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ccrpsorg · 1 year

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Good Pharmacovigilance Practice

Good Pharmacovigilance Practice Modules: A Comprehensive Guide to EMA GVP Modules

Good pharmacovigilance practices are the best way to ensure the safe and effective use of medicines. The European Medicines Agency (EMA) has set out a number of guidelines to ensure that all medicines are monitored safely and securely throughout their life cycle. You can review and become certified in these modules through our pharmacovigilance training program which is the only IAOCR-recognized program now taken by over 6,000 students.

Good pharmacovigilance practice PDF

In line with international standards, good pharmacovigilance practices require that companies or marketing authorization holders (MAHs) have an appropriate system in place to monitor the safety of medicines, collect data on potential risks and report any suspected adverse reactions. It is important for MAHs to be able to identify any potential safety issues quickly and take action when necessary.

In addition, EMA's Risk Management Plans provide further guidance on how companies should manage any risks associated with their products across the entire product lifecycle. These plans cover topics such as risk minimisation measures, benefit-risk assessment methods, additional monitoring systems and post-marketing studies.

It is essential that all pharmaceutical companies comply with good pharmacovigilance practices in order to ensure patient safety and quality medicines reach patients without unnecessary risks or delays. Following best practice guidelines helps protect public health by allowing for rapid detection of safety signals before serious harm can occur.

1.Pharmacovigilance Systems

The Guideline on Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems outlines key principles, requirements and expectations for managing effective pharmacovigilance systems, as well as providing guidance on how to develop and maintain a quality system. The document provides a comprehensive overview of the regulatory framework and highlights the importance of an efficient, effective and compliant pharmacovigilance system. It includes information such as the definition of what constitutes a PV system, the role of relevant parties in setting up and operating such a system, expectations regarding PV processes and procedures, criteria for evaluating adequacy of PV systems, risk management activities, safety data exchange agreements and safety reporting procedures.

The document outlines the responsibilities associated with setting up a PV system and maintaining its quality assurance program. This includes ensuring that applicable laws or regulations are followed; obtaining the necessary resources (people, equipment); identifying appropriate roles for personnel involved in PV activities; developing policies, procedures and standards; monitoring performance; making sure that any changes to the system are properly validated/re-validated; implementing risk management plans; establishing an internal audit program; performing regular internal audits to ensure compliance with applicable laws or regulations; interacting with external organizations involved in safety surveillance activities. Additionally, it discusses topics such as data protection requirements, individual case safety report reconciliation processes, periodic safety update reports (PSURs), risk management plans (RMPs), signal detection methods and other related topics.

Overall this guideline is an essential reference tool for industry professionals responsible for setting up or maintaining pharmacovigilance systems. It provides a detailed description of all aspects relating to pharmacovigilance systems including those related to regulatory requirements, quality assurance programs and data protection measures. This makes it an ideal source of information for industry professionals looking to stay informed about best practices in this field.

2. Pharmacovigilance System Master File

The Guideline on Good Pharmacovigilance Practices (GVP) Module II – Pharmacovigilance System Master File (Rev 2) is a comprehensive document that outlines the best practices for companies involved in the pharmaceutical industry to ensure the safe use of their products. The document covers topics such as the required contents of a pharmacovigilance system master file (PSMF), recommendations for setting up, running and maintaining a PSMF, as well as safety-related responsibilities for healthcare professionals and companies.

The GVP Module II provides clear guidance on what should be included in the PSMF, including elements such as organizational information, operational processes, safety data management and reporting, safety risk management and analysis, and communication processes. It also outlines good practices related to quality assurance such as validation of data entry systems and implementation of change control procedures. Moreover, it provides detailed instructions related to specific roles within a pharmacovigilance system such as medical advisors, clinical evaluation experts and signal detection staff.

In addition to providing recommendations on how to implement adequate pharmacovigilance systems, this guideline also includes discussion points on how companies can validate their own individual systems. This includes guidance on how to audit against established standards such as those outlined by the European Medicines Agency (EMA). Furthermore, it outlines requirements for drug development plans including preclinical studies, clinical trials, post-authorization studies and post-marketing surveillance programs.

Overall, this document is an invaluable resource for anyone involved in any aspect of drug safety or pharmacovigilance. It provides clear guidance about what constitutes an adequate pharmacovigilance system for both healthcare professionals and companies involved in the pharmaceutical industry. Its detailed descriptions make it easy to understand exactly what needs to be done from concept through implementation and operation of a PSMF. Additionally its discussion points provide valuable insights into how existing systems may be evaluated or improved upon if needed.

3. Pharmacovigilance Inspections

The Guideline on Good Pharmacovigilance Practices (GVP) Module III – Pharmacovigilance Inspections (Rev 1) provides an overview of the inspection process and methodology used in pharmacovigilance. This document is intended to standardize the approach taken by authorities when carrying out inspections as part of their pharmacovigilance activities. The document starts by providing an overview of the objectives and scope of inspections, as well as a list of key elements that should be assessed during such inspections. It then goes on to outline the organization and conduct of inspections, including the roles and responsibilities of all those involved, before concluding with a discussion of post-inspection activities.

The document contains information on how to prepare for an inspection, including identifying risks, developing a detailed plan and appointing appropriately qualified inspectors. It also covers topics such as evidence gathering, reporting requirements, defining corrective and preventive actions (CAPA), handling disagreements between authorities and documentation requirements. The document also includes guidance on how to manage conflicts of interest during inspections, assess data integrity issues in clinical studies or establish a dialogue between authorities and inspected companies.

