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Pharmacovigilance

On your behalf, we can take over and fulfil your duties in all matters of drug safety vis-à-vis the Federal Institute for Drugs and Medical Services (BfArM) and other authorities. This comprises all work for the weekly research up to tasking over the activity of the appointed persons (graduated plan officer, EU-QPPV). Not every company requires support in all fields of activity. In direct consultation with you, we will offer you a specially-tailored catalogue of services for the field of drug safety.

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PHARMA­COVIGILANCE

Overview of services

We offer you the following range of pharmacovigilance services, specially tailored to your company. But we will only carry out activities for you when they are actually necessary:

Setting up a pharmacovigilance system

A pharmacovigilance system consists of more than just PV SOPs. It is characterised above all by the linking of different tools such as research, signal detection, PSUR, etc. We set up the individual systems and their linkages individually and maintain them continually.

Production of a “Pharmacovigilance System Master File (PSMF)”

The PSMF is the core of the PV system because it describes the structure, products, processes, partners and many other aspects as related to pharmacovigilance. We produce and maintain this elaborate document for you, which can be requested by the authorities within seven days.

Weekly literature research

We carry out the weekly literature research for you in the countries Germany, Austria, the Netherlands, Belgium and Switzerland. In other countries, we coordinate the research with partners and combine the results centrally.

Analysis and processing of the “Medical Literature Monitoring (MLM)” of the EMA

The EMA provides the product licence holder with the individual cases of possibly safety-relevant information which it has found in the literature. In order to incorporate this information in the downstream analyses, data queries are carried out by our qualified employees for each active agent and the results are processed in accordance with a standardised procedure designed by us.

Case management

We take over the entire case management. This includes, among other things, the analysis and processing of indi-vidual cases including input into a PV database and, if necessary, re-porting to authorities via EudraVigilance. We are trained for this on various PV database systems such as, among others, sapheus and SafetyDrugs.

Carrying out of signal detections

Based on the information obtained from research, spontaneous registration system and cases for the authorities we continually analyse the riskbenefit ratio in signal detections.

Designated persons

Our range of services comprises the assigning of legally specified persons in accordance with the AMG, AMWHV and EU law. This includes the information officer (§ 74a AMG), the phased plan officer (§ 63a AMG) and EU QPPV.

Analysis of PV-relevant publications (e.g. study reports)

Study reports are an important source of safety information regarding pharmaceuticals. Because this is part of our daily work, we can lighten your workload of analysis tasks, at short notice and within a narrow time frame.

Writing of “Periodic Safety Update Reports (PSURs)” and/or “Periodic Benefit-Risk Evaluation Reports (PBRERs)”

The aim of the PSUR is to submit a comprehensive and critical analysis of the product’s benefit-risk ratio in which new or emerging safety in-formation is taken into account in connection with the cumulative information on risks and benefits. We will take on this demanding task for you incl. the submission of a PSUR to the European PSUR portal.

Production of “risk management plans (RMPs)”

The production and updating of risk management plans according to European standards is part of our portfolio.

Input and maintenance of “EudraVigilance Me-dicinal Product Diary (xEVMPD)” data

We carry out new registrations for your products in the xEVMPD data-base. In the case of more extensive updates we can also perform this by bulk update.

Readability tests

We have already been conducting such tests in accordance with the European Medicines Law since 2006. Our readability tests follow a specific procedure developed by us for German-language texts.

PSUR

The EC Directive 2001/83/EC in its amended version, Directive 2010/84/EC, the Regulation No. 726/2004, the Implementing Regulation 520/2012, the AMG and the current version of the Guideline on good pharmacovigilance practices (GVP) – Module VII “Periodic safety up-date report” give detailed instructions on the content and format of PSURs. We have transferred these standards into effective processes, in order to carry out PSUR obligations quickly and efficiently.

For us, the submission of a PSUR is part of PSUR processing.

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Designated persons

According to European and national law, every pharmaceutical compa-ny is obliged to designate people responsible for certain tasks and to notify the authorities of them by name.

