Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Regulatory authorities conduct pharmacovigilance inspections of pharmaceutical companies to ensure adequate PV processes and compliance. Inspections review PV data and processes as part of GMP and GCP audits. Companies should prepare by resolving previous issues, reviewing files for completeness, and identifying contacts. It is best to regularly conduct internal self-inspections and audits. This information is from the book "Pharmacovigilance - An Industry Perspective" which provides an in-depth chapter on pharmacovigilance inspections.
An audit is an official inspection done by an independent body to evaluate processes and ensure they comply with regulatory standards. Audits of pharmacovigilance systems are important to ensure patient safety, identify risks for improvement, and maintain compliance. The audit process involves planning, conducting interviews and documentation reviews, reporting findings, developing corrective actions, and following up to ensure issues are addressed. Being prepared for audits at all times is important for pharmacovigilance systems.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
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
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
This document discusses signal detection and management in pharmacovigilance. It provides a brief history of pharmacovigilance programs internationally and in India. It defines pharmacovigilance and outlines the objectives, processes, and key steps involved in signal detection, validation, prioritization, assessment, and recommendation for action. These include ongoing monitoring of adverse event reports, signal detection methods, validation criteria, prioritization factors, signal assessment, and potential recommendations that may involve regulatory reporting, labeling changes, or additional studies. The goal is to identify potential safety issues and determine appropriate actions to prevent or minimize patient risk.
Regulatory authorities conduct pharmacovigilance inspections of pharmaceutical companies to ensure adequate PV processes and compliance. Inspections review PV data and processes as part of GMP and GCP audits. Companies should prepare by resolving previous issues, reviewing files for completeness, and identifying contacts. It is best to regularly conduct internal self-inspections and audits. This information is from the book "Pharmacovigilance - An Industry Perspective" which provides an in-depth chapter on pharmacovigilance inspections.
An audit is an official inspection done by an independent body to evaluate processes and ensure they comply with regulatory standards. Audits of pharmacovigilance systems are important to ensure patient safety, identify risks for improvement, and maintain compliance. The audit process involves planning, conducting interviews and documentation reviews, reporting findings, developing corrective actions, and following up to ensure issues are addressed. Being prepared for audits at all times is important for pharmacovigilance systems.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
Pharmacovigilance "Module I" Pharmacovigilance system & their quality systemMohamed Raouf
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
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
This document discusses signal detection and management in pharmacovigilance. It provides a brief history of pharmacovigilance programs internationally and in India. It defines pharmacovigilance and outlines the objectives, processes, and key steps involved in signal detection, validation, prioritization, assessment, and recommendation for action. These include ongoing monitoring of adverse event reports, signal detection methods, validation criteria, prioritization factors, signal assessment, and potential recommendations that may involve regulatory reporting, labeling changes, or additional studies. The goal is to identify potential safety issues and determine appropriate actions to prevent or minimize patient risk.
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.
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
If you are involved with Pharmacovigilance Audits or GPvP, you need to read this.
We also offer online courses for GPvP.. ask me for more details manish.kainth@infonetica.net
Importance of aggregate reporting in pharmacovigilanceSollers College
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved.
Presentation: Periodic safety update reportsTGA Australia
The TGA approach to reviewing PSURs (Periodic Safety Update Reports) focuses on evaluating new or emerging safety information to assess the benefit-risk balance of approved medicines. PSUR reviews are prioritized based on risk factors like a product's safety profile and therapeutic importance. If a safety issue is identified that warrants a label change, the PSUR reviewer will recommend an update to the sponsor. Requests may also be made for additional monitoring or analyses in future PSURs. PSUR reviewers collaborate with other TGA departments to enhance post-market vigilance and ensure safety signals are investigated. Sponsors can expect direct communication regarding recommendations from PSUR reviews and are encouraged to submit PSURs using the eCTD format.