Overall, this guideline provides comprehensive information about conducting pharmacovigilance inspections. It sets out detailed instructions for all stages of such inspections – from preparing for them to taking corrective actions afterwards – helping ensure that these activities are carried out in a consistent manner across different countries. As such, this guideline is likely to be beneficial for both authorities responsible for managing safety concerns related to medicines and inspected companies which must comply with relevant regulations.

4. Pharmacovigilance Audits

The Guideline on Good Pharmacovigilance Practices (GVP) Module IV provides guidance for conducting pharmacovigilance audits. This document is intended to provide an overview of the essential elements of a robust quality system and auditor qualification, planning and preparation for the audit, conduct of the audit, closure and follow-up activities, and reporting.

The main objectives of conducting pharmacovigilance auditing are to ensure that the pharmacovigilance system meets applicable regulatory requirements and industry standards, while also promoting continuous improvement in safety management. The document outlines the expectations for planning and preparing for an audit including scope, criteria, documents to be reviewed, personnel to be interviewed and potential sources of evidence. It addresses important considerations such as effective communication with stakeholders during planning and performance of the audit.

The document also covers criteria to be used when selecting auditors to ensure objective assessments. Qualifications should include relevant knowledge within the area of pharmacovigilance as well as experience in conducting audits. Additionally, it specifies standards for verbal/written communications with all parties involved during an audit including respect for confidentiality/privacy requirements.

The document describes principles related to conducting the audit including appropriate documentation methods such as notes from witness interviews or observation forms. Guidelines are provided regarding evidence gathering techniques such as sample size determination, selection of subjects or records to review, duration of observations and additional topics related to ensuring effective data collection techniques are employed when necessary.

Additionally, this guideline outlines requirements for properly closing an audit including findings discussions with all parties involved followed by appropriate action plans that address any non-conformities found during the process. This action plan should aim at remediation of deficiencies found during either corrective or preventative actions if necessary/justified as well as a timeline for completion/follow-up actions on actions taken. Lastly, it describes expectations related to reporting post-audit activities which should include written reports addressing nonconformities found along with recommendations on corrective actions taken or additional preventive measures needed in order to ensure compliance with GVP guidelines going forward.

5. Risk Management Systems

The Guideline on Good Pharmacovigilance Practices (GVP) Module V- Risk Management Systems, revised for 2020, is a comprehensive document provided by the European Medicines Agency that outlines a framework for risk management systems of pharmaceutical products. It provides detailed guidance for manufacturers and marketing authorization holders during their production and distribution of medicinal products in Europe. The guideline covers topics such as the safety assessment process, risk minimization activities, communication of safety information to healthcare professionals and patients, pharmacovigilance audit procedures and training requirements.

The main aim of GVP Module V is to ensure that the risks associated with medicinal products are managed effectively throughout their lifecycle. This is achieved through an effective risk management system (RMS). To this end, the GVP sets out five core principles that should be adhered to when designing and implementing an RMS: monitoring and evaluation of safety information; risk minimization strategies; communication of safety information; audit and inspection; and training requirements.

Each principle is then broken down into more detailed elements which manufacturers/marketing authorization holders should consider when designing their RMS. These include: establishing objectives for the RMS; setting up a robust infrastructure to monitor safety data; developing risk minimization plans; communicating safety information to stakeholders on a regular basis; conducting audits/inspections on a regular basis; ensuring staff are trained appropriately in pharmacovigilance practices; setting up reporting systems to enable timely alerts if any significant new risks are identified; assessing performance metrics regularly to ensure processes remain effective over time.

6. Individual Case Safety Reports

The Guideline on good pharmacovigilance practices (GVP) Module VI provides guidance for companies and organizations in the collection and management of individual case safety reports (ICSRs) as well as their submission to regulatory authorities. The main purpose of this module is to ensure that pharmacovigilance activities are performed in a consistent and effective manner across the EU Member States, in order to protect public health, improve patient safety, and strengthen confidence in healthcare products.

The module covers topics such as process for ICSR collection, management, and submission process; risk management plan; responsibilities; quality control measures; data integrity requirements; monitoring of adverse events reporting systems; ICSR privacy considerations; electronic exchange of ICSRs between marketing authorization holders and national competent authorities; and post-marketing surveillance.

In addition to providing practical guidance on these topics, the module also outlines best practices for maintaining a comprehensive pharmacovigilance system. These include establishing an appropriate risk management plan for each authorized medicinal product, assigning roles and responsibilities appropriately, collecting timely ICSRs from all relevant sources (including spontaneous reports from healthcare professionals or patients), tracking safety signals on an ongoing basis, ensuring data integrity when exchanging ICSRs electronically with regulatory authorities, ensuring the security of personal data related to patients who report adverse reactions, and performing regular monitoring activities to assess compliance with pharmacovigilance obligations.

Overall, the Guideline on good pharmacovigilance practices (GVP) Module VI is a valuable resource for companies and organizations that seek to ensure that their pharmacovigilance operations are up-to-date with current regulations and standards. It provides useful information on how to develop an effective ICSR collection, management, and submission process while also emphasizing best practices for maintaining a comprehensive pharmacovigilance system that is compliant with applicable laws.

7. Period Safety Update Reports

The Guideline on good pharmacovigilance practices (GVP) Module VII is designed to provide guidance for the development and submission of periodic safety update reports (PSURs). This document provides information on the regulatory aspects, content and format for PSURs, as well as best practices for preparing and submitting them in accordance with the applicable risk management plan.

