#ema 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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#Pharmacovigilance System Master File #PSMF #EMA #EU #MAH #Market Authorization Holder #Pharmacovigilance system #Good Pharmacovigilance Practices #MA #GVP #EEA #XEVMPD #EU Directive 2010/84/EU

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Paediatric trial of AZ COVID jab ‘halted as a precaution’

Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood clotting is investigated by the UK drugs regulator. 

Around 300 volunteers have been enrolled into the trial, but investigators have decided to pause dosing with the Oxford/AZ vaccine while they wait for an update from the Medicines and Healthcare products Regulatory Agency (MHRA).

The university has stressed that no safety concerns have emerged among young people who have already been dosed in the study, and it says parents and children should continue to attend all scheduled visits.

The trial started in February with the aim of recruiting 300 subjects aged between six and 17 years, with 240 due to receive the AZ1222 vaccine – now called Vaxzevria – while 60 would get a control meningitis vaccine. Results were expected in the summer.

The MHRA, EMA and WHO are all due to publish an update on cases of the rare blood clot cerebral venous sinus thrombosis (CVST) among people taking the AZ vaccine later this week, but are all saying that dosing with the shot should continue uninterrupted for now.

MHRA Chief Executive Dr June Raine reminds everyone to report side effects of Covid-19 vaccine to the #YellowCard scheme. Help make vaccines better for everyone.

Report at https://t.co/T6bTRtehs2#MHRAYellowCard #EveryReportCounts #Covid19 #Vaccination pic.twitter.com/um4llITp5k

— MHRAgovuk (@MHRAgovuk) April 6, 2021

One EMA official jumped the gun yesterday however, telling Italian newspaper il Messaggero in an interview there was a link between the AZ vaccine and CVST that would be announced shortly, possibly later today.

Marco Cavaleri, who heads the EMA’s vaccines strategy group, reiterated that the EMA’s advice remains that the AZ vaccine’s benefits outstrip any risks.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is meeting all this week, and according to its agenda is reviewing safety signals for both Vaxzevria and the Janssen-Cilag one-shot coronavirus vaccine, which was cleared for emergency use in the EU last month.

The document says blood clotting cases for both the AZ and Janssen-Cilag jabs will be assessed, along with a possible signal of capillary leak syndrome with Vaxzevria.

In a statement posted after the newspaper article was published, the EMA insisted that the PRAC “has not yet reached a conclusion and the review is currently ongoing”.

Sputnik V probe

It also emerged this week that the EMA is planning a separate investigation into the Russian Sputnik V vaccine, although that isn’t looking at safety.

Rather, the regulator is concerned that clinical testing of the shot may have contravened ethical and scientific standards, according to a Financial Times article, citing people familiar with the EMA’s approval process.

The probe stems from claims that military servicemen and state employees were pressured into taking part in the trial. The agency is in the midst of a review of Sputnik V to see if it can be granted emergency authorisation, but can’t give a green light if a trial has contravened good clinical practice (GCP) standards.

The Russian Direct Investment Fund (RDIF) promoting Sputnik V said that the vaccine has already been approved in dozens of countries around the world with no concerns about GCP. It has made repeated claims of bias against the shot in western nations.

Moderna rollout starts in Wales

Meanwhile, there was more good news for the UK’s coronavirus vaccination programme today as it emerged that the first doses of the Moderna vaccine have been delivered to health authorities in Wales, with dosing due to start imminently.

It is the third COVID-19 vaccine to be made available in the UK after the Oxford/AZ and Pfizer/BioNTech jabs, and the delivery comes a little earlier than expected. The first doses will be administered at Carmarthen’s Glangwili Hospital.

The arrival of the Moderna shot could go some way towards ameliorating an anticipated dip in supply of the AZ vaccine in the coming weeks.

The post Paediatric trial of AZ COVID jab ‘halted as a precaution’ appeared first on .

from https://pharmaphorum.com/news/paediatric-trial-of-az-covid-jab-halted-as-a-precaution/

[regulatoryinstitute]

Online Course for Pharmacovigilance - Career Upgrades and More

An online course for Pharmacovigilance is a necessity for professionals in this lucrative and promising career path. More and more fresh graduates and experienced professionals in the pharma industry are experiencing the importance of this training. Certification in this domain is the best thing if you want to stand ahead of your competitors. 