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
This document provides guidance on conducting pharmacovigilance audits according to international standards. It discusses the legal, technical, and scientific context of pharmacovigilance audits. A risk-based approach to auditing is recommended, focusing on high risk areas like critical processes, quality systems, and areas of noncompliance. Audit findings should be graded based on their criticality and risk level. Corrective actions should address critical and major issues to ensure patient safety and compliance.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
Monitoring and auditing in clinical trialsJyotsna Kapoor
Monitoring and auditing are important quality control activities in clinical trials. Monitoring ensures accurate and compliant conduct of trials, while auditing independently evaluates trial conduct and compliance. Key aspects include:
Monitoring involves overseeing trial progress to ensure compliance. Monitors verify participant rights and data accuracy. Auditing independently examines trials and documents to determine GCP compliance. Audit findings help ensure future compliance. Together, monitoring and auditing protect participants and validate trial results.
“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.”
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.
The document outlines the format and content requirements for a Development Safety Update Report (DSUR), which provides a comprehensive safety summary of investigational medicinal products during clinical development. A DSUR is submitted annually and includes information such as estimated subject exposure, significant safety findings from completed and ongoing trials, actions taken for safety reasons like protocol amendments, and an overall safety assessment. The document details each section that must be included in a DSUR, such as the title page, executive summary, introduction, estimated exposure, clinical trial information, safety findings, and conclusions.
Literature monitoring for pv what are we doing at galderma elsevier webinarAnn-Marie Roche
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.
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.
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst 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
Quality, Risk & Compliance: Risk Management for Sponsors, Site, and CROsMedpace
This document discusses risk management in clinical trials from multiple perspectives. It provides statistics on the high costs and time required to bring new drugs to market. It defines quality as an absence of errors that matter and compliance as adherence to regulatory and GCP requirements. Key aspects of risk management are identified, including risk identification, evaluation, control, and review. Process mapping and risk assessment tools are presented. Quality by design and continual improvement concepts are also covered.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
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.
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
If you are involved with Pharmacovigilance Audits or GPvP, you need to read this.
We also offer online courses for GPvP.. ask me for more details manish.kainth@infonetica.net
Importance of aggregate reporting in pharmacovigilanceSollers College
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved.
Presentation: Periodic safety update reportsTGA Australia
The TGA approach to reviewing PSURs (Periodic Safety Update Reports) focuses on evaluating new or emerging safety information to assess the benefit-risk balance of approved medicines. PSUR reviews are prioritized based on risk factors like a product's safety profile and therapeutic importance. If a safety issue is identified that warrants a label change, the PSUR reviewer will recommend an update to the sponsor. Requests may also be made for additional monitoring or analyses in future PSURs. PSUR reviewers collaborate with other TGA departments to enhance post-market vigilance and ensure safety signals are investigated. Sponsors can expect direct communication regarding recommendations from PSUR reviews and are encouraged to submit PSURs using the eCTD format.
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
This document provides guidance on conducting pharmacovigilance audits according to international standards. It discusses the legal, technical, and scientific context of pharmacovigilance audits. A risk-based approach to auditing is recommended, focusing on high risk areas like critical processes, quality systems, and areas of noncompliance. Audit findings should be graded based on their criticality and risk level. Corrective actions should address critical and major issues to ensure patient safety and compliance.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
Monitoring and auditing in clinical trialsJyotsna Kapoor
Monitoring and auditing are important quality control activities in clinical trials. Monitoring ensures accurate and compliant conduct of trials, while auditing independently evaluates trial conduct and compliance. Key aspects include:
Monitoring involves overseeing trial progress to ensure compliance. Monitors verify participant rights and data accuracy. Auditing independently examines trials and documents to determine GCP compliance. Audit findings help ensure future compliance. Together, monitoring and auditing protect participants and validate trial results.
“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.”
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.
The document outlines the format and content requirements for a Development Safety Update Report (DSUR), which provides a comprehensive safety summary of investigational medicinal products during clinical development. A DSUR is submitted annually and includes information such as estimated subject exposure, significant safety findings from completed and ongoing trials, actions taken for safety reasons like protocol amendments, and an overall safety assessment. The document details each section that must be included in a DSUR, such as the title page, executive summary, introduction, estimated exposure, clinical trial information, safety findings, and conclusions.
Literature monitoring for pv what are we doing at galderma elsevier webinarAnn-Marie Roche
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.
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.
