This document discusses the key aspects of pharmacovigilance in the European Union. It provides an overview of the process of monitoring medicine safety, outlines the authorities involved, and describes the evolution of the regulatory environment over time. Major changes introduced by new EU legislation include the Good Pharmacovigilance Practice guidelines, the new Pharmacovigilance Risk Assessment Committee, requirements for a Pharmacovigilance System Master File, changes to periodic safety reports, more stringent rules for reporting adverse events, publishing Risk Management Plan summaries, and the potential for requiring post-approval safety studies. The overall aim is to strengthen the EU pharmacovigilance system and better protect public health.
Update on new pv legislation plg june2012danisowich
The document provides an overview and update on new European pharmacovigilance legislation coming into effect in July 2012. It discusses timelines for implementation, introduces the new legislation and its aims, outlines Good Pharmacovigilance Practices including 16 new modules, and summarizes some of the key modules covering pharmacovigilance systems, risk management systems, adverse reaction reporting and periodic safety reports.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
The document discusses the role of the EU Qualified Person for Pharmacovigilance (QPPV). The QPPV must be appropriately qualified, reside in the EEA, and act as a single point of contact for drug safety issues in Europe. The QPPV is responsible for establishing and maintaining the company's pharmacovigilance system, monitoring product safety, submitting regulatory documents, and ensuring compliance with European legislation on safety reporting and risk management. Both the marketing authorization holder and QPPV have overlapping obligations to support pharmacovigilance activities and ensure the safe use of medicinal products in the EU.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Exploring information exchange opportunities between Industry and the TGATGA Australia
The TGA is undertaking a Business Improvement Program to update their systems and processes. As part of this, they are starting an Adverse Event Management project to improve how adverse event reports are collected, processed, and analyzed for medicines, vaccines, and medical devices. They outlined the current reporting systems, volumes and formats, and are seeking industry input on capabilities and needs to help design new reporting formats that meet stakeholder and international standards. Interested parties can register for the project by email.
Presentation: Prescription Medicines ReformsTGA Australia
The document summarizes recent and upcoming reforms to Australia's prescription medicine regulations. It discusses the following key points:
1) The launch of the MedSearch app, which allows consumers to access medicine information directly from the Australian Register of Therapeutic Goods.
2) Changes to the format of Product Information documents to highlight important safety and usage details upfront.
3) The introduction of expedited pathways called Priority Review and Provisional Approval to facilitate earlier access to important new medicines.
4) Reforms to the orphan drug program criteria and pathways to incentivize medicines for rare diseases.
5) The upcoming Black Triangle Scheme to more easily identify new medicines and encourage adverse event reporting.
Update on new pv legislation plg june2012danisowich
The document provides an overview and update on new European pharmacovigilance legislation coming into effect in July 2012. It discusses timelines for implementation, introduces the new legislation and its aims, outlines Good Pharmacovigilance Practices including 16 new modules, and summarizes some of the key modules covering pharmacovigilance systems, risk management systems, adverse reaction reporting and periodic safety reports.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
The document discusses the role of the EU Qualified Person for Pharmacovigilance (QPPV). The QPPV must be appropriately qualified, reside in the EEA, and act as a single point of contact for drug safety issues in Europe. The QPPV is responsible for establishing and maintaining the company's pharmacovigilance system, monitoring product safety, submitting regulatory documents, and ensuring compliance with European legislation on safety reporting and risk management. Both the marketing authorization holder and QPPV have overlapping obligations to support pharmacovigilance activities and ensure the safe use of medicinal products in the EU.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Exploring information exchange opportunities between Industry and the TGATGA Australia
The TGA is undertaking a Business Improvement Program to update their systems and processes. As part of this, they are starting an Adverse Event Management project to improve how adverse event reports are collected, processed, and analyzed for medicines, vaccines, and medical devices. They outlined the current reporting systems, volumes and formats, and are seeking industry input on capabilities and needs to help design new reporting formats that meet stakeholder and international standards. Interested parties can register for the project by email.
Presentation: Prescription Medicines ReformsTGA Australia
The document summarizes recent and upcoming reforms to Australia's prescription medicine regulations. It discusses the following key points:
1) The launch of the MedSearch app, which allows consumers to access medicine information directly from the Australian Register of Therapeutic Goods.
2) Changes to the format of Product Information documents to highlight important safety and usage details upfront.
3) The introduction of expedited pathways called Priority Review and Provisional Approval to facilitate earlier access to important new medicines.
4) Reforms to the orphan drug program criteria and pathways to incentivize medicines for rare diseases.
5) The upcoming Black Triangle Scheme to more easily identify new medicines and encourage adverse event reporting.
