Signal Detection_Katalyst HLS
Similar to Pharmacovigilance in USA and Europe_Katalyst HLS
Medical Devices Law 2015 (Addition by DRAP)
The addition of the medical device law by the Drug Regulatory of Pakistan to register medical devices in Pakistan, as per national requirements (equivalence of FDA, CE, and ISO)
Medical Devices Law 2015
The document outlines the Medical Devices Rules 2015 introduced by the Drug Regulatory Authority of Pakistan. Some key points:
- The rules were introduced to regulate over 1 million medical devices in Pakistan and protect public health by ensuring safety and effectiveness.
- A Medical Devices Board (MDB) is established as the regulatory authority responsible for registration of devices and conformity assessment bodies, issuing licenses, and enforcing implementation of the rules.
- The rules cover various aspects of medical devices including classification, registration, import/export, labeling, usage and advertising. Formats and a fee chart for various regulatory activities are also provided.
Regulatory agency
The document discusses several regulatory agencies that oversee medicines and medical devices. The United States Food and Drug Administration (USFDA) regulates food, drugs, cosmetics, and medical devices in the US. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. The Central Drugs Standard Control Organization (CDSCO) regulates drugs and cosmetics in India under the Ministry of Health and Family Welfare. Each agency is responsible for ensuring the safety and efficacy of products under its purview.
Guide to Global GDP Guidelines
This one-page document provides a summary of Good Distribution Practice (GDP) guidelines around the world. GDP ensures that medical products are stored, transported, and handled under suitable conditions as required by their authorizations. There is no single global GDP standard. The document lists GDP requirements for various countries and regions, including Australia, Argentina, Brazil, Denmark, the UK, Ireland, India, China, Canada, the US, and the European Commission. It also lists GDP guidelines from organizations like IATA, IPEC Europe, PDA, and WHO. Users can click on locations for more detailed information on each area's GDP guidelines.
Discussion #1Is there any additional subjective or objective inf.docx
- Ms. Johnston, a 60-year-old woman, presented with complaints of intermittent chest pain for the past 3 months on exertion. She has a history of hypertension, hyperlipidemia, and a family history of diabetes and cardiac disease.
- Physical exam and diagnostic testing, including EKG, labs, chest X-ray, stress test, and cardiac cath with stent placement, were performed. Labs showed an ASCVD score of 7.2%, increasing her risk for cardiac events.
- The treatment plan includes medication compliance monitoring, diet and lifestyle counseling, referral to cardiology, and follow-up in 6-12 weeks to recheck lipids. The importance of health education and literacy is discussed
PCSK-9 inhibitors: The next blockbuster?
An introduction to PCSK-9 inhibitors: a new therapeutic class of drugs approved by US FDA in July 2015 to treat Heterozygous familial hypercholesterolemia (HeFH) and its superiority over gold standard statins in treatment. Does it have potential to become a blockbuster and emulate Lipitor's success?
23. Prof. Shynar Baidullayeva - National Center for Medicines, Medical Device...
23. Prof. Shynar Baidullayeva - National Center for Medicines, Medical Device...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
“Pharmacovigilance in the Republic of Kazakhstan -Peculiarities. Biological medicinal products safety monitoring”
Shows the current pharmacovigilance system and practices in Kazakhstan, with a focus on biotherapeutic medicinesCatalyst Tracker 1-23-16
Leerink Equity Research provides a catalyst tracker previewing top upcoming catalysts over the next 3-6 months for various healthcare stocks. Key events include data readouts from clinical trials that could significantly move stock prices depending on the results. The report lists dozens of stocks and their associated drug or product, indication, type of event, timeline, and estimated stock price impact. Upcoming catalysts highlighted include data presentations, regulatory decisions, product launches, and business development deals.
ANOVA and its application
1) A trial was conducted to compare the effects of three drugs (losartan, alasartan, and blasartan) on systolic blood pressure in hypertensive patients.
2) The mean reductions in systolic BP were 4.95, 7.74, and 7.44 mmHg for the losartan, alasartan, and blasartan groups respectively.
3) One-way ANOVA indicated a statistically significant difference between the groups, so pairwise t-tests were used to determine which groups differed. The alasartan and blasartan groups had significantly greater reductions than the losartan group.
Epilepsy, Industry Snapshot. Oct 17-25.
Epilepsy market -snapshot- , weekly report Oct 17-25. News and market analysis of pharmaceutical companies. Competitive Intelligence.