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst 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
Quality, Risk & Compliance: Risk Management for Sponsors, Site, and CROsMedpace
This document discusses risk management in clinical trials from multiple perspectives. It provides statistics on the high costs and time required to bring new drugs to market. It defines quality as an absence of errors that matter and compliance as adherence to regulatory and GCP requirements. Key aspects of risk management are identified, including risk identification, evaluation, control, and review. Process mapping and risk assessment tools are presented. Quality by design and continual improvement concepts are also covered.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
Presentation: An Update on post-market regulatory requirementsTGA Australia
Along with implementation of expedited medicine registration pathways TGA has undertaken enhancements to its post-market monitoring of medicines, with a focus on assisting sponsors meet their regulatory requirements. TGA's new Pharmacovigilance Inspection Program (PVIP) involves interviewing sponsors and reviewing documents in order to assess sponsors' level of compliance with pharmacovigilance obligations. Work is also ongoing with sponsors to determine how best to confirm risk management plan (RMP) commitments are being met. This presentation will provide further detail on how TGA is working with and assisting sponsors satisfy their regulatory requirements.
This document provides an overview of key considerations for preparing Investigational New Drug (IND) and Clinical Trial Authorization (CTA) submissions to regulatory agencies. It discusses essential pre-submission planning steps like defining roles and timelines. It also reviews the structure and content of IND and CTA applications, highlighting similarities and differences between FDA, EMA, MHRA, and Health Canada requirements. The document emphasizes strategies for improving efficiency in multi-country submissions, such as reusing common documents and templates across applications.
Bilcare_GCS Quality and Regulatory OveriewBilcare GCS
Bilcare is committed to providing innovative clinical trial material supply services globally according to quality and regulatory standards. It offers services including clinical trial manufacturing, packaging, labeling, sourcing of drugs, and storage and distribution. Bilcare aims to provide cost-effective and creative solutions through strategic partnerships to help customers succeed. It focuses on customer satisfaction, continual self-improvement, and compliance with regulations like cGMP, GCP, and ISO 9001. Bilcare works to improve through learning from audits and implementing systems improvements.
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot ProgramTGA Australia
This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.
The document discusses implementing a quality assurance framework for plant breeding. It outlines benefits like increased competitiveness, knowledge transfer within institutes, and improved partnerships. Examples of relevant quality standards like ISO 9001 and ISO 17025 are provided. Implementing a framework requires documenting processes, training, equipment records, and validating data. Buy-in requires incentives for compliance since currently consequences are lacking. The framework must be tailored to different partners' capacities and emergencies may require early solutions. Quality systems can demonstrate competence and improve projects if expectations are appropriately set.
1) A Contract Research Organization (CRO) is a service organization that conducts clinical trials and provides other research services to the pharmaceutical, biotechnology, and medical device industries.
2) CROs take responsibility for planning, setting up, and managing clinical trials on a daily basis to handle the technical aspects and ensure trials are conducted properly.
3) Main responsibilities of CROs include implementing safety procedures for clinical trials, following research contracts, communicating with sponsors, ensuring quality and accurate results, and recording and maintaining trial results.
Presentation investing-in-medical-device-safetyTGA Australia
The document discusses the importance of having a functional Quality Management System (QMS) for medical device companies. It notes that over 5000 medical device incident reports are filed each year, with most incidents being rooted in quality system deficiencies. The Therapeutic Goods Administration (TGA) regulates medical devices in Australia and may get involved when investigations into incidents find insufficient clarity or corrective actions from companies. A case study highlights how the TGA intervened when a company failed to adequately address increased failure rates in a patient monitoring device. The key takeaway is that companies should invest in quality control processes and actively maintain their QMS to avoid safety issues.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Presentation: Earlier access to medicines and medical technologies and the MMDRTGA Australia
This document discusses new expedited pathways being introduced by the Therapeutic Goods Administration (TGA) to provide earlier access to medicines and medical technologies in Australia. It outlines priority review pathways for prescription medicines and expedited review for novel medical devices. The priority review pathway for medicines allows provisional approval based on early clinical data showing promising safety and efficacy. The expedited pathway for devices provides front-of-queue assessment for breakthrough technologies that address unmet needs. Both pathways aim to make therapies available sooner while maintaining standards of safety, quality and effectiveness through post-market monitoring and follow-up requirements.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
This document provides a summary of Darral Addison's qualifications and experience. It includes over 20 years of experience in clinical, pharmaceutical, biotech, medical device, food and IT industries, with strong communication and regulatory skills. Addison has held roles at various companies focused on quality assurance, validation, clinical trials, and project management. He has a background in chemistry and quality systems with various industry certifications and a master's degree.
