Mit der EU-Verordnung 2025/1466 verändern sich zentrale Anforderungen an die Pharmakovigilanz (PV) spürbar: Der Fokus verschiebt sich weg von reinem Formalismus hin zu Nachweisbarkeit, Prozessqualität und transparenter Dokumentation. Für pharmazeutische Unternehmen bedeutet das konkret: PV-Prozesse müssen nicht nur funktionieren, sondern belegt, versioniert und auditfähig sein und zwar entlang der gesamten Prozesskette von der Erkennung bis zur Maßnahme. 

Damit steigen die Erwartungen an Organisation, IT-Systeme und Governance gleichermaßen. Gefordert sind insbesondere: 

• lückenlose Dokumentation PV-relevanter Inhalte und Entscheidungen 

• risikobasierte Bewertung von Abweichungen und Prozessrisiken 

• schnelle Reaktionsfähigkeit auf potenziell kritische Meldungen 

• internationale Datenstandards und konsistente Nachweisketten 

• Audit- und Inspektionsfähigkeit für interne sowie behördliche Prüfungen 

evalii® bietet dafür die technologische und prozessuale Grundlage. Die Plattform unterstützt Unternehmen dabei, regulatorische Anforderungen nicht nur zu erfüllen, sondern aktiv zu steuern. 

 evalii® ist ein strukturiertes System zur Überwachung, Bewertung und Dokumentation potenziell Pharmakovigilanz-relevanter Inhalte, insbesondere aus digitalen Kanälen. Genau hier liegt häufig ein praktisches Problem: Unternehmen können häufig zwar Social Media, Kontaktformulare oder Plattform-Kommentare überwachen, aber die regulatorisch erforderliche Dokumentation erfolgt oft manuell, fragmentiert und nicht durchgängig auditfest. 

evalii® schafft hier Abhilfe, indem sämtliche Prozessschritte standardisiert und nachvollziehbar abgebildet werden. 

Die Plattform unterstützt bei der Beantwortung zentraler Auditfragen wie: 

• Welche Meldung wurde wann erkannt? 

• Wie wurde sie bewertet, klassifiziert und priorisiert? 

• An wen wurde sie weitergeleitet und wann? 

• Wer war involviert und welche Maßnahmen wurden ergriffen? 

Damit entsteht ein transparenter, revisionssicherer Workflow, der sich an bestehende Rollenmodelle und SOPs anpassen lässt. 

 Die neue EU-Regelung verstärkt den Anspruch, dass PV-Prozesse nicht nur „gelebt“, sondern auch formal nachweisbar sein müssen. In der Praxis bedeutet das: Unternehmen benötigen einen dokumentierten Nachweis darüber, 

• dass PV-relevante Inhalte identifiziert werden, 

• wie sie bewertet werden, 

• wie Entscheidungen zustande kommen, 

• und welche Maßnahmen getroffen wurden. 

Mit evalii® wird diese Dokumentation nicht zum manuellen Aufwand.  

Das unterstützt insbesondere: 

Einhaltung neuer PSMF-Anforderungen (Pharmacovigilance System Master File) 

Die Anforderungen an das PV-System und dessen Nachweisführung steigen. evalii® ermöglicht die konsistente Abbildung von Prozesslogik, Verantwortlichkeiten und Entscheidungswegen – eine wesentliche Grundlage für prüffähige PV-Dokumentation. 

Risikobasierte Bewertung von Prozessabweichungen 

Statt pauschalem Formalismus rückt die risikobasierte Betrachtung in den Vordergrund: Welche Abweichung ist kritisch? Welche ist tolerabel? Welche Maßnahmen sind erforderlich? evalii® liefert dafür strukturierte Datengrundlagen. 

Audits verlangen eine lückenlose Begründung von Entscheidungen und Zuständigkeiten. evalii® bietet hierfür eine durchgängige Historie: Wer hat was wann bewertet – und warum? Das reduziert Auditaufwand und schafft Sicherheit bei Behördenanfragen. 

Digitale Kanäle sind heute ein zentraler Risikofaktor und zugleich ein entscheidender Informationsraum. Die kontinuierliche Überwachung ist daher nicht nur eine organisatorische Pflicht, sondern zunehmend eine Governance-Anforderung: Unternehmen müssen sicherstellen, dass relevante Inhalte erkannt und bewertet werden, bevor daraus regulatorische oder haftungsrechtliche Risiken entstehen. 

evalii® bietet hier nicht nur Sicherheit, sondern eine echte Frühwarnfunktion: 

• potenziell kritische Inhalte werden erkannt 

• priorisiert und klassifiziert 

• den zuständigen Stellen zugewiesen 

• und entlang der Prozesskette dokumentiert 

Das schafft Reaktionsfähigkeit – und gleichzeitig die geforderte Nachweisbarkeit. 

