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Pharmacovigilance

Med Communications’ team of highly skilled pharmacovigilance professionals bring practical experience and diverse perspectives to the table, having worked with a variety of product portfolios including pharma, vaccine, cosmetics, medical devices, and combination products. Our PV specialists have medical, pharmaceutical, and scientific backgrounds, and many held positions in sponsor and MAH organizations before joining Med Communications.

Our pharmacovigilance team features independent thinkers who help create tailored solutions for our clients and adapt to evolving needs of the industry. Backed by the latest applicable technology, our staff is able to provide flexible and compliant solutions for our clients, acting as true partners for your in-house teams.

Med Communications works closely with clients to cover all aspects of the pharmacovigilance process, including individual case safety reports, periodic reports, signal detection activities, and reports to regulatory authorities. We have established pharmacovigilance systems in the US and many countries worldwide, including in the EMEA and APAC regions.

We continuously keep track of technological trends and the regulators’ views on them, as we are exploring possibilities to leverage technology in order to optimize our internal PV processes and increase efficiency while decreasing costs.

Whether you are looking for a flexible service provider that offers a complete pharmacovigilance program or just want to outsource some parts of your PV activities, we are the right partner for you.

Full Suite of Pharmacovigilance Services:

  • Case Processing

    At Med Communications, we provide full support for pharmacovigilance (PV) projects—from all phases of clinical trials, over spontaneous and solicited post-marketing individual case safety reports (ICSR), to patient support programs, pregnancy registries, and scientific and medical literature reports. We offer our clients complete end-to-end workflow management for their PV activities, including collection, processing, medical evaluation, and single case reporting of adverse events.

    Our PV team includes professionals from various medical, pharmaceutical, and academic backgrounds who together offer a broad range of experience and knowledge in the different case processing areas. We assess the validity and seriousness of incoming cases and ensure the timelines for submission to regulatory authorities are met. At the core of case processing, we determine causality as well as listedness according to the reference safety information of the product. In addition to routine case reports of adverse events, we also process special situations, such as pregnancy, overdose, abuse, misuse, lack of effect, and medication errors.

    We handle compliant submissions of single cases following the E2B R2 and R3 standards via industry standard gateways. We use state-of-the-art database software, such as Argus and SafetyEasy, to process and report cases to regulatory authorities. Our expertise includes working within the regulatory environments of the United States, with the Food and Drug Administration (FDA), and Europe, with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory agencies worldwide. With a functional PV system in place, our depth of experience gives us the unique opportunity not only to offer our clients support in the markets within which their products are already available, but also to assist during expansion into new markets.

    In addition to processing and submitting cases in a high-quality and compliant manner, we conduct reconciliation with teams in other non-PV functions, such as medical information, study teams, quality assurance teams, and other business partners.

  • Aggregate Reports

    Aggregate reports provide periodic review of safety data in a global and cumulative way instead of looking at individual cases. While the concept is simple, the process can become complex to manage. To understand the benefit-risk profile of a product, the process requires the collection and assessment of safety data, as well as handling the necessary aggregate reports across a product’s lifecycle in various markets.

    The Med Communications Pharmacovigilance (PV) team provides complete end-to-end management of all aggregate report types including, but not limited to, the Periodic Adverse Drug Experience Report (PADER or PAER); the Periodic Benefit Risk Evaluation Report (PBRER); the legacy Periodic Safety Update Report (PSUR), which is still used in some markets; and Investigational New Drug (IND) Annual Reports, especially where there is no Development Safety Update Report (DSUR) waiver available. Our PV services include periodic submission of individual case safety reports (ICSRs) to the appropriate regulatory authorities in support of the aggregate reports. Our PV team can also handle ad hoc report requests, such as Suspected Unexpected Serious Adverse Reaction (SUSAR)/Serious Adverse Event (SAE)/Adverse Event (AE) line listings, AE summary tabulations, and CIOMS II line listings, for clients and regulatory authorities.