About Online Course for Pharmacovigilance

Enrolling in a course training to usher in your career in the field of pharmacovigilance is more of a necessity than an option. Even those with years of experience as a pharma professional can enhance their skills by enrolling in this course. This comprehensive training allows understanding of the different drug safety regulations. These laws include the EU-EMA, FDA, and ICH.

You develop advanced knowledge with an online course for Pharmacovigilance. The 12-week training empowers those who are key players in the industry particularly Drug Safety departments. Other functionaries that can be fully developed with this training course include Qualified Person for Pharmacovigilance (QPPV). 

Who needs to enroll?

Participating in certified pharmacovigilance training boosts your skills, thus, your career entry or promotion. Fresh graduates of any streams can jump-start their careers in this in-demand and relevant profession. However, it is also a good way to achieve much higher job positions than your current one.

Those who would benefit from enrolling in an online course for pharmacovigilance are Drug Safety Physicians and Auditors. Drug Safety Entry Associates, Drug Safety Data Analysts, and Drug Safety Triage Officers can also participate in the course. Drug Safety Regulatory Associates, Drug Safety Scientists, and Team Leaders/Managers in a pharmaceutical company also enroll.

Additional inputs are for those who want to achieve expertise in writing regulatory reports, aggregate reports, and other regulatory compliance. It will also benefit those who want detailed training in MedDra coding as well as medical narrative writing. 

Technical and Practical Training

One of the important things you need to consider when enrolling in pharmacovigilance courses is the service provider. Training institutes are not created equal. For instance, some offer a more comprehensive and efficient course than others. There are part-time and full-time training as well. Choose the training program that caters to your professional needs and preferences.

Comprehensive training programs usually require 12 weeks of extensive technical and practical training for participants. This training is provided by professional instructors. You will get the chance to work on live projects. This helps in better understand of this field. 

Online course for Pharmacovigilance opens doors for remarkable work opportunities in this lucrative and promising sector. All you have to do is fully equip yourself with the necessary tools. Start with calling the Global Institute for Regulatory Affairs for more course details and registration!

#pharmacovigilance training #pharmacovigilance course #pharmacovigilance certificate training #pharmacovigilance certification #pharmacovigilance course in Pune #pharmacovigilance online training #pharmacovigilance training courses

[lonnysapotheek]

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Canada believes it is too small to facilitate U.S. wholesale importation of lower-cost drugs. This post will explore a much greater potential for importation from the European Union.

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. personal importation) often rely on the common belief that the U.S. Food and Drug Administration exemplifies the “gold standard” in drug safety. This “gold standard” importation talking point from the Pharmaceutical and Researchers of America (PhRMA) fuels Americans’ fear of ordering medication internationally despite proof that importation can be very safe and provide financial relief and better adherence to prescriptions:

“The United States is the gold standard when it comes to regulating the safety of our medicine supply. Importing medicines from countries that do not have our same strong standards could taint our medicine supply.”

The first sentence is something you are supposed to take at face value. The second sentence is deceptively broad: as in, yes, importing medicines from countries that do not have our “same” standards could taint our medicine supply. Not necessarily, but it could.

If the U.S. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments.

The title of this blog post includes the name of the sequel to Lewis Carrol’s novel “Alice and Wonderland” called “Through the Looking Glass” – a world that Alice steps into through a mirror to discover everything is upside down. Testimony this week by the Government Accountability Office before the House Energy and Commerce Subcommittee on Oversight and Investigations about the FDA’s potential failures to protect the public health may not take you into such a totally lopsided universe, but it shows that things may not be so golden. The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” Eban walked us through the corruption and negligence among pharmaceutical manufacturers but also at the FDA, which has led to far more instances of substandard drugs than most people know.

The GAO’s report sharpens Eban’s point on why we will continue to see quality problems without improvements. According to the GAO, there were fewer domestic and foreign inspections from 2016-2018, 10% and 13% fewer respectively, after an increase between 2012-2016 that followed passage of the Food and Drug Administration Safety and Innovation Act of 2012.

Job vacancies seem to be endemic for foreign drug establishment FDA inspectors. Out of 168 available positions for U.S.-based inspectors who go overseas, 66 remained unfilled. For foreign-based inspectors, the vacancy rate in China and India was 30% and 33%, respectively.