 Conclusion:  

Die neue EU-Verordnung fordert Transparenz, Reaktionsschnelligkeit und dokumentierte Qualität. Unternehmen stehen damit vor der Aufgabe, PV-Prozesse nicht nur effizienter zu gestalten, sondern vor allem auditfähig und revisionssicher aufzubauen. 

evalii® bietet eine Lösung, die regulatorische Anforderungen strukturiert abbildet, Aufwand reduziert und Unternehmen bei der Umsetzung moderner PV-Standards unterstützt. 

Mit evalii® gelingt der Umstieg auf moderne Pharmakovigilanz. 

Der Beitrag Regulatorische Anforderungen mit evalii® umsetzen: EU-Verordnung 2025/1466, Pharmakovigilanz und auditfähige Prozesse erschien zuerst auf evalii - pharmacovigilance monitoring service.

In der digitalen Kommunikation gilt heute mehr denn je: Nähe erzeugt Verantwortung. Auch Unternehmen im Gesundheitsbereich profitieren enorm von Kanälen wie Instagram, WhatsApp oder Facebook, aber sie müssen sich auch den regulatorischen Realitäten stellen. Denn sobald Nutzer öffentlich posten, wird das Unternehmen zumindest in bestimmten Bereichen (mit)verantwortlich.

Ob nun ein Erfahrungsbericht, eine Empfehlung oder gar ein Medikamentenname genannt wird – was authentisch und harmlos wirkt, kann rechtlich heikel werden. Besonders im Kontext des Heilmittelwerbegesetzes (HWG) und interner Kommunikationsrichtlinien.

Viele Nutzer schildern online ihre persönlichen Krankheitsgeschichten – gerne auch verbunden mit werbenden und vergleichenden Aussagen.

Doch solche Aussagen können, je nach Kontext, gegen §11 HWG oder allgemeine wettbewerbsrechtliche Vorgaben verstoßen – insbesondere, wenn:

• konkrete Produkte genannt werden
• Krankheitsverläufe oder Therapieerfolge geschildert werden
• Danksagungen oder Empfehlungen ausgesprochen werden

Auch wenn der Beitrag von einem Dritten stammt, sind Unternehmen verpflichtet, solche Inhalte zu moderieren oder zu entfernen, sobald sie davon Kenntnis erlangen. Und die Unternehmen, müssen auch entsprechend dafür Sorge tragen, dass sie entsprechend regelmäßig Kenntnis erlangen können.  Ansonsten könnte ihnen die Aussage zugerechnet werden.

Und genau hier kommt evalii® ins Spiel: als Tool für die gesamte digitale Kommunikation.

evalii® ist weit mehr als ein System zur  Pharmakovigilanz-Überwachung: Eingehende Inhalte können nicht nur auf potenzielle Nebenwirkungsmeldungen überprüft werden, sondern auch auf:

• HWG-kritische Aussagen
• Verstöße gegen Netiquette-Richtlinien
• problematische Kommentartypen wie Falschinformationen oder sensible Inhalte

Sobald ein relevanter Inhalt erkannt wird, erfolgt auch hier die Meldung nach einem abgestimmten Prozess:

• Entweder durch unser Team: Wir prüfen, bewerten und handeln gemäß Ihrer Vorgaben.
• Oder durch Ihre interne Stelle/ ihre Agentur: evalii® versendet sofort eine E-Mail-Benachrichtigung an die zuständige Person.

So können Sie individuell entscheiden, wer moderiert, verpassen aber keinen Kommentar.

Warum das für Sie zählt:

• Mehr Sicherheit im digitalen Raum – auch bei hoher Interaktion und hohem Kommentaraufkommen

• Frühwarnsystem für potenzielle HWG-Verstöße – Risiken werden sofort sichtbar
• Proaktive Moderation senkt rechtliche Risiken und schützt vor Eskalationen oder Shitstorms
• Auditsichere Dokumentation aller Vorfälle – jederzeit nachvollziehbar und prüfbar
• Nahtlose Integration in bestehende SOPs, Rollenmodelle und interne Prozesse – evalii® passt sich Ihrer Organisation an

 

Während andere Tools bei PV-Meldungen enden, sorgt evalii® für umfassende Kommunikationssicherheit – von Social Media über Messenger bis hin zu Webformularen.