The GVP Module VII outlines the process needed to assess drug safety data from various sources, including spontaneous reports, clinical trials, epidemiological studies and post-authorization safety studies. It emphasizes that periodic safety reviews should be conducted at least annually and whenever new data suggests it is necessary. The main objective of a PSUR is to provide an assessment of the benefit-risk balance of a medicinal product over a defined period of time.

In order to ensure that all relevant data is accurately captured and tracked, the GVP Module VII recommends that companies maintain a comprehensive database containing both adverse event and non-adverse event information related to their products. This information should include any relevant clinical trial results or other relevant safety issues identified during pharmacovigilance activities. Additionally, the document outlines methods for evaluating reported events in order to identify potential safety signals.

Overall, Guideline on good pharmacovigilance practices (GVP) Module VII provides detailed guidance regarding the development and submission of periodic safety update reports (PSURs). It outlines processes for capturing, tracking, evaluating and assessing drug safety data from various sources. Furthermore, it discusses strategies for analyzing this data in order to identify potential safety signals which help inform regulatory decision making about a particular pharmaceutical product's risk-benefit balance over time.

8. Post Authorization Safety Studies

The Guideline on Good Pharmacovigilance Practices (GVP) Module VIII provides detailed guidance on the post-authorisation safety studies (PASS). This document is designed to help drug manufacturing companies, regulatory agencies and other stakeholders understand their respective roles and responsibilities in designing and conducting PASS.

The document outlines the principles of good pharmacovigilance practice and incorporates several international standards including those from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The document also highlights the potential benefit of using available data sources such as Electronic Health Records and administrative healthcare databases, as well as patient registries.

In addition to general requirements related to PASS design, GVP Module VIII outlines specific requirements regarding patient eligibility criteria, study protocol adherence, sample size calculation and analysis, ethics/informed consent requirements, as well as specific reporting requirements.

The document contains clear instructions on how sponsors should prepare a detailed risk management plan (RMP) with respect to PASS. This includes outlining different types of safety monitoring procedures that should be conducted during a study. Furthermore, it provides guidance on providing adequate training to ensure appropriate execution of the RMP. Moreover, it outlines the importance of appropriately packaging and labelling test articles used in clinical trials to minimize any potential risks or harm associated with them.

Overall, GVP Module VIII provides comprehensive guidance for all stakeholders involved in Post-Authorisation Safety Studies by outlining clear roles and responsibilities as well assessing potential risks associated with these studies. It serves as an essential reference guide for manufacturers who wish to design effective PASS protocols that adhere to international standards in order to ensure patient safety while at the same time promoting innovation within the industry.

9. Signal Management

The Guideline on Good Pharmacovigilance Practices (GVP) Module IX on Signal Management is a comprehensive set of guidelines which provides the framework for the appropriate management of signals and safety issues related to medicines. It outlines the process for detecting and evaluating potential safety issues and risks associated with medicinal products, as well as providing guidance on when additional investigations should be considered, and how to respond when safety signals are identified. The document focusses on areas such as risk minimisation plans, benefit-risk assessments, laboratory tests, product recalls and market withdrawals.

The GVP Module IX begins by outlining the definitions and concepts associated with signal management. These include definitions of what a signal is, how a signal should be classified, when it is appropriate to consider further action and how to differentiate between pharmacovigilance activities and regulatory actions. This section also provides guidance on data sources which can be used to identify signals, including both spontaneous reports from healthcare professionals or consumers as well as epidemiological studies.

The next section details specific aspects of signal management such as risk minimisation activities, benefit-risk assessments, laboratory investigations and product recalls or market withdrawals. It outlines key points such as: planning risk minimisation strategies in advance; monitoring effectiveness; assessing the benefit-risk balance at regular intervals; conducting laboratory tests which are relevant to safety issues; recalling or withdrawing products where necessary; ensuring availability of up-to-date information about risks associated with medicines; considering other types of regulatory action where appropriate; maintaining records of all decisions made related to signal management; and reporting/publishing new information regarding any changes in risk assessment/benefit-risk balance.

Finally, GVP Module IX provides detailed guidance on post-marketing surveillance activities which should be conducted following implementation of any risk minimisation plans. This includes setting up systems for monitoring changes in safety profile after introduction into use in humans or in the environment, implementing quality control processes for data capture & analysis, garnering collaboration from stakeholders (e.g healthcare professionals & customer feedback), sharing data with other organisations/authorities where appropriate ,and implementing communication plans so that stakeholders are kept informed of any changes in risk assessment/benefit-risk balance due to new evidence becoming available over time.

10. Additional Drug Safety Monitoring

The Guideline on Good Pharmacovigilance Practices (GVP) Module on Additional Monitoring offers a comprehensive guide to the principles, methods and processes of additional monitoring in the field of pharmacovigilance. This document outlines the purpose, rationale and requirements of additional monitoring activities as well as providing practical guidance for its implementation. The module is divided into five sections: Introduction; Overview; Objectives; Policies and Procedures; and Resources and Tools. In addition, it provides detailed best practice recommendations for each of these subject areas.

The Introduction section offers an overview of pharmacovigilance as well as outlining the structure and purpose of GVP Module X on Additional Monitoring. It also provides definitions for key terms related to this area such as safety surveillance, signal detection, signal assessment, signal evaluation, risk management plan (RMP), post-marketing commitment (PMC) etc.

