pharmacovigilance

As the global reach and the complexity of the program grows, so too do the possible services, including literature search and review, custom database reports, or signal management. We share your cost concerns and have created options for many of our services from database access to Global Safety Plans—each with different price tags depending on the level of service chosen. You want to choose where to trim down and where to invest, and we want to help.

Post-marketing Pharmacovigilance

Post-marketing pharmacovigilance programs should not be handled applying a one-size-fits-all mentality. Requirements may look very different depending on the country or region in which a marketing authorization is held. The addition of business partners may create the need to write and maintain a safety data exchange agreement or a PV agreement.

Changes to the safety profile of the product may require a more robust signal detection program to be implemented. A health authority may require a post-authorization safety study or a Risk Evaluation and Mitigation Strategy. Whichever way the life- cycle of your product takes you, ProPharma is here to support all of your needs. From our Benefit-Risk team to our QPPV office. Monitoring the safety of our client’s products, it’s what we do every day.

Safety Systems

The Pharmacovigilance System Master File (PSMF) describes the PV system of the Marketing Authorization Holder (MAH) and is a legal requirement for MAHs to maintain and make available to Health Authorities . Prior to inspections, Health Authorities routinely request this document and it can also be requested on an ad hoc basis. Information is included from many stakeholders including Quality Assurance, Regulatory Affairs, and all areas of PV, so keeping the PSMF up-to date is a critical task. Using well-honed processes, standardized templates, and experienced staff, ProPharma can support you with this activity.

The Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategy (REMS) describes the PV system for mitigating risk in a program. These documents identify, characterize, and work to minimize the significant risks of a medicinal product. The overall aim of any risk management program is to ensure that the benefits of the medicinal product exceed the risks by the greatest achievable margin, and here’s where ProPharma can help. Our team of experts can support the preparation and maintenance of your RMP or take over the preparation and maintenance altogether. Our experience extends to the preparation of RMPs for well-established products, generics, innovators, biosimilars, as well as fixed combination products.

QPPV Office

Appointing an experienced Qualified Person for Pharmacovigilance (QPPV), Local Person for Pharmacovigilance (LPPV), and deputy QPPV/LPPV can require considerable time and resources.

Although the requirements and responsibilities of a QPPV are specified in EU and UK legislation, LPPVs are subject to their own national legislation (e.g., the Graduated Plan Officer "Stufenplanbeauftragter" for Germany), which can also be daunting. As a global pharmacovigilance provider, ProPharma can advise you on the varied requirements for QPPVs and LPPVs to determine the services that will accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location.

Role of the EU QPPV

Every Marketing Authorization Holder (MAH) in Europe has an obligation to establish a pharmacovigilance (PV) system for the fulfillment of PV tasks for its products. When setting up a PV system in Europe, the MAH must appoint an EU QPPV to establish and maintain the MAH’s PV system. In addition to the establishment and oversight of the PV system, the QPPV also has several legislative responsibilities.

Responsibilities of the EU QPPV include:

• Establish and maintain the MAH’s PV system
• Monitor the safety of the MAH’s drug products
• Coordinate actions to stay compliant with local legislation
• Serve as the 24/7 point of contact for Competent Authorities
• Conduct audits and inspections to ensure compliance with EU regulations

Get Expert Guidance Managing Legislation Requirements

ProPharma can support your organization through the provision of appropriately qualified and experienced QPPVs, LPPVs, and deputies.

ProPharma’s experts can advise you about the different roles and responsibilities of the EU QPPVs and LPPVs and offer services that can accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location. We have a team of local persons available to fulfill these positions and strengthen your country PV operations as your company grows. Contact us to learn more about our QPPV and LPPV services.

Explore our LPPV Services

Case Management

At ProPharma, our teams of clinical and post-marketing Pharmacovigilance specialists provide subject matter expertise and comprehensive case processing services that are customized to meet the needs of the client and PV system. We start with the fundamentals of quality, compliance, and efficiency enabling us to build the program you want rooted in the requirements you need.

Case processing at ProPharma includes clinical trial serious adverse events (SAEs), adverse events of special interest (AESI), pregnancies, serious and non-serious spontaneous or solicited cases, legacy cases, literature search cases, and social media cases. The case management process starts with case intake, data entry, MedDRA and WHO Drug coding, followed by narrative writing based on a template approved by the client or sponsor, quality control, medical review, follow up, and reconciliation. Case processing and quality review activities go hand-in-hand, so we pay particular attention to timelines, industry guidelines, and submission requirements for global health authorities.

