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.
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.
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
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.
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
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.
“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.”
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.
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
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.
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
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.
“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.”
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
A Risk Management Plan (RMP) is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug)
At the time of authorization, information on the safety of a
medicine is relatively limited. This is due to the limitations
of clinical trials, including:
relatively small numbers of subjects in clinical trials compared with the intended treatment population
restricted population in terms of age, gender or ethnicity
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.
What are some of the challenges in pharmacovigilance? This presentation offers you more information on signal detection, signal management and risk minimisation measures.
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.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
Literature searches in Pharmacovigilancesamikshagupta
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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.
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
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.
Safety reports. addendum to the clinical overview. acoAzierta
Critical discussion addressing the current benefit/risk balance for the product on the basis of a consolidated version of safety/efficacy data accumulated since the initial MA or the last renewal, taking into account PSURs submitted, suspected adverse reactions reports, additional pharmacovigilance activities and the effectiveness of risk minimization measures contained in the RMP, if applicable.
Then it is explained how to prepare an ACO according to European guidelines and following the required structure.
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
A Risk Management Plan (RMP) is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug)
At the time of authorization, information on the safety of a
medicine is relatively limited. This is due to the limitations
of clinical trials, including:
relatively small numbers of subjects in clinical trials compared with the intended treatment population
restricted population in terms of age, gender or ethnicity
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.
What are some of the challenges in pharmacovigilance? This presentation offers you more information on signal detection, signal management and risk minimisation measures.
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.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
Literature searches in Pharmacovigilancesamikshagupta
This presentation provides a detailed description of various literature searches performed in pharmacovigilance including search criteria, different search engines etc
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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.
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
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.
Safety reports. addendum to the clinical overview. acoAzierta
Critical discussion addressing the current benefit/risk balance for the product on the basis of a consolidated version of safety/efficacy data accumulated since the initial MA or the last renewal, taking into account PSURs submitted, suspected adverse reactions reports, additional pharmacovigilance activities and the effectiveness of risk minimization measures contained in the RMP, if applicable.
Then it is explained how to prepare an ACO according to European guidelines and following the required structure.
Farmacovigilancia. Pharmacovigilance System Master File. Good Vigilance Pract...Azierta
Farmacovigilancia:
Pharmacovigilance System Master File (PSMF)
Archivo maestro de farmacovigilancia
Good vigilance Practices (GVP)
buenas practicas de farmacovigilancia
Azierta. Consultoría y asesoría científica. Farmacovigilancia España.
SJ Pharma is a leading expert in Signal Detection, Management, & Consulting. View some signaling examples here or visit SJ Pharma online to learn more about the benefits our signaling and data mining services can bring to your business.
Farmacovigilancia. Auditorías. Good Pharmacovigilance Practices (GVP). Módulo IVAzierta
Farmacovigilancia:
Auditorías en Farmacovigilancia
Good vigilance Practices (GVP)
Modulo IV
Azierta. Consultoría y asesoría científica. Farmacovigilancia España.
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.
Documentation on PMP Risk Management Plan & Template.
If you like a downloaded version, add me to your network on Linkedin
www.linkedin.com/in/alliegentry
and in the invite, please let me know you would like a word copy of this document.
Allie Gentry
PivotLogix
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
Presentation: Pharmacovigilance requirements inspected and example findingsTGA Australia
Presentations given at the TGA information sessions cover the pharmacovigilance inspection guidelines, preparing for inspections, inspection process, and close out of inspections.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEWS & Its PREPARATIONSJonaid Ali
FREQUENTLY asked questions about pharmacovigilance in an interview. Pharmacovigilance is fastest growing career in these days in the healthcare sector specially for pharmacy students although some corporates allow non pharm candidates also
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4, Opposite To Expert Global, Garware Stadium Road, Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 9028839789
Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
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BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
Solutions
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Farmacovigilancia informe pass good vigilance practices (gvp) modulo viiiAzierta
La European Medicines Agency dedica el octavo de los módulos publicados sobre las buenas prácticas de farmacovigilancia (GVP) a los informes PASS. En 2016 entró en vigor la última revisión de este documento para incorporar nuevas exigencias que ya se han implementado. Con el fin de armonizar los estudios de seguridad post autorización (PASS) y su uso a nivel europeo, se definió una estructura tanto para el protocolo como para el informe final.