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides background information on Australia's Therapeutic Goods Advertising legislation and Code. It discusses key aspects of the legislation including:
- The Therapeutic Goods Act and Regulations set advertising requirements for therapeutic goods. Advertising must also comply with the Australian Consumer Law.
- The Act prohibits off-label promotion and requires pre-approval of medicine ads in certain media. It also places restrictions on advertising certain medical conditions.
- The Therapeutic Goods Advertising Code provides the framework for ensuring advertising is conducted properly and does not mislead consumers. It was recently revised to provide more clarity.
- The Code applies broadly to any advertising of therapeutic goods. It exempts genuine news reporting and ads directed to health
This document summarizes the major changes brought about by the new European Union pharmacovigilance legislation. It overviews the goals of improving safety monitoring and decision making. Key changes include new guidelines on pharmacovigilance systems and risk management, the establishment of the Pharmacovigilance Risk Assessment Committee, more stringent reporting rules, and increased transparency including public access to safety information. The legislation aims to modernize the EU pharmacovigilance system and better protect public health.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
TGA presentation: MMDR Consultation - Strengthening monitoring of medicines i...TGA Australia
The document outlines new and enhanced pharmacovigilance activities being implemented by the TGA to strengthen post-market monitoring of medicines in Australia. Key changes include establishing a Pharmacovigilance Inspections Program, implementing a Black Triangle Scheme, monitoring compliance with Risk Management Plans, developing a new Adverse Events Management System, reformatting Product Information, and increasing collaboration with overseas regulators and use of advanced data analytics. The changes aim to ensure the ongoing safety of medicines on the Australian market through improved monitoring and risk mitigation strategies.
Regulatory Reform - Are we heading in the right direction?TGA Australia
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
Presentation: Conformity assessment evidenceTGA Australia
An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.
Online Clinical Trial Notification (CTN)TGA Australia
This presentation provides a brief background on the TGA's role in the regulation of clinical trials as well as guidance on using the new online Clinical Trial Notification form
Building on Drug Safety - the new EU guidelines May 2012Doctors.net.uk
This document discusses new EU regulations that are changing how drug safety is monitored. Key changes include centralized adverse drug reaction reporting, required risk management plans for new drugs, and a new risk assessment committee. The regulations aim to take a more proactive, proportional, and transparent approach to pharmacovigilance to better protect public health. National authorities and the EMA will provide information on company drug safety systems, adverse events, risk minimization plans, and committee decisions.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Presentation: Periodic safety update reportsTGA Australia
The TGA approach to reviewing PSURs (Periodic Safety Update Reports) focuses on evaluating new or emerging safety information to assess the benefit-risk balance of approved medicines. PSUR reviews are prioritized based on risk factors like a product's safety profile and therapeutic importance. If a safety issue is identified that warrants a label change, the PSUR reviewer will recommend an update to the sponsor. Requests may also be made for additional monitoring or analyses in future PSURs. PSUR reviewers collaborate with other TGA departments to enhance post-market vigilance and ensure safety signals are investigated. Sponsors can expect direct communication regarding recommendations from PSUR reviews and are encouraged to submit PSURs using the eCTD format.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
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.
Presentation: The Australian and International landscape - keynote forumTGA Australia
This document summarizes a keynote forum on the Australian and international regulatory landscape presented at the 2017 ARCS Annual Conference. It discusses several topics, including an increasing number of oncology drugs and trials, new pathways for priority and provisional drug approvals in Australia and comparisons to other countries, regulation of biosimilars and orphan drugs, clinical trial complexity, and developments in medical device and software regulation. It also touches on issues of regulatory transparency and uncertainties from Brexit.
“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.”
TGA presentation: Provisional approval pathway for prescription medicinesTGA Australia
This presentation provided an overview of some of the reform activities relevant to prescription, OTC and complementary medicines and implementation of recommendations from the Review of Medicines and Medical Devices Regulation including the content of the consultations on enhancements
The document summarizes pharmacovigilance in Australia. It describes Australia's health care system and spending, the leading causes of illness and death, and key events that led to the establishment of pharmacovigilance guidelines and committees. It provides details on guidelines adopted from the EU and ICH, adverse drug reaction reporting procedures to the TGA and ADRAC, and statistics on reported adverse events.
The document discusses the art element of line. It explains that line can be used in various ways within artwork, including as curvilinear or rectilinear lines, actual or implied lines, contour lines to define shapes, and to express values through techniques like hatching and cross-hatching. Line quality can also be manipulated to convey different emotions, with thick, dark lines expressing heavy moods and thin, fluid lines conveying delicacy. The effective use of line allows artists to create composition and define forms, shadows, and values in both drawings and paintings.