1505 the solution to the manufacturer pbm and pharmacy disconnect
Curant Health presentation at Armada 2015: The Solution to the Manufacturer, PBM and Pharmacy Disconnect
Primary biliary cholangitis (PBC) Epidemiology and Compitive landscape_Thelan...
This document provides epidemiological data on primary biliary cholangitis (PBC) in China from 2018 to 2030. It estimates that the number of new PBC cases diagnosed annually in China will increase from 20,145 in 2018 to 21,108 in 2030. The total number of prevalent PBC cases in China is estimated to increase from 105,542 cases in 2018 to 110,588 cases in 2030. The document also summarizes the current treatment landscape and pipeline for PBC in China and other major markets.
Pharma Uptoday Monthly Magazine - Volume 11, Issue Feb 2015
3 News Uptoday
35 New Guidance
42 Audit Findings
483 Observations
- Top Drug 483 Observations
46 EMA Non-Compliance Reports
- Wockhardt Limited, Aurangabad
- AGEPHA, Austria
- North China Pharmaceutical Group Semisyntech Co., Ltd, China
48 Regulations of the Month
- § 211.188 Batch production and control records
- § 211.192 Production record review
- § 211.194 Laboratory records.
WHO MEC Wheel.pdf
This document is the 2015 update of the WHO Medical Eligibility Criteria Wheel for Contraceptive Use. It provides guidance for health providers on recommending safe and effective contraception methods for women with various medical conditions. The wheel matches 9 common contraceptive methods (such as pills, IUDs, implants) with medical factors (such as STIs, migraines, liver disease) using a 1-4 categorization system, with 1 indicating the method can generally be used and 4 indicating it should not be used. It aims to help providers determine eligibility and make informed choices about contraception.
4. The Power of Real Nutrition Science - Unvbelievable Benefits Accrued.pptx
The Slidepacks to go with the Chronic Disease University! Number 4 - The Power of Real Nutrition Science - Unbelievable Benefits Accrued
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...
This document discusses post-authorization safety studies (PASS) and ongoing safety surveillance. It provides background on the legal basis and guidelines for PASS from the EMA and ICH. It notes that about 25% of products under additional monitoring by EMA have PASS requirements. The number of studies registered in the EU PAS register has risen significantly in recent years. PASS can be either imposed as an obligation or conducted voluntarily. Key differences between PASS and pre-approval studies are also outlined. The role and significance of PASS is increasing as a way to decrease drug development costs and times while increasing the collection of real-world data.
Oxyrecall Pro Recall November 2013 Attorneys 404 451 7781
The FDA announced that USPlabs LLC is recalling certain OxyElite Pro dietary supplement products linked to liver illnesses. The FDA notified USPlabs that products containing aegeline, a new dietary ingredient lacking evidence of safety, were adulterated. Reports from Hawaii linked OxyElite Pro to 27 cases of liver illness, including one death and another requiring transplant. The FDA advises consumers not to use recalled OxyElite Pro products or those labeled VERSA-1 and to report any health issues to their provider.
Corporate Presentation Fall 2014
This corporate presentation discusses BELLUS Health's focus on developing drugs for rare diseases. Their lead product candidate, KIACTA, is in Phase 3 trials for AA amyloidosis, a rare and deadly kidney disease with no existing treatment. Positive results from a previous Phase 3 trial showed KIACTA slowed kidney function decline. If successful, KIACTA could achieve premium pricing compared to other orphan drugs. BELLUS is also developing treatments for other rare diseases including sHUS and AL amyloidosis through clinical trials and partnerships.
Global orphan drug market future outlook 2020
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
Valeritas Investor Presentation
1) The document provides confidential information about Valeritas, Inc. to shareholders, including an overview of their V-Go insulin delivery device, clinical data demonstrating its effectiveness at lowering A1C levels and daily insulin doses, and the experience and focus of the leadership team.
2) Valeritas believes V-Go is well-positioned for success due to its ability to address unmet needs in the large type 2 diabetes market, its demonstrated commercial traction, established reimbursement, and capital efficient strategy.
3) Clinical studies show patients experienced statistically significant improvements in A1C levels and reductions in daily insulin needs after switching to V-Go from multiple daily injections.
