Evali_registered

Efficient and secure
Pharmacovigilance monitoring
for your digital projects.

Evali_registered

evalii – always
in safe hands.

evalii works reliably and audit compliant. The redundant system was built according to the following requirements:

German Drug Law (Arzneimittelgesetz)

The Pharmaceuticals Act of the Federal Republic of Germany stipulates that after the approval of a medicinal product, the experience of its use be

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and systematically collected and evaluated. According to § 63c AMG, it obliges you, as the holder of a marketing authorisation for a medicinal product intended for human use, to record any suspected case of a serious adverse reaction that has occurred in Germany or abroad and to notify the competent authorities. Notification must take place immediately, but no later than 15 days. § 63b AMG requires you to monitor pharmacovigilance data in order to determine whether there are new risks, changes to existing risks or changes to the benefit-risk balance of pharmaceuticals. Monitoring comments from users of your social media channels is essential to filter out potential reporting-related content and comply with the legal obligation imposed on you. evalii is your faithful companion, enabling you to comply with legal requirements.

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Medical Devices Safety Plan Ordinance (MPSV)

As a manufacturer of medical devices in the sense of the Medical Devices Act (MPG), you are required to report obligations under the Medical Devices

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Safety Plan Ordinance (MPSV). Thus in accordance with § 3 of this regulation you are under obligation to report incidents that have occurred in Germany and other member states that are party to the Agreement on the European Economic Area to the competent authorities. In order to be able to reliably identify any occurrences, the monitoring of user comments must also be ensured. evalii will take care of monitoring for you and keep you up to date on any incidents.

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European Guidelines

The institutions of the European Union have dealt extensively with the topic of pharmacovigilance in recent years and have issued various legal

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provisions governing the monitoring of reportable events relating to pharmaceuticals.

Article 12 para. 1 of the Commission’s Ordinance (EU) No 520/2012 of June 19, 2012 on the implementation of the provisions of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and the pharmacovigilance tasks provided for by the Council contains the regulation that marketing authorisation holders are required to record all pharmacovigilance information and to ensure that they are handled and stored in such a way as to allow the correct reporting, interpretation and verification of the information. Marketing authorisation holders must also provide mechanisms to ensure the traceability and follow-up of adverse drug reactions.

At the beginning of 2012, the European Medicines Agency (EMA) issued a guideline on good pharmacovigilance practices. For example, in Section VI.B.1 approval holders are encouraged to take appropriate action to collect reports of potential adverse reactions.

In Article 87, the Medical Device Regulation (MDR), which came into force in May 2017 and is mandatory for all member states from May 2020, imposes incident reporting obligations on manufacturers of medical devices, not only for incidents in connection with their products, but also for those arising that have any possible connection with them.

evalii not only helps you to extract the relevant information from various social media channels, but also to comply with the documentation requirement. Our software solution allows you to export logs of posts and comments, including the entire message and its time.

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Food and Drug Administration (FDA)

The Food and Drug Administration of the United States of America requires the holder of the authorization pursuant to the Code of Federal Regulations

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Title 21 Sec. 314.80 (b) after approval of a medicinal product, to investigate all adverse reactions reported (from any source, from home and abroad). The US authorities are also aiming for immediate notification and set a maximum deadline of 15 days. As part of the obligation to report to the US authorities, evalii is your reliable partner. In this case, you also benefit from the extensive protocol functions for comments and user generated content.

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Your advantages at a glance:

No personnel expense

Our team supports you within setup of the system. On request we cover daily monitoring of all kinds of adverse drug effects.

Technical support inclusive

Do you have particularly complex requirements? No worries. We are able to customize our systems in accordance with your conditions.

Validated Software

Our system which has been tried and tested in practice for more than three years was audited several times and always successfully.

Audit Trail

evalii is able to document every step automatically. We give you the opportunity to track each step and detail within the system.

Fast response time

We are doing monitoring 365 days a year. 24/7. Every medical report will reach you within 24 hours.

Data privacy protection

Every kind of documentation is fully compliant with data protection and comply with the specifications of DSGVO.

The solution for your
digital health projects

Our team of experts in the central of Berlin is fully specialized in the segment of healthcare. We are experienced in the field of monitoring of websites with comment option, mobile app reviews and various social media platforms such as Facebook, Twitter & Co.

That’s how it works:

1.

evalii scans incoming contributions and comments all day long and documents it within seconds.

2.

Our own developed algorithm classifies new entries/ messages totally automatic in accordance with their pharmacovigilance relevance.

3.

One of our pharmacovigilance managers considers all incoming entries and forwards them if needed.

Start to optimize your monitoring on social media platforms today:

Youtube

Instagram

Vimeo

Linkedin

Interest aroused?

Give us a call or send us an e-mail for a non-binding consultation with one of our experts:

+49 30 746 895 00

info@cross4channel.de

Where you can find us

Germaniastraße 137, 12099 Berlin

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