Ihre Nutzer dürfen kommunizieren. Und Sie behalten die Kontrolle.

Bild: © Adobe Stock / 1518317541

Der Beitrag Mehr als Pharmakovigilanz: Wie evalii® auch Netiquette und HWG-Konformität sichert erschien zuerst auf evalii - pharmacovigilance monitoring service.

Social Media has become a central communication channel for many pharmaceutical companies. Whether it's a Facebook page, Instagram campaign, or YouTube channel – information about medications, services, and indications is increasingly shared via social networks.

It is often underestimated that with increasing visibility on social media comes increasing regulatory responsibility.
Pharmacovigilance on social media is not an option, but a legal requirement.

This duty to monitor also extends to Social media platforms like Facebook, Instagram, X (formerly Twitter) or YouTube.

However, companies are not responsible for third-party content, but for all channels on which you are active or have influence.
This means that all posts, comments, reactions, and direct messages on the company's own profiles or profiles equivalent to these must be regularly checked for possible indications of adverse drug reactions (AEs).

Social media differs significantly from traditional communication channels – especially with regard to Pharmacovigilance:

Real-time communication around the clock
Comments can appear at any time—even at night or on weekends. A sporadic review isn't enough; continuous monitoring is required.

High interaction density
A single post on Facebook or Instagram can trigger hundreds of comments. Personal experiences are common, especially when it comes to health or product questions – and potentially relevant to PV.

Different formats and channels
On Instagram, people often respond via stories, on YouTube via the comment function, and on Facebook via Messenger. An effective solution must take all of these formats into account.

Public visibility
Statements on social media are often visible to everyone. Overlooking indications of side effects can have not only regulatory but also reputational consequences.

evalii® is a specialized solution to Implementing pharmacovigilance requirements on social media in an automated and legally compliant manner – around the clock, on all relevant platforms.

What evalii® offers:

Automated monitoring of your own social media channels
Whether Facebook, Instagram, X or YouTube, evalii® systematically and continuously scans comments, messages and posts on company profiles.

Recognition of PV-relevant statements
Side effects are identified, classified and marked, even in indirect or colloquial formulations.

Documentation & Compliance
Every find is documented, including timestamp, channel, text excerpt, and processing status – fully auditable and GDPR compliant.

Integration into existing processes
evalii® can be adapted to individual SOPs, role models and approval processes.

Conclusion: Anyone who communicates on social media must also ensure pharmacovigilance

Pharmacovigilance on social media is not just a regulatory obligation – it is a patient safety imperative.
As social media presence grows, so does responsibility. Companies that actively use Facebook, Instagram or other platforms must also Check for PV-relevant content around the clock.

evalii® makes this task not only feasible but also efficient. Social media becomes a channel that is not only informative but also secure.

 

Do you have any questions about evalii® or feasibility? Please contact us: https://www.cross4channel.de/kontakt/

Interested? Feel free to contact us here – or by WhatsApp:

Der Beitrag Pharmakovigilanz auf Social Media: Pflicht, Herausforderung und digitale Lösung mit evalii® erschien zuerst auf evalii - pharmacovigilance monitoring service.

Digital communication in the pharmaceutical sector is developing rapidly – especially in direct exchanges with patients and healthcare professionals (HCPs). WhatsApp is playing an increasingly important role: fast, trusted, and ubiquitous. But with this opportunity comes greater responsibility. As soon as patients share information or ask questions, WhatsApp becomes a relevant source for potential suspected adverse drug reactions. This poses a challenge for your pharmacovigilance.

evalii®: Intelligent monitoring, immediate detection

evalii® is our specialized tool for automated monitoring of digital channels. It scans incoming posts and comments around the clock and documents them within seconds. A specially developed algorithm detects and channels messages with potentially PV-relevant content. Each identified message is manually reviewed by a trained pharmacovigilance agent and processed according to your specifications and in compliance with regulations.

Our quality assurance: trained, tested, certified

Security and compliance are at the heart of evalii®:

• Our pharmacovigilance staff undergo a certified training program and are regularly trained on legal requirements and internal SOPs.
• All processes are based on structured Standard Operating Procedures (SOPs) that can be audited at any time.
• evalii® operates according to an ISO 9001-certified quality management system. This means defined responsibilities, documented procedures, and continuous process optimization – for maximum traceability and quality assurance.

WhatsApp? Yes – but of course. With Comviira.

Many pharmaceutical companies already use WhatsApp – but often in the form of simple channels that offer no feedback or real interaction. But modern communication demands more: With Comviira WhatsApp becomes a true service and dialogue channel. Patients and HCPs can actively access content, ask questions, and, if desired, chat directly with service teams – in compliance with all legal requirements.

