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
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
The institutions of the European Union have dealt extensively with the topic of pharmacovigilance in recent years and have issued various legal
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.
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
No personnel expense
Our team supports you with the system setup of the system. On request we cover daily monitoring of all kinds of adverse drug effects.
Do you have particularly complex requirements? No worries. We are able to customize our systems in accordance with your conditions.
Our system which has been tried and tested for more than three years was audited several times and always successfully.
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 24/7, 365 days a year. Every medical report will reach you within 24 hours.
Data privacy protection
Every documentation is fully compliant with data protection and comply with the specifications of DSGVO.
Evalii scans incoming messages and comments all day long and documents it within seconds.
Our own developed algorithm classifies new entries/ messages totally automatic in accordance with their pharmacovigilance relevance.
One of our pharmacovigilance managers reads all incoming entries and forwards them if needed.
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