The Overview section provides a general overview of additional monitoring including an explanation of its objectives, purpose and importance in the management of drug safety risks. It goes on to discuss how additional monitoring data can be used by authorities to make informed decisions regarding marketing authorization or changes to an authorized product's RMP. The section also looks at how regulators can assess the adequacy of existing safety information and consider whether further data collection should be undertaken through additional monitoring activities.

The Objectives section outlines in detail the objectives to be fulfilled when undertaking additional monitoring activities such as obtaining further safety information about a marketed product or conducting ongoing risk-benefit assessments necessary for regulatory decision making about medicine availability or changes to an authorized product's RMP. It also discusses how appropriate target populations can be identified in order maximize benefit from the activity while minimizing risk from potential harms caused by inappropriate use or misuse of medicines.

The Policies and Procedures section explains in detail what should be included when developing procedures for implementing additional monitoring activities such as setting objectives for data collection, deciding target populations for data collection, identifying relevant sources of information (including electronic health records) etc. It also covers legal considerations such as patient consent requirements when collecting personal data through registries or other sources outside hospital settings etc., which are important when planning any form of clinical trial activity that uses anonymized patient data collected retrospectively from various sources (e.g., primary care centers).

Finally, the Resources and Tools section suggests some practical tools that may help with developing appropriate procedures when implementing additional monitoring activities such as questionnaires that could be used to collect patient reported outcome measures (PROMs) etc. In addition it outlines relevant international frameworks/agreements which must be taken into account when collecting global safety data sets through international registry networks such as those developed through ICH-GCP partnerships between different countries/regions across Europe or North America etc..

Overall this Guideline on Good Pharmacovigilance Practices Module X Additional Monitoring is an essential resource for anyone involved with designing or implementing pharmacovigiance systems since it provides comprehensive best practice advice that will help ensure safe use/distribution/monitoring of medicines worldwide

15. Pharmacovigilance Safety Communication

The Guideline on good pharmacovigilance practices (GVP) Module XV Safety Communication was developed to provide guidance to pharmaceutical companies and other healthcare stakeholders involved in the management of medicinal products. This document contains detailed instructions on how to effectively communicate risk related information about medicinal products.

The guidelines are designed to ensure that such communication is consistent, timely and accurate. It also highlights the importance of making sure that both healthcare professionals and patients have access to sufficient information so that they can make informed decisions about the medicine they are taking.

The document outlines a number of principles for effective safety communication, including: ensuring that all risk related information is identified and included in the communication; providing clear, accurate, up-to-date information; understanding who needs to be informed; responding quickly to questions raised by healthcare professionals; and making sure that patients have access to appropriate support after receiving information.

The guideline also sets out various requirements for monitoring and assessing the effectiveness of safety communications, including evaluating the impact of risk minimisation measures, collecting feedback from health professionals and consumers following safety communications, conducting surveys among healthcare professionals and monitoring changes in prescribing behaviour. The documentation also provides advice on dealing with adverse events associated with medicines as well as what steps should be taken when product recalls or withdrawals occur.

Overall, this Guideline on good pharmacovigilance practices (GVP) Module XV Safety Communication provides a comprehensive overview of best practices relating to safety communications concerning medicinal products. It provides specific advice on how pharmaceutical companies should communicate risk-related information about their medicines, as well as how to monitor the effectiveness of such communication. The guidance is invaluable for all stakeholders involved in managing medicinal products so that they can ensure patient safety is maintained at all times.

Want to understand good pharmacovigilance practice modules through examples, video lectures, and quizzes all while receiving The IAOCR internationally recognized certificate available for PV officers? Consider enrolling in CCRPS Pharmacovigilance certification.

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sudheervanguri · 25 days

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IQVIA is hiring a Safety Aggregate Report Specialist 2 (exclusively in Kolkata). Work Type: Full-Time Workplace Duties: Work Summary: IQVIA is seeking a Safety Aggregate Report Specialist to work in Kolkata, India. Managing safety aggregate reports, literature surveillance, signal management operations, and benefit risk management paperwork are among your responsibilities in this position. Crucial Roles: Assume responsibility for the SARA deliverables and make sure that service level agreements (SLAs) are followed. Oversee the creation and completion of numerous aggregate reports, such as line listings, RMPs, DSURs, PADERs, PBRERs/PSUR, and RMPs. When necessary, draft answers to questions from the Pharmacovigilance Risk Assessment Committee (PRAC) and regulatory bodies. Maintain continuous literature safety surveillance, including identification of ICSRs and aggregate data review, for both marketed and investigational products. Assume the role of Signal Management Lead for post-marketing and clinical trial initiatives, establishing signaling protocols, carrying out signal identification tasks, and recording signals. Interface with clients and collaborate with internal functional groups within Lifecycle Safety and other business units. Take part in audits, support departmental objectives, and follow standard operating procedures (SOPs). Qualifications: Requires a bachelor's degree in a medical or scientific field. Preferably two to three years of relevant work experience. outstanding familiarity with Lifecycle Safety services and procedures combined with a readiness to pick up new abilities. Understanding of global regulatory requirements such as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines. Proven ability to meet deadlines, manage competing priorities, and maintain high-quality standards. Proficiency in Microsoft Office applications and familiarity with medical terminology. Strong communication, organizational, and time management skills. good judgment, self-reliance, and ability to make decisions. Self-driven, adaptable, and possessing strong coaching and mentoring abilities. strong project management, operational metrics, and leadership skills knowledge. [caption id="attachment_47409" align="aligncenter" width="930"] IQVIA Jobs; PV Safety Aggregate Report Specialist 1[/caption] About IQVIA: IQVIA is a world leader in clinical research services, technology solutions, and advanced analytics for the life sciences sector. Come along with us to positively influence healthcare around the world. Visit IQVIA Careers to learn more. How to Apply: Don't miss this opportunity to contribute to impactful work and grow your career at IQVIA. Apply now for the IQVIA Hiring Safety Aggregate Report Specialist 2 - Kolkata using the IQVIA PV Referral Link.

