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.
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.
“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.”
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
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.
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.
“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.”
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
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.
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.
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.
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.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
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.
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.
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.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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.
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.
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.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
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.
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.
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.
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
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.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Investigation of Medicinal Product Dossier (IMPD) and Investigator Brochure (...Tanvi Mhashakhetri
Contents:
European Medicines Agency (EMA)
IMPD Introduction
Contents of IMPD
Objectives
Scope
Introduction of IB
General Consideration
Content of IB
European Medicines Agency (EMA)
It is a decentralized agency of the European union.
The Management Board is the European Medicines Agency’s integral governance Body.
The Agency is responsible for the scientific evaluation, supervision and safety monitoring of the medicines developed by pharmaceutical companies use in EU.
EMA protects public and animal health in 27 EU member states, as well as the countries of the European economic area , by ensuring that all medicines available on the EU market are safe, effective and of high quality.
History
European medical agency was found in 1995, has worked across the EU and globally to protect public and animal healty by assessing medicines to rigorous scientific standards and providing with independent, science-based informations on medicines.
EMA has 20 year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the developments of medicines.
In first two decades, the agency recommended the authorization of the total of 975 humans and 188 veterinary medicines.
Các quy định về hậu lưu hành thuốc ở Nhật Bản sử dụng dữ liệu thế giới thực để đánh giá và kiểm soát. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
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
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…
• Employers are legally obliged to provide a work environment that does not threaten the health of the workers (Chemical Agent Directive 98/24/EC and Framework Directive 89/391/EEC).
• Under Directive 89/391/EEC, OELs can be developed nationally, Indicative Occupational Exposure Limit Values (IOELVs).
Evaluacion del riesgo cuantitativo (oel) y categorizacion de la exposicion oc...Azierta
El OEL (Occupational Exposure Limit) se define como la concentracion en el aire de una sustancia en la que se cree que casi todos los trabajadores podría exponerse sin efectos adversos.
Los limites de exposicion profesional (OEL) son un instrumento útil para la prevencion de los efectos en la salud durante el manejo de sustancias químicas.
Farmacovigilancia. Informe periodico de seguridad. periodic safety update rep...Azierta
El modulo VII de las GVP define como se debe realizar un PSUR, con el fin de actualizar el balance riesgo-beneficio de un medicamento.
Con estos módulos, la EMA busca garantizar la seguridad y eficacia de los medicamentos.
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 gestión y desarrollo de informes individual safety case r...Azierta
Descripción del funcionamiento de la unidad de farmacovigilancia respecto a la gestión de casos clínicos. Repaso del módulo VI de las Good Vigilance Practices de la EMA.
Farmacovigilancia. RMP. Risk Management Plan. Good Pharmacovigilance Practice...Azierta
Descripción de un plan de gestion de riesgos o srisk management plan (RMP) donde se hace un repaso al modulo V de las guideline publicadas por la EMA.
Se ponen de manifiesto los objetivos que busca este organismo. Ademas se definen concetos importantes dentro de la farmacovigilancia y se evidencia cuándo es necesario desarrollar un RMP.
Por último, se explica detalladamente la estructura de un RMP.
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.
Casos de éxito en el desarrollo de innovadores y biosimilaresAzierta
Casos de éxito en el desarrollo de innovadores y biosimilares
Desarrollo de pequeñas moléculas de síntesis frente al desarrollo de biológicos/biosimilares
Oportunidades en el mercado biotecnologico: Medicamentos biologicos y biosimilares.
Repaso a los puntos críticos en el proceso de desarrollo y comercialización de medicamentos biologicos y biosimilares. Principales necesidades
Farmacovigilancia. Inspecciones. Good Pharmacovigilance Practices: Modulo IIIAzierta
Farmacovigilancia.
Inspecciones en Farmacovigilancia. Good vigilance practices (GVP) Modulo III.
Repaso general al modulo III de las GVP de la EMA. Diferencias entre auditorias e inspecciones, objetivos, tipos de inspecciones, flujo de actividades durante una inspección, y consejos prácticos a la hora de llevar a cabo una inspección.
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.
Farmacovigilancia Good Vigilance Practices I Sistemas de calidadAzierta
Good vigilance practices I.
Farmacovigilancia sistemas de calidad GVP I. Descripcion del modulo I de Buenas Practicas en Farmacovigilancia (GVP).
Aplicación de las normas ISO a las unidades de farmacovigilancia.