    Aggregate reports project management assists clients with templates, data retrieval/requests, the review process, and timelines to facilitate the contribution of the different stakeholders involved in the process and to assure compliance with submission deadlines. To analyze the data and draft the content of the required reports, our experienced PV professionals query the safety database to retrieve the necessary data and listings to be analyzed and review the additional information provided by the client. As a standard to the aggregate reports process, the PV team employs internal quality and medical reviews before submitting the reports to the client for their review and approval.

    Our PV team will use their expertise and all available tools to assist clients with forecasting the reports required for each market and product and with planning the appropriate reporting periods, data lock points, and submission dates for each regulatory authority.

  • Signal Management

    In the last few years signal management has caught the attention of regulatory authorities, especially in the context of the exponential rise in data volume and the change in the type of sources. At Med Communications, the Pharmacovigilance (PV) team is constantly refining their skills and technologies to provide our clients with state-of-the-art methodologies for signal detection and management activities.

    Med Communications’ signal management processes are focused on the review of aggregate data from all sources, the analysis of individual case safety reports (ICSRs), and the impact of emerging signals on the risk-benefit profile of the product. Our team applies a comprehensive approach to optimize signal detection and management activities, finding efficiencies and leveraging the appropriate methods without compromising quality. Our best practice-based process takes into account the characteristics of our clients’ portfolios and includes the most effective methods to their data sets.

    Our PV team provides oversight, reviews signals, and offers valuable recommendations. We perform routine analysis and identification of potential signals, signal validation, confirmation, signal analysis, and prioritization, as well as signal assessment and recommendations for action, in accordance with applicable regulations (Good Pharmacovigilance Practices [GVP]—Module IX, FDA’s Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, CIOMS Working Group VIII recommendations, etc).

    Through our expertise and clearly defined process, applying consistent signal evaluation and documentation methods, validated templates, and a well-established decision process, we provide an audit-ready environment.

  • Pharmacovigilance Consulting Services

    Pharmacovigilance (PV) regulatory requirements are constantly evolving. At the same time, the volume and complexity of collected safety data continue to increase, coming from an expanding variety of sources and shifting rapidly.

    The experienced team of PV professionals at Med Communications can provide companies in the biomedical industry with the support they need for navigating this complex and dynamic environment, ensuring full compliance with regulations across all markets and streamlining the process of managing safety data. Our knowledge spans across various therapeutic areas and geographical regions and all phases of product development.

    Building on years of hands-on experience and leveraging a well-established quality management system, PV processes, and appropriate digital tools, our PV professionals can help companies establish a fit-for-purpose PV system, on time and on budget.

    We can work with you to optimize your PV system and processes by helping you:

    • prepare standard operating procedures (SOPs), working instructions and handling guides, templates, trackers, job descriptions, training plans, and aggregate reports
    • perform literature screening and full safety signal evaluation and documentation, in compliance with applicable guidelines
    • prepare responses to requests coming from regulatory authorities
    • perform medical review of safety data.

    We can also provide guidance and support during audits and regulatory inspections, write and implement safety data exchange agreements with corporate partners, offer drug safety database support, and assist with vendor selection.
    Our project leaders, dedicated senior PV professionals, handle your PV project end to end and serve as your point of contact, applying excellent communication and project management skills.

    Working with our team of PV professionals can help elevate your business by improving safety and compliance standards and streamlining PV processes. This, in turn, can help you save time and money by allowing your in-house experts to adopt a more strategic role to improve the safety profile of your products.

  • Pharmacovigilance System Master File (PSMF)

    Marketing authorization holders are required to establish or to have access to a pharmacovigilance (PV) system that covers all PV activities. A PV system needs to clearly show the organization of the roles and responsibilities involved and include the activities of collection and processing of safety information, reporting to regulatory authorities, signal detection, and risk minimization. These PV activities and processes need to be described in standard operating procedure (SOP) documents that become part of the PV Quality Management System (QMS).

    Since 2012, a detailed document, titled the Pharmacovigilance System Master File (PSMF), has been required in the European Union (EU)/European Economic Area (EEA) to describe a company’s PV system and its associated QMS. The PSMF must indicate all PV activities and stakeholders involved, and it must be continuously updated. Several other countries around the world also require a PSMF or a similar document, which may have country-specific requirements.