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bcri-bangalore · 8 months

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Discover the essence of pharmaceutical safety with the Guideline on Good Pharmacovigilance Practices (GVP)

🔍 Discover the essence of pharmaceutical safety with the Guideline on Good Pharmacovigilance Practices (GVP). 🌟 At BCRI, we're dedicated to equipping you with the knowledge and skills you need through our comprehensive Pharmacovigilance Training. 📚 Join us on this journey to ensure the safety and effectiveness of medications for all.

#online courses #pharmacovigilance training

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whitehalltraining · 8 months

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GPvP- Signalling & Risk Assessment

GPvP-Signalling & Risk Assessment is a set of guidelines that describes the process of detecting, assessing, and managing risks associated with medicinal products. It is a key component of pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

The GPvP-Signalling & Risk Assessment guidelines cover the following topics:

Identification of potential signals: This involves identifying new or unexpected adverse events that may be associated with a medicinal product.

Assessment of signals: This involves evaluating the available evidence to determine whether there is a causal relationship between the medicinal product and the adverse event.

Management of risks: This involves taking steps to mitigate the risks associated with a medicinal product, such as issuing a safety alert or changing the product labeling.

The GPvP-Signalling & Risk Assessment guidelines are important for ensuring the safety of medicinal products. They help to identify and assess potential risks, and they provide a framework for managing these risks.

Here are some of the key steps involved in GPvP-Signalling & Risk Assessment:

Identify potential signals: This involves collecting and reviewing data on adverse events reported for a medicinal product. This data can come from a variety of sources, such as spontaneous reports, clinical trials, and post-marketing surveillance studies.

Assess signals: This involves evaluating the available evidence to determine whether there is a causal relationship between the medicinal product and the adverse event. This evaluation takes into account factors such as the strength of the evidence, the consistency of the findings, and the dose-response relationship.

Manage risks: This involves taking steps to mitigate the risks associated with a medicinal product. This may involve issuing a safety alert, changing the product labeling, or withdrawing the product from the market.

The GPvP-Signalling & Risk Assessment guidelines are a dynamic and evolving document. They are updated regularly to reflect new scientific knowledge and regulatory requirements.

If you are involved in the development, marketing, or use of medicinal products, it is important to be familiar with the GPvP-Signalling & Risk Assessment guidelines. These guidelines can help you to ensure the safety of patients and to protect public health.

Here are some additional resources that you may find helpful:

Good Pharmacovigilance Practices (GVP) - Module IX: Signal Management: This guideline provides detailed information on the process of signal detection, assessment, and management.

European Medicines Agency (EMA) - Signal Detection and Assessment: This website provides information on the EMA's approach to signal detection and assessment.

US Food and Drug Administration (FDA) - Pharmacovigilance: This website provides information on the FDA's pharmacovigilance activities.

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crbtech123 · 1 year

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Pharmacovigilance Interview Questions 2023

Pharmacovigilance is a critical component of the pharmaceutical industry, and ensuring that the public is safe from any harmful effects of drugs is of paramount importance. As such, pharmacovigilance plays a key role in the development of new drugs and the monitoring of their safety in the marketplace. In this article, we will discuss the best pharmacovigilance interview questions that you can expect in 2023.

What is pharmacovigilance, and why is it important? This is a basic question that is likely to come up in most pharmacovigilance interviews. The interviewer wants to assess your knowledge of the field and your understanding of its importance. You should be able to explain what pharmacovigilance is, the different stages involved in it, and how it contributes to the overall safety of drugs.

What is your experience with signal detection, and how do you approach it? Signal detection is a crucial aspect of pharmacovigilance, and the interviewer will want to know how experienced you are in this area. You should be able to explain your approach to signal detection, the methods you use, and your experience with various tools and databases.

How do you manage adverse event reporting, and what is your experience in this area? Adverse event reporting is a critical part of pharmacovigilance, and you should be able to explain how you manage this process. You should be familiar with the regulatory requirements for adverse event reporting, the different types of adverse events, and the reporting timelines.

What is your understanding of risk management plans, and how do you develop them? Risk management plans are a crucial aspect of pharmacovigilance, and the interviewer will want to know how familiar you are with this area. You should be able to explain the purpose of risk management plans, the different components involved, and how you go about developing them.

What is your experience with regulatory submissions, and how do you ensure compliance with regulatory requirements? Regulatory compliance is a crucial aspect of pharmacovigilance, and you should be able to demonstrate your knowledge of this area. You should be familiar with the regulatory requirements for pharmacovigilance, the different types of regulatory submissions, and the timelines for submitting them.

What is your understanding of Good Pharmacovigilance Practice (GVP), and how do you ensure compliance with GVP guidelines? Good Pharmacovigilance Practice (GVP) is a set of guidelines for pharmacovigilance that are designed to ensure the safety of drugs. You should be familiar with these guidelines and be able to explain how you ensure compliance with them.