A majority of inspections resulted in findings of non-compliance. Between 2012-2018, inspectors found “deficiencies” in 64% and 59% of foreign and domestic establishments, respectively. Perhaps most troubling is that when inspectors’ findings included the most severe designation, called Official Action Indicated, the FDA’s Center for Research and Development (CEDR) downgraded that determination to Voluntary Action Indicated. The GAO plans to follow up on that to find out why.

The GAO also reported that foreign inspections are usually pre-announced by 12 weeks, whereas domestic inspections maintain the element of surprise. The FDA inspectors often must rely on translators hired by the drug companies, where the best option is having independent translators onsite. To make matters worse, the FDA did not know exactly how many inspections were pre-announced vs. those that were not. The FDA told the GAO that the agency “does not have a data field in its database to systematically track this information.” Add one.

There are certainly strong counterpoints against the above criticisms, including the ones I wrote about in defense of the FDA’s overall public health mission and work. I pointed out that the last two decades have actually seen improvements in the FDA’s drug plant inspection program. Those improvements were also duly noted in the GAO’s report. The reality is that in 2008 the FDA’s inspection database was kind of a complete mess (there’s no need to put that eloquently). GAO stated:

“In our 2008 report we found that, because of inaccurate information in FDA’s databases, the agency did not know how many foreign drug establishments were subject to inspection.”

In 2018, an estimated 8% of foreign establishments subject to inspection were actually inspected. Today, the FDA tells the GAO that 1,000 foreign establishments without an inspection record in 2017 have either all been inspected or were no longer subject to inspection.

What about other countries? The European Union (EU) has similar challenges to us when it comes to drug safety, including inspections of the plants that make pharmaceuticals for the European market. In fact, they have the exact same problems as we do in ensuring that the active pharmaceutical ingredients (APIs) used to make our drugs are of the highest quality and without contaminants. Why do I write “exact same”? Because sometimes we’re dealing with same factories making the same APIs, which turn out to have problems. In 2018, as reported in FiercePharma, on the same day the EU revoked its certificate of approval from a Chinese manufacturer Zhejiang Huahai due to impurities found in its Valsartan API, the FDA slapped an import alert on the same company banning its products.

The two agencies realize that they need to cooperate more for better results and acted on that realization. Clearly, the FDA acknowledges the relative strength of the EU on drug safety. That’s why increasingly the FDA is relying on inspections from EU member countries in lieu of an FDA inspection through the U.S.-EU Mutual Recognition Agreement, which the FDA titles “A New World for Pharmaceutical Inspections.” They both require the most advanced cGMP or current Good Manufacturing Practices. This quote from Pearl Pathways sums it up nicely:

“The Mutual Recognition Agreement allows EMA and FDA to optimize their inspection capacity and eliminate the need for inspections from multiple agencies. This will enable patients to trust the safety, identity, strength, purity, and quality of all medicines, no matter where the products are manufactured or which agency inspected the manufacturer.”

When it comes to the approval of new drugs, brand and generic, the systems of the U.S. and the EU are very similar.  The two agencies almost always agree on which drugs should be approved, although there is some dialog of a potential growing divergence. For each drug regulatory authority, before a drug is approved, three phases of clinical trials of increasing complexity and scope in human subjects and proof that a drug will be manufactured correctly under Current Good Manufacturing Practices are required. Both the EU and the U.S. also track a drug’s safety even after approval, by detecting, recording and monitoring a drug’s side effects, which is called pharmacovigilance. 

For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system

For a longer report about the U.S drug regulatory system, see: How FDA Approves Drugs and Regulates Their Safety and Effectiveness

When it comes to a system of track and trace of approved prescription drugs through their respective supply chains, which help prevent fake meds, the EU is ahead of the U.S. The EU already mandates full compliance with the Falsified Medicines Directive (FMD). FMD requires that every single prescription drug dispensed in the EU must be verified for authenticity via a mandatory 2D barcode on the packaging. The U.S. counterpart, the Drug Supply Chain Security Act (DSCSA) doesn’t come into full force until 2023.  Also, the DSCSA doesn’t require verification of all dispensed drugs, but only requires the ability to do so if there’s a suspect product.