    At Med Communications we understand that the PSMF can be a challenging document to create and maintain and that there are no workarounds. Our PV professionals have the tools, templates, and accelerators to quickly and efficiently help our clients establish a complete and compliant PSMF. We take on this responsibility for our clients, working closely with them to collect the required information, write the main document and annexes, and maintain the PSMF over time within defined review cycles. We develop the PSMF based on specific local requirements, thereby helping our clients expand their businesses.

  • PV Support for Clinical Trials

  • Literature Surveillance

    The Med Communications Pharmacovigilance (PV) department provides a dedicated team for scientific literature surveillance activities. In the United States, literature surveillance is required from the point at which a medicinal product receives marketing authorization. In Europe, weekly surveillance of the worldwide scientific and medical literature is required from the moment the marketing authorization request is submitted to the European Medicines Agency (EMA). We also offer literature surveillance for products in clinical trial stages that is tailored to each client’s needs and expectations.

    Our literature surveillance support includes retrieval, assessment, and case processing of individual case reports from the scientific literature. We provide weekly reports regarding activities in the literature and the cases that have been retrieved for entry into the safety database and reporting to the regulatory authorities. In addition, we track relevant aggregate data and reports of special situations that are included in periodic safety update reports (PSUR) or for assessment during signal detection activities.

    Our team has years of experience in the configuration of literature search terms for different medicinal products, including medical devices. We use online Embase and Medline databases for our standard literature search analyses. We also use a compliant software tool to track and retain all information pertaining to safety data received from the literature. We work in accordance with the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VI and can assure compliance and audit readiness for our clients.

  • Risk Management Plans (RMP)

Case Processing

At Med Communications, we provide full support for pharmacovigilance (PV) projects—from all phases of clinical trials, over spontaneous and solicited post-marketing individual case safety reports (ICSR), to patient support programs, pregnancy registries, and scientific and medical literature reports. We offer our clients complete end-to-end workflow management for their PV activities, including collection, processing, medical evaluation, and single case reporting of adverse events.

Our PV team includes professionals from various medical, pharmaceutical, and academic backgrounds who together offer a broad range of experience and knowledge in the different case processing areas. We assess the validity and seriousness of incoming cases and ensure the timelines for submission to regulatory authorities are met. At the core of case processing, we determine causality as well as listedness according to the reference safety information of the product. In addition to routine case reports of adverse events, we also process special situations, such as pregnancy, overdose, abuse, misuse, lack of effect, and medication errors.

We handle compliant submissions of single cases following the E2B R2 and R3 standards via industry standard gateways. We use state-of-the-art database software, such as Argus and SafetyEasy, to process and report cases to regulatory authorities. Our expertise includes working within the regulatory environments of the United States, with the Food and Drug Administration (FDA), and Europe, with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory agencies worldwide. With a functional PV system in place, our depth of experience gives us the unique opportunity not only to offer our clients support in the markets within which their products are already available, but also to assist during expansion into new markets.

In addition to processing and submitting cases in a high-quality and compliant manner, we conduct reconciliation with teams in other non-PV functions, such as medical information, study teams, quality assurance teams, and other business partners.

Aggregate Reports

Aggregate reports provide periodic review of safety data in a global and cumulative way instead of looking at individual cases. While the concept is simple, the process can become complex to manage. To understand the benefit-risk profile of a product, the process requires the collection and assessment of safety data, as well as handling the necessary aggregate reports across a product’s lifecycle in various markets.

The Med Communications Pharmacovigilance (PV) team provides complete end-to-end management of all aggregate report types including, but not limited to, the Periodic Adverse Drug Experience Report (PADER or PAER); the Periodic Benefit Risk Evaluation Report (PBRER); the legacy Periodic Safety Update Report (PSUR), which is still used in some markets; and Investigational New Drug (IND) Annual Reports, especially where there is no Development Safety Update Report (DSUR) waiver available. Our PV services include periodic submission of individual case safety reports (ICSRs) to the appropriate regulatory authorities in support of the aggregate reports. Our PV team can also handle ad hoc report requests, such as Suspected Unexpected Serious Adverse Reaction (SUSAR)/Serious Adverse Event (SAE)/Adverse Event (AE) line listings, AE summary tabulations, and CIOMS II line listings, for clients and regulatory authorities.