This document discusses pharmacovigilance in clinical trials, which involves monitoring the safety of medicines being tested. It outlines the responsibilities of various stakeholders like sponsors, investigators, and regulators in pharmacovigilance activities like adverse event reporting, risk assessment, and safety monitoring. Key aspects covered are the protocol guidance for safety reporting, use of case report forms and investigator brochures to document adverse drug reactions, and management of safety issues that arise during trials.
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
Keerthivasan Kunchithapatham Pillai, Co-Founder of Linux Laboratories on the topic of 'M Health – A Revolution' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Meaningful Access To Healthcare - The Good, The Bad - The Future of Healthcar...IFAH
Manish Chabbra, Founder & CEO, Shifa International FZ- LLC on the topic of 'Meaningful Access To Healthcare - The Good, The Bad - The Future of Healthcare With Technology' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Blockchain Technology In Healthcare As A Trustworthy Solution For IoTIFAH
Pravash Dey, Disruptor-In-Chief, US India Blockchain Council on the topic of 'Blockchain Technology In Healthcare As A Trustworthy Solution For IoT' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
This document discusses emerging trends in healthcare and wellness, including the rise of integrated medical wellness centers and resorts. It notes the growing demand for preventative and functional healthcare options as populations age and adopt healthier lifestyles. Examples of potential integrated medical wellness developments across Southeast Asia are provided, combining elements of medicine, wellness, hospitality and active living communities. Key opportunities exist in developing more of these types of mixed-use centers that incorporate both medical and wellness programs.
Dr. Ruchi Dana, President & COO, Duluth Medical Technologies Inc. on the topic of 'Work & Life In The Age Of AI & Robots' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
The Role Of Data and Emergent Technologies In Managing Health IFAH
This document discusses 5 trends in the healthcare industry driven by increased data availability and data-sharing: 1) Increased sharing of data across the healthcare ecosystem, 2) Nanomedicine, sensors, and AI driving innovation through increased data capture, 3) Emergence of a "digital backbone" across the industry but uncertainty around who will own it, 4) Growing empowerment and influence of patients over other stakeholders, 5) Specialized business models positioning companies to outperform through focus on data capabilities aligned to business models.
Sir Ganga Ram Hospital Model: A Different Model for Healthcare DeliveryIFAH
Dr. Ajay Swaroop, Honorary Secretary cum Treasurer - Board of Management at Sir Ganga Ram Hospital on the topic of 'Sir Ganga Ram Hospital Model: A Different Model for Healthcare Delivery' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Dr. Pramod Tripathi, Founder, Freedom From Diabetes Pvt Ltd on the topic of 'Reversing Diabetes and Lifestyle Disorders' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
DESTINY – An Innovative Platform for Personalized Medicine from Doctors for D...IFAH
Arnfin Bergmann, CEO at NeuroTransData GmbH, on the topic of 'DESTINY – An Innovative Platform for Personalized Medicine from Doctors for Doctors & Patients' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Innovative Approaches To Service For Patients In Pharma SectorIFAH
Takeda is a global values-based biopharmaceutical company committed to developing innovative treatments to improve patient health. The presentation discusses Takeda's acquisition of Shire which expanded its therapeutic areas and pipeline. It also outlines Takeda's R&D strategy which focuses on developing new treatments in oncology, gastroenterology, neuroscience, and rare diseases. Additionally, the presentation notes Takeda is exploring innovative approaches beyond traditional medicines, such as cell, gene, and RNA therapies, to serve more patients.