Formacion
Sistemas CAPA
Plan PDCA
Azierta. Consultoria y asesoria farmaceutica. Farmacovigilancia España
Farmacovigilancia: Vision general de la farmacovigilanciaAzierta
Farmacovigilancia:
Que es la farmacovigilancia. farmacovigilancia definicion. Farmacovigilancia concepto
GPV definiciones conceptos legislacion principios organismos. Repaso general sobre todos los temas relacionados con la farmacovigilancia:
Breve introducción sobre el concepto segun la OMS.
Evolución histórica y sucesos más importantes.
Conceptos y definiciones.
Metodología.
Organismos reguladores más importantes.
Legislación.
GVP: Good Vigilance Practices. Modulos sobre las buenas prácticas en farmacovigilancia y breve descripción de cada uno de ellos.
Conclusiones.
Azierta. Consultoria y asesoria farmaceutica. Farmacovigilancia España
Multi-source connectivity as the driver of solar wind variability in the heli...Sérgio Sacani
The ambient solar wind that flls the heliosphere originates from multiple
sources in the solar corona and is highly structured. It is often described
as high-speed, relatively homogeneous, plasma streams from coronal
holes and slow-speed, highly variable, streams whose source regions are
under debate. A key goal of ESA/NASA’s Solar Orbiter mission is to identify
solar wind sources and understand what drives the complexity seen in the
heliosphere. By combining magnetic feld modelling and spectroscopic
techniques with high-resolution observations and measurements, we show
that the solar wind variability detected in situ by Solar Orbiter in March
2022 is driven by spatio-temporal changes in the magnetic connectivity to
multiple sources in the solar atmosphere. The magnetic feld footpoints
connected to the spacecraft moved from the boundaries of a coronal hole
to one active region (12961) and then across to another region (12957). This
is refected in the in situ measurements, which show the transition from fast
to highly Alfvénic then to slow solar wind that is disrupted by the arrival of
a coronal mass ejection. Our results describe solar wind variability at 0.5 au
but are applicable to near-Earth observatories.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
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(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
2. Index
1. What is a Periodic Safety Update Report (PSUR)?
2. Objective of the PSUR
3. Periodicity, EU Reference Dates and Data lock Points
4. Exemption from submitting PSURS
5. EU single assessment of PSUR (PSUSA)
6. Summary of GVP Module VII
7. How to review a PSUR/PBRER
Safety Reports: PSUR/PBRER
3. 1. WHAT IS A PERIODIC SAFETY REPORT (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 at defined time
points during the post-authorisation phase.
PBRER (Periodic Benefit Risk Evaluation Report) are referred to as PSUR
since implementation in Europe via GVP module VII.
4. 2. OBJECTIVE OF THE PSUR (1)
To present a comprehensive and critical analysis of new or emerging
information on the risks and, where pertinent, new evidence of benefit to
enable an appraisal of overall benefit risk.
To contain an evaluation of new relevant information that became available to
the MAH during the reporting interval, in the context of cumulative
information:
• 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 (where new important safety
information has emerged)
5. 2. OBJECTIVE OF THE PSUR (2)
This evaluation of risk-benefit assessment should be undertaken in the
context of ongoing pharmacovigilance and risk management:
Module VII: Post-authorization safety studies
Module V: Risk management systems
6. 3. PERIODICITY (1)
PSUR must be prepared at the following intervals:
• Immediately upon request
• Every six months from authorisation until product placed on the market
• Every six months for first two years on the market
• Annually for the next two years
• Thereafter every 3 years
Exception – frequency and dates of submission are laid down as a condition of the MA
or determined otherwise in the list of Union Reference Dates (EURD List).
Submit:
• By day 70 for intervals up to 12 months
• By day 90 for intervals in excess of 12 months
7. 3. INTERNATIONAL BIRTH DATE AND DATA LOCK POINT (2)
The date of the first marketing approval for the medicinal product in
any country in the world is the International Birth Date (IBD). Data
lock point is the date designated as the cut-off for data to be included,
based on IBD.
8. The EU Reference Dates List is a comprehensive list of active
substances and combinations of active substances for which PSURs
shall be submitted:
• Legally binding
• Periodicity defined on a risk-based approach
The EU Reference Dates List was put in place in order to facilitate the
harmonisation of Data Lock Points (DLPs) and frequency of
submission of PSURs for medicinal products containing the same
active substance or the same combination of active substances
subject to different marketing authorisations, authorised in more than
one Member State.
EMA has published the list of Union reference dates and frequency of
submission information which will be legally binding when Module VII
becomes effective 2 July 2012.