Why this is also legally relevant

As soon as you use WhatsApp for patient communication – for example, for inquiries about therapies, products, or side effects – potentially reportable content can arise. And this is precisely where the regulatory obligation comes into play: Relevant reports must be identified, documented, and processed via this channel as well. Without an integrated PV screening system like evalii®, you risk failing to comply with your reporting obligation – with all the resulting liability consequences. If you communicate there, you must also ensure that:

• relevant messages are reliably identified and processed,
• the documentation is complete,
• and your processes always comply with regulatory requirements.

Conclusion: Modern communication needs integrated security

WhatsApp is not an exception – it is a fully-fledged communication channel. Anyone who uses it must also consider the regulatory requirements. With evalii® and Comviira This can be done easily, efficiently and safely.

Interested? Feel free to contact us here – or by WhatsApp:

Der Beitrag Pharmakovigilanz in Echtzeit – auch auf WhatsApp: Warum evalii® und Comviira zusammengehören  erschien zuerst auf evalii - pharmacovigilance monitoring service.

Case 1: The “harmless” comment that was an alarm signal 

One patient commented in a social media post: "The new medication is working well, but sometimes I feel like I'm dancing... a little too much." 

A harmless comment? Not for our PV agents! The comment was immediately flagged, reported, and investigated further. Indeed, it turned out that the patient had cardiac arrhythmia—a rare but serious side effect in this case.  
Moral of the story: Reading between the lines is a real superpower! 

Case 2: The Emoji Code 

An Instagram post about a drug contained the words: “Now I can finally breathe again “. 

A relieved emoji? Our PV agents knew better! They checked the history and discovered that the patient had recently complained of side effects such as shortness of breath. This case was a prime example of how important it is to take even the most subtle clues in patient communication seriously.  

Case 3: When the past returns – Old comments, rediscovered

In July 2024, a side effect report for a medication was submitted to a social media post, reporting headaches as a side effect. The case was documented in the system, reported, and marked as "closed." But then, in November, another user reported under the old post: 

"I've been taking the medication for four weeks and have the same headaches as described above. Have you had any reaction yet?" 

In the past, such a comment would have easily been overlooked, as older cases are often only opened when necessary. Thanks to evalii® and the attentive agents, this case was documented and the new information was quickly forwarded to the pharmacovigilance team.  

Case 4: The classic confusion trick 

One user wrote in a product review: “After the second tablet, my dog got a rash.” Huh? 

Our PV agents had to chuckle, but investigated anyway. It quickly became clear that the user had accidentally given his medication to his dog – instead of the intended veterinary medication. The case was documented, and a tip was forwarded to the responsible department. Conclusion: Even unusual side effects deserve attention – even in furry patients! 

Why PV Agents are indispensable: 

These cases demonstrate how complex and diverse the world of pharmacovigilance is. Our PV Agents combine: 

• Technology: The evalii® platform detects relevant clues in real time. 

• Common sense: A trained eye recognizes risks that algorithms alone cannot see. 

• Linguistic sense: An empathetic grasp of linguistic subtleties  

Whether it's subtle hints, emojis, or slurred comments, the PV Agents ensure nothing is overlooked. Their work is not only important but also proof that pharmacovigilance is anything but boring. 

So, the next time you see a seemingly harmless comment on social media, remember that one of our PV Agents might already be taking a eagle-eyed look. And that's a good thing!   

Der Beitrag Die heimlichen Helden der Pharmakovigilanz: Wie unsere PV Agents mit evalii® für Sicherheit sorgen erschien zuerst auf evalii - pharmacovigilance monitoring service.

In this article we take a detailed look at vigilance as an integral but not exclusive component of the PMS system.

What is vigilance?

Under vigilance In the field of medical devices, this means the continuous and systematic collection, documentation and evaluation of all safety-relevant data on a medical device, after it was introduced to the marketVigilance is therefore the core of the official reporting obligations and includes, among other things:

• Reports of incidents such as malfunctions or unexpected side effects
• User reports, e.g. doctors, nursing staff or patients
• Results from studies (e.g. post-market clinical follow-up, PMCF)
• Feedback from authorities, distributors and other stakeholders

While the PMS system as a whole collects, documents and uses all data relating to quality, performance and safety for the continuous improvement of the product, the vigilance primarily on the Reporting safety-relevant events and dealing with the resulting measuresThis ensures that potential risks are identified at an early stage and corrective or preventive measures can be taken promptly. This not only serves to ensure patient safety, but also strengthens trust in medical devices and contributes to sustainable product improvement.