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides background information on Australia's Therapeutic Goods Advertising legislation and Code. It discusses key aspects of the legislation including:
- The Therapeutic Goods Act and Regulations set advertising requirements for therapeutic goods. Advertising must also comply with the Australian Consumer Law.
- The Act prohibits off-label promotion and requires pre-approval of medicine ads in certain media. It also places restrictions on advertising certain medical conditions.
- The Therapeutic Goods Advertising Code provides the framework for ensuring advertising is conducted properly and does not mislead consumers. It was recently revised to provide more clarity.
- The Code applies broadly to any advertising of therapeutic goods. It exempts genuine news reporting and ads directed to health
This document summarizes the major changes brought about by the new European Union pharmacovigilance legislation. It overviews the goals of improving safety monitoring and decision making. Key changes include new guidelines on pharmacovigilance systems and risk management, the establishment of the Pharmacovigilance Risk Assessment Committee, more stringent reporting rules, and increased transparency including public access to safety information. The legislation aims to modernize the EU pharmacovigilance system and better protect public health.
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
TGA presentation: MMDR Consultation - Strengthening monitoring of medicines i...TGA Australia
The document outlines new and enhanced pharmacovigilance activities being implemented by the TGA to strengthen post-market monitoring of medicines in Australia. Key changes include establishing a Pharmacovigilance Inspections Program, implementing a Black Triangle Scheme, monitoring compliance with Risk Management Plans, developing a new Adverse Events Management System, reformatting Product Information, and increasing collaboration with overseas regulators and use of advanced data analytics. The changes aim to ensure the ongoing safety of medicines on the Australian market through improved monitoring and risk mitigation strategies.
Regulatory Reform - Are we heading in the right direction?TGA Australia
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
Presentation: Conformity assessment evidenceTGA Australia
An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.
Online Clinical Trial Notification (CTN)TGA Australia
This presentation provides a brief background on the TGA's role in the regulation of clinical trials as well as guidance on using the new online Clinical Trial Notification form
Building on Drug Safety - the new EU guidelines May 2012Doctors.net.uk
This document discusses new EU regulations that are changing how drug safety is monitored. Key changes include centralized adverse drug reaction reporting, required risk management plans for new drugs, and a new risk assessment committee. The regulations aim to take a more proactive, proportional, and transparent approach to pharmacovigilance to better protect public health. National authorities and the EMA will provide information on company drug safety systems, adverse events, risk minimization plans, and committee decisions.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Presentation: Periodic safety update reportsTGA Australia
The TGA approach to reviewing PSURs (Periodic Safety Update Reports) focuses on evaluating new or emerging safety information to assess the benefit-risk balance of approved medicines. PSUR reviews are prioritized based on risk factors like a product's safety profile and therapeutic importance. If a safety issue is identified that warrants a label change, the PSUR reviewer will recommend an update to the sponsor. Requests may also be made for additional monitoring or analyses in future PSURs. PSUR reviewers collaborate with other TGA departments to enhance post-market vigilance and ensure safety signals are investigated. Sponsors can expect direct communication regarding recommendations from PSUR reviews and are encouraged to submit PSURs using the eCTD format.
Presentation: Spotlight on complementary medicines MMDR reformsTGA Australia
The document discusses reforms to the regulation of complementary medicines in Australia resulting from a 2015 review. It focuses on 5 streams of work: 1) enhancing the listing framework; 2) improving transparency for consumers; 3) increased flexibility for sponsors and improving the evidence base; 4) increased flexibility and predictability for industry; and 5) enhanced post-market monitoring and compliance actions. Key reforms discussed include establishing a permitted indications list, new pathways for assessing medicines, incentives for innovation, and enhanced post-market monitoring.
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.
Presentation: The Australian and International landscape - keynote forumTGA Australia
This document summarizes a keynote forum on the Australian and international regulatory landscape presented at the 2017 ARCS Annual Conference. It discusses several topics, including an increasing number of oncology drugs and trials, new pathways for priority and provisional drug approvals in Australia and comparisons to other countries, regulation of biosimilars and orphan drugs, clinical trial complexity, and developments in medical device and software regulation. It also touches on issues of regulatory transparency and uncertainties from Brexit.
“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.”
TGA presentation: Provisional approval pathway for prescription medicinesTGA Australia
This presentation provided an overview of some of the reform activities relevant to prescription, OTC and complementary medicines and implementation of recommendations from the Review of Medicines and Medical Devices Regulation including the content of the consultations on enhancements
The document summarizes pharmacovigilance in Australia. It describes Australia's health care system and spending, the leading causes of illness and death, and key events that led to the establishment of pharmacovigilance guidelines and committees. It provides details on guidelines adopted from the EU and ICH, adverse drug reaction reporting procedures to the TGA and ADRAC, and statistics on reported adverse events.
