#ema guidelines on good pharmacovigilance practices

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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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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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Demystifying Regulatory Compliance for Biotechnology Products

Introduction

Biotechnology products, which include biologics, gene therapies, and cell-based therapies, are at the forefront of medical advancements, offering new treatment options for various diseases. However, due to their complex nature, ensuring regulatory compliance for biotechnology products can be challenging. In this article, we will demystify regulatory compliance for biotechnology products by exploring the key aspects and considerations involved in meeting regulatory requirements.

Understanding the Regulatory Landscape

The first step in ensuring compliance for biotechnology products is to understand the regulatory landscape. Different countries have specific regulatory agencies and guidelines governing the development, manufacturing, and marketing of biotechnology products. In the United States, for example, biologics are regulated by the US Food and Drug Administration (FDA), while the European Medicines Agency (EMA) oversees biologics in the European Union.

Preclinical and Clinical Development

Compliance with preclinical and clinical development requirements is essential to demonstrate the safety and efficacy of biotechnology products. This involves conducting comprehensive preclinical studies in animal models and well-designed clinical trials in human subjects. Following Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines ensures the reliability and integrity of data generated during these phases.

Quality Control and Manufacturing

Biotechnology products are often complex and sensitive to manufacturing processes. Compliance with Good Manufacturing Practice (GMP) is critical to ensure the consistency and quality of the final product. Manufacturers must implement robust quality control measures to monitor product attributes and address potential deviations. Check here pharma compliance consulting

Regulatory Submissions

Compliance with regulatory submissions involves preparing and submitting dossiers containing detailed information about the biotechnology product's development, manufacturing, safety, and efficacy data. These submissions may include Investigational New Drug (IND) applications, Biologics License Applications (BLAs), or Marketing Authorization Applications (MAAs), depending on the regulatory pathway.

Risk Management and Pharmacovigilance

Biotechnology products often carry unique safety considerations. Compliance with risk management and pharmacovigilance requirements involves continuous monitoring of safety data and taking appropriate risk mitigation measures when necessary. Post-market safety reporting and signal detection are essential to ensure patient safety.

Post-Market Surveillance

Compliance with post-market surveillance is essential for biotechnology products to assess their long-term safety and effectiveness. Manufacturers must continue to collect and analyze real-world data to monitor the product's performance in the broader patient population.

Labeling and Advertising

Compliance with labeling and advertising regulations ensures that the product's information provided to healthcare professionals and patients is accurate, comprehensive, and in line with regulatory requirements. Clear and transparent labeling is essential for informed decision-making.

Compliance Audits and Inspections

Regulatory authorities may conduct compliance audits and inspections to assess a company's adherence to regulatory requirements. Being prepared for such audits and promptly addressing any findings is crucial to maintain compliance.

Continuous Improvement

Compliance for biotechnology products is an ongoing process. Manufacturers must continuously improve their processes, address emerging issues, and update their practices in response to new regulations and scientific advancements.

Conclusion

Regulatory compliance for biotechnology products is a complex and dynamic process, but it is essential to ensure patient safety and the availability of innovative therapies. By understanding the regulatory landscape, conducting thorough preclinical and clinical development, implementing robust quality control and manufacturing processes, and complying with post-market surveillance requirements, stakeholders in the biotechnology industry can navigate the regulatory pathway successfully. Continuous improvement and proactive engagement with regulatory authorities are key to staying compliant and bringing safe and effective biotechnology products to patients worldwide.

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Ensuring Compliance and Safety: The Role of Auditing in the Pharmaceuticals Industry

Introduction:

The pharmaceuticals industry plays a critical role in improving global health by developing and manufacturing life-saving drugs and medications. As the demand for pharmaceutical products continues to rise, so does the need for stringent quality control measures and regulatory compliance. To maintain the highest standards of safety and efficacy, pharmaceutical companies rely on auditing as an indispensable tool in their operations.

Understanding Auditing in the Pharmaceuticals Industry:

Auditing in the pharmaceuticals sector involves a systematic examination of various aspects of a company's operations, processes, and documentation to ensure they meet industry regulations, quality standards, and best practices. These audits can be internal or external, with the primary objective of identifying potential issues, deviations, and areas for improvement.

Compliance with Regulatory Requirements: The pharmaceuticals industry is heavily regulated by government authorities worldwide. Auditing is a proactive approach to verify that a company adheres to the stringent regulations set by agencies such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA), and other international regulatory bodies. Non-compliance can lead to severe penalties, product recalls, and reputational damage, making auditing a vital safeguard.

Good Manufacturing Practices (GMP): GMP regulations are crucial to ensure the consistent quality and safety of pharmaceutical products. Auditing helps pharmaceutical companies assess their adherence to GMP guidelines, covering areas such as facility cleanliness, equipment maintenance, personnel training, and record-keeping. By identifying potential GMP gaps, companies can take corrective actions before issues escalate.

Quality Control and Assurance: In an industry where the consequences of product defects can be life-threatening, maintaining a robust quality control and assurance program is essential. Auditing provides an objective assessment of a company's quality management systems, testing procedures, and validation processes, helping to maintain the integrity of the drug manufacturing process.

Supply Chain Integrity: The pharmaceuticals industry relies on complex global supply chains. Auditing not only examines a company's internal processes but also extends to auditing suppliers and partners to ensure they meet the same high standards. This ensures that the raw materials used in drug production are of the highest quality and are obtained through legitimate channels.

Pharmacovigilance and Adverse Event Reporting: Pharmacovigilance is the practice of monitoring and assessing the safety of medications after they enter the market. Auditing helps pharmaceutical companies evaluate their pharmacovigilance systems, ensuring they promptly report any adverse events related to their products, which is crucial for patient safety.

For more info:-

Auditing In the Pharmaceuticals Industry

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EMA Seeks Feedback on Tracking Drug Safety in Pregnancy and Breastfeeding

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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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 оригинального 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 руко��одитель 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»