Legal Framework and Responsibility

1. MDR and IVDR

The MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746) have revised the requirements for placing medical devices on the market in the EU. Both regulations require manufacturers to set up a robust PMS system, which also includes vigilance. The PMS system has the overarching purpose of Collect and evaluate data throughout the entire life cycle of a medical device.

2. Roles and responsibilities

• Manufacturer have primary responsibility for setting up and maintaining an appropriate PMS system. Within this system, they must clearly define and adhere to processes for recording, evaluating and reporting incidents.
• Authorized Representatives in the EU area assume similar obligations if the manufacturer is based outside the EU.
• distributors and importers are obliged to report safety-relevant incidents to the manufacturer immediately.
• authorities such as the Federal Institute for Drugs and Medical Devices (BfArM) in Germany collect and analyze the reports. They can order measures if necessary.

The Process of Vigilance in the Context of PMS

1. Data collection and reporting management

The vigilance process begins with the systematic collection of all relevant data sources. These may be complaints, clinical studies, literature searches or reports from healthcare institutions. As soon as a report is received, the manufacturer (or its authorised representative) must check whether it is a reportable incident is.

Important factors for a reportable incident are:

• Deaths, serious deterioration of health or serious risks
• Previously unknown or unexpected side effects
• Significant technical malfunctions that pose a potential hazard

2. Assessment and risk analysis

After the recording, the Evaluation of the reports: How serious is the incident? Is it an isolated problem or is there a systematic error? For this purpose, risk assessments are carried out on the basis of existing data (e.g. from clinical studies or from the risk management process).

3. Corrective actions and feedback

The evaluation may result in: Corrective and Preventive Actions (CAPA) Typical measures can be:

• recall of the product or affected batches
• software updates or design adjustments
• Extensions or clarifications of the instructions for use
• Adaptation of packaging or labeling

The vigilance processes provide the framework when which messages to the authorities and which preventive measures must be initiated. Effective implementation of these measures requires that all relevant actors – from suppliers to users – are informed and trained in a timely manner.

4. Documentation and Reporting

All steps within the vigilance process must be carefully documented in order to be able to demonstrate to both the authorities and the notified bodies during audits and inspections that the legal requirements are met. The following documents are usually created or updated:

• incident reports and their assignment
• risk assessments and analysis methods
• action plans (CAPA process) and implementation reports
• Follow-up of measures (are they working as planned?)

Practical tips for successful vigilance and PMS

1. Early planning: Integrate both PMS and vigilance processes during the product development phase so that you can react quickly when the product is launched on the market.
2. Clearly defined roles: Ensure that responsibilities for PMS and in particular the vigilance reporting structures are clearly assigned.
3. Efficient reporting management: Establish internal communication channels and external platforms (hotlines, online portals) so that reports reach the right contact person immediately.
4. Regular training: Train employees and distributors on how to recognize, report and handle safety-related events.
5. Continuous Improvement: Use the results from PMS and vigilance not only to meet legal requirements, but also as an opportunity to continuously optimize your products.

Bottom line

Vigilance is central element of the Post Market Surveillance system more than just a legal obligation – it is an essential part of quality management and product responsibility. While the PMS collects data on quality, performance and safety in a holistic manner, vigilance focuses on the reporting management and initiating any necessary measures. By continuously collecting, evaluating and (in the event of incidents) reporting data from the field, it can be ensured that risks are identified early and measures are implemented promptly. In this way, vigilance not only strengthens trust in a medical device, but also makes an important contribution to constantly improving the company's own product range and ensuring patient safety in the long term.

Those who plan the vigilance process strategically and integrate it into a holistic PMS system not only remain compliant with the law, but also ensure the quality standards and reputation of their company.

Are you looking for support in setting up or optimizing your vigilance and PMS processes?

Our experts will be happy to advise you on all aspects of risk management, reporting management and communication with authorities. Benefit from our expertise to make your processes legally compliant and efficient.

Notice: This article is for informational purposes only and does not constitute legal advice.

Der Beitrag Medizinprodukte – Vigilanz als Teil des Post Market Surveillance (PMS)-Systems erschien zuerst auf evalii - pharmacovigilance monitoring service.

Medical devices such as wearables and digital applications, such as mobile health apps, are increasingly coming onto the market and expanding the spectrum of products to be monitored These new technologies, which often offer personalized healthcare services, generate enormous amounts of data containing potentially important information for pharmacovigilance. In this article, we examine how pharmacovigilance monitoring is changing in the age of social media and digital health applications and what challenges and solutions this presents for companies in the pharmaceutical industry.