Similar to Pharmacovigilance in USA and Europe_Katalyst HLS (20)
Discussion #1Is there any additional subjective or objective inf.docx
Discussion #1Is there any additional subjective or objective inf.docx
23. Prof. Shynar Baidullayeva - National Center for Medicines, Medical Device...
23. Prof. Shynar Baidullayeva - National Center for Medicines, Medical Device...
1505 the solution to the manufacturer pbm and pharmacy disconnect
1505 the solution to the manufacturer pbm and pharmacy disconnect
Primary biliary cholangitis (PBC) Epidemiology and Compitive landscape_Thelan...
Primary biliary cholangitis (PBC) Epidemiology and Compitive landscape_Thelan...
Pharma Uptoday Monthly Magazine - Volume 11, Issue Feb 2015
Pharma Uptoday Monthly Magazine - Volume 11, Issue Feb 2015
4. The Power of Real Nutrition Science - Unvbelievable Benefits Accrued.pptx
4. The Power of Real Nutrition Science - Unvbelievable Benefits Accrued.pptx
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...
Oxyrecall Pro Recall November 2013 Attorneys 404 451 7781
Oxyrecall Pro Recall November 2013 Attorneys 404 451 7781
More from Katalyst HLS
Risk Based Approach CSV Training_Katalyst HLS
Risk Based Approach - Computer Systems Validation Training_Katalyst HLS
Katalyst HealthCares & Life Sciences Inc.,
285 Durham Ave, Suite 12, South Plainfield, NJ 07080.
Phone: +1 (908) 967-5588; Fax: +1 (908) 967-5589
email: info@KatalystHLS.com
21 CFR Part11_CSV Training_Katalyst HLS
21 CFR Part11_Computer Systems Validation Training_Katalyst HLS
Katalyst HealthCares & Life Sciences Inc.,
285 Durham Ave, Suite 12, South Plainfield, NJ 07080.
Phone: +1 (908) 967-5588; Fax: +1 (908) 967-5589
email: info@KatalystHLS.com
Study Setup_Katalyst HLS
The document discusses the key activities involved in clinical study setup for data management, including designing case report forms (CRFs), developing the study database, programming validation and derivation procedures, and conducting user acceptance testing (UAT). It provides an overview of the study setup process and outlines the objectives, requirements, responsibilities, and deliverables for each setup activity.
Safety_Data_Reconciliation_Katalyst HLS
Safety data reconciliation involves comparing safety data between a clinical database and safety database to ensure consistency. Key fields like adverse event term, action taken, causality, and outcome are reconciled. Discrepancies between the databases are identified and queries are issued to sites for resolution. The process aims to clean 100% of agreed upon safety data points and document any acceptable discrepancies.
Reports & Analysis_Katalyst HLS
The 3 main types of reports are:
1) Summary reports that summarize the data
2) Listings reports that list the entire data as is
3) Figures and graphs that provide graphical representations of the data
A programming plan outlines the algorithms, data presentations, and programming standards to generate derived datasets. Test plans are created for quality control to validate the derived datasets and reports meet specifications. SDTM is the clinical trial data standard used for regulatory submissions. Annual reports summarizing trial progress are submitted annually to the US FDA.
Protocol Understanding_Katalyst HLS
The document provides an overview of clinical study protocols, including their purpose, key components, and importance. It describes the various sections of a protocol, such as the background and objectives, study design, subject selection criteria, study procedures, safety and efficacy assessments, and data handling. Maintaining adherence to the protocol is important to ensure the safety of participants and integrity of the clinical trial.
Oracle Study Setup_Katalyst HLS
Teams involved in clinical trials include the clinical trials team, statistician team, study set up team, and data management team. These teams perform various functions like conducting trials, generating reports for regulatory authorities, developing electronic case report forms, and managing data and discrepancies.
There are typically four phases in a clinical trial process: planning, implementation, analysis, and reporting. Clinical trials can be open label, single blinded, or double blinded depending on whether the patient and/or doctors are aware of the treatment given.
Oracle Clinical Overview_Katalyst HLS
Oracle Clinical is a clinical data management software that supports all aspects of clinical data management, including defining and managing clinical studies, collecting and validating data, generating data entry screens, managing queries and discrepancies, and extracting data for analysis. It has several subsystems that handle tasks like study design, the global library, data collection, validation, and extracts. Key functions include entering data manually or via batch load, extracting data, managing discrepancies, and freezing and locking data.
OCRDC Graphical Layout Features_Katalyst HLS
The document provides guidance on graphical layouts and structures for RDC and PDF studies. Key points include:
- Enforce maximum repeats on repeating question groups.
