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.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
An Individual Case Safety Report (ICSR) is a document that contains information about a single adverse event or suspected adverse reaction to a medicinal product. It is a critical component of pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
ICSRs are typically generated by healthcare professionals, patients, or clinical trial investigators, and they include a detailed description of the adverse event, patient demographics, medical history, and details about the medicinal product(s) involved. The report also contains an assessment of the causal relationship between the adverse event and the medicinal product(s), as well as any medical interventions or outcomes that occurred.
ICSRs are essential for identifying potential safety issues with medicinal products and for assessing the risk-benefit profile of a product. They also help to ensure that regulatory authorities, such as the FDA or EMA, are notified of any safety concerns associated with a medicinal product.
ICSRs must comply with international reporting requirements, which specify the information that must be included in the report, as well as the timeframe for submission. The information in an ICSR must be accurate and complete to enable effective analysis and evaluation of the safety data.
ICSRs are a crucial aspect of pharmacovigilance and the regulatory process, as they provide valuable information for the ongoing evaluation of the safety of medicinal products. The prompt reporting of ICSRs is essential for ensuring the timely detection and assessment of any safety concerns associated with the use of medicinal products.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
“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.”
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
An Individual Case Safety Report (ICSR) is a document that contains information about a single adverse event or suspected adverse reaction to a medicinal product. It is a critical component of pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
ICSRs are typically generated by healthcare professionals, patients, or clinical trial investigators, and they include a detailed description of the adverse event, patient demographics, medical history, and details about the medicinal product(s) involved. The report also contains an assessment of the causal relationship between the adverse event and the medicinal product(s), as well as any medical interventions or outcomes that occurred.
ICSRs are essential for identifying potential safety issues with medicinal products and for assessing the risk-benefit profile of a product. They also help to ensure that regulatory authorities, such as the FDA or EMA, are notified of any safety concerns associated with a medicinal product.
ICSRs must comply with international reporting requirements, which specify the information that must be included in the report, as well as the timeframe for submission. The information in an ICSR must be accurate and complete to enable effective analysis and evaluation of the safety data.
ICSRs are a crucial aspect of pharmacovigilance and the regulatory process, as they provide valuable information for the ongoing evaluation of the safety of medicinal products. The prompt reporting of ICSRs is essential for ensuring the timely detection and assessment of any safety concerns associated with the use of medicinal products.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
“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.”
Here is a detailed description of ICH guidelines for PBRER (ICH E2C R2) & Expedited reporting (E2D). I have prepared it by keeping in mind to cover each and every aspect of these 2 guidelines, it is a bit long but complete understanding of guidelines because nothing important is missed. If you go through this ppt no need to study ICH guidelines further.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...László Árvai
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
Aggregate reporting refers to the process of collecting and summarizing data from multiple sources or individual data points to provide a comprehensive overview or analysis. It involves combining data from various entities or sources and presenting it in a consolidated format.
In various fields and industries, aggregate reporting serves several purposes, such as:
Financial Reporting: In finance, aggregate reporting involves consolidating financial information from different divisions, subsidiaries, or business units within an organization. It provides a comprehensive view of the company's financial performance, including revenues, expenses, assets, and liabilities.
Market Research: In market research, aggregate reporting involves combining data from multiple surveys, interviews, or studies to generate insights and trends. It helps researchers and analysts understand market dynamics, consumer behavior, and preferences at a larger scale.
Public Health: In public health, aggregate reporting is crucial for monitoring and controlling the spread of diseases. Health authorities collect data from healthcare providers, laboratories, and other sources to track disease incidence, prevalence, and other epidemiological indicators. Aggregated data allows health officials to identify trends, allocate resources effectively, and develop appropriate interventions.
Data Analysis: In data analytics, aggregate reporting involves summarizing and analyzing large datasets to identify patterns, trends, or anomalies. By aggregating data, analysts can gain insights into overall performance, identify key metrics, and make data-driven decisions.
Project Management: In project management, aggregate reporting helps track the progress and performance of various project components or tasks. It involves consolidating data from different teams or departments to create a holistic view of the project's status, resource allocation, budget, and milestones.
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
Turacoz Healthcare Solutions - Risk management plan is one of the many documents that come under regulatory writing. It is meant to be submitted to the health authorities during the process of gaining market authorization or at the time of any safety updates to the medicinal product.
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.
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
Pharmacovigilance planning refers to the systematic and proactive approach taken by pharmaceutical companies, regulatory agencies, and other stakeholders to establish strategies and procedures for monitoring the safety of drugs throughout their lifecycle. It involves creating a comprehensive framework to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Here are some key aspects to consider in pharmacovigilance planning
A PSUR (Periodic Safety Update Report) is a pharmacovigilance document that provides an update on the safety profile of a drug product over a defined period of time. PSURs are submitted to regulatory authorities on a regular basis to ensure the continued safety and efficacy of the drug.