We offer our clients a fully compliant and validated global safety database as a single repository for the myriad events reported throughout the lifecycle of a product. The Argus platform includes appropriate backup, security measures, business continuity, and disaster recovery procedures and our long history of compliance involves processes and systems which are regularly audited. A global safety database promotes convenience while drafting an Analysis of Similar Events, ease in looking across the multiple datasets involved in aggregate reports and becomes a single source of truth for a product’s safety data.

Speak with our highly skilled data migration team about the options available for combining all of your safety data in one permanent home.

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Global Literature Review

The review of worldwide scientific literature is an essential part of the ongoing safety surveillance of your product, regardless of commercial status. To ensure compliance with regulatory legislation worldwide, it is essential that global and local literature screening is regularly conducted to identify reportable ICSRs and detect potential safety signals.

For Marketing Authorization Holders (MAHs) with active substances included in the EMA’s Medical Literature Monitoring (MLM) list, we perform EudraVigilance checks using the ICSR Export module based on the frequency contracted. In addition, we provide local literature searches in relevant local scientific and medical journals in countries where your product is marketed and legally required.

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Signal Management

Signal management is a critical process for the proactive and timely identification of potential new safety risks for medicinal products that requires the utmost expertise. Signal management can be deployed throughout both the clinical development and post-marketing phases of the product lifecycle. Safety issues may affect the benefit-risk balance of the product, requiring updates to product labels and other steps that help protect patients from harm.

ProPharma has deep expertise across all signal management activities, including detection, validation, prioritization, and assessment. We do this using a wide range of sources (e.g., spontaneous cases, safety data from clinical trials, and noninterventional studies and literature reports). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. Using a variety of options, we leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

Periodic Safety Reports and Risk Management Plans

The preparation of Periodic Safety Reports is required throughout both the clinical development and post-marketing phases of the product lifecycle. The periodic review of safety data from relevant sources is essential for the ongoing benefit risk evaluation to ensure patients´ safety and well-being.

At ProPharma, our team works diligently to ensure compliance with applicable regulations for aggregate safety reports. We have wide-ranging experience in analyzing and evaluating data and generating required periodic reports such as:

• Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs),
• Periodic Adverse Drug Experience Report (PADER),
• Development Safety Update Reports (DSURs)
• Country-specific periodic reports

We also can support you in:

• Responding to Request for Information (RFI) from Regulatory Authorities
• Preparing the addendum to Clinical Overviews (ACO)
• Submission of the reports

ProPharma is staffed with highly experienced and qualified staff to ensure a timely development of Periodic Safety Reports and RMPs with high quality.

Global ICSR Submissions

ProPharma recognizes the critical nature of accurate and on-time submissions to health authorities, Institutional Review Boards (IRBs), Ethics Committees (ECs) and other entities involved in the clinical research. We perform ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) reports for various product types including approved and non-approved drugs, biologics, devices, vaccines, dietary supplements, generics, homeopathic products, and natural health products. ICSRs are exchanged with clients and Sponsors for review and comment before the final submission, if requested. Clients and Sponsors also maintain oversight of case processing and reporting activities during the submission process via Case Explorer, a read-only application that allows for real-time database querying and review of database information within individual cases without incurring additional costs. Clients and sponsors who wish to maintain oversight of case processing within the safety database may also do so via read-only direct access to the safety database for additional licensing fees.

Regulatory compliance is our top priority. Each month, compliance metrics are generated from the safety database submission reports for all pharmacovigilance and clinical safety programs and shared with all interested clients. ProPharma is proud to post a greater than 99% compliance rate, successfully submitting over 2,000 ICSRs per month to health authorities and business partners on behalf of post-marketing pharmacovigilance clients and clinical trial Sponsors. Our submission process is built on the use of our comprehensive database of global Safety Regulatory Intelligence (RI) information. Leveraging our local knowledge and the support of subject matter experts, we have developed our own safety regulatory intelligence tool. ProPharma RI team utilizes various RI tools, manual health authority website searches, and local knowledge to collect and evaluate local and global regulations. This ensures that all submissions at ProPharma are performed in compliance with applicable local and global regulations. For clients utilizing our PV submission services, we offer access to the relevant RI for no additional cost and for clients not utilizing our submissions services, we offer subscriptions to our PV RI information and updates. This information is provided in three different options that build upon each other, so single format or combined formats are available. These options include providing a table of the regulations; as a table of the PV regulations plus the ProPharma interpretations of those regulations; or providing a RI consultant to directly support your questions and RI needs.

We understand that timely submission is crucial to your company’s success, impacting regulatory compliance, market strategy, patient safety, and financial performance. We are here to support you in achieving this.