See: FMD (EU) and DSCSA (US) — how they differ

Is the EU now the gold standard for combatting drug quality problems and fake meds?  

According to product safety and quality experts at Mettler and Toledo: “Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients.” I agree with this 100%.

For the reasons stated above: an American who is able to safely import a drug from a licensed pharmacy in the European Union or the UK (!), assumes no additional health risks different from those present at a local Walgreens. And, as discovered in research from the House Ways and Means Committee and PharmacyChecker, the drug prices will often be about 72% less.

We can no longer afford to accept Pharma’s Alice in Wonderland arguments against drug importation. Let’s step back through the looking glass to see things as they really are: Drugs in the European Union are just as safe as they are here. Maybe Canada is too small a market but the European Union has over half a trillion people, much bigger than the U.S. That makes the prospect for importation very real.

from PharmacyChecker Blog https://ift.tt/34g9Frp via IFTTT

#IFTTT #PharmacyChecker Blog

[pacificbiosafety]

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…

View On WordPress

#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

[healthcaremarketresearch201-blog]

Healthcare Contract Research Outsourcing Market Latest Trends, Demand and Analysis 2025

Healthcare Contract Research Outsourcing Market: Snapshot

The global healthcare contract research outsourcing market is rising with increasing complex regulatory process & growing regulatory burden. The global healthcare contract research outsourcing market was valued over US$ 30 Bn in 2016 and is projected to witness cumulative annual growth rate (CAGR) of over 6% from 2017 to 2025 to surpass the value of US$ 54 Bn by 2025. The global market is witnessing relatively higher growth owing to globalization of clnical trials, increasing efforts for optimization of costs and development time for drug development and rise in varied services and solutions offered by the CROs.

View Report: https://www.transparencymarketresearch.com/hcro-market.html

Healthcare companies often outsource drug development functions to contract research organizations to efficiently and effectively use the development capabilities internationally. The clinical, therapeutic and regulatory expertise of CROs helps to improve the complete cost of development and accelerate time to market for a new product. CROs have become larger and enormously more diversified across various therapeutic areas and functions, expanding their penetration. CROs are anticipated to expand geographically and add competencies in emerging therapeutic areas, while boosting their current services beyond traditional clinical capabilities, including post-approval, commercial, informatics, among other auxillary offerings where low outsourced penetration observed, further enhancing the demand for CROs, driving greater outsourcing demand. The healthcare contract research outsourcing market is projected to witness strong growth during the forecast period driven by increase in funding of small to midsized pharmaceutical, biotechnology, and medical devices companies leading the companies to opt for CRO services with focus on niche market.

Small pharmaceutical companies are also looking for advancement in product development through CRO services due to rise in demand for innovative products and patent expiration. Also outsourcing improves the global reach with respect to drug development with minimum maintenance cost, as CROs are well-versed with regulatory requirements of various regions to fuelling the expansion of healthcare contract research outsourcing market.

Request a Brochure of the Report @ https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=800

The global healthcare contract research outsourcing market is broadly segmented into four categories based on service, therapeutic area and end user and by region. In terms of services, the global market is categorized into on clinical trial services, regulatory services, clinical data management & biometrics (electronica data management, electronic patient report outcomes and others), medical writing, pharmacovigilance, site management protocol and others. The clinical trial services is further segmented into preclinical & clinical. The clinical data management & biometrics is further segmented into electronica data management, electronic patient report outcomes and others. The market for clinical trial services accounted for key share (in terms of revenue) in global market in 2016, the regulatory services in healthcare contract research outsourcing is estimated to grow at exponential growth rate during the forecast period and the segment is estimated to report significant gain in its market share by the end of 2025. The regulatory services outsourcing is anticipated to increase due to increased scrutiny by regulatory bodies such as the FDA and EMA at every stage of clinical trial and changing regulatory requirements as per the region.

In terms of therapeutic area, the global healthcare contract research outsourcing is segmented into oncology/hematology, CNS, CV/metabolic, respiratory, infectious diseases, immunology, rare diseases, medical devices and others. The oncology/hematology segment dominated the global market and is likely to maintain its dominance by the end of 2025 with marginal decline in its market share. A robust pipeline of more than 600 molecules for oncology in late-stage development and the emergence of oncology therapy as a personalized medicine has led to prominent share of the segment in global market. By end-user, the global healthcare contract research outsourcing market has been segmented into pharmaceutical companies, biotechnology companies, medical devices and academic institutes & government organizations.