The Role of Social Media in Pharmacovigilance

With the advent of social media such as Facebook, Twitter, Instagram and specialized patient forums, patient and consumer behavior has changed significantly. People are increasingly sharing their experiences with medicines and medical devices on social networks, often in real time. This presents both opportunities and challenges for pharmacovigilance. While traditional communication channels tend to be more formal, social media provides an unfiltered platform where patients can openly report adverse reactions and safety issues.

The challenge is that this information is often scattered, unstructured and published in different languages. Patients rarely use the medically correct terms and it can be difficult to identify a relevant side effect from a simple experience report. Add to this the enormous amount of data generated daily through these platforms. Manual monitoring would be inefficient and hardly feasible.

New requirements: medical devices and digital applications

In addition to pharmaceuticals, medical devices and digital health applications are also becoming increasingly important. Wearables such as fitness trackers, smart blood glucose meters and blood pressure monitors that record health data in real time are becoming increasingly common. Mobile health applications that help patients monitor their health are also experiencing a real boom.

These digital products must be monitored according to regulatory requirements. Medical device vigilance, which is closely related to pharmacovigilance, involves monitoring safety and performance issues. Manufacturers of digital health applications must ensure that their products are safe and do not have any undesirable effects. This requires continuous monitoring and proactive management of risks that may arise in the digital world.

Another example is the increasing use of telemedicine and digital health services, where doctors communicate with patients via apps and digital platforms. This also creates new challenges for pharmacovigilance, as communication via these channels also needs to be monitored.

The challenges of monitoring digital channels

Monitoring social media and other digital channels brings with it a multitude of challenges. The biggest hurdles include:

1. data volume and speed: The sheer volume of posts, comments and reviews published daily on social platforms makes manual monitoring impossible. However, quickly identifying and acting on security-related information is crucial to respond to potential risks in a timely manner.
2. Unstructured data: Most information shared on social networks is unstructured. Patients often report their experiences in colloquial terms and rarely use the medically correct terms for adverse reactions. This makes it difficult to assess the relevance of this information for pharmacovigilance.
3. variety of channels: In addition to the classic social networks such as Facebook and Twitter, there are numerous specialized forums, patient communities, app store reviews, blogs and even comments in e-commerce portals such as Amazon. This multitude of sources must be monitored simultaneously to ensure that no safety-relevant information is overlooked.
4. linguistic diversity: The global availability of medicines and medical devices means that social media content is also published in different languages. Efficient monitoring must therefore be multilingual to ensure that all relevant posts are captured.
5. Regulatory requirements: Legal requirements for pharmacovigilance are strict and vary from country to country. Pharmaceutical companies must ensure that they collect, document and forward all relevant information to the competent authorities. This requires precise and continuous monitoring.

The use of artificial intelligence (AI) to overcome the challenges

To overcome these challenges, more and more companies in the pharmaceutical industry want to use artificial intelligence (AI) and machine learning. These technologies offer the ability to analyze large amounts of unstructured data in real time and automatically identify relevant information. Algorithms can be used to detect potentially safety-relevant contributions and classify them according to their relevance for pharmacovigilance.

A particularly effective approach is to use text mining and natural language processing (NLP) techniques to analyze unstructured data. These algorithms can learn to associate colloquial terms with medical terminology and identify potential ADRs. In addition, they can operate in near real-time, making it possible to react immediately to new information.

evalii®: A solution for digital pharmacovigilance and vigilance

In this context, evalii®, a software solution from Cross4Channel GmbH, has proven to be particularly effective. evalii® offers comprehensive monitoring of social media channels, digital platforms, app stores and wide channels. Using a specially developed algorithm, posts and comments are monitored in real time for their pharmacovigilance relevance and checked by a trained team.

This solution supports not only pharmacovigilance, but also vigilance for medical devices and digital health applications. With evalii®, companies can ensure that they capture, analyze and document all relevant information from the various digital channels.

In addition, it offers additional functions such as moderation of community posts. This means that the tool not only identifies potentially security-relevant posts, but also reacts to netiquette violations or legally problematic statements. evalii® thus helps to significantly reduce manual effort while increasing the efficiency and accuracy of monitoring processes.

Bottom line

Pharmacovigilance and vigilance requirements have changed dramatically with the advent of social media, medical devices and digital health applications. Manual monitoring is no longer sufficient to cope with the enormous amount of data. Pharmaceutical companies must be able to capture relevant information in real time and respond quickly to potential risks.