Michael Phillips Moskowitz, Founder/CEO of AeBeZe Labs and Moodrise, on the topic of 'Digital Nutrition' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Evolution Of Traditional Medical Devices IndustryIFAH
A session by Bruce Huici, Founder & CEO, Hallstat on the topic of 'Evolution Of Traditional Medical Devices Industry' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
A session by Susan P. Gibson, President & Founder, Vivolor Therapeutics, Inc. on the topic of 'Is Pharma Drug Pricing Being Disrupted?' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
1) The document discusses a study utilizing a proprietary cardiovascular management system and remote heart management system to provide computer assisted medication management and precision medicine modeling for 394 outpatients with chronic cardiovascular disease.
2) The remote heart management system utilized machine learning techniques like supervised and unsupervised learning to provide predictive diagnostics and a precision medicine model.
3) Results found lower 30-day readmission rates and 1-year hospitalization rates compared to controls, demonstrating the potential of machine learning and remote monitoring to improve outcomes for heart failure patients.
Invisible But Indispensable: Caregivers In An Aging WorldIFAH
A session by Dr. Aaron Blight, Founder, Caregiving Kinetics on the topic of 'Invisible But Indispensable: Caregivers In An Aging World' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
Population Health Management & Volume To Value Based CareIFAH
A session by Amish Purohit, CEO and CMO, US Health Systems on the topic of 'Population Health Management & Volume To Value Based Care' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
Photobiomodulation, Biophysics and Energy Medicine Technology: The Science an...IFAH
A session by Leanne Venier, CEO, Leanne Venier International on the topic of 'Photobiomodulation, Biophysics and Energy Medicine Technology: The Science and Practical Applications of Treating at the Root of Illness and Disease' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
Accounting & Financial Reporting In Healthcare InstitutionsIFAH
A session by Will Schmidt, CEO & Founder, RxSuccess Consulting on the topic of 'Accounting & Financial Reporting In Healthcare Institutions' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
Blockchain Innovation In Healthcare & Life SciencesIFAH
A session by Michael Irish, CEO, Vivacitas Healthcare on the topic of 'Blockchain Innovation In Healthcare & Life Sciences' at IFAH USA 2019 held at Caesars Palace, 18-20 June, 2019.
Get Covid Testing at Fit to Fly PCR TestNX Healthcare
A Fit-to-Fly PCR Test is a crucial service for travelers needing to meet the entry requirements of various countries or airlines. This test involves a polymerase chain reaction (PCR) test for COVID-19, which is considered the gold standard for detecting active infections. At our travel clinic in Leeds, we offer fast and reliable Fit to Fly PCR testing, providing you with an official certificate verifying your negative COVID-19 status. Our process is designed for convenience and accuracy, with quick turnaround times to ensure you receive your results and certificate in time for your departure. Trust our professional and experienced medical team to help you travel safely and compliantly, giving you peace of mind for your journey.
We are one of the top Massage Spa Ajman Our highly skilled, experienced, and certified massage therapists from different corners of the world are committed to serving you with a soothing and relaxing experience. Luxuriate yourself at our spas in Sharjah and Ajman, which are indeed enriched with an ambiance of relaxation and tranquility. We could confidently claim that we are one of the most affordable Spa Ajman and Sharjah as well, where you can book the massage session of your choice for just 99 AED at any time as we are open 24 hours a day, 7 days a week.
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COPD Treatment in Ghatkopar,Mumbai. Dr Kumar DoshiDr Kumar Doshi
Are you or a loved one affected by Chronic Obstructive Pulmonary Disease (COPD)? Discover comprehensive and advanced treatment options with Dr. Kumar Doshi, a preeminent COPD specialist based in Ghatkopar, Mumbai.
Dr. Kumar Doshi is dedicated to delivering the highest standard of care for COPD patients. Whether you are seeking a diagnosis, a second opinion, or exploring new treatment avenues, this presentation will guide you through the exceptional services available at his practice in Ghatkopar, Mumbai.
2024 HIPAA Compliance Training Guide to the Compliance OfficersConference Panel
Join us for a comprehensive 90-minute lesson designed specifically for Compliance Officers and Practice/Business Managers. This 2024 HIPAA Training session will guide you through the critical steps needed to ensure your practice is fully prepared for upcoming audits. Key updates and significant changes under the Omnibus Rule will be covered, along with the latest applicable updates for 2024.
Key Areas Covered:
Texting and Email Communication: Understand the compliance requirements for electronic communication.
Encryption Standards: Learn what is necessary and what is overhyped.
