Pharmacovigilance Interview Questions Part 2
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Building upon the foundational knowledge established in Part 1, 'Advancing in Pharmacovigilance: Part 2 Insights' delves deeper into the intricacies of drug safety. This segment takes a focused approach toward advanced concepts within the field, shedding light on critical aspects such as signal detection and management, risk assessment, and proactive risk management strategies. Participants in this journey will gain a more nuanced understanding of how pharmacovigilance goes beyond mere surveillance, actively engaging with emerging drug safety issues. From exploring innovative methodologies to tackle complex adverse events to understanding the critical role of real-world evidence, Part 2 serves as a bridge connecting the basics to the more sophisticated realms of pharmacovigilance. As we navigate through this advanced exploration, the audience is empowered with the knowledge needed to navigate the evolving landscape of drug safety, setting the stage for the broader perspectives and global considerations that await in subsequent installments of this comprehensive series.
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Series of interview Questions
Pharmacovigilance (PV) plays a crucial role in ensuring the safety of drugs and monitoring their adverse effects. During an interview for a pharmacovigilance position or a related role, you may come across questions about the uses and importance of pharmacovigilance. Here are some potential interview questions related to the uses of pharmacovigilance
Ich guidelines Seminar ( Efficacy & Multidisciplinary)
The International Conference on Harmonisation (ICH) brings together regulators and industry representatives from the European Union, Japan, and the United States to discuss scientific and technical aspects of pharmaceutical product registration. The goal of ICH is to promote international harmonization of technical requirements through the development of common guidelines. ICH guidelines cover various topics including quality, safety, efficacy, and multidisciplinary issues. The guidelines provide recommendations on nonclinical studies, clinical trial design and analysis, and the format and content of registration documents to harmonize the technical requirements for pharmaceuticals across ICH regions.
NDA.pptx
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
NDA.pptx
The document provides an overview of the New Drug Application (NDA) process. It discusses that an NDA is required for approval to market a new drug in the US. The goals of an NDA are to demonstrate a drug's safety, efficacy, appropriate labeling, and quality manufacturing. An NDA contains extensive data from non-clinical and clinical trials. It follows a common technical document format and is reviewed by the FDA to determine if the drug's benefits outweigh the risks for approval.
Planning for the New Individual Case Safety Report (ICSR) International Stand...
This document summarizes a presentation about upcoming changes to the standards for reporting individual case safety reports (ICSRs) and identifying medicinal products. Key points include: 1) New IDMP standards will be introduced to uniquely identify products, substances, and other attributes. 2) A new ICSR format called E2B(R3) will improve reporting quality and allow attachments. 3) Implementation guides for E2B(R3) are being finalized by international and European regulators. 4) Software vendors expect to support the new standards in upcoming versions beginning in 2013. Attendees are advised to upgrade safety reporting systems and plan for electronic reporting changes.
Regulatory affairs-Introduction to CTD
Regulatory affairs is the bridge between pharmaceutical companies and government regulatory agencies. It involves all activities related to drugs, including research, clinical trials, manufacturing, registration, distribution, pricing, advertising, and post-marketing surveillance. Regulatory dossiers contain all required technical data and documentation needed to obtain approval to market a drug in a given country or region. Common formats include the Common Technical Document for Europe, US, and other markets and Form 44 for India. Compliance with good practices and local regulations is essential for regulatory approval.
CTD (common technical document)
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
ICH guidelines
The document discusses the International Conference on Harmonization (ICH), an international body that aims to harmonize technical requirements for pharmaceutical product registration. ICH seeks to eliminate unnecessary duplication in drug development studies required by different regions, make more efficient use of resources, and ensure timely access to new medicines for patients. The document outlines ICH's structure and working groups focused on quality, safety, efficacy, and multidisciplinary topics. Guidelines produced by ICH provide a common technical framework to help regulators and industry agree on specifications, test procedures and acceptance criteria for drugs.