The use of AI-based solutions offers a promising way to address these challenges. The future of pharmacovigilance is becoming increasingly digital, and solutions like evalii® are key to meeting the growing demands while ensuring patient safety.

Der Beitrag Pharmakovigilanz und Vigilanz in der Pharmaindustrie: Neue Anforderungen bei der Überwachung von Social Media und digitalen Anwendungen erschien zuerst auf evalii - pharmacovigilance monitoring service.

TikTok has rapidly developed into one of the most important platforms for short videos in recent years. With over 1 billion monthly active users worldwide, the app is particularly popular with younger target groups. In Germany, TikTok enjoys a steadily growing user base, with around 20 million users who are active on the platform every day【1】. This popularity makes TikTok an important channel for social interactions, entertainment and, increasingly, for sharing health and medication experiences.

Unlike Facebook or Instagram, TikTok is based almost entirely on video content. This creates a dynamic environment in which trends and challenges play a major role. Especially for companies in the healthcare sector, including the pharmaceutical industry, TikTok opens up new opportunities for patient communication, but also challenges in the area of pharmacovigilance (PV).

Interaction possibilities and pharmacovigilance

There are various interaction options on TikTok that are relevant for pharmacovigilance:

Videos and comments:

The core function of TikTok is short videos uploaded by users. These videos can be commented on and liked by other users. The comments are of particular interest to pharmacovigilance, as users can report on their experiences with medications or treatment methods. These comments must be regularly monitored to identify and report potential adverse drug reactions (ADRs).

The challenge on TikTok is that content can quickly go viral, and therefore continuous monitoring is necessary. Comments on viral videos shared by medical influencers or pharmaceutical companies can contain valuable clues about ADRs. However, identifying such comments requires advanced technologies and a systematic approach.

TikTok Stories:

TikTok also offers the function of posting "stories" that disappear after 24 hours, similar to Instagram and Facebook. Users can react to these stories by liking them as well as commenting. These comments are particularly relevant in the context of pharmacovigilance, as users could share their experiences with medications there. Since stories are only available temporarily, they need to be monitored in real time to ensure that potentially important information is not lost.

Private messages (direct messages, DMs):

Like other platforms, TikTok allows direct messaging between users. This feature is often used for private conversations, but it can also be used to exchange information relevant to pharmacovigilance. Since these messages can contain confidential information, it is important to strictly adhere to data protection policies and have a reliable system for monitoring and documenting such messages.

Stitch and Duet videos:

TikTok offers unique interaction opportunities through "Stitch" and "Duet" functions. Users can react to existing videos or edit them and add their own content. When a user reports on their experience with a drug and other users respond with their own experiences, potentially relevant information for PV can emerge. Monitoring such content is particularly challenging because it is often shared in different formats and across multiple videos.

Special features of the TikTok platform for PV monitoring

Unlike Facebook and Instagram, TikTok does not currently offer a public API that allows for easy monitoring of content. This means that manual monitoring on TikTok can be particularly time-consuming and error-prone. The platform is also heavily influenced by rapid changes and new features, making it difficult to establish a consistent monitoring process.

Another aspect is the speed at which content can go viral on TikTok. A single video can reach millions of views in a matter of hours, making continuous, automated monitoring essential.

Monitoring with evalii®

TikTok is a platform that particularly appeals to younger users, but is also becoming increasingly relevant for health and medical devices. By systematically monitoring videos, comments and private messages, potential PV events can be identified and reported at an early stage, as required by legal requirements.

evalii® offers you the possibility to efficiently monitor your TikTok projects and campaigns and ensure that no relevant information is overlooked. With evalii® you can take advantage of modern technologies to optimize your patient communication and ensure the safety of your products.

Sources:

【1】 Statista: Number of TikTok users in Germany

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Der Beitrag TikTok & Pharmakovigilanzmonitoring erschien zuerst auf evalii - pharmacovigilance monitoring service.

Facebook is one of the largest social platforms in the world and plays a central role in digital communication. With over 2.8 billion monthly active users worldwide, Facebook is a platform that connects people, exchanges opinions and shares information. In Germany, around 32 million people are active on Facebook, making the platform an important channel for social interactions and information exchange. 【1】

Recently, the use of Facebook in Germany has changed. While the number of younger users has decreased, the number of older users is steadily growing. This is because Facebook not only serves as a social network, but also as a source of news and a means of communication for different age groups.