Request a Sample of the Report @ https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=800

Geographically, the global dental practice management market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America dominated the global market and is projected to slightly lose its market share by the end of 2025. The Market in the North America is primarily driven by the advanced infrastructure of clinical research sites, and effective government incentive programs in United States. Moreover increased access to specialized technologies and therapeutics expertise is projected to fuel the expansion of clinical trial services in the United States during the forecast period. Asia Pacific region is projected to be fastest growing region in global healthcare contract research outsourcing market during the forecast period. In Asia Pacific region, China and India dominated the Healthcare CRO market and India is estimated to grow at exponential CAGR during the forecast period.

The companies like Syneos Health, IQVIA, PRA Health Sciences, Inc., ICON PLC, and Laboratory Corporation of America Holdings etc. accounted for the major share in global healthcare contract research outsourcing market in 2016. The IQVIA Company has presence in more than 100 countries with domain expertise, institutional knowledge across scientific methods, diseases and geographies. Other global players operating in the market PAREXEL International, Charles River, Medpace and Pharmaceutical Product Development, LLC are adopting the strategy acquisition and collaboration with parallel companies to expand its service and strengthen its geographic presence in international market.

About Us

Transparency Market Research (TMR) is a market intelligence company, providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants, use proprietary data sources and various tools and techniques to gather, and analyze information. Our business offerings represent the latest and the most reliable information indispensable for businesses to sustain a competitive edge.

Each TMR syndicated research report covers a different sector - such as pharmaceuticals, chemicals, energy, food & beverages, semiconductors, med-devices, consumer goods and technology. These reports provide in-depth analysis and deep segmentation to possible micro levels. With wider scope and stratified research methodology, TMR’s syndicated reports strive to provide clients to serve their overall research requirement.

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[azveille]

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. 

[vovamayskiy]

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 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. Р��зультаты 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 пр��менения.

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»

[pharmaphorumuk]

WHO backs safety of AstraZeneca vaccine ahead of key EU meeting

The World Health Organization has backed the safety of the Oxford University/AstraZeneca vaccine ahead of a key announcement from European safety experts later today.

Several major European countries including Germany, Italy and France have temporarily suspended use of the vaccine amid fears that it could be linked to blood clots.

There have been cases of blood clots after administration of the vaccine, but it’s a common health condition and data so far suggest that rates of blood clots in the vaccinated population are lower than in the general population.

Underlying the regulators’ decision is a whiff of politics, as several journalists pointed out in a press briefing with the European Medicines Agency yesterday.

The EU ordered its vaccines from AstraZeneca much later than the UK and some states have been quick to blame the pharma company for delivery shortfalls.

Later today the EMA’s Pharmacovigilance Risk Assessment Committee is due to make an announcement on the safety of the vaccine following a fast review.

In a statement the WHO noted the decision by some EU countries to suspend use of the vaccine, noting that other EU states, having considered the same information, have decided to continue using it as part of their immunisation programme.

The WHO noted in its statement that vaccination against COVID-19 will not reduce illness or deaths from other causes.

The WHO added: “Thromboembolic events are known to occur frequently. Venous thromboembolism is the third most common cardiovascular disease globally.

“In extensive vaccination campaigns, it is routine for countries to signal potential adverse events following immunisation.

“This does not necessarily mean that the events are linked to vaccination itself, but it is good practice to investigate them. It also shows that the surveillance system works and that effective controls are in place.

“WHO is in regular contact with the European Medicines Agency and regulators around the world for the latest information on COVID-19 vaccine safety.

“The WHO Global Advisory Committee on Vaccine Safety is carefully assessing the latest available safety data for the AstraZeneca vaccine. Once that review is completed, WHO will immediately communicate the findings to the public.

“At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue.”