Aggregate reports project management assists clients with templates, data retrieval/requests, the review process, and timelines to facilitate the contribution of the different stakeholders involved in the process and to assure compliance with submission deadlines. To analyze the data and draft the content of the required reports, our experienced PV professionals query the safety database to retrieve the necessary data and listings to be analyzed and review the additional information provided by the client. As a standard to the aggregate reports process, the PV team employs internal quality and medical reviews before submitting the reports to the client for their review and approval.

Our PV team will use their expertise and all available tools to assist clients with forecasting the reports required for each market and product and with planning the appropriate reporting periods, data lock points, and submission dates for each regulatory authority.

Signal Management

In the last few years signal management has caught the attention of regulatory authorities, especially in the context of the exponential rise in data volume and the change in the type of sources. At Med Communications, the Pharmacovigilance (PV) team is constantly refining their skills and technologies to provide our clients with state-of-the-art methodologies for signal detection and management activities.

Med Communications’ signal management processes are focused on the review of aggregate data from all sources, the analysis of individual case safety reports (ICSRs), and the impact of emerging signals on the risk-benefit profile of the product. Our team applies a comprehensive approach to optimize signal detection and management activities, finding efficiencies and leveraging the appropriate methods without compromising quality. Our best practice-based process takes into account the characteristics of our clients’ portfolios and includes the most effective methods to their data sets.

Our PV team provides oversight, reviews signals, and offers valuable recommendations. We perform routine analysis and identification of potential signals, signal validation, confirmation, signal analysis, and prioritization, as well as signal assessment and recommendations for action, in accordance with applicable regulations (Good Pharmacovigilance Practices [GVP]—Module IX, FDA’s Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, CIOMS Working Group VIII recommendations, etc).

Through our expertise and clearly defined process, applying consistent signal evaluation and documentation methods, validated templates, and a well-established decision process, we provide an audit-ready environment.

Pharmacovigilance Consulting Services

Pharmacovigilance (PV) regulatory requirements are constantly evolving. At the same time, the volume and complexity of collected safety data continue to increase, coming from an expanding variety of sources and shifting rapidly.

The experienced team of PV professionals at Med Communications can provide companies in the biomedical industry with the support they need for navigating this complex and dynamic environment, ensuring full compliance with regulations across all markets and streamlining the process of managing safety data. Our knowledge spans across various therapeutic areas and geographical regions and all phases of product development.

Building on years of hands-on experience and leveraging a well-established quality management system, PV processes, and appropriate digital tools, our PV professionals can help companies establish a fit-for-purpose PV system, on time and on budget.

We can work with you to optimize your PV system and processes by helping you:

  • prepare standard operating procedures (SOPs), working instructions and handling guides, templates, trackers, job descriptions, training plans, and aggregate reports
  • perform literature screening and full safety signal evaluation and documentation, in compliance with applicable guidelines
  • prepare responses to requests coming from regulatory authorities
  • perform medical review of safety data.

We can also provide guidance and support during audits and regulatory inspections, write and implement safety data exchange agreements with corporate partners, offer drug safety database support, and assist with vendor selection.
Our project leaders, dedicated senior PV professionals, handle your PV project end to end and serve as your point of contact, applying excellent communication and project management skills.

Working with our team of PV professionals can help elevate your business by improving safety and compliance standards and streamlining PV processes. This, in turn, can help you save time and money by allowing your in-house experts to adopt a more strategic role to improve the safety profile of your products.

Pharmacovigilance System Master File (PSMF)

Marketing authorization holders are required to establish or to have access to a pharmacovigilance (PV) system that covers all PV activities. A PV system needs to clearly show the organization of the roles and responsibilities involved and include the activities of collection and processing of safety information, reporting to regulatory authorities, signal detection, and risk minimization. These PV activities and processes need to be described in standard operating procedure (SOP) documents that become part of the PV Quality Management System (QMS).