What is your experience with safety data management, and what tools and databases are you familiar with? Safety data management is a critical part of pharmacovigilance, and the interviewer will want to know how experienced you are in this area. You should be familiar with the different tools and databases used in safety data management and be able to explain how you use them.

How do you ensure quality in pharmacovigilance, and what metrics do you use to measure it? Quality is a crucial aspect of pharmacovigilance, and the interviewer will want to know how you ensure it. You should be able to explain the different quality control measures you use, the metrics you use to measure quality, and how you ensure compliance with quality standards.

What is your experience with pharmacovigilance audits, and how do you prepare for them? Pharmacovigilance audits are a critical part of ensuring compliance with regulatory requirements and quality standards. You should be able to explain your experience with these audits and your approach to preparing for them.

What is your experience with pharmacovigilance?

If you are searching for a guid who can help you to crack pharmacovigilance interview 2023 then here CRBtech is a leading corporate training institute. It has focused on training candidates in IT, Mechanical, Electrical,Civil and Clinical Research. It helps students to start their career journey with a good beginning in the industry.

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elearningserv · 3 years

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Good Pharmacovigilance Practices Compliance training is very useful for employees particularly in the field of drug trials.

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#pharmacovigilancecourses #ComplianceTraining #eLearning #training #employees

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regulatoryinstitute · 3 years

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Pharmacovigilance Online Training - On Good Pharmacovigilance Practices (GVP)

Pharmacovigilance or drug safety is the study of and prevention of the different adverse effects due to pharmaceutical products. Thus, pharmacovigilance online training is the need of the hour for the candidates who wants to build their career in the pharmacovigilance. You are on the right track if you are planning on building up your skills for this career path.

Good Pharmacovigilance Practices in Pharmacovigilance Online Training

One of the most important topics that will be tackled during your training is Good pharmacovigilance practices (GVP). These are different measures, which are put together for the facilitation of the performance of professionals in this niche. The European Union in July 2012 emphasized the importance of GVP as applied to the new pharmacovigilance legislation.

Participants of the pharmacovigilance online training will be able to access beautifully and strategically designed interactive content. Moreover, good quality training programs that you can access online are optimized for all devices. Individuals that need pharmacovigilance knowledge should get their training from the right instructors and source persons.

Learning Objectives

What are the goals of enrolling in pharmacovigilance online training? Completion of the online course training benefits all trainees especially fresh graduates. For instance, they will be given a platform to understand the fundamentals of Good Pharmacovigilance. They also learn about the current legal guidelines and regulations.

Trainees acquire the confidence, which they cannot otherwise get without formal and comprehensive training. They get a thorough outline of the main GVP requirements particularly in relation to risk management systems. Taking part in this program gives you the venue to familiarize yourself with the essential GVP-related documents.

Your training helps you understand the purpose, structure, and essence of the salient trial about pharmacovigilance files. These essential files include the periodic safety update report (PSUR). It also highlights the pharmacovigilance system master file (PSMF) and study protocol.

Quality Systems in Pharmacovigilance

The online pharmacovigilance training covers the scope of quality systems of the pharmacovigilance industry. This will focus on the principles and quality objectives of GVP, qualified person, and documentation. Trainees will likewise learn about record management as well as proper personnel training.

Pharmacovigilance Inspections

Discover the different types of pharmacovigilance inspections concerning the observance of good pharmacovigilance practices. The training program will also cover inspection follow-up and regulatory sanctions and actions.

Other salient scopes of the training also include risk management systems particularly objectives, structure, and content. The management as well as reporting of adverse reactions is an important chapter to learn. It trains participants about the collection of reports, types, validation, and time frames. Know how to enroll in a pharmacovigilance online training to invest in your credentials. Call Global Institute for Regulatory Affairs now!

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pepgra-healthcare · 4 years

Video

Periodic Safety Update Reports (PSURs) | Pepgra.com

· PSURs are pharmacovigilance documents that provide risk-benefit balance assessment.

· The notion of PSUR is to offer a wide and complex evaluation of risk-benefit balance of a medicinal product.

· PSUR reporting first came into existence in 1992.

· Purpose of PSUR is to provide an update of global safety experience with a specific pharmaceutical.

· It is imperative to consult the guideline on good pharmacovigilance practices (GVP) while preparing PSUR.

· MAHs are supposed to submit all PSURs in EU to the central PSUR repository.

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#pharmacovigilance services #pharmacovigilance literature search #pharmacovigilance literature screening services #pharmacovigilance documents

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super-saltyfestcollection-w-blog · 5 years

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Germany pharmacovigilance market accounted for 23.2% market share of European pharmacovigilance market in 2017 and is expected to show considerable growth over the coming years. Favorable public and private initiatives conducted in the country such as German Pharmacovigilance Day will propel Germany pharmacovigilance market growth. Such events help in bringing together safety professionals from the healthcare and pharmaceutical domain such as medical devices and biopharmaceutical companies, academic research centers and regulatory authorities. Furthermore, development of good pharmacovigilance practices (GVP) modules and guidelines by the European Medicines Agency will drive Europe pharmacovigilance market growth.

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pacificbiosafety · 4 years

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EMA Seeks Feedback on Tracking Drug Safety in Pregnancy and Breastfeeding

From the desk of EMA- 11 December 2019

The European Medicines Agency (EMA) is seeking feedback on its draft good pharmacovigilance practice (GVP) guideline that covers specific considerations for dealing with adverse events in pregnant and breastfeeding women.

