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Post Authorisation Pharmacovigilance

Pharmacovigilance System Management 

What is it? 

It is a legal requirement for pharmaceutical companies with marketing authorisations to have a clearly defined pharmacovigilance system that effectively monitors the safety of its authorised products.

Within the European Economic Area (EEA), the pharmacovigilance system must be documented within the Pharmacovigilance System Master File (PSMF). It is also a legal requirement to have a Qualified Person for Pharmacovigilance (QPPV) and a deputy. These individuals are ultimately responsible for ensuring compliance with any pharmacovigilance related legal requirements, establishing and maintain the pharmacovigilance system and PSMF, provide an overview of the safety profiles of authorised products, and act as a single point of contact on a 24-hour basis to regulatory authorities

How we can help

Kinapse has the capabilities to provide a gap analysis of your current pharmacovigilance system to help verify already identified gaps and find any unidentified gaps. We would provide a walk-through of core regulatory requirements and provide support to fill any gaps within your system.

We can also provide highly experienced and qualified pharmacovigilance professionals for the management of pharmacovigilance systems. These professionals all reside within the European Union (EU)/EEA and meet the requirements defined in EU Directive 2001/83/EC for the role of EU QPPV. All our QPPVs have extensive knowledge and practice in all aspects of pharmacovigilance and an in-depth knowledge of EU and global pharmacovigilance legislation. In addition, we offer a standalone QPPV Consulting service to help guide in all aspects of pharmacovigilance system development.

Risk Management Plans (RMP)

What is it? 

The aim of a Risk Management Plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product. Within the European Economic Area (EEA), the RMP is a mandatory document as part of the marketing authorisation application dossier and therefore must be submitted at the time of applying for a licence for a medicinal product.

An RMP contains the following:

  • Safety Specification
    The identification or characterisation of the safety profile of the medicinal product, with emphasis on important identified and important potential risks and missing information, and also on which safety concerns need to be managed proactively or further studied
  • Pharmacovigilance Plan
    The planning of pharmacovigilance activities to characterise and quantify clinically relevant risks and to identify new adverse reactions
  • Risk Minimisation Plan
    The planning and implementation of risk minimisation measures, including the evaluation of the effectiveness of these activities.

How we can help

We will assist you in developing a risk strategy and plan that is tailored to your needs and your products. The requirements, safety profile, specific updates, special scenarios and mandate by regulatory authority are all taken into consideration.

Kinapse has a long successful track record of producing RMPs. We have knowledgeable physicians and scientists with significant experience in developing the risk strategies and authoring risk management plans; both for innovator and generic molecules. Our approach aims to protect the patient / consumer through effective risk minimisation measures that can be efficiently implemented; while taking into account the European Economic Area (EEA) regulations and guidance, the health care system(s) within EEA, and the role of the health care professionals.

Safety Data Report Writing (PSUR/PBRER, PADER) and Submissions

What is it? 

Periodic analysis of aggregated safety data is an important part of both the clinical development of a medicinal product and for the ongoing maintenance of drugs with marketing authorisations. These reports summarise the assessment of any new safety issues that could affect patient safety. It also provides the status of a clinical programme or marketed drugs alongside their risk-benefit profile.

How we can help

Kinapse offers the following post-authorisation safety report writing services:

  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Periodic Adverse Drug Experience Report (PADER)

The Kinapse team has a successful record of accomplishment in authoring aggregate safety reports for a wide variety of biopharmaceutical and gene therapy customers. We provide flexible and customised end-to-end authoring, benefit-risk assessment, management of report preparation and coordination of stakeholder contributions, and submission.

We have a dedicated team of report writers and safety physicians that work exclusively on safety report writing programmes. Our team is experienced in writing in accordance with the relevant regulatory requirements (e.g. ICH, CIOMS, GVP and FDA). We provide a fully flexible solution to safety report writing service that covers the complete authoring of safety documents. This encompasses benefit-risk assessment, medical review, authoring of characterisation of risks, preparation of safety evaluation reports, and strategic support.

Literature Services

What is it? 