The document discusses the art element of line. It explains that line can be used in various ways within artwork, including as curvilinear or rectilinear lines, actual or implied lines, contour lines to define shapes, and to express values through techniques like hatching and cross-hatching. Line quality can also be manipulated to convey different emotions, with thick, dark lines expressing heavy moods and thin, fluid lines conveying delicacy. The effective use of line allows artists to create composition and define forms, shadows, and values in both drawings and paintings.
IBN technologies provides complete Risk & Quantitative Analysis services to their client. Our team consist of highly professionals with more than 8 years of exp
Misura dell'inquinamento luminoso del cielo notturno di Asiago / Measurement ...Anna Vedovato
Study about methods of measurement of the night sky brightness through the analysis of the curve of brightness and systematic and random factors able to change it during the night.
Assessment of the state of light pollution in the sky of Asiago
La región Andina de Colombia es la más poblada y urbanizada del país. Cubre aproximadamente una tercera parte del territorio nacional e incluye departamentos como Cundinamarca, Boyacá, Santander y Antioquia. Su economía se basa en la agricultura, la industria, el textil y otros sectores. La gastronomía andina se caracteriza por platos como el ajiaco, la bandeja paisa y los tamales.
Ringkasan dokumen tersebut adalah:
1. Dokumen tersebut membahas pengaruh pelatihan kecerdasan adversitas terhadap motivasi berprestasi siswa kelas X SMA Negeri 8 Surakarta.
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This document discusses redefining the role of health support services in humanitarian aid and disaster relief operations. It argues that health services units deployed on such missions must be allocated the same rights as maneuver units. Currently, health services units are traditionally employed as combat support under logistics commands with little flexibility. However, during relief efforts their primary mission is dealing with medical issues of civilians, making them key enablers for mission success. The document examines conditions that could allow health services units to serve as maneuver units during disaster relief operations. It proposes adopting a model where health services have more autonomy and flexibility to effectively support humanitarian missions.
This short document promotes creating presentations using Haiku Deck, a tool for making slideshows. It encourages the reader to get started making their own Haiku Deck presentation and sharing it on SlideShare. In just one sentence, it pitches the idea of using Haiku Deck to easily design slideshows.
Hiring a virtual CFO provides 5 key benefits: 1) It saves money compared to a full-time CFO since there are no health or other employee benefits. 2) It offers more flexibility since virtual CFO services can scale up or down as needed. 3) Virtual CFOs can help with transactions and provide financial advice beyond what a busy founder has time for. 4) They have experience dealing with common financial problems and can offer solutions. 5) A virtual CFO provides a fresh outside perspective from working with different companies.
The document discusses several important elements of effective writing, including using sensory detail to help readers experience what is being described, drawing readers in with interesting introductions and conclusions, maintaining a narrowed focus to keep readers engaged without overloading them with details, and using thesis statements and conclusions to inform readers and leave them satisfied.
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Este documento resume los conceptos clave de la administración según diferentes autores como Fayol, Levitt, Drucker y Mintzberg. Explica las definiciones, procesos, funciones, formas de conducta, aspectos, crecimiento y estrategias de las organizaciones. También describe las etapas de evolución de las organizaciones y las ideas de autores pioneros como Taylor y Fayol sobre la administración científica y sus principios.
The document discusses the harmful effects of smoking and alcohol addiction. It notes that tobacco contains over 4,000 chemicals, including tar, nicotine, carbon monoxide and other toxic substances. Smoking is linked to numerous cancers and respiratory, cardiovascular and reproductive illnesses. The document also discusses how alcoholism is a disease influenced by genetics and psychiatric issues. Teenage drinking is especially dangerous as it can impact brain development and learning. Both smoking and alcohol abuse financially and emotionally damage families.
1. Dokumen tersebut membahas tentang aktivitas ibadah pada malam Ramadhan mulai dari doa, solat sunat, membaca Al-Quran, istighfar, tasbih, hingga berdoa.
2. Termasuk jenis-jenis solat sunat seperti Tahajjud, Hajat, Taubat, Tasbih, Lailatul Qadar, dan Witir beserta tata cara pelaksanaannya.
3. Dibahas pula doa-doa yang dibaca setelah solat sunat se
This document provides an overview of Volume 9A which contains guidelines for pharmacovigilance of medicinal products for human use in the EU. It defines pharmacovigilance and describes the roles and responsibilities of marketing authorization holders, competent authorities, and the EMA. Key aspects covered include pharmacovigilance systems, signal detection, safety reporting, risk management plans, and safety communication.
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.