Se define un estudio de seguridad post autorización (PASS) como cualquier estudio relativo a un medicamento autorizado realizado con el fin de identificar, caracterizar o cuantificar un peligro para la seguridad, confirmando el perfil de seguridad del medicamento, o de medir la eficacia de las medidas de gestión de riesgos.
Existen dos tipos de informe: aquellos que son de conformidad con una obligación impuesta por una autoridad competente, o los No intervenciones realizados voluntariamente
Un estudio debe considerarse PASS cuando incluya los siguientes objetivos:
• cuantificar los riesgos potenciales o identificados
• evaluar los riesgos de un medicamento utilizado en una población de pacientes para la cual la información de seguridad es limitada o falta
• evaluar los riesgos de un medicamento después de un uso prolongado
• evaluar patrones de utilización de fármacos que aporten conocimientos sobre la seguridad del medicamento o la eficacia de una medida de gestión de riesgos
Los informes PASS tendrán un protocolo de estudio escrito, el cual debe ser desarrollado por personas con formación y experiencia científica apropiadas. El formato y protocolo de estudio de un informe PASS no es libre y está recogido en la EMA en el propio modulo.
Un informe PASS también ha de tener un informe final del estudio el cual seguirá el formato especifico descrito por la EMA y deberá presentarse dentro de los 12 meses siguientes al final de la recopilación. Si un estudio es suspendido, se debe presentar un informe final y se deben proporcionar las razones de suspensión del estudio.
En Azierta, Consultoría y Asesoría Científica, somos expertos en Farmacovigilancia y contamos con un equipo de especialistas altamente cualificado que da soporte a nuestros clientes de cara a gestionar la Farmacovigilancia de manera óptima. Nuestro trabajo cubre todos los ámbitos de la Farmacovigilancia, tanto a nivel de medicamentos como de productos sanitarios y cosméticos.
Si tienes interés en profundizar en los contenidos del módulo VIII de las GVP, así como en otros aspectos relacionados con la Farmacovigilancia, te invitamos a visitar el siguiente enlace donde podrás descargar gratuitamente documentación al respecto.
Ich q3d for elemental impurities risk evaluationAzierta
Directive ICH Q3D aims to limit the presence of potentially toxicelemental impurities (also known as heavy metals) in pharmaceutical products intended for human use.
This directive is linked to changes in the pharmacopoeias (Ph.Eur. & USP) with the introduction of new, safer, more selective and precise analytical methods with greater reproducibility and better recovery.
Likewise the directive establishes the toxicity limits of potentially present elements.
Directive ICH Q3D sets out a list of 24 elements divided into four categories (classes 1, 2A, 2B and 3), in relation to their toxicity and their probability of occurrence and the maximum permitted daily exposure (PDE: Permitted Daily Exposure) for each impurity according to the administration route (µg / day).
Occupational exposure limits (OEL) to chemical agents APIs - Quantitative Ris...Azierta
The Occupational Exposure Limit (OEL) is defined as the airborne concentration of a substance (expressed as a weighted average in time for a working day of 8 hours/day and 40 hours/working week) under which it is believed that nearly all workers may be repeatedly exposed (day after day, over a working lifetime) without adverse health effects (ACGIH, 2006; DFG, 2005).
Occupational exposure limits (OELs) are a useful tool to prevent adverse effects on health when managing chemical substances.
On a European scale…
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2. Index
1. What is a Risk Management Plan?
2. Dates of implementation
3. Objective of the RMP
4. Definitions
5. When is a RMP necessary?
6. Structure
SAFETY REPORT: RMP
3. 1. WHAT IS A RISK MANAGEMENT PLAN (RMP)?
A Risk Management Plan is a document based on:
1. Safety profile of the medicine.
2. Plan of all pharmacovigilance activities.
3. Planning and implementation of different measures in order to
minimize risk; and evaluation of effectiveness of those measures.