Medical Messaging and Voice Data: Ensure secure handling of sensitive information.
IT Risk Factors: Identify and mitigate risks related to your IT infrastructure.
Why Attend:
Expert Instructor: Brian Tuttle, with over 20 years in Health IT and Compliance Consulting, brings invaluable experience and knowledge, including insights from over 1000 risk assessments and direct dealings with Office of Civil Rights HIPAA auditors.
Actionable Insights: Receive practical advice on preparing for audits and avoiding common mistakes.
Clarity on Compliance: Clear up misconceptions and understand the reality of HIPAA regulations.
Ensure your compliance strategy is up-to-date and effective. Enroll now and be prepared for the 2024 HIPAA audits.
Enroll Now to secure your spot in this crucial training session and ensure your HIPAA compliance is robust and audit-ready.
https://conferencepanel.com/conference/hipaa-training-for-the-compliance-officer-2024-updates
Chandrima Spa Ajman is one of the leading Massage Center in Ajman, which is open 24 hours exclusively for men. Being one of the most affordable Spa in Ajman, we offer Body to Body massage, Kerala Massage, Malayali Massage, Indian Massage, Pakistani Massage Russian massage, Thai massage, Swedish massage, Hot Stone Massage, Deep Tissue Massage, and many more. Indulge in the ultimate massage experience and book your appointment today. We are confident that you will leave our Massage spa feeling refreshed, rejuvenated, and ready to take on the world.
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This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdfDr Rachana Gujar
The "Comprehensive Rainy Season Advisory: Safety and Preparedness Tips" offers essential guidance for navigating rainy weather conditions. It covers strategies for staying safe during storms, flood prevention measures, and advice on preparing for inclement weather. This advisory aims to ensure individuals are equipped with the knowledge and resources to handle the challenges of the rainy season effectively, emphasizing safety, preparedness, and resilience.
MBC Support Group for Black Women – Insights in Genetic Testing.pdfbkling
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DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
2. Disclaimer
“The views and opinions expressed in this presentation are those
of the author and do not necessarily represent official policy or
position of Takeda”
2
3. Agenda
• Importance of Pharmacovigilance
• Pharmacovigilance Inspection Management
• PV System Legislation Updates
• Regulatory Agency Trends & Inspection
Findings
• Consequences of Poor Inspections
3
4. Importance of Pharmacovigilance
• Pharmacovigilance is the science and activities
relating to the
– Detection
– Assessment
– Understanding and
– Prevention
of adverse effects or any other medicine-related
problem.
4
5. PV in Product LifeCycle
• Before a medicine is authorised for use, evidence of its safety and
efficacy is limited to the results from clinical trials
– where patients are selected carefully and followed up very closely
under controlled conditions.
– This means that at the time of a medicine's authorisation, it has been
tested in a relatively small number of selected patients for a limited
length of time.
• After authorisation the medicine may be used in a large number of
patients, for a long period of time and with other medicines.
– Certain side effects may emerge in such circumstances.
• It is therefore essential that the safety of all medicines is monitored
throughout their use in healthcare practice.