Our range of services comprises the assigning of legally specified persons in accordance with the AMG, AMWHV and EU law. This includes the information officer (§ 74a AMG), phased plan officer (§ 63a AMG) and EU QPPV.

Graduated plan officer (Section 63a AMG [German Medicinal Products Act])

According to the German Medicinal Products Act, every pharmaceutical entrepreneur (pU) must have a PV system, for which the graduated plan officer is responsible. In addition to this, the graduated plan officer gathers and analyses all reports about risks of medicines (including deficiencies in quality) and coordinates the necessary measures. A benefit-risk profile is to be produced as a result of this procedure and updated on an ongoing basis.

QPPV in accordance with "Article 104 (3)(a) of Directive 2001/83/EC"

A QPPV is required for medicinal product marketing authorisation outside Germany in the EU. This abbreviation refers to a pharmacovigilance officer (Qualified Person Responsible For Pharmacovigilance) who – unlike the graduated plan officer in Germany – is not responsible for the processing of quality defects. At EU level, the QP (qualified person) is responsible for any quality defects.

Information officer (Section 74a AMG)

The information officer is to ensure that “the labelling, the package leaflets, the expert information and the advertisements correspond with the content of the marketing authorisation or registration” (Section 74a (1) AMG ). The information officer checks the informative texts (package leaflet, expert information etc.), advertising texts and advertisements for their conformity with the marketing authorisation documents.

Provision of PV SOP system

As a pharmaceutical company we maintain an SOP system for the entire field of pharmacovigilance. We offer you the option of referring to our system instead of having to spend a lot of time and resources on implementing and maintaining a new system.

Thanks to the maintaining of our system you will also always be up to date.

Checking of informative texts

For us, the checking of informative texts, incl. for the printing of package leaflet information, for commercial purposes, etc., is part of pharmacovigilance. Because in our view information texts have an important influence on drug safety. Incorrect texts can have a negative effect upon this. Our trained and experienced employees check your texts carefully and promptly. Especially when the launching of a product depends on the approval of the informative texts, we divide our time up flexibly, in order to prevent any delay arising in your plans.

Clinical research

We take over the task of pharmacovigilance in all phases of clinical trials. We are familiar with the special features of this subdomain of drug safety from many projects.

Our range of services also includes other aspects of clinical research. Talk to us – we will be happy to help – or find out about this subject in more detail on our sites on Clinical Trials.

Readability tests for pharmaceuticals and medical devices

We have been carrying out readability tests since 2006. Our readability tests follow a specific procedure developed by us for German-language texts. On the basis of 50 linguistic criteria, each test passes through the following steps:
Adaptation of your package information leaflet to the current QRD guidelines
Optimisation of the layout
Optimisation of linguistic style through the application of linguistic criteria for readability and comprehensibility
Development of a product-specific questionnaire
Recruitment of probands (native speakers!)
Conducting of individual interviews with 20 probands
Analysis and production of the test report (in English)
We possess experience in readability testing for all types of pharma-ceuticals e.g. prescription-only (Rx) and OTC preparations, but also of medical devices.

Depending on your requirements, we also conduct proband tests with native speakers in other languages such as e.g. in English, French or Dutch.

We produce the tests for fixed prices!

Drug safety for veterinary pharmaceuticals

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The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and the Commission Implementing Regulation (EU) 2021/1281 contain new legal requirements for pharmacovigilance in veterinary medicine. For example, a PSMF is now required, as for human pharmaceuticals. New databases such as UPD and EVVet 3 have been added to this and are mandatory.

The new regulatory requirements are necessitating a greater and greater degree of indepth knowledge and expertise for veterinary drug safety too. Instead of you having to laboriously build up this knowledge, we can help you to meet all the requirements quickly and in a target-oriented way. Of course, as a specialist company, our team also includes a veterinarian who evaluates and classifies facts from daily practice.

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Office

Thaerstraße 4a
47533 Kleve

Opening hours

Mo-Fr: 8:30 a.m. – 1:00 p.m.
Mo-Fr: 2:00 p.m. – 4:30 p.m.

Phone

+49 (2821) 7277-0