Common arab guidelines in pharmacovigilanceNahla Amin
The document outlines guidelines for good pharmacovigilance practices for Arab countries. It discusses 10 modules that cover key aspects of pharmacovigilance systems including quality systems, the pharmacovigilance system master file, inspections, audits, risk management, safety reporting and communication. The guidelines were developed by the Arab League to harmonize pharmacovigilance standards across countries in the region based largely on European Union guidelines. The guidelines aim to help national regulatory authorities ensure marketing authorization holders have appropriate systems, processes and resources for pharmacovigilance obligations.
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.
The document discusses pharmacovigilance in Australia. It notes that Australia spends over $121 billion annually on health care, accounting for 9.4% of total economic spending. The Therapeutic Goods Administration regulates medicines and vaccines in Australia. Adverse drug reactions are monitored through spontaneous reporting to the Australian Adverse Drug Reactions Advisory Committee, which medical experts review. Over 10,000 reports are received annually, mostly involving prescription medicines. Pharmacovigilance guidelines provide requirements for risk management plans and adverse event reporting. Education initiatives aim to increase reporting by health professionals.
The document discusses proposed expedited pathways for prescription medicines in Australia, including a Priority Review pathway. It outlines proposed eligibility criteria focusing on serious conditions with unmet needs where the medicine provides a major therapeutic advantage.
A draft designation process is presented involving assessment of eligibility criteria within 6-8 weeks. Designations would lapse if no registration submission is made within 3 months. Appeals of designation decisions are proposed.
Priority Review is aimed to complete assessments in 150 working days through flexible business processes and expert advice. Provisional Approval could grant earlier conditional registration based on early safety and efficacy data, with enhanced post-market monitoring required. Public consultation on
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
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.
The world of Regulatory convergence: an Australian reflectionTGA Australia
This presentation provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods.
Pharmacovigilance - a regulator's perspectiveTGA Australia
The document discusses pharmacovigilance from the perspective of the Therapeutic Goods Administration (TGA) in Australia. It provides an overview of the TGA's pharmacovigilance activities, including pre-market risk management plans and post-market adverse event reporting and signal detection. It describes how the TGA monitors the safety of medicines throughout their lifecycle to identify new or unknown risks following approval.
DADA Consultancy B.V. is a premier consulting agency based in Nijmegen, Netherlands that has provided regulatory affairs and pharmacovigilance services since 1984. They focus on establishing long-term partnerships with international clients. Their services include full regulatory support and pharmacovigilance activities like safety signal detection, monitoring safety issues, and preparing reports for health authorities. As experts in communicating with health authorities, their goal is to ensure products' safety profiles are properly managed to maintain marketing authorization.
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
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The document provides an agenda for the Rephine Symposium 2018 on Good Distribution Practices. The morning session includes presentations on updates from Rephine, the GDP regulatory framework, and regulatory inspections. The afternoon includes a presentation on auditing of intermediates and an open discussion on audit case studies. A brief history of Rephine is given showing its expansion from consultancy to include regulatory affairs, clinical practice, and sourcing services. The document outlines Rephine's services in GMP, GDP, clinical practice, and sourcing.
201 regulatory aspects of drug and cosmetics .pdfBhavikaAPatel
regulatory aspects of drug and cosmetics
1. Regulatory Requirements for Registration of Drugs & Post Approval Requirements in WHO through Prequalification Program
2. FDA ORGANIZATION CHART
3. Marketing Authorization of EU for APPLICATION PROCEDURES
4. Global Countries Classification
5. Organization and structure of EMA&EDQMActive substance Master files IMPD
6. DRUG MASTER FILE in USA
ICH pharmacovigilance planning, an efficacy guidelinebibilicavesela
This document provides guidance for developing a pharmacovigilance plan, including a safety specification and action plan. It recommends summarizing important identified risks, potential risks, and missing safety information. The safety specification would then be used to develop a pharmacovigilance plan outlining routine monitoring and specific actions to address safety issues. Milestones should be set to evaluate safety results on a defined schedule. A variety of observational study methods are available to investigate particular safety concerns depending on the product, population, and type of risk being examined.
PV modules are documents that specify requirements for pharmacovigilance (PV) in the European Union. They cover PV systems, quality systems, inspections, audits, risk management, adverse reaction reporting and management, and periodic safety update reports. Companies with marketing authorization in the EU must comply with these modules to maintain their authorization and avoid financial penalties for noncompliance. The modules are continuously updated to improve patient safety monitoring of medical products in the EU.
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.
Similar to Changes in European PV post July 2011 (20)
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Changes in European PV post July 2011
1.
2. PHARMACOVIGILANCE
• The process and science of monitoring the safety of medicines and taking action to reduce the
risks and increase the benefits of medicines.