3. EU REFERENCE DATES LIST (3)
10. The EURD list is a living document which will be amended whenever
considered necessary by the PRAC, the CHMP or CMDh in response to
the emergence of relevant new safety information, newly authorised
substances and requests received from MAHs. Substances can be
added or removed as appropriate. The EURD list is updated on a
monthly basis; MAHs should therefore maintain an awareness of the
current status of the list. PSURs shall also be submitted at any time
immediately upon request by the regulatory authorities.
3. EU REFERENCE DATES LIST (EURD List) (5)
11. 3. EU REFERENCE DATES LIST (EURD List)
REGULATORY NETWORK (6)
11
The Co-ordination Group for Mutual Recognition and
Decentralised Procedures – Human, examine any question
relating to marketing authorisation of a medicinal product in
two or more Member States in accordance with the mutual
recognition procedure or the decentralised procedure.
Executive body of the European
Union responsible for proposing
legislation, implementing
decisions, upholding the Union's
treaties and day-to-day running of
the EU.
Helps protect and promote health in Europe by evaluating
medicines for both human and veterinary use.
Heatlh Authorities of each Member State
The Committee for Medicinal Products for Human Use is the
committee at the EMA that is responsible for preparing
opinions on questions concerning medicines for human use.
CHMP
The committee at the EMA that is responsible for assessing
and monitoring safety issues for human medicines.
EMA
PRAC
National Competent Authorities (NCA)
12. 4. EXEMPTION FROM SUBMITTING PSURS
Generics, well-established use, and traditional herbal medicinal
products are exempted from submitting PSURs except in the
following circumstances:
The marketing authorisation provides for the submission of
PSURs as a condition.
PSURs is (are) requested due to concerns relating to PV data or
due to the lack of PSURs relating to an active substance after
the MA has been granted (e.g. when the “reference” medicinal
product is no longer marketed).
For the products where PSURs are no longer required to be
submitted routinely, it is expected that marketing authorisation
holders will continue to:
• Evaluate the safety of their products on a regular basis and
Report any new safety information that impacts on the benefit-
risk profile or the product information.
13. 5. EU SINGLE ASSESSMENT OF PSUR (PSUSA) (1)
PSUSA is a PSUR single assessment of substances contained in
centrally authorised product(s) AND nationally authorised
products. This assessment lead to legally binding outcomes:
maintenance, variation, suspension, revocation of the marketing
authorisation.
Objectives: harmonise and strengthen the safety and benefit-risk
review of medicines across the EU; increase the shared use of
resources between competent authorities; Assessment by the
PRAC with CHMP involvement (for CAP and CAP/NAP) or CMDh
(for NAP) in case of regulatory action.
15. 5. EU SINGLE ASSESSMENT OF PSUR (PSUSA) (3)
The EMA publishes a list of outcomes for NAPs on their website
while outcomes for CAPs are published as part of each medicine’s
European public assessment report (EPAR). Any changes to the
product information as a result of the PSUR assessment are
implemented without subsequent variation for CAPs and through
the appropriate variation at national level for NAPs.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/g
eneral/general_content_000620.jsp&mid=WC0b01ac0580902b8d
16. 6. SUMMARY OF GVP MODULE VII
Module VII includes guidance on the objectives, format and contents of the
PSUR, as well as recommendations for quality systems for PSURs and training
of staff members on the PSUR process.
Overall Content
PSURs should provide greater emphasis on analysis of case reports; to
include:
scientific evaluation of the benefit-risk profile
summaries of relevant scientific/clinical data including literature searches
available sales/prescription data to calculate patient exposure
The reaction terms used in the PSUR should be in accordance with the
MedDRA terminology.
17. 7. HOW TO REVIEW A PSUR/PBRER
Review by an experienced person who knows the drug and who knows
drug safety.
HIGH QUALITY /AUDITS/ INSPECTIONS
• All promises and commitments made to the Health Agencies (HAs), whether in
the PSUR itself or in accompanying emails or communications should be noted.
Responses to HAs.
• Make sure you have in hand the appropriate labels (CCSI, national labeling etc.).
• The reviewer should be aware of any current concerns (safety signals, special
populations, new or removed indications, any actions taken for safety reasons by
the company or another health agency, any label changes for safety reasons
anywhere in the world….)
• Careful review of the SAEs/ADRs:
• In which SOCs have most SAEs/ADRs occurred?
• Any surprises or signals in the listed SAEs/ADRs?
• Any surprises or signals in the unlisted SAEs/ADRs?
• Any surprises or issues in the fatal SAEs/ADRs?
• Are there any findings in specific patient populations as defined by disease, age,
vulnerable groups etc?
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