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from https://pharmaphorum.com/news/who-backs-safety-of-astrazeneca-vaccine-ahead-of-key-eu-meeting/

[healthcaremarketresearch201-blog]

Healthcare Contract Research Outsourcing Market Current Trends and Future Aspect Analysis 2025

Healthcare Contract Research Outsourcing Market: Snapshot

The global healthcare contract research outsourcing market is rising with increasing complex regulatory process & growing regulatory burden. The global healthcare contract research outsourcing market was valued over US$ 30 Bn in 2016 and is projected to witness cumulative annual growth rate (CAGR) of over 6% from 2017 to 2025 to surpass the value of US$ 54 Bn by 2025. The global market is witnessing relatively higher growth owing to globalization of clnical trials, increasing efforts for optimization of costs and development time for drug development and rise in varied services and solutions offered by the CROs.

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Healthcare companies often outsource drug development functions to contract research organizations to efficiently and effectively use the development capabilities internationally. The clinical, therapeutic and regulatory expertise of CROs helps to improve the complete cost of development and accelerate time to market for a new product. CROs have become larger and enormously more diversified across various therapeutic areas and functions, expanding their penetration. CROs are anticipated to expand geographically and add competencies in emerging therapeutic areas, while boosting their current services beyond traditional clinical capabilities, including post-approval, commercial, informatics, among other auxillary offerings where low outsourced penetration observed, further enhancing the demand for CROs, driving greater outsourcing demand. The healthcare contract research outsourcing market is projected to witness strong growth during the forecast period driven by increase in funding of small to midsized pharmaceutical, biotechnology, and medical devices companies leading the companies to opt for CRO services with focus on niche market. Small pharmaceutical companies are also looking for advancement in product development through CRO services due to rise in demand for innovative products and patent expiration. Also outsourcing improves the global reach with respect to drug development with minimum maintenance cost, as CROs are well-versed with regulatory requirements of various regions to fuelling the expansion of healthcare contract research outsourcing market.

The global healthcare contract research outsourcing market is broadly segmented into four categories based on service, therapeutic area and end user and by region. In terms of services, the global market is categorized into on clinical trial services, regulatory services, clinical data management & biometrics (electronica data management, electronic patient report outcomes and others), medical writing, pharmacovigilance, site management protocol and others. The clinical trial services is further segmented into preclinical & clinical. The clinical data management & biometrics is further segmented into electronica data management, electronic patient report outcomes and others. The market for clinical trial services accounted for key share (in terms of revenue) in global market in 2016, the regulatory services in healthcare contract research outsourcing is estimated to grow at exponential growth rate during the forecast period and the segment is estimated to report significant gain in its market share by the end of 2025. The regulatory services outsourcing is anticipated to increase due to increased scrutiny by regulatory bodies such as the FDA and EMA at every stage of clinical trial and changing regulatory requirements as per the region.

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In terms of therapeutic area, the global healthcare contract research outsourcing is segmented into oncology/hematology, CNS, CV/metabolic, respiratory, infectious diseases, immunology, rare diseases, medical devices and others. The oncology/hematology segment dominated the global market and is likely to maintain its dominance by the end of 2025 with marginal decline in its market share. A robust pipeline of more than 600 molecules for oncology in late-stage development and the emergence of oncology therapy as a personalized medicine has led to prominent share of the segment in global market. By end-user, the global healthcare contract research outsourcing market has been segmented into pharmaceutical companies, biotechnology companies, medical devices and academic institutes & government organizations.

Geographically, the global dental practice management market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America dominated the global market and is projected to slightly lose its market share by the end of 2025. The Market in the North America is primarily driven by the advanced infrastructure of clinical research sites, and effective government incentive programs in United States. Moreover increased access to specialized technologies and therapeutics expertise is projected to fuel the expansion of clinical trial services in the United States during the forecast period. Asia Pacific region is projected to be fastest growing region in global healthcare contract research outsourcing market during the forecast period. In Asia Pacific region, China and India dominated the Healthcare CRO market and India is estimated to grow at exponential CAGR during the forecast period.

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The companies like Syneos Health, IQVIA, PRA Health Sciences, Inc., ICON PLC, and Laboratory Corporation of America Holdings etc. accounted for the major share in global healthcare contract research outsourcing market in 2016. The IQVIA Company has presence in more than 100 countries with domain expertise, institutional knowledge across scientific methods, diseases and geographies. Other global players operating in the market PAREXEL International, Charles River, Medpace and Pharmaceutical Product Development, LLC are adopting the strategy acquisition and collaboration with parallel companies to expand its service and strengthen its geographic presence in international market.

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