• All medicinal products in the EU are subject to a strict testing and assessment of their quality,
efficacy and safety before being authorised. Once placed on the market they continue to be
monitored so to assure that any aspect which could impact the safety profile of a medicine is
detected and assessed and that necessary measures are taken. This monitoring is called
pharmacovigilance.
• Pharmacovigilance activities include:
• Collecting and managing data on the safety of medicines.
• Looking at the data to detect 'signals' (any new or changing safety issue).
• Evaluating the data and making decisions with regard to safety issues.
• Pro-active risk management to minimise any potential risk associated with the use of the
medicine.
• Acting to protect public health (including regulatory action).
• Communicating with and informing stakeholders and the public.
• Audit, both of the outcomes of action taken and of the key processes involved.
3. EUROPEAN UNION
• A politico-economic union of 28 member
states that are located primarily in Europe.
• European Free Trade Association (EFTA):
Iceland, Liechtenstein and Norway.
• European Economic Area (EEA) countries.
6. EARLY CHALLENGES
• Increased demands requiring resources.
• Potential differences and conflicts in pharmacovigilance requirements across different
Health Authorities.
• A need to change to a new way of thinking about pharmacovigilance with a patient
centred approach and greater transparency.
7. KEY DATES
• The rules within the Regulation will apply from 2 July 2012, and the
provisions of the Directive will apply from 12 July 2012.
• Member States must transpose the provisions of the Directive into their
national laws by October 2013.
• The Commission must report to the Parliament and Council on the
shortcomings of package leaflet and summary of products by January
2013.
• The Member States have to do an audit of their pharmacovigilance
system and provide a report to the Commission by September 2013 at the
latest.
• The Commission will publish a report on the performance of
pharmacovigilance tasks by the Member States by 21 July 2015, and
thereafter every 3 years.
8. AIMS
• Improve the EU-PV system.
• Simplify regulatory decision making.
• Provide a legal basis for proactive Pharmacovigilance.
• Involve patients more closely in the reporting of ADRs.
• Overall Objective: “To protect public health”
9. THE NEW EUROPEAN PHARMACOVIGILANCE
LEGISLATION
“This new public health legislation is far reaching in scope and depth and
goes far beyond any narrow concept of pharmacovigilance.”
- European Medicines Agency, “Planning for the Implementation of the New Legislation on Pharmacovigilance” (31 January 2011)
12. MAJOR/KEY CHANGES
1. The new Good Vigilance Practice Guidelines (GVP).
2. The Pharmacovigilance Risk Assessment Committee (PRAC).
3. The Pharmacovigilance System Master File (PSMF).
4. Using a Periodic Benefit Risk Evaluation Report (PBRER).
5. More stringent ICSR submission rules.
6. Publishing summaries of Risk Management Plans (RMP).
7. Requirement to perform Post-Approval Safety Studies (PASS).
8. Assignment of an Additional Monitoring Status.
9. Commitment to openness and transparency.
10. Eudravigilance policy to disclose post marketing safety information to the
Public.
13. 1. Good Pharmacovigilance Guidelines(GVP):
• Replaces Eudralex Volume 9A.
• set of measures drawn up to facilitate the performance of pharmacovigilance in the EU.
• Applies to all medicinal products, irrespective of the MA granting procedure.
• Divided into 16 modules.
• Uses MedDRA terminology.
14. GVP (@) TITLE STATUS Release Date
MODULE I Pharmacovigilance Systems and their Quality Systems Final Jun 2012
MODULE II Pharmacovigilance System Master File Final. Rev.1 Apr 2013
MODULE III Pharmacovigilance Inspections Final Dec 2012
MODULE IV Audits Final Dec 2012
MODULE V Risk Management Systems Final Jun 2012
MODULE VI Management and Reporting of Adverse Reactions to Medicinal Products Final / (Rev.1- Draft) Jun 2012 / (Jun 2013)
MODULE VII Periodic Safety Update Reports Final Rev.1 Dec 2013
MODULE VIII Post-Authorization Safety Studies Final Rev.1 Apr 2013
Annex to Module VIII Member States' requirements for transmission of information on non-interventional PASS Final Rev.1 Apr 2013
MODULE IX Signal Management Final Jun 2012
MODULE X Additional Monitoring Final Apr 2013
MODULE XI Public Participation in Pharmacovigilance PC Planned Q2 2014
MODULE XII Continuous PV, Ongoing Benefit-Risk Evaluation, Regulatory Action & Planning of Public Communication PC Planned Q2 2014
MODULE XIIICancelled Incident Management - All topics originally intended covered in this module to be included in XII. NA
MODULE XIV International cooperation PC planned Q2 2014
MODULE XV Safety Communication Final Jan 2013
MODULE XVI Risk-minimization measures: selection of tools and effectiveness indicators Final Feb 2014
ANNEX I Definitions Final Rev.2 Jan 2014
ANNEX II Templates: Direct Healthcare Professional Communication (DHPC) Final Jan 2013
ANNEX II Templates: Cover page of periodic safety update report (PSUR) Rev.1 Final Apr 2013
ANNEX III Other Guidance Documents
ANNEX IV ICH Guidelines for pharmacovigilance
ANNEX V Abréviations Final Apr 2013
P. I Vaccines for prophylaxis against infectious diseases Final Dec 2013
P. II Biological medicinal products PC Planned Q2 014
15. 2. Pharmacovigilance Risk Assessment Advisory
Committee (PRAC):
• A new EMA committee-meets monthly from September 2012.