- For RDC studies, one data type DCM can be used per DCI with qualifying values depending on study design.
- Provide standard upper and lower bound ranges and assign to questions.
- Layouts will not be modified except for data entry proficiency. Special instructions should be in guidelines, not screens.
- For PDF layouts, use 11pt Arial Bold for titles and 9pt Arial for other text. Mirror PDS Core Safety module layouts.
OC Procedure Progarmming Module_Katalyst HLS
Here are the key points about the Sort Order fields:
- Event: Specifies the primary sort order for data retrieval. Common values are DCM_DATE or CPE_DATE.
- Extension: Provides a secondary sort order in case of ties in the primary sort. Common values are PATIENT_ID or RESPONSE_ID.
- Together these define the order in which data will be retrieved and evaluated by the procedure. For example, sorting first by DCM_DATE then by PATIENT_ID ensures data is grouped and evaluated chronologically for each patient.
- The sort order is important to ensure logical evaluation of data across events/visits for a given patient or record.
So in summary, the Sort
OC Backend_Katalyst HLS
This document discusses the backend structure of an Oracle Clinical (OC) system. It describes how OC modules map to SQL schemas, the format and contents of tables, how test and production tables differ, and journal tables that store historical records. Modules include Plan, Design, Admin, Glib, Definition, Conduct, and Data Entry which map to the RXA_DES, RXC, and RXA_LR schemas. Tables follow conventions like naming columns ending in "_ID" or "_FLAG" and including audit history fields. A CLINICAL_STUDY_ID variable identifies records by study.
Mock CRF Design_Katalyst HLS
This document outlines the design of a mock clinical report form (CRF) for a clinical trial conducted by Katalyst Healthcares & Life Sciences. The CRF collects data on visit dates, vital signs, pregnancy tests, and hematology for screening and baseline visits on November 20, 2017. It provides contact information for Katalyst Healthcares & Life Sciences in South Plainfield, New Jersey.
Medical Coding_Katalyst HLS
This document provides an overview of medical coding and the process involved. It discusses the objectives of medical coding, which include standardizing medical terminology and ensuring data is mapped to standardized medical dictionaries. It also describes the pre-coding process and prerequisites for assigning codes, such as having clinical data and using standardized coding dictionaries. Finally, it reviews some common medical coding dictionaries like MedDRA and WHODD, how they are structured in a hierarchy, and how codes are assigned based on the dictionary terminology.
Labs Module_Katalyst HLS
The document provides an overview of the standard lab system in Oracle Clinical. It discusses how to establish and maintain laboratories, lab units and questions, conversions between lab units, and assignment of normal ranges for questions based on age and sex. The basic process flow includes creating lab questions, units, assigning units to questions, defining conversions, assigning ranges manually or via load, and setting up criteria for assignment of labs to clinical data. It also covers creating textbook ranges, preferred copy groups, and electronic loading of lab ranges.
Handling Third Party Vendor Data_Katalyst HLS
The document discusses handling third party vendor data in clinical trials. It covers four types of external data including safety laboratory data, PK/PD data, pharmacogenetics data, and device data. Centralized vendors provide standardized testing across sites and electronic transfer of data to minimize errors. Data reconciliation involves generating discrepancy reports using primary keys like sponsor ID, study ID, and subject ID, and secondary keys like date of birth. Queries are raised to sites or vendors to resolve inconsistencies between third party and clinical trial databases.
Discrepany Management_Katalyst HLS
The document provides an overview of discrepancy management in clinical data management. It defines discrepancies as inconsistencies in clinical trial data that need correction. It discusses the goal of discrepancy management as accurately representing captured study data. It also describes different types of discrepancies like system-generated, electronically-generated, and manual discrepancies. Additionally, it outlines the discrepancy management process which involves identifying discrepancies, resolving them by updating data or sending queries to investigators, and updating the clinical database.
Discovery of Drug and Introduction to Clinical Trial__Katalyst HLS
This document provides an overview of the drug discovery and clinical trials process. It discusses the goals of drug discovery which include identifying new chemical entities and developing medicines to address unmet medical needs. The drug discovery process involves target identification, validation, lead generation, and optimization. Pre-clinical testing is then conducted to evaluate safety and effects. If successful, an investigational new drug application is filed with the FDA prior to beginning clinical trials. Clinical trials involve 4 phases to test safety and efficacy in humans. Upon completion, a new drug application can be filed for FDA review and potential approval.