If you want to get more information check out the following link:
GVP Module V: Risk Management Plan
5. 3. OBJECTIVE OF THE RMP
• Early identification of any risk taking into consideration all the existing
information
• Identification of areas where it is necessary to perform an in depth
evaluation
• Project new studies to characterize and identify scientific-based risks.
• Pharmacovigilance starts before marketing authorization and it
continues during all the life-cycle.
6. 4. DEFINITIONS
• Risk Management System:
Set of activities to identify, characterize, prevent or minimize
any risk related to medicinal products, including evaluation of
effectiveness of these measures.
• Risk Management Plan:
Detailed description of the Risk Management System.
It includes all the existing and missing information about the
safety profile of the medicine; certainty level of the
effectiveness shown in clinical trials, measures to prevent any
risk associated to the medicine including evaluation of
effectiveness of these measures.
7. 4. DEFINITIONS (2)
• What is an important identified risk?
An adverse event for which there is enough evidence to associate the risk
with the medicine:
• An adverse event that occurs in pre-clinical and is confirmed by clinical
data.
• An adverse event identified in clinical trials or epidemiological studies
when the magnitude of the difference with the comparator group
suggests that there is a causality relationship.
• An adverse event suggested by a large amount of well-documented
spontaneous reactions with causality strongly supported by:
❖ Temporal relationship.
❖ Biological plausability.
8. 4. DEFINITIONS (3)
• What is an important potential risk?
An adverse event for which there is a suspicion of association with the
medicine, but causality is not confirmed:
• Pre-clinical toxicological findings that have not been confirmed by
clinical data.
• An adverse event observed in clinical trials or epidemiological studies
when the magnitude of the difference with the comparator group is not
enough to establish a causality relationship.
• A signal obtained by spontaneous notification.
• A class efect.
9. 4. DEFINITIONS (4)
• What is missing information?
Unknown information about the safety of medicines representing a limit in
safety data
Populations not studied in clinical trials: pregnant women, patients with
hepatic/renal failure, paediatrics, etc.
10. 5. WHEN IS A RMP NECESSARY?
New Marketing Authorization, independently of its legal type of application.
Traditional herbal products and homeopathic products registered under a
simplified procedure are exented to develop a RMP.
When it is required by a Regulatory Agency.
11. 6. STRUCTURE OF A RMP
I. Part I: General Overview of the medicine
II. Part II: Safety Specification
III. Part III: Pharmacovigilance Plan
IV. Part IV: Plan for post-authorisation efficacy studies
V. Part V: Risk Minimisation Measures
VI. Part VI: Summary of RMP
VII. Part VII: Annex
13. b. Safety Concerns
Summary of the safety profile, including
❖ Important Identified Risks
❖ Important Potential Risks
❖ Missing information
❖ Potential populations at risk
❖ Safety gaps that must be under follow-up
14. c. Pharmacovigilance Plan
The objective of a MAH is to early identify and/or characterize any potential
risk.
❖ Identify any new safety concern
❖ Better understanding of known concerns
❖ Investigate if those risks are likely to be real.
❖ To expose how MAH plans to obtain better information
All these activities can be:
Routine PV Activities Additional PV Activities
15. d. Post-marketing Research Plan
Post-authorisation efficacy studies refer to current indications and not to
research aimed at extending the indication.
Summary figures of planned studies, together with the agenda and protocols
of all drafts, should be included in Annex 8 of the RMP.
16. e. Risk Minimization Measures
According to the safety concerns, the MAH must assess the need for risk
minimization activities for any risk included in the RMP.
These should be considered on a case by case basis, and they will depend on
risk severity, indication, targeted population, etc.
A single risk can have more than one risk minimization measure.
Each risk minimization measure must be reviewed on a regular basis and its
effectiveness must be assessed (GVP module XVI).
17. f. Summary of the RMP
The RMP Part VI:
• is made publicly available, including key factors of the RMP and
emphasizing on risk minimization activities.
• should be written in a non specialized language (lay language)
• describes all risks taking into account the benefits associated to the
use of that medicine
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