• Replaces the Pharmacovigilance Working Party.
• Advises to CHMP and CMDh.
• Members include (appointed by MS and EC) :
• Experts from the EU Member States.
• Representatives from Patient organizations.
• Representatives from Healthcare professionals.
• responsible for assessing all aspects of the risk management of the use of medicinal products
[human use] approved in EEA.
• responsible for the design and evaluation of post-authorisation safety studies and
pharmacovigilance audit.
16.
17. 3. Pharmacovigilance System Master File (PSMF)
• PSMF replaces DDPS.
• A legal requirement-document describing the company’s PV system.
• Presents the management organization of the Company PV system from a corporate perspective
including its affiliated entities in respect of the applicable regulatory requirements.
• Includes additional descriptions process (RMP, Safety, commitments,etc.) and figures pertaining to the
company portfolio, and results from system audits and Key Performance Indicators.
• Tool for QPPV to maintain oversight with the Pharmacovigilance System in the company.
• MA applicants and MAHs are required to maintain PSMF.
• To be provided within 7 days upon request by the EMA.
• The Pharmacovigilance System Summary comprises of:
• a signed statement.
• the location of PSMF.
• the name and contact details of the QPPV.
• the Member States in which the QPPV resides and operates.
• proof that the applicant has a QPPV.
18. 4. Periodic Benefit Risk Evaluation Report (PBRER)
• Replaces Periodic Safety Update Report (PSUR).
• Scope changed from interval safety analysis to benefit-risk evaluation.
• Includes a Benefit versus Risk statement.
• New evaluation sections, including a section to give an overview on signals (tabulated as
new, ongoing or closed).
• Interval listings no longer required.
• Deletion of the chapter “Analysis of individual case histories”.
• Not required for generic products, well-established use products, homoeopathic products
and traditional herbal products.
• Six-monthly reports, summary bridging reports, or addendum reports will not be
accepted.
• Time interval between data-lock point and submission – expanded.
• New assessment procedure involving PRAC.
• Assessment will lead to automatic regulatory action (i.e, variation, suspension or
revocation).
• Assessment reports of PSURs will be published on a European medicines web portal.
19. 5. Individual Case Safety Report (ICSR):
• Direct patient reporting.
• New Reporting arrangements:
• All EU and non-EU Serious ADRs to Eudravigilance (EV) only within 15 days , including
consumer reports.
• All EU non-serious reports to EV only within 90 days.
• EV database is the single point of receipt for expedited reports-until EMA can “ensure the
functionalities of EV“ (not before 2015) - Transitional arrangements.
• Requirement to submit non-serious ICSRs is extended to cases reported from Post-
authorization solicited settings such as:
• Post-Authorisation Safety Studies (PASS).
• Post-Authorisation Efficacy Studies (PAES).
• Non-Interventional Studies (NIS).
• Patient Support Program (PSP).
• Market Research Studies (MRS).
• Literature monitoring (starting 2015).
20.
21. 6. Risk Management Plan (RMP):
• The RMP will include
• a summary of the efficacy of the product.
• an evaluation of the effectiveness of risk minimization measures.
• PRAC will have regulatory oversight of RMPs.
• PRAC will appoint a rapporteur for an individual RMP, who will work with the (co-) rapporteur
appointed by CHMP.
• Summaries of RMPs shall be made publicly available via web portals.
• Educational materials for health professionals and patients are required in RMP for a new
product.
• UK version must be submitted to the MHRA prior to issue.
• MA application (after 21 July 2012) are required to submit a RMP.
• Includes generic MA applications also.
• Should be submitted in template for the EU-RMP.
• For MAs granted before 21 July 2012 without an existing RMP - no obligation to submit a
RMP (unless concerns arise).
22. 7. Post-Authorization Safety Study (PASS):
• Performing a PASS/PAES(Post-Authorisation Efficacy Studies) may be required at first authorisation as
well as post-authorisation.