Recommended
Series of interview Questions
Pharmacovigilance (PV) plays a crucial role in ensuring the safety of drugs and monitoring their adverse effects. During an interview for a pharmacovigilance position or a related role, you may come across questions about the uses and importance of pharmacovigilance. Here are some potential interview questions related to the uses of pharmacovigilance
Ich guidelines Seminar ( Efficacy & Multidisciplinary)
The International Conference on Harmonisation (ICH) brings together regulators and industry representatives from the European Union, Japan, and the United States to discuss scientific and technical aspects of pharmaceutical product registration. The goal of ICH is to promote international harmonization of technical requirements through the development of common guidelines. ICH guidelines cover various topics including quality, safety, efficacy, and multidisciplinary issues. The guidelines provide recommendations on nonclinical studies, clinical trial design and analysis, and the format and content of registration documents to harmonize the technical requirements for pharmaceuticals across ICH regions.
NDA.pptx
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
NDA.pptx
The document provides an overview of the New Drug Application (NDA) process. It discusses that an NDA is required for approval to market a new drug in the US. The goals of an NDA are to demonstrate a drug's safety, efficacy, appropriate labeling, and quality manufacturing. An NDA contains extensive data from non-clinical and clinical trials. It follows a common technical document format and is reviewed by the FDA to determine if the drug's benefits outweigh the risks for approval.
Planning for the New Individual Case Safety Report (ICSR) International Stand...
This document summarizes a presentation about upcoming changes to the standards for reporting individual case safety reports (ICSRs) and identifying medicinal products. Key points include: 1) New IDMP standards will be introduced to uniquely identify products, substances, and other attributes. 2) A new ICSR format called E2B(R3) will improve reporting quality and allow attachments. 3) Implementation guides for E2B(R3) are being finalized by international and European regulators. 4) Software vendors expect to support the new standards in upcoming versions beginning in 2013. Attendees are advised to upgrade safety reporting systems and plan for electronic reporting changes.
Regulatory affairs-Introduction to CTD
Regulatory affairs is the bridge between pharmaceutical companies and government regulatory agencies. It involves all activities related to drugs, including research, clinical trials, manufacturing, registration, distribution, pricing, advertising, and post-marketing surveillance. Regulatory dossiers contain all required technical data and documentation needed to obtain approval to market a drug in a given country or region. Common formats include the Common Technical Document for Europe, US, and other markets and Form 44 for India. Compliance with good practices and local regulations is essential for regulatory approval.
CTD (common technical document)
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
ICH guidelines
The document discusses the International Conference on Harmonization (ICH), an international body that aims to harmonize technical requirements for pharmaceutical product registration. ICH seeks to eliminate unnecessary duplication in drug development studies required by different regions, make more efficient use of resources, and ensure timely access to new medicines for patients. The document outlines ICH's structure and working groups focused on quality, safety, efficacy, and multidisciplinary topics. Guidelines produced by ICH provide a common technical framework to help regulators and industry agree on specifications, test procedures and acceptance criteria for drugs.
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
Specifically, you will learn:
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Pharmacovigilance Interview Questions Part 4
In the final installment of our exploration, 'Future Trends and Innovations in Pharmacovigilance: Part 4' propels us into the forefront of drug safety, where innovation and technology intersect to shape the future landscape. This segment delves into the cutting-edge advancements and emerging technologies that are revolutionizing pharmacovigilance practices. From Artificial Intelligence-driven analytics for proactive risk assessment to the integration of blockchain for enhanced data security, participants will gain a glimpse into the transformative trends steering the future of drug safety. 'Part 4' also examines the evolving role of pharmacovigilance in the era of personalized medicine, exploring how individualized treatments impact adverse event reporting and analysis. As we navigate through this futuristic chapter, the audience is invited to envision the evolving role of pharmacovigilance in healthcare, embracing the innovations that promise to redefine the way we monitor and ensure the safety of pharmaceutical products in the years to come.
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This document provides an introduction and overview of MedDRA, the medical terminology used for medical coding in the pharmaceutical industry. It discusses the history and development of MedDRA, which originated from the need for a single, standardized terminology to classify medical information for regulatory purposes. The document outlines the requirements for MedDRA, how it addresses issues with prior terminologies, and its scope and uses in clinical research and by regulatory authorities. It also provides examples of the structural elements of MedDRA and how it has been expanded over multiple versions to include more terms and enhance functionality.
guidelines-150703103126-lva1-app6891.pdf
This document provides an overview of pharmacovigilance and International Council for Harmonisation (ICH) guidelines related to pharmacovigilance. It defines key terms like adverse events, adverse drug reactions, and serious adverse events. It also summarizes several ICH guidelines that provide recommendations for clinical safety data management, expedited reporting, periodic benefit-risk evaluation reports, and pharmacovigilance planning over the lifecycle of a drug. The document outlines guidelines for good clinical practice, clinical trials in special populations like pediatrics, and evaluation of new drugs like antihypertensives and those affecting the QT interval.