Since 2012, a detailed document, titled the Pharmacovigilance System Master File (PSMF), has been required in the European Union (EU)/European Economic Area (EEA) to describe a company’s PV system and its associated QMS. The PSMF must indicate all PV activities and stakeholders involved, and it must be continuously updated. Several other countries around the world also require a PSMF or a similar document, which may have country-specific requirements.

At Med Communications we understand that the PSMF can be a challenging document to create and maintain and that there are no workarounds. Our PV professionals have the tools, templates, and accelerators to quickly and efficiently help our clients establish a complete and compliant PSMF. We take on this responsibility for our clients, working closely with them to collect the required information, write the main document and annexes, and maintain the PSMF over time within defined review cycles. We develop the PSMF based on specific local requirements, thereby helping our clients expand their businesses.

PV Support for Clinical Trials

Literature Surveillance

The Med Communications Pharmacovigilance (PV) department provides a dedicated team for scientific literature surveillance activities. In the United States, literature surveillance is required from the point at which a medicinal product receives marketing authorization. In Europe, weekly surveillance of the worldwide scientific and medical literature is required from the moment the marketing authorization request is submitted to the European Medicines Agency (EMA). We also offer literature surveillance for products in clinical trial stages that is tailored to each client’s needs and expectations.

Our literature surveillance support includes retrieval, assessment, and case processing of individual case reports from the scientific literature. We provide weekly reports regarding activities in the literature and the cases that have been retrieved for entry into the safety database and reporting to the regulatory authorities. In addition, we track relevant aggregate data and reports of special situations that are included in periodic safety update reports (PSUR) or for assessment during signal detection activities.

Our team has years of experience in the configuration of literature search terms for different medicinal products, including medical devices. We use online Embase and Medline databases for our standard literature search analyses. We also use a compliant software tool to track and retain all information pertaining to safety data received from the literature. We work in accordance with the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VI and can assure compliance and audit readiness for our clients.

Risk Management Plans (RMP)

For more information on pharmacovigilance and risk management, click the following links.

  • What Is Pharmacovigilance?

    Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.1

    Patient safety is always a priority for pharmaceutical companies. Making medicines to improve lives requires monitoring all aspects of safety and assessing the data associated with the patient experience for the life of the product. The tasks associated with the collection, input, and assessment of the adverse event information are performed by skilled health care professionals. Across the industry, these professionals are technically proficient. They recognize the importance of staying current, given the dynamic regulatory environment around the world.

    The collection and processing of adverse event information requires many steps by individuals with special training in pharmacovigilance. The manner in which these steps are executed are dictated by regulations. Each country or geographical area are governed by regulatory authorities. Each of these regulatory authorities, where a product is marketed, determine how and when qualifying adverse event information gets reported. Pharmaceutical companies often rely on external vendors to perform daily or periodic regulatory reporting tasks on their behalf.

    Med Communications has a global pharmacovigilance team ready to serve your company’s needs. Physicians, pharmacists, nurses, and other health care professionals are fully trained in all aspects of pharmacovigilance and provide outstanding support.

    References:

    1 World Health Organization. The importance of pharmacovigilance: safety Monitoring of medicinal products. [Internet]. 2002. [cited 14 Oct 2020]. Available from: http://whqlibdoc.who.int/hq/2002/a75646.pdf?ua=1&ua=1

  • What Is Risk Management?

    Risk management activities within pharmacovigilance have evolved in the last several years. The development of new products outside of the traditional small and large molecules require broader views of how to obtain adverse event information and use current technologies to assess this data. The industry must keep an eye to the future and be prepared to anticipate how best to capture and evaluate this data.

    According to the Drug Information Association (DIA), “Today’s safety and pharmacovigilance professionals assess and manage risk of a broad and changing scope of therapeutic products. Their ability to apply best practices in current daily operations while anticipating coming changes associated with new therapies and technologies is key to putting safe products on the market and optimizing benefits to patients.”1

    Health care professionals working in pharmacovigilance understand this changing landscape and are trained to navigate through the data points to guide companies in determining safety profiles for their product. This information helps populate the reference safety information / product label and helps guide the architecture of future trials to further learn about safety and the patient experience.