Review of literature relating to medicinal products is required for the following safety related purposes:

  • Identification of adverse drug reactions
  • Risk-benefit evaluation (including effects of products within the same class)
  • Epidemiological information for Risk Management Plan
  • Any other relevant safety information (including class effects) for aggregate reports

How we can help

Kinapse delivers global medical literature monitoring as a core service and specific area of expertise. Our first-hand knowledge of best industry standard practices regarding literature is embed into delivering client requirements on our literature-based programmes. We deliver global systematic literature search and review with consistent quality, routinely and at scale, to a range of clients. On average, our team reviews over 45,000 per month for all pharmacovigilance purposes.

Our experience is supported by a strong record of accomplishment in high quality compliant delivery of agreed key performance indicators. We have achieved this track record through continuous improvement measures and would similarly provide suggestions in process and system changes for the programme throughout the collaboration, in order to improve the efficiency and quality of the literature service.

Signal Detection

What is it? 

Safety signals are new or updated information on adverse effects that could be caused by a medicinal product. It is a legal responsibility of all marketing authorisation holders to perform frequent review of the safety data for the purposes of identifying potential safety signals.

Signal detection should follow a methodology that takes into account the nature of data and the characteristics (e.g. time on market, patient exposure, target population) as well as the type of medicinal product concerned. Data from all appropriate sources should be considered and clinical judgement should always be applied. This may involve a review of Individual Case Safety Reports (ICSR), statistical analyses, or a combination of both, depending on the size of the data set. When it is not relevant or feasible to assess each individual case (e.g. signals detected from published studies, healthcare record data), assessment of aggregated data should be performed.

How we can help

We have a team of skilled physician with extensive safety signal experience who are able to support you with all signal detection activities. This includes medical evaluation related activities including adverse event medical review, risk minimisation and risk management.

Our signal detection and risk minimisation service utilises data mining (e.g. EVDAS, FAERS), screening, and frequency tabulation review, to detect signals at an early stage. We conduct proactive regular signal detection meetings to review any signals from aggregate case reports, adverse drug reactions, literature and other relevant sources as received during that period for the product to determine any new or changed safety concerns or new potential signals.

Adverse Event Processing and Expedited Submissions

What is it? 

Sponsors of clinical trials and marketing authorisation holders of medicinal products must legally capture, process and submit adverse events that occur with their products. The processing should be efficient, effective and allow for the assessment in change in frequencies, severity or seriousness of these adverse events. Individual Case Safety Reports (ICSR) captured within a validated database provide information in individual adverse events within a standardised format.

How we can help

Within our organisation we provide support across the full span of single case processing; including triage, medical literature monitoring, quality review and expedited reporting.

Our timely, thorough, and accurate processing and reporting of adverse events are among the most important services that we provide. As a combined entity, we have been providing post authorisation safety services since 2001. During this time, our pharmacovigilance group has grown to include over 1,000-experienced safety associates globally.

Our centralised team within pharmacovigilance maintains our regulatory intelligence information in coordination with our local teams around the globe. The centralised submissions associates perform submissions to health authorities.

We employ the use of Oracle Argus Safety database as our global comprehensive solution for product safety monitoring and compliance. Argus functionality supports the pharmacovigilance regulatory/industry requirements with the ability to produce international expedited and periodic reports.

Independent Quality Control

What is it? 

Retrospective independent quality control of Individual Case Safety Reports (ICSR) with the aim to improve the first-time quality of case processing.

How we can help

We offer independent review of the output of pharmacovigilance case processing teams with the aim of improving case-level consistency and case compliance, a reduction in reviewer bias and independent training. This results in a better overall pharmacovigilance data quality, increased employee knowledge and reduced time spent processing cases.

Safety Call Centre

What is it? 

Call centre staffed with nurses and pharmacists for intake and handling of adverse events, product complaints and medical information requests.

How we can help

Our Safety Call Centre based in North America is staffed with health care professional associates providing intake of adverse events and product complaints under the guidance of a highly experienced call centre management team with relevant experience to complement our customer’s need. We have an effective suite of standard operating procedures (SOP), and processes to guide call centre processes to ensure quality and compliance and smooth operations.

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Clinical Trial Drug Safety

  • Case Processing and Submissions
  • Safety Data Report Writing (DSUR)

Database Support

  • Substance, Product, Organisation and Referential (SPOR)
  • EudraVigilance
  • Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)