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This document summarizes guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regarding pharmacovigilance and clinical drug development. It defines key terms like adverse events and serious adverse events. It also provides overviews of ICH guidelines on topics like safety reporting standards, post-approval safety data management, risk-benefit analysis, clinical study design and conduct, and special populations like pediatrics. The document aims to aid understanding of ICH guidelines for pharmacovigilance and clinical evaluation of pharmaceutical products.
mHealth Summit EU 2015
This document discusses the process for bringing a mobile health application to market as a medical device in the European Union. It covers determining if the app meets the definition of a medical device, classifying the device, complying with applicable directives and standards, establishing a quality management system, and obtaining CE marking. The challenges of navigating this regulatory process for an existing app already in app stores are also addressed.
Registration of Indian Drug Product in Overseas Market.pptx
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
ICH_Public_Mtg._Montreal_2017-converted.pptx
This document provides an agenda and overview for an International Council for Harmonisation meeting between the USFDA, Health Canada, and other parties. The agenda covers topics on quality, efficacy, safety, and electronic standards currently being discussed by ICH working groups. It also describes the ICH process and recent reforms, including the establishment of a non-profit association to focus global pharmaceutical regulatory harmonization.
How to Comply with IDMP Regulatory Requirements
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
13 Medical Device Single Audit Program (MDSAP) Working Group.pdf
The document discusses the International Medical Device Regulators Forum (IMDRF) and its Medical Device Single Audit Program (MDSAP) Working Group. The IMDRF aims to strategically accelerate international regulatory convergence for medical devices. The MDSAP Working Group is developing a standard set of requirements for auditing organizations to conduct single audits of medical device manufacturers' quality systems. This involves creating recognition criteria for auditing organizations based on standards from ISO, the EU, Health Canada, Japan, the US FDA and others. The goal is to establish a single audit program to improve regulatory convergence.
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The document discusses pharmaceutical regulatory and healthcare laws in Pakistan. It outlines several key organizations that regulate the pharmaceutical industry, including the Drug Regulatory Authority of Pakistan (DRAP). It also summarizes various federal and provincial regulations related to drugs, healthcare facilities, and medical devices. Finally, it provides an overview of international pharmaceutical guidelines from organizations like the International Council for Harmonisation (ICH).
ICH.pdf
The document discusses the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It summarizes that ICH is unique in bringing together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration and develop harmonized guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration globally to help ensure safe, effective and high-quality medicines are developed and registered efficiently. It outlines ICH's structure and processes for developing guidelines through working groups and regulatory and industry members.
Clinical Evaluation Report.pdf
We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
https://mavenprofserv.com/clinical-evaluation-report/
ICH Guidelines for Pharmacovigilance.pptx
Serious and unexpected AEs: FDA recommends report to be submitted within 15 days
Follow up - Up to 15 days alert reports should be
submitted within 15 days
cmc [ chemistry manufacturing control ]
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regulatory Affairs role in Pharmaceutical Industry
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
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The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
ICH GUIDELINES MULTIDISCIPLINARY
The document discusses the International Conference on Harmonisation (ICH), which brings together regulatory authorities and pharmaceutical experts from Europe, Japan, and the US to discuss product registration. ICH topics are divided into four categories: quality, safety, efficacy, and multidisciplinary. Several multidisciplinary topics are then summarized, including M1 (MedDRA terminology), M2 (electronic standards), M3 (non-clinical safety studies), M4 (common technical document), M7 (mutagenic impurities), M8 (electronic common technical document), M9 (BCS-based biowaivers), and M10 (bioanalytical method validation).
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While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
ICH GUIDELINES.pptx
The document provides information on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize technical requirements for drug registration among countries in Europe, Japan, and the United States. It seeks to increase international harmonization, ensure safety and efficacy of medicines, and develop pharmaceuticals efficiently. The ICH provides guidelines on drug quality, efficacy, and safety. It covers topics like stability testing, analytical validation, impurities, biotechnology products, specifications, good manufacturing practices, quality risk management, and quality systems.
Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
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Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.
The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.
So what exactly are the implications of all these changes for device manufactures?
How does this affect your CERs?
How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).
Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.
(You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4)
Specifically, you will learn:
What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
What are some of the most significant changes? (There are a lot of them)
How does it align with the changes to the new EU MDR?
In what ways will demonstrating “equivalence” now be harder?
How often you must update your CERs now and what qualifications the evaluators must have?
How should you prepare for the increased notified body scrutiny?
How do you perform a clinical literature review to meet the new expectations?
Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Pharmacovigilance Interview Questions Part 4
In the final installment of our exploration, 'Future Trends and Innovations in Pharmacovigilance: Part 4' propels us into the forefront of drug safety, where innovation and technology intersect to shape the future landscape. This segment delves into the cutting-edge advancements and emerging technologies that are revolutionizing pharmacovigilance practices. From Artificial Intelligence-driven analytics for proactive risk assessment to the integration of blockchain for enhanced data security, participants will gain a glimpse into the transformative trends steering the future of drug safety. 'Part 4' also examines the evolving role of pharmacovigilance in the era of personalized medicine, exploring how individualized treatments impact adverse event reporting and analysis. As we navigate through this futuristic chapter, the audience is invited to envision the evolving role of pharmacovigilance in healthcare, embracing the innovations that promise to redefine the way we monitor and ensure the safety of pharmaceutical products in the years to come.
Med dra Basics
This document provides an introduction and overview of MedDRA, the medical terminology used for medical coding in the pharmaceutical industry. It discusses the history and development of MedDRA, which originated from the need for a single, standardized terminology to classify medical information for regulatory purposes. The document outlines the requirements for MedDRA, how it addresses issues with prior terminologies, and its scope and uses in clinical research and by regulatory authorities. It also provides examples of the structural elements of MedDRA and how it has been expanded over multiple versions to include more terms and enhance functionality.
guidelines-150703103126-lva1-app6891.pdf
This document provides an overview of pharmacovigilance and International Council for Harmonisation (ICH) guidelines related to pharmacovigilance. It defines key terms like adverse events, adverse drug reactions, and serious adverse events. It also summarizes several ICH guidelines that provide recommendations for clinical safety data management, expedited reporting, periodic benefit-risk evaluation reports, and pharmacovigilance planning over the lifecycle of a drug. The document outlines guidelines for good clinical practice, clinical trials in special populations like pediatrics, and evaluation of new drugs like antihypertensives and those affecting the QT interval.
Pharmacovigilance and ICH guidlines
This document summarizes guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regarding pharmacovigilance and clinical drug development. It defines key terms like adverse events and serious adverse events. It also provides overviews of ICH guidelines on topics like safety reporting standards, post-approval safety data management, risk-benefit analysis, clinical study design and conduct, and special populations like pediatrics. The document aims to aid understanding of ICH guidelines for pharmacovigilance and clinical evaluation of pharmaceutical products.
mHealth Summit EU 2015
This document discusses the process for bringing a mobile health application to market as a medical device in the European Union. It covers determining if the app meets the definition of a medical device, classifying the device, complying with applicable directives and standards, establishing a quality management system, and obtaining CE marking. The challenges of navigating this regulatory process for an existing app already in app stores are also addressed.
Registration of Indian Drug Product in Overseas Market.pptx
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
ICH_Public_Mtg._Montreal_2017-converted.pptx
This document provides an agenda and overview for an International Council for Harmonisation meeting between the USFDA, Health Canada, and other parties. The agenda covers topics on quality, efficacy, safety, and electronic standards currently being discussed by ICH working groups. It also describes the ICH process and recent reforms, including the establishment of a non-profit association to focus global pharmaceutical regulatory harmonization.
How to Comply with IDMP Regulatory Requirements
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
13 Medical Device Single Audit Program (MDSAP) Working Group.pdf
The document discusses the International Medical Device Regulators Forum (IMDRF) and its Medical Device Single Audit Program (MDSAP) Working Group. The IMDRF aims to strategically accelerate international regulatory convergence for medical devices. The MDSAP Working Group is developing a standard set of requirements for auditing organizations to conduct single audits of medical device manufacturers' quality systems. This involves creating recognition criteria for auditing organizations based on standards from ISO, the EU, Health Canada, Japan, the US FDA and others. The goal is to establish a single audit program to improve regulatory convergence.
Pharmaceutical regulatory & healthcare laws
The document discusses pharmaceutical regulatory and healthcare laws in Pakistan. It outlines several key organizations that regulate the pharmaceutical industry, including the Drug Regulatory Authority of Pakistan (DRAP). It also summarizes various federal and provincial regulations related to drugs, healthcare facilities, and medical devices. Finally, it provides an overview of international pharmaceutical guidelines from organizations like the International Council for Harmonisation (ICH).
ICH.pdf
The document discusses the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It summarizes that ICH is unique in bringing together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration and develop harmonized guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration globally to help ensure safe, effective and high-quality medicines are developed and registered efficiently. It outlines ICH's structure and processes for developing guidelines through working groups and regulatory and industry members.
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We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
https://mavenprofserv.com/clinical-evaluation-report/
ICH Guidelines for Pharmacovigilance.pptx
Serious and unexpected AEs: FDA recommends report to be submitted within 15 days
Follow up - Up to 15 days alert reports should be
submitted within 15 days
cmc [ chemistry manufacturing control ]
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regulatory Affairs role in Pharmaceutical Industry
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
MDSAP Presentation
The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
ICH GUIDELINES MULTIDISCIPLINARY
The document discusses the International Conference on Harmonisation (ICH), which brings together regulatory authorities and pharmaceutical experts from Europe, Japan, and the US to discuss product registration. ICH topics are divided into four categories: quality, safety, efficacy, and multidisciplinary. Several multidisciplinary topics are then summarized, including M1 (MedDRA terminology), M2 (electronic standards), M3 (non-clinical safety studies), M4 (common technical document), M7 (mutagenic impurities), M8 (electronic common technical document), M9 (BCS-based biowaivers), and M10 (bioanalytical method validation).
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory Compliance
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
ICH GUIDELINES.pptx
The document provides information on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH aims to harmonize technical requirements for drug registration among countries in Europe, Japan, and the United States. It seeks to increase international harmonization, ensure safety and efficacy of medicines, and develop pharmaceuticals efficiently. The ICH provides guidelines on drug quality, efficacy, and safety. It covers topics like stability testing, analytical validation, impurities, biotechnology products, specifications, good manufacturing practices, quality risk management, and quality systems.
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Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
Clinical data security and Integrity in Clinical Research
Clinical data security and integrity are paramount in maintaining patient confidentiality, protecting sensitive medical information, and ensuring the reliability of healthcare data. Security measures encompass various strategies and technologies aimed at safeguarding clinical data from unauthorized access, breaches, or manipulation.
Encryption techniques, access controls, and secure authentication mechanisms are commonly employed to restrict access to patient records and prevent unauthorized individuals from viewing or altering sensitive data. Additionally, robust network security protocols, such as firewalls and intrusion detection systems, help safeguard against external threats and cyberattacks targeting healthcare systems.
Pharmacovigilance in Patriatics and Geriatrics
Pharmacovigilance in pediatrics and geriatrics is of paramount importance due to the unique physiological and pharmacokinetic characteristics of these populations. In pediatrics, factors such as rapid growth, organ maturation, and differences in drug metabolism can influence the safety and efficacy of medications. Therefore, monitoring for adverse drug reactions (ADRs), including both known and unexpected effects, is crucial in ensuring the safe use of drugs in children. Additionally, since pediatric patients often receive off-label or unlicensed medications due to limited clinical trials in this population, pharmacovigilance efforts play a critical role in gathering real-world data to inform pediatric drug use.
Presenting- Signal mining in Pharmacovigilance
Signal mining in pharmacovigilance involves the systematic analysis of large datasets to identify potential safety signals associated with medications. It encompasses a variety of computational and statistical methods aimed at detecting patterns or trends that may indicate previously unrecognized adverse drug reactions (ADRs). Signal mining relies on data from sources such as spontaneous reporting systems, electronic health records, clinical trials, and medical literature. Advanced algorithms and data mining techniques, including disproportionality analysis, Bayesian data mining, and machine learning, are employed to sift through vast amounts of data to uncover potential signals of concern. These signals are then subjected to further evaluation to determine their clinical relevance and potential impact on patient safety. By leveraging the power of big data and analytics, signal mining plays a crucial role in enhancing pharmacovigilance efforts, enabling proactive identification and mitigation of medication-related risks, and ultimately contributing to improved patient care and drug safety.
Patient centered Pharmacovigilance .. .
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Introduction to Blogs, Presentations and Review Articles- Noorush Shifa Nizami
Blogs, presentations, and review articles stand as dynamic mediums, each with its unique power to engage, inform, and influence. Blogs, the conversational storytellers; presentations, the visual orchestrators; and review articles, the comprehensive knowledge curators, collectively play pivotal roles in shaping how we share, learn, and explore diverse subjects. This exploration delves into the distinct characteristics and purposes of these forms of communication, unveiling the art of effective expression and knowledge sharing in the digital age.
Patient-Centric Approaches in Precision Medicine Trials: Strategies for Success
Precision medicine, with its focus on tailoring medical treatment to the individual characteristics of each patient, has ushered in a new era in healthcare. Within this paradigm, clinical trials play a pivotal role in testing and validating targeted therapies. This article explores the importance of adopting patient-centric approaches in precision medicine trials and outlines strategies to enhance their success. By prioritizing patient engagement, leveraging digital technologies, and fostering collaborative partnerships, precision medicine trials can not only advance scientific understanding but also ensure that patient perspectives and experiences are integral to the research process.
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Collaborative initiatives involving patient advocacy groups play a crucial role in advancing the success of precision medicine. Precision medicine, also known as personalized medicine, tailors medical treatment and interventions to the characteristics of each patient, considering factors such as genetic makeup, lifestyle, and environment. Patient advocacy groups contribute to the success of precision medicine in several ways:
Raising Awareness and Education:
Patient advocacy groups are instrumental in raising awareness about precision medicine among their communities.
They provide education and resources to patients, caregivers, and the general public, promoting a better understanding of the benefits and implications of precision medicine.
Patient Empowerment:
Advocacy groups empower patients by providing them with information about their conditions and treatment options.
They help patients understand the importance of participating in precision medicine initiatives, including clinical trials and genetic testing.
Supporting Research and Development:
Patient advocacy groups often collaborate with researchers and industry stakeholders to support the development of targeted therapies and diagnostics.
By actively participating in research initiatives, advocacy groups contribute to the identification of genetic markers, biomarkers, and other factors that influence treatment response.
Influencing Policy and Regulation:
Advocacy groups advocate for policies that support the advancement of precision medicine.
They work to ensure that regulations promote patient access to personalized treatments and protect patient rights, privacy, and data security.
Fostering Collaboration:
Patient advocacy groups facilitate collaboration among patients, researchers, healthcare providers, and industry partners.
They create platforms for sharing information, experiences, and best practices, fostering a collaborative environment that accelerates progress in precision medicine.
Clinical Trial Recruitment:
Advocacy groups play a crucial role in recruiting patients for clinical trials related to precision medicine.
Their engagement helps ensure diverse and representative participant populations, leading to more robust and applicable research outcomes.
Feedback and Patient-Centric Approaches:
Advocacy groups provide valuable feedback on the patient experience, preferences, and priorities.
This patient-centric approach helps researchers and healthcare professionals tailor precision medicine strategies to better meet the needs and expectations of the individuals they serve.
Championing Access to Treatments:
Patient advocacy groups work to improve patient access to precision medicine treatments.
They advocate for affordable and equitable access to innovative therapies, ensuring that the benefits of precision medicine are accessible to a broader population.
In summary, patient advocacy groups play a multifaceted role in advancing precision medicine by fostering awareness,
Ethical Dilemmas in Precision Medicine: Navigating the Intersection of Scienc...
The Ethical dilemmas in precision medicine arise from balancing the potential benefits of tailored treatments with concerns about privacy, consent, equity, and the implications of genetic information. These Dilemmas include issues around informed consent for data sharing, ensuring equitable access to precision medicine technologies, and safeguarding against discrimination based on Information. The potential for misuse or unintended consequences further complicate the ethical landscape of precision medicine. The Precision medicine widely used in Data Integration, Biomarkers, Targeted Therapies, predictive modeling, Clinical Decision Support. Precision Medicine improves the Patient outcomes, enhancing treatment efficacy, and reducing healthcare costs by minimizing trial and error in treatment selection. The precision medicine also raises Ethical legal and social complications related to data privacy, consent and equitable access and the potential for Discrimination based on information.
Regulatory Considerations in Precision Medicine: Navigating the Approval Process
Precision medicine, with its focus on tailoring medical treatments to individual characteristics, presents unique regulatory challenges in the drug development and approval process. This ppt delves into the regulatory considerations associated with precision medicine, exploring the key aspects that pharmaceutical and biotechnology companies need to navigate
Emerging Technologies and Tools in Precision Medicine Research
Precision medicine has witnessed significant advancements with the integration of emerging technologies and innovative tools. This abstract explores the current landscape of precision medicine research, focusing on the role of cutting-edge technologies and tools in revolutionizing healthcare approaches.
Precision Medicine in Action: Case Studies and Success Stories
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
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Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Integration of Clinical Trial Systems: Enhancing Collaboration and Efficiency
Clinical trials are complex endeavors that involve numerous stakeholders, vast datasets, and intricate processes. To streamline operations, enhance collaboration, and improve efficiency, the integration of clinical trial systems has emerged as a pivotal solution. This strategic approach involves connecting various components, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHR), fostering a cohesive ecosystem that accelerates the pace of research and ensures data accuracy.
Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...
Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.
Adoptive Design: Optimizing Clinical Trial Strategies for Precision Medicine
Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.
Artificial Intelligence In Clinical Trial
Clinical trials are a cornerstone of medical research, paving the way for new treatments and advancements in healthcare. In recent years, Artificial Intelligence (AI) has emerged as a transformative force, reshaping the landscape of clinical trials. This article explores the various ways in which AI is revolutionizing the design, execution, and analysis of clinical trials.
Emerging Technologies Shaping the Future of Precision Medicine
Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.
Innovations in Liquid Biopsies for Precision Cancer Diagnosis
Precision medicine, with its focus on tailoring medical interventions to individual characteristics, benefits significantly from the integration of machine learning (ML) algorithms for predictive analytics. These algorithms analyze complex datasets, identify patterns, and generate predictions that inform personalized treatment strategies. This article explores the diverse applications of ML in precision medicine, highlighting the key algorithms driving predictive analytics in this transformative field.
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Breast cancer: Post menopausal endocrine therapy
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
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Endocrine Therapy
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Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
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Combination Therapies
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Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
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Pharmacovigilance Interview Questions Part 2
- 2. INDEX 1 2 3 4 5 1.In which ICH guideline information about Pharmacovigilance is provided? 2.What is E2 and name the different types of its Guidelines under this section? 3.Define GVP and how many modules are there in it. 5. Define GCP and name the ICH guideline that describes GCP and explain its purpose. 4.What are the GVP modules that speak about Pharmacovigilance?
- 3. ICH E2 Guidelines- talks about Pharmacovigilance guidelines. ‘E’ here stands for the category “Efficacy” under ICH topics. In which ICH guideline information about pharmacovigilance is provided?
- 4. •E2 is ICH Guideline for Pharmacovigilance. The different types are, • E2A guidelines for expedited reporting of Clinical Safety Data Management •E2B(R3)-data elements for transmission of ICSR •E2C-Peiodic Benefit Risk Evaluation Report (PBRER) •E2D- guidelines for expedited reporting of Post Approval Safety Data Management •E2E-Pharmacovigilance Planning •E2F-Development Safety Update Report (DSUR) What is E2 and name the different types of its Guidelines under this section?
- 5. •Good Pharmacovigilance Practice (GVP) is a set of measures drawn up to facilitate the performance of pharmacovigilance . •It has got 16 modules in it. Define GVP and how many modules are there in it.
- 6. •Module I-Pharmacovigilance systems and their quality system •Module II-Pharmacovigilance system master file •Module III-Pharmacovigilance inspection •Module IV-Pharmacovigilance audits What are some of the GVP modules that speak about Pharmacovigilance?
- 7. •Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting of clinical trials that involves the participation of human subjects. •ICH guideline E6(R3)describes about GCP. •Its purpose is to achieve greater harmonization worldwide for the development and approval of safe, effective, andhigh- quality medicines in the most resource-efficient manner. Define GCP and name the ICH guideline that describes GCP and explain its purpose.