    The pharmacovigilance team at Med Communications are highly skilled in the assessment and evaluation of safety information. The benefit-risk profile of a product is reviewed per regulatory guidelines. Our global pharmacovigilance team works cohesively with our clients to provide robust assessment and documentation. We remain inspection-ready as we perform our work and support our clients during inspection, taking responsibility for our outsourced work.

    We welcome the opportunity to discuss your company’s pharmacovigilance needs. Risk Management will continue to evolve and our Med Communications team is committed to keeping current with industry and regulatory trends and guidelines to keep patient safety a priority!

    References:

    1 Drug Information Association. Pharmacovigilance and risk management in 2020: A global perspective. 2020 [Internet]. 2015 [cited 14 May 2020]. Available from: http://engage.diaglobal.org/2020-Global-PV-eBook.html

  • Comprehensive Pharmacovigilance SOPs

    Standard operating procedures, or SOPs, are quality documents critical to any pharmacovigilance (PV) quality system. Experienced PV professionals need to dedicate time and diligence to ensure these documents are clear, concise, and easy to follow. SOPs need routine content review to ensure they are in compliance with current regulations.

    Although it is well known that a list of SOPs is one of the first items to be requested during an FDA inspection, lack of or inadequately written SOPs, or failure by the companies to follow their own SOPs, is still one of the most common inspection findings.

    Knowing the challenges that our clients face, Med Communications offers our clients a comprehensive PV SOP package that is:

    • Fully auditable
    • Regularly reviewed
    • Maintained by Med Communications through our own Quality Management System

    Companion documents, such as Work Instructions and Handling Guides, are also created to provide the client-specific and product-specific details necessary to effectively manage your safety information. With Med Communications’ team of experts, we can ensure your SOPs and companion documents are inspection ready.

  • Safety Data Overload

    Dealing with safety data overload is nothing new for biotech companies, it has been an ongoing discussion in the industry for many years now. As companies are “drowning” in post-approval safety information from a growing variety of sources, the quality of it is sometimes less than relevant, turning the safety surveillance activities increasingly difficult.
    The ICH E2D (R1) group is dealing with an ambitious task updating the ICH E2D guideline on the management of post-approval safety data, in place since 2003.
    The challenges come from the lack of harmonized regulatory requirements across ICH member regions, the need for consistency with other pertinent documents and from the sometimes poor understanding among different regulatory authorities on the various projects companies put in place to receive feedback (including patients’ safety-related) on their approved products: patient support programs, drug delivery/continuity programs, or the so-called “social media listening” and “sentiment analysis” programs.
    A draft version of the revised guideline is hoped to be issued for consultation by Q4, 2022.

    https://lnkd.in/eGzWzwye
    #pharmacovigilance #data #socialmedia #safety #surveillance #ichguidelines

  • Providing Submissions in Electronic Format – Postmarketing Safety Reports

    The FDA has issued the final guidance. The document is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s CDER and CBER.
    This guidance is intended for any party with postmarketing safety reporting responsibilities for human drug products and licensed biological products, except for vaccines and its revised draft version was issued in June 2014.
    The agency made minimal changes in the final guidance, clarifying and updating topics included in the draft guidance on how to submit postmarketing safety reports that FDA can process, review, and archive. The final guidance also provides recommendations on postmarketing safety reports submissions to FDA for other categories of products, including compounded and combination products.

    #fda #postmarketing #safetyreporting #pharmacovigilance

  • EMA Information Regarding the Raw Data Proof-of-Concept Pilot for Industry

    EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorization applications for new medicines as well as post-authorization applications and to explore the practical aspects of the submission and analysis of such data.
    This pilot stems from one of the ten priority recommendations issued by the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) in 2020.
    There are several potential benefits the analysis of raw data might bring, including faster evaluation through fewer questions being put to applicants and a better definition of the target treatment population, enabling faster and better access to new medicines for patients.

    #clinicaltrials #dataanalysis #ema

Our Pharmacovigilance Partners