A PSUR SlideShare is a presentation that summarizes the key information contained within a PSUR report. It typically includes information such as adverse events, drug interactions, and any changes in the safety profile of the drug since the last report. The presentation may also include charts, graphs, and other visual aids to help illustrate the data.
The purpose of a PSUR SlideShare is to provide an easily digestible overview of the safety information contained within the PSUR report. This can be particularly useful for stakeholders who may not have the time or expertise to read through the full report, such as healthcare providers, patients, or investors.
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.
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
2. WHAT IS PSUR
PERIODIC SAFETY UPDATE REPORTS (PSURS)
are pharmacovigilance documents intended to
provide an evaluation of the risk-benefit balance of a
medicinal product for submission by marketing
authorisation holders (MAHs) in the light of new or
changing information at defined time points during the
post-authorisation phase.
PBRER (PERIODIC BENEFIT RISK EVALUATION
REPORT) are referred to as PSUR since
3. OBJECTIVE OF PSUR
Examine whether new information is in accord with
previous knowledge of the benefit risk profile
Summarises relevant new safety information that may
impact the benefit risk profile
Summarises any important new efficacy and effectiveness
information
Conduct an integrated Benefit/Risk evaluation
This evaluation of risk-benefit assessment should be
undertaken in the context of ongoing pharmacovigilance
and risk management:
5. SUMMARY OF GVP MODULE V
Risk management includes a set of PV activities and interventions
designed to identify, characterize prevent or minimize risks relating to
medicinal products including the assessment of the effectiveness of
those activities & interventions.
Module V provides guidance on the description of risk management
systems for medicinal product in form of risk management plan.
8. RESPONSIBILITIES: EMA
Coordination of the pharmacovigilance and monitoring of
the safety concerns
• Maintain a list of products subject to additional
monitoring
• Maintain repository of PSUR and coordinate their
assessment
PRAC
Frequency of
submission of PSUR
Recommendations after
reviewing the PSUR
CHMP
opinions based
on PRAC
recommendations
(For CAP)
CMDh
positions based on
PRAC
recommendations
(For NAP)
10. GENERAL PRINCIPLES
General scope – presentation, analysis and evaluation of
new or changing safety data received during period covered
by the PSUR
ONE PSUR – ONE MAH – All elements of the data for the
product should be presented in separate sections and
included in a single PSUR
Products authorised to more than one MAH – Where a
product is authorised to more than one Marketing
Authorisation Holder, in the case of multiple applications,
submission of common PSURs is acceptable provided that
the products remain identical in all respects apart from their
11. REGULATORY GUIDELINES
ICH guideline E2C(R2) Periodic Benefit-Risk Evaluation Report
(PBRER) (step 5 Dec 2012)
Guideline on Good Pharmacovigilance Practices (GVP) Module
VII (revision 1, 9 Dec 2013) - supersede vol 9A
As the PSUR should be a single stand–alone document for the
reporting interval, based on cumulative data, summary bridging
reports (SBRs) and addendum reports (ARs), introduced in ICH-
E2C(R1) guideline, will not be accepted
12. GOOD PHARMACOVIGILANCE PRACTICES
The good pharmacovigilance practice (GVP) guidelines came
into effect in July 2012 to facilitate the performance of
Pharmacovigilance (PV) in the EU.
The GVP guidelines are divided into 16 modules, each covering a
major process in PV. Module VII discusses changes to the format
and content of the PSUR.
There is no longer a routine requirement for PSURs for generic,
well established, homeopathic and herbal products (exceptions:
if a risk is identified or if there is a lack of information).
The European Medicines Agency (EMA) generates a list of EU
reference dates and frequency of
submission. This list is displayed on the EMA web-portal and is
15. CHANGES TO PSUR
The following are the important changes in the new format PSUR
(PBRER) based on ICH E2C (R2) compared to old format PSUR based
on ICH E2C (R1):
RISK-BENEFIT ANALYSES:
Risk evaluation: signals (new, ongoing or closed), evaluation of risks and
new information, and effectiveness of risk minimization activities.
Benefit evaluation: important baseline efficacy/effectiveness, evaluation of
efficacy/effectiveness and new information.
Integrated risk-benefit analysis.
SUMMARY TABULATIONS
The detailed adverse drug reaction (ADR) line listings will be replaced by
more concise cumulative summary
tabulation of serious adverse events from clinical trials and cumulative and
interval summary tabulations of ADRs.
16. Modular approach: The PSUR now has a modular format, which is
intended to maximize efficiencies between different document types,
since the same modules can be used in different documents
PSUR vs. Development Safety Update Report (DSUR): These
documents share a number of common sections synchronization of
submission schedules for these documents should facilitate the use of
common text.
PSUR vs. Risk Management Plan (RMP): Certain PSUR and RMP
sections can be used interchangeably across reports.
Detailed analyses of cases for special populations: (e.g.
pregnant/lactating women; organ-impaired patients;
pediatric/elderly patients) is no longer required, unless being
assessed as a potential risk.