Facebook's functions have also evolved to meet the needs of users. New features such as Facebook Stories, Marketplace and Groups have helped to keep the platform attractive. The demographic development, which could reduce the relevance of Facebook in Germany in the long term, makes the platform particularly relevant for the moment for any medical indications that affect patients aged 40+.

Interaction options and their relevance for pharmacovigilance

Facebook offers a variety of opportunities for interaction that make appropriate pharmacovigilance monitoring essential. These include comments, guest posts and private messages that may contain potentially reportable events.

Comments:

Comments are one of the most common forms of interaction on Facebook. Users can comment on posts by companies, organizations or other users. Comments on posts by a pharmaceutical company are of particular interest to pharmacovigilance, as users often share personal experiences with medications. Such comments can provide evidence of adverse drug reactions (ADRs). It is important that these comments are regularly monitored to identify and report potential PV events. A systematic approach to monitoring and analyzing comments can not only help to identify potential safety issues at an early stage, but also reveal valuable information about your target audience.

Guest contributions:

Guest posts, also known as user-generated content (UGC), are posts posted by users on company pages or in groups. While most companies do not allow or disable guest posts, these posts, if not blocked, can contain detailed accounts of personal experiences with medications. Guest posts often provide more detailed information than comments and can provide specific data on ADRs and their circumstances. Systematic monitoring and evaluation of these posts is essential for regulatory compliance and can provide important insights into the safety and effectiveness of medications.

Private messages:

Private messages provide a direct and personal means of communication between users and companies. While many users use this feature for personal conversations, information about ADRs can also be shared here. It is necessary for companies to have an effective system for monitoring and documenting such messages to ensure that no relevant information is missed. Since private messages can contain sensitive information, it is important to strictly adhere to data protection policies and protect user privacy.

Special features of the Facebook platform for PV monitoring

While META provides an interface for retrieving comments, it can by no means be described as reliable. Changes to the interface, which META makes frequently and irregularly, must always be kept in mind in order to enable the retrieval of comments reliably.

There are also a number of interaction options on Facebook pages, such as the so-called page ratings, which are rarely used but still allow free text. Due to the complexity of the platform, which has grown over a long period of time, changes or additions to these interaction options can easily be overlooked, so it is crucial for pharmacovigilance monitoring to keep a close eye on them.

Monitoring with evalii

In summary, Facebook is still an important platform in Germany today. Through systematic monitoring of comments, guest posts and private messages, potential PV events can be identified and reported at an early stage, as required by law.

evalii offers you the opportunity to efficiently monitor your Facebook projects & campaigns and ensure that no relevant information is overlooked. With evalii you can take advantage of modern technologies to optimize your patient communication and ensure the safety of your products.

Sources:

【1】 [Statista: Number of Facebook users in Germany](https://de.statista.com/statistik/daten/studie/221041/umfrage/anzahl-der-facebook-nutzer-in-deutschland/)

Der Beitrag Facebook & Pharmakovigilanzmonitoring erschien zuerst auf evalii - pharmacovigilance monitoring service.

Instagram has established itself as one of the fastest-growing social platforms worldwide, with a focus on visual content. The platform allows users to share photos and videos, post stories and communicate via direct messages. With over 1 billion monthly active users worldwide, including around 21 million in Germany, Instagram is an important channel for personal and commercial exchange 【1】.

In recent years, Instagram has evolved from a platform for lifestyle and leisure photos to an important tool for brand communication and customer interaction. Companies are increasingly using Instagram to reach their target audiences with engaging visual content, and this is also true for the pharmaceutical industry.

In Germany, Instagram has steadily grown in popularity in recent years, especially among younger users. Companies are increasingly recognizing the platform's potential for marketing and customer communication. The introduction of features such as IGTV, Reels and shoppable posts has expanded the opportunities for interaction and engagement. For pharmacovigilance (PV), Instagram offers unique challenges and opportunities, as users often share their health and medication experiences in images and videos.

Interaction possibilities and pharmacovigilance

Monitoring Instagram in the context of pharmacovigilance requires a deep understanding of the platform and its different forms of interaction:

Posts and comments:

The most popular format on Instagram is regular posts. These photos and videos can be commented on by users at any time, both immediately after they are published and weeks or months later. This fact makes it crucial to establish a reliable process for monitoring profiles that publish new posts weekly, for example. In reality, a strictly manual process is often not efficiently feasible, so when operating your own profiles you should always rely on an automated solution to identify new comments.

Stories and Reels:

Instagram Stories and Reels are short, temporary videos that often complement posts. Like the posts themselves, Stories and Reels can be commented on. Users often share everyday moments here, including their experiences with medication. This