Pharmacovigilance
What is Pharmacovigilance?
Pharmacovigilance plays a critical role throughout the whole life cycle of a medicine. It’s primary goal is to ensure patient safety and it is essential for understanding and completing the knowledge of a medicine’s effectiveness and risk. Pharmacovigilance provides insights that aid continuous improvement of medical treatments.
Our Services:
- Development and maintenance of comprehensive pharmacovigilance systems
- Creation and regular updates of the Pharmacovigilance System Master File (PSMF)
- Preparation and revision of pharmacovigilance-related quality documentation
Pharmacovigilance System
The safety of medicines is monitored throughout their entire life cycle via a Pharmacovigilance System. EU law mandates that each marketing authorization holder, national competent authority, and the EMA operate a Pharmacovigilance System.
We provide the necessary services for maintaining a functional system, which include:
- Development and maintenance of a Pharmacovigilance System
- Creation and updates of the Pharmacovigilance System Master File (PSMF)
- Pharmacovigilance (PV)-related quality documents
Safety Case Management
EU law mandates that competent authorities and marketing authorization holders should gather safety information. Safety Case Management, a key process within pharmacovigilance, involves the collection, evaluation, and analysis of safety information reported by healthcare professionals and patients.
We offer Individual Case Safety Report (ICSR) case management services tailored to your needs, comprising of:
- Collection of safety information from a variety of monitored sources such as:
- safety inbox,
- literature (local and global),
- authority websites,
- EudraVigilance (EVWEB) database (L2A/L2B and MLM),
- digital media.
- Local case processing in the Nordic and Baltic countries: translation and forwarding of safety information to the client in a desired, structured format (e.g. CIOMS form), including quality check
- Follow-up: since only valid ICSRs meet the requirements for submission, follow-ups are conducted to obtain necessary and relevant information on safety reports
- Global case processing in MAH database: data entry and MedDRA coding, quality check, and medical review of cases
- Authority submission: submission of valid ICSRs to the European Medicines Agency (EMA) via EudraVigilance (EVWEB)
Literature Screening
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.
By European law, per GVP Module VI, Marketing Authorization Holders (MAHs) are required to monitor scientific and medical publications in local journals within countries where the medicinal products are authorized. These journals are typically published in the respective local languages.
We can assist you in ensuring that the literature review process is seamless. This involves developing search strategies, selecting relevant data sources, identifying suitable keywords, and constructing literature queries for your products. We can review the selected literature sources and screen for potential safety information both retrospectively and regularly. Furthermore, we provide reporting and translating of potential safety information and perform regular reconciliations to guarantee that no data is overlooked.
The literature screening services involve the following:
- Local Literature Monitoring: Review of non-indexed local journals in the Nordic and Baltic countries
- Global Literature Monitoring: Review of indexed journals through databases such as PubMed and Embase
Local Contact Person
The Local Contact Person acts as the primary point of contact between the pharmaceutical company and national regulatory bodies concerning pharmacovigilance matters. The focus is on ensuring that the company adheres to local pharmacovigilance regulations and guidelines. This role also encompasses supporting internal pharmacovigilance activities and providing training for company employees on pharmacovigilance practices.
Some countries require an official appointment of a Local Contact Person for Pharmacovigilance to the National Competent Authorities.
LPPV should be appointed in Estonia if medicinal product has aRMMs. It is mandatory requirement that this person should be Estonian speaking.
If the QPPV does not live or work in Latvia, it is mandatory to appoint and notify to LV SAM a LPPV who lives and works in Latvia and speaks Latvian language who is responsible for pharmacovigilance issues at national level;:
The Local Drug Safety Officer (LDSO) acts as the primary point of contact between the pharmaceutical company and national regulatory bodies concerning pharmacovigilance matters. The focus is on ensuring that the company adheres to local pharmacovigilance regulations and guidelines. This role also encompasses supporting internal pharmacovigilance activities and providing training for company employees on pharmacovigilance practices.
EU QPPV and Deputy
In the EU, every MAH for human or herbal medicinal is required to designate a single contact person, along with a deputy, who is accessible around the clock. This individual serves as the Qualified Person for Pharmacovigilance (QPPV). The QPPV should have comprehensive knowledge in all areas of pharmacovigilance and must live and work within the boundaries of the European Economic Area (EEA).
We provide the necessary services to uphold the responsibilities of a QPPV, which include: establish and maintain the MAH’s PV system,
- overseeing the safety of the medicinal products of the MAH
- coordinating actions to stay compliant with local legislation
- ensuring compliance with EU regulations
- acting as a round-the-clock point of contact for Competent Authorities
Legislation Monitoring
We provide Pharmacovigilance legislation monitoring on EU-level and locally in the Nordic and Baltic countries. Pharmacovigilance requirements can vary between countries and our service addresses the diverse requirements and the regular monitoring detects relevant updates in the field. We also perform local intelligence monitoring in relation to medical devices and clinical trials. The legislation monitoring service ensures compliance with regulations, guidelines and procedures.
Weekly monitoring is performed in national competent authority websites in the Nordic and Baltic countries, as well as monitoring on EU-level. Relevant updates are reviewed, analyzed, and informed to clients promptly. Our goal is to help navigate potential legislative updates and we can support with translations of local requirements to ensure compliance.
EudraVigilance Activities
EudraVigilance is the system managed by the European Medicines Agency (EMA) for managing and analysing information on suspected adverse reactions to medicines which have been authorised or are studied in clinical trials in the EEA.
MAHs and sponsors of clinical trials are obligated to use EudraVigilance for electronic reporting of adverse reactions and product information.
MAHs are obliged to report suspected serious adverse reactions occurring within and outside the EEA, suspected non-serious adverse reactions occurring within the EEA and information on authorised medicinal products via product reports (XEVPRMs/acknowledgements) electronically through EudraVigilance.
Sponsors of clinical trials in the EEA are obliged to report suspected unexpected serious adverse reactions (SUSARs) and Information on investigational medicinal products.
By enabling electronic exchange of ICSRs between EMA, national competent authorities (NCAs), MAHs, and sponsors of clinical trials, as well as by supporting early detection and evaluation of possible safety signals, EudraVigilance plays a crucial role in ensuring safe and effective use of medicines within the EU.
We offer XEVMPD management, the handling of your data. Additionally, we offer the capability to perform L2A/L2B and MLM report queries and download the results for your convenience. Lastly, we support EVWEB submissions, ensuring a smooth process for your regulatory compliance needs.
Signal & Benefit-Risk Management
Signal Management in pharmacovigilance involves a series of procedures aimed at identifying new risks linked to a medicinal product or active substance or assessing changes in known risks. This is achieved through a comprehensive review of ICSRs, combined data from monitoring systems, and scientific literature.
Our services include activities related to:
- the identification and management of signals
- the creation of Periodic Safety Update Reports (PSURs).
The process of Benefit-Risk Management is implemented to ensure the safe use of medicinal products. Its main objective is to confirm that the positive outcomes of a specific product exceed its associated risks for a treatment, considering both individual patients and the broader population group.
We provide services such as:
- the development of Risk Management Plans (RMPs)
- the establishment and upkeep of additional risk minimization measures (aRMM)
- the production of educational resources, the translation of aRMM materials into local languages
- the submission of these materials to relevant authorities
Pharmacovigilance Audits
We provide pharmacovigilance audits on site or remotely.
Pharmacovigilance activities are document based activities and there are seldom workspace related matters to be audited. Therefore the PV audits – interview and document review – suit well to be conducted remotely.
In addition, remote audits are an eco-friendly and a cost-effective alternative because there are no travel or accommodation.