Database Lock _ Unlock Procedure_Katalyst HLS
The document discusses database lock and unlock procedures. Database lock denotes completion of data collection and signals that no further changes can be made to trial data, making it ready for analysis. Database unlock allows for selective changes, usually to address critical errors found post-lock. Procedures should define how errors are categorized, handled, and documented. Unlocking requires approval and strict controls to prevent unauthorized changes.
Data Management Plan_Katalyst HLS
A data management plan (DMP) ensures consistent and effective clinical data management practices throughout a clinical trial. The DMP describes all data management activities, responsibilities, and deliverables to promote agreement among parties. It not only describes the data management process, but also provides documentation of data handling for regulatory compliance. The DMP components include data flow, capture, setup, entry, transfer, processing, coding, safety data, external data, database locking and unlocking, archiving, and quality reports. It serves to plan, communicate, and reference all data management tasks during a study.
Data Loading and Data Entry_Katalyst HLS
This document provides an overview of data loading and data entry for clinical trials. It discusses the types of data that data entry operators should be aware of, including medical terms and abbreviations. It describes the process of double data entry, where two operators independently enter the same data from case report forms to ensure accuracy. Common errors made during data entry are also outlined, such as spelling errors, numerical errors, and missed terms. The document provides remedial actions like developing a mock database for practice before production entry. It emphasizes the importance of leaving proper spacing between words and being careful to not change responses when tabbing between fields.
More from Katalyst HLS (20)
Discovery of Drug and Introduction to Clinical Trial__Katalyst HLS
Discovery of Drug and Introduction to Clinical Trial__Katalyst HLS
Recently uploaded
pathology MCQS introduction to pathology general pathology
pathology MCQS introduction to pathology general pathology
The Nervous and Chemical Regulation of Respiration
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Do you have abnormal smell after periods? It may be vaginitis. Do not worry, herbal medicine Fuyan Pill can help you get a cure.
Journal Article Review on Rasamanikya
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.
Ketone bodies and metabolism-biochemistry
This slide consists of all the topics of ketone . This can be used for exam purpose for writing about Diabetic keto acidosis etc . Thank you
Histopathology of Rheumatoid Arthritis: Visual treat
Histopathology of Rheumatoid Arthritis: Visual treat
Cell Therapy Expansion and Challenges in Autoimmune Disease
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Top Travel Vaccinations in Manchester
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.share - Lions, tigers, AI and health misinformation, oh my!.pptx
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
NARCOTICS- POLICY AND PROCEDURES FOR ITS USE
This document outlines policies and procedures for handling narcotic and controlled drugs in NABH accredited hospitals.
Artificial Intelligence Symposium (THAIS)
Artificial Intelligence Symposium (THAIS). Parc Taulí. Sabadell
Recently uploaded (20)
pathology MCQS introduction to pathology general pathology
pathology MCQS introduction to pathology general pathology
The Nervous and Chemical Regulation of Respiration
The Nervous and Chemical Regulation of Respiration
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Histopathology of Rheumatoid Arthritis: Visual treat
Histopathology of Rheumatoid Arthritis: Visual treat
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptx
Pharmacovigilance in USA and Europe_Katalyst HLS
- 1. Pharmacovigilance (PV) in USA & EU 1 Katalyst Healthcares & Life Sciences 12-15-2016
- 2. 2 Katalyst Healthcares & Life Sciences 12-15-2016
- 3. 3 Katalyst Healthcares & Life Sciences 12-15-2016
- 4. 4 Katalyst Healthcares & Life Sciences 12-15-2016
- 5. 5 Katalyst Healthcares & Life Sciences 12-15-2016
- 6. 6 Katalyst Healthcares & Life Sciences 12-15-2016
- 7. 7 Katalyst Healthcares & Life Sciences 12-15-2016
- 8. 8 Katalyst Healthcares & Life Sciences 12-15-2016
- 9. 9 Katalyst Healthcares & Life Sciences 12-15-2016
- 10. 10 Katalyst Healthcares & Life Sciences 12-15-2016
- 11. 11 Katalyst Healthcares & Life Sciences 12-15-2016
- 12. 12 Katalyst Healthcares & Life Sciences 12-15-2016
- 13. 13 Katalyst Healthcares & Life Sciences 12-15-2016
- 14. 14 Katalyst Healthcares & Life Sciences 12-15-2016
- 15. 15 Katalyst Healthcares & Life Sciences 12-15-2016