• The Competent Authority may impose an obligation on the MAH to conduct such a study.
• If the same safety concern applies to more than one product a joined PASS may be advised.
• New information detected during such studies shall be communicated to the competent authority.
• Proposed format and content of study protocols/reports. (outlined in GVP module VIII).
• If a PASS is condition of MA, must be described in RMP and results included in next PSUR.
23. 8. Additional monitoring list:
• The Additional Monitoring Status can be assigned at any time of
the product life cycle.
• Subjected to more intense scrutiny (same as UK’s ‘Black Triangle’
list).
• New medicines and vaccines that are under additional monitoring
have an inverted black triangle symbol (▼) displayed in their
package leaflet and summary of product characteristic, together
with a short sentence explaining what the triangle means – it does
not mean the medicine is unsafe. You should report all suspected
ADRs for these products.
• EU-wide list (published by EMA) will replace the Black Triangle list
previously published by the MHRA.
• MAHs can remove Black Triangle status without contacting the
MHRA. (for products that are not listed on additional monitoring
list).
24. 9. Openness and transparency:
• Provides the public with information about
• The safety of marketed medicines.
• How to report suspected ADRs.
• If MAHs want to make a public announcement, they shall inform the NCA, the EMA and
the EC.
• Two important changes:
• EU public hearings.
• Creation of medicines web portals-Extended EudraVigilance Medicinal Product
Dictionary(xEVMPD).
• Setup of interconnected web-portals:
• European medicines web-portal (www.ema.europa.eu) maintained by the EMA.
• Will be linked to national web-portals.
• Alternative reporting media remains available.
25. 10. EudraVigilance Access Policy:
• ICSRs are expected to be submitted by MAHs directly to EudraVigilance rather
than via National Health Authorities.
• Formerly, only Member State HA, the EMA and the European Commission had
access to EudraVigilance.
• The EudraVigilance access policy is changed to allow HCPs, patients and
consumers, as well as MAH and research organisations accessing the
information.
26. ADR REPORTING/SIGNAL MANAGEMENT
• Centralized reporting-by industry to the Eudravigilance database at EMA.
• Inclusion of reports from patients as valid, reportable ADRs.
• Only medication errors that result in a serious ADR should be submitted.
• Non-serious cases should not be reported to EudraVigilance during the transitional
period.
• Sending non-EU serious consumer reports by the company is not mandatory.
• MAHs will also be required to monitor the Eudravigilance database according to their
level of access.
• Signals should follow a process of validation, prioritization and assessment.
27. AUDIT/INSPECTION
• PSMF should be made available to the NCA upon request.
• Changes to PSMF will not be automatically notifiable to the Competent Authorities.
• Transitional period for introduction of PSMF ends in July 2015.
• Quality Systems:
• MAHs, NCAs and the EMA will be required to have a quality system in place.
• Particularly for resource management, staff training, procedural documentation, quality
control, monitoring, and improvement.
• Inspections:
• Harmonization of inspection activities in the EU.
• Legal basis for the conduct of pre-authorisation inspections.
• Adequate pharmacovigilance system as a condition of MA.
• MA applicants should be aware that the PSMF may be requested.
• For centrally authorised products, the Supervisory Authority will be determined by the PSMF
location.
• MHRA will continue to operate a risk-based inspection programme.
28. MAIN PILLARS OF NEW LEGISLATION
• Proactive and proportionate risk management.
• Higher quality of safety data.
• Stronger link between safety assessments and regulatory action.
• Strengthened transparency, communication and patient involvement.
• Clear tasks and responsibilities for all parties (marketing authorisation holders, competent authorities,
EMA).
• Improved EU decision-making procedures (harmonised decisions and efficient use of resources).
• Establishment of a new scientific committee at the European Medicines Agency:
The Pharmacovigilance Risk Assessment Committee.
29. CONCLUSION
• New legislation:
• Provides strong legal basis for use of MedDRA through all steps of the
pharmacovigilance process
• Major change project that will take a few years to fully implement.
• Provides an opportunity to greatly improve the European system for the
benefit of public health.
30. REFERENCES
• http://ec.europa.eu.
• http://www.emea.europa.eu.
• Update on the New Pharmacovigilance Legislation by Product Life Group,
Consulting and operational assistance for Life Sciences.
• Experiences with Adverse Drug Reaction Reporting by Patients-An 11 Country
Survey by Florence van Hunsel,Linda Ha¨rmark,Shanthi Pal, Sten Olsson and Kees
van Grootheest; Drug Saf 2012; 35 (1).
• Appendix 4: The new pharmacovigilance legislation in the EU, Pharmacovigilance
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