5
6. Objectives of PV System Inspections
• To determine that the marketing authorisation holder has the
following in place to meet their pharmacovigilance obligations
– Personnel
– systems
– facilities
• To identify, record and address non-compliance
– which may pose a risk to public health
• To use the inspection results
– For enforcement action basis, where considered necessary
6
8. PV System Element Ownership
Research
Non-clinical
studies and
Literature
Owned by Global Safety Team
Owned by other R&D functions
Safety Review
Team
Company Core
Data Sheet
Aggregate
reports
Risk
Management
Plan
Investigator
Brochure/
Informed Consent
Ad Hoc
Communication
Global Safety
Individual Case
Safety Reports
Tech Op
Quality
Complaints
Epidemiology
Population data
Epi Studies
Regulatory
Affairs
HA Requests
Clinical
Clinical trials
Registries
Local
Label
Labelling
Committee
Commercial
Patient Support
Programs/MR
Product
Council
Medical
Affairs
Medical Info
Literature
Quality Management System
Procedural documents
Training
Deviations
CAPA process
Audits
Metrics
Inspection management
Owned by commercial
Owned by Tech Ops/Mfg
9. How do you decide support model?
• Determined by the following
– Country of inspection
– Inspectorate/Regulatory Authority experience
– Announced or unannounced
– Inspection Duration
– Previous inspection experience and any previous inspection findings
and severity across GxPs
– Language of inspection conduct
– Scope of inspection (R&D, Tech Ops, Commercial) & MAH entities
– Size of site (incl. Quality personnel) & PV System related activities
– Subject matter experts location
– Scope of PV system related changes
– Risk areas
9
10. Inspection Management
10
Lead Inspection Readiness
Activities
Host Inspections or
oversee if delegated
Share Lessons learnt and
findings with R&D
stakeholders and LOCs
Coordinate Responses &
CAPAs
Review evidence of CAPA
completion
Perform CAPA
Effectiveness Checks
11. Inspection Readiness – Who?
• All Company Employees
• All Agents of Company
– Contractors & temporary employees
– CROs
– Distributors, Vendors and Other External Service Providers
• Anyone who may receive Safety Information/AEs in the
normal course of their daily work
11
12. Inspection
Readiness
Step 1 Step 2 Step 3 Step 4
Step4Step3Step2Step1
People
Integrity
Excellence
Sharing Industry
Findings
Sharing previous audit/
Inspection findings, reports and
responses
Understand the Inspection
process, legislation
Complete trainings
Update CVs and JDs
Review
Inspection
Readiness
checklist
Attend the
Inspection
Kick off meeting
Identify SMEs
Interview
Prep
Run through
the Inspection
logistics
Write Position
Statements
Identify CAPAs
Highlight areas of non
Compliance or risk to
Management and Quality
Print the prep
documentation
Review processes
& documentation
Work in cross functional
Teams to prepare
Document
Deviations
Review the inspection
Readiness checklist
Create a
collaboration
site
Logistics
planning
13. Where are Authorities actively inspecting?
Australia
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Costa Rica
Croatia
Denmark
Europe
France
Indonesia
Japan
Jordan
Moldova
Netherlands
Poland
Portuguese
Saudi Arabia
Slovenia
Sweden
Switzerland
UK
USA
EVOLVING…
Arab GVPs
China, India, Australia
Singapore, Malaysia, Vietnam, Egypt
• Implementation and
adoption of EU GVP
like legislation
• Implementation of
Compliance
Questionnaires
• Focus on QMS
• Focus on Contact
person responsible for
pharmacovigilance
• Implementation
of ISO, ICH E2B(R3),
EVDAS
• FDA unannounced
• focus on ICSR, QMS, Deviations and CAPA
• European Authorities
• Concept of supersite/volume of requests
• Health Canada
• unexpected lack of effect, QMS and training
• SwissMedic
• Swiss PV requirements, causality assessment
14. GVP - MHRA Findings
Source: MHRA Symposium May 2018 &
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761289/GPvP_Metrics_2017-18_.pdf
14
April 2016 – March 2017 April 2017 – March 2018
Critical
Reference Safety Information on
decrease
Increase in relation to signal
management and supervision and
oversight of the PV system
Major
Quality Management
Ongoing safety evaluation and RSI
supervision and oversight of the PV
system
Critical & Majors
Risk Management
Quality Management System
Ongoing Safety Evaluation
16. GCP – MHRA Critical Findings
• “The MHRA approved Reference Safety Information (RSI) in effect
at the time of occurrence of a Serious Adverse Event (SAE) was not
being used for expectedness assessments as required by CT-3
guidance.”
Source:
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/706356/GCP_INSPECTIONS_
METRICS_2016-2017__final_11-05-18_.pdf
16
17. Consequences of Poor Inspections
• Failure to demonstrate remediation of major findings results in critical
findings
• Initiates ANNUAL inspections – major resource consumption
• Remediation efforts become greater and more costly
• Regulatory Agency meetings
• Could negatively impact current approvals and future filings
• Require a response from industry within a specific timeframe
• FDA 483 letters
• Enforcement Actions
– Administrative: license suspension or revocation
– Legal: seizure, injunction, consent decree, prosecution
• Infringement notices e.g., MHRA & Injunction letters published e.g.,
ANSM
17