Typically, companies bring medicines to market without showing their safety and efficacy in pregnant and breastfeeding women…

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#breast-feeding #dr nisha nair #draft guidance #drug regulations #drug safety #ema #european medicines agency #european union #good pharmacovigilance practices #GVP #medical writing #pacific biosafety group #pharmaceutical industry #pharmacovigilance #pharmacovigilance training #post authorization studies #pregnancy guidance #regulatory guidance

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jforcs-blog · 6 years

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Pharmacovigilance in the European Union In 2012, the European Union (EU) introduced regulatory controls for good pharmacovigilance practices (GVPs) to its member states.

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azveille · 6 years

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L'ANSM met à jour les bonnes pratiques de pharmacovigilance

L'Agence nationale de sécurité du médicament et des produits de santé (ANSM) a annoncé la mise à jour des bonnes pratiques de pharmacovigilance, lundi dans un point d'information.Les premières bonnes pratiques avaient été publiées en 2005 puis avaient été complétées en 2011.

Leur mise à jour doit permettre de "compléter le travail entrepris dans le cadre du renforcement du système de pharmacovigilance" et d'"adapter l’exercice de la pharmacovigilance européenne aux spécificités nationales"."Ces bonnes pratiques ont pour objectif de guider l’ensemble des acteurs du système de pharmacovigilance en détaillant le rôle de chacun dans ce système, les modalités de déclarations des effets indésirables, leur gestion et leur traitement", commente l'ANSM.L'agence avait lancé en 2016 une consultation publique afin de mettre à jour les bonnes pratiques, expliquant que celles-ci devaient être actualisées en raison de l'évolution des textes européens et nationaux.

La réglementation communautaire en matière de pharmacovigilance, entrée en vigueur en 2012, a renforcé le cadre légal pour la surveillance des médicaments. Afin de faciliter l'exécution des activités de pharmacovigilance au sein de l'Union européenne (UE), l'Agence européenne du médicament (EMA) a élaboré des lignes directrices en matière de bonnes pratiques de pharmacovigilance ("good pharmacovigilance practices" -GVP), qui doivent être déclinées dans les Etats membres.En outre, la loi française du 26 janvier 2016 de modernisation de notre système de santé et ses décrets d'application ont initié une réforme nationale des vigilances qui a conduit, en mars 2017, à l'ouverture d'un portail internet unique de signalement des évènements indésirables par les professionnels de santé et les patients (cf dépêche du 26/08/2016 à 18:45 et dépêche du 13/03/2017 à 19:04).Il a aussi été demandé aux agences régionales de santé (ARS) de mettre en place et d'animer des réseaux régionaux de vigilances et d’appui (RREVA) à compter d'avril 2017 (cf dépêche du 05/12/2016 à 12:42 et dépêche du 22/03/2017 à 16:10).

L'ANSM rappelle que la mise à jour des bonnes pratiques de pharmacovigilance était jusqu'ici entérinée par un arrêté du ministre chargé de la santé publié au Journal officiel. L'ordonnance du 15 juillet 2016 portant simplification de procédures mises en oeuvre par l'ANSM, ratifiée par une loi datée du 23 février 2017, a transféré cette compétence au directeur général de l'agence.

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vovamayskiy · 6 years

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Касторки нет ! Но вы держитесь ...

New Post has been published on http://kastorki.net/doktora-rekomenduyut/v-evrope-predstavleno-postregistracionnoe-issledovanie-rossiiskogo-originalnogo-preparata.html

В Европе представлено пострегистрационное исследование российского оригинального препарата

Пострегистрационное исследование (PASS) российского оригинального препарата Полиоксидоний® в Европе представлено на международной конференции.

Уникальный для России проект многоцентрового открытого пострегистрационного исследования безопасности Post Authorisation Safety Study (PASS) инъекционной формы препарата Полиоксидоний® 6 мг в Европейском союзе (Словакия) представлен 15 ноября в рамках шестой международной конференции «Клинические исследования в России», организованной Институтом Адама Смита в Москве.

Российские фармацевтические компании все активнее развивают экспортное направление, и процесс проведения пострегистрационных клинических исследований в других странах становится одной из важных задач географической экспансии. Информации о том, что представляют собой пострегистрационные исследования безопасности (PASS) в ЕС, а также рассмотрению примера первого пострегистрационного исследования препарата Полиоксидоний® в Европе была посвящена отдельная сессия международной конференции.

Исследование было инициировано «НПО Петровакс Фарм» в 2015 году с целью дополнительного изучения профиля безопасности препарата в рутинной клинической практике. В 2017 году компания получила отчет о его успешных результатах, который подтвердил высокий профиль безопасности лекарственного средства и хорошую переносимость среди пациентов.

«Полиоксидоний® хорошо известен в России, странах СНГ, а также Словакии. Более 20 лет препарат успешно применяется в практическом здравоохранении 11 стран и заслужил доверие врачей и потребителей. За многие годы накоплен большой опыт клинических исследований лекарственного средства в России. И наш шаг в области проведения пострегистрационного исследования Полиоксидония® в Европе – это продолжение стратегии развития экспортного потенциала продукта за рубежом, в частности на территории Европейского союза. Это первый опыт пострегистрационных исследований российских препаратов в Европе в целом, который подтвердил высокую безопасность ��ригинального препарата, созданного российскими учеными, — отметила медицинский директор «НПО Петровакс Фарм» Наталья Чирун: — Пострегистрационные исследования безопасности относятся к лучшим практикам, которые приветствуются регуляторами Евросоюза. Для осуществления проекта наша компания привлекла контрактную исследовательскую организацию Биомапас, обладающую большим опытом проведения подобных исследований в ЕС».

«Проводя исследование препарата Полиоксидоний®, мы руководствовались обновленными требованиями стандарта ICH GVP Module VII (rev. 2) и ICH GCP, — продолжил управляющий директор компании Биомапас (Biomapas) Аудрюс Свейката. — Многоцентровое исследование PASS включало 502 взрослых пациента в 15 исследовательских центрах, которые были расположены по всей Словакии. Пациенты с показаниями «острые инфекции и хронические рецидивирующие заболевания вирусной и бактериальной этиологии» наблюдались в течение курса лечения, в среднем 22 дня. В финале исследования осуществлялась оценка общей переносимости лекарственного средства по мнению врачей-исследователей и пациентов. Результаты PASS показали, что Полиоксидоний® обладает высоким профилем безопасности и хорошо переносится исследуемой популяцией пациентов, — поделился данными спикер. — 75,3% пациентов и 79,7% исследователей оценили переносимость как очень хорошую, 21,1% пациентов и 19,3% исследователей — как хорошую».

Наталья Чирун обратила внимание на то, что PASS-исследование проводилось в соответствии с европейскими стандартами1 и было одобрено Регуляторным органом Словацкой Республики. Контроль клинических исследований осуществлялся в рамках Sponsor Oversight, все процедуры которого были строго регламентированы. Со стороны «НПО Петровакс Фарм» регулярно проводился мониторинг и аудит проекта в соответствии со стандартными операционными процедурами. Отчет об успешном окончании исследования войдет в состав регистрационного досье препарата для Словацкого регуляторного органа SUKL. Исследование зарегистрировано в Европейском регистре PASS2 и получило одобрение Европейского этического комитета. Этот опыт, безусловно, интересен для российской фармацевтической индустрии в рамках пострегистрационных исследований, заключила Наталья Чирун.

В чем особенность и преимущества PASS исследований по сравнению с рандомизированными клиническими исследованиями? Когда в России появятся регламенты, описывающие проведение таких исследований? – поднял вопросы в ходе дискуссии модератор сессии директор проектов Maxwell Biotech Group Дмитрий Мануилов.

«Основное преимущество PASS-исследований в том, что они помогают оценить выявленные, потенциальные или теоретические риски лекарственных препаратов, обеспечивают получение объективных данных по безопасности, взаимодействию с другими лекарственными средствами в долгосрочной перспективе, а также оценивают соотношения «польза — риск» лекарственных препаратов при практическом применении, — отметил Аудрюс Свейката. — Данные о препарате, которые аккумулируются в рамках стандартной процедуры фармаконадзора, не предоставляют полной информации о возможном развитии нежелательных реакций. Особенность PASS состоит в том, что исследование проводится после регистрации лекарственного препарата. Данные о применении собираются в рутинной медицинской практике, когда врачи не ограничены жесткими рамками, в том числе более строгими критериями отбора, которые сопровождают рандомизированные клинические исследования».

На вопрос модератора о том, когда PASS придут в Россию руководитель Центра по мониторингу эффективного, безопасного и рационального применения лекарственных средств ФГБУ «ИМЦЭУАОСМП» Росздравнадзора Виталий Поливанов ответил, что в настоящее время работа в этой области ведется. Появление нормативных требований, регламентирующих проведение таких исследований, ожидается к 2020 году.

Также было подчеркнуто, что система мониторинга безопасности лекарственных средств в России активно развивается в соответствии с международными требованиями. Профиль безопасности должен отслеживаться на протяжении всего жизненного цикла препарата, в том числе в пострегистрационном периоде. Эти агрегированные данные аккумулируются в отчетах по безопасности препаратов.

Значимость подобных проектов для пациентов и врачей подчеркнул заведующий лабораторией вакцинопрофилактики и иммунотерапии аллергических болезней Научно-исследовательского института вакцин и сывороток им. И. И. Мечникова Михаил Костинов. «Создание грамотно выстроенной практики пострегистрационных исследований в России нужно только приветствовать, — считает эксперт. – Важно только правильно расставить акценты: помнить, что обсуждается не эффективность препарата, а его безопасность; то есть именно то, на что мы должны обращать внимание с момента появления препарата и в течение всего его жизненного цикла. При этом важно оценивать не только клиническую, но и иммунологическую безопасность». По словам эксперта, независимое исследование безопасности иммунобиологических препаратов под государственным контролем должно проводиться регулярно и положительно восприниматься врачебным сообществом.

В заключение, спикеры резюмировали, что первый опыт пострегистрационного международного исследования оригинального российского препарата, инициированного компанией «НПО Петровакс Фарм», повысит интерес к проведению пострегистрационных исследований безопасности другими отечественными компаниями.

Пострегистрационные исследования безопасности (PASS) – это подгруппа пострегистрационных исследований, направленных на изучение и детализацию профиля безопасности лекарственного препарата и/или оценку мер по минимизации рисков медицинского применения.

1 EU PAS Register Guide [EMA/613603/2012]; Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies [EMA/48663/2013]; Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies [EMA/623947/2012]; Guideline on good pharmacovigilance practice (GVP), Module VIII, Rev1 [EMA/813938/2011]

2Регистрационный номер ЕU PAS: ENCEPP/SDPP/12387

Источник публикации: ООО «НПО Петровакс Фарм»

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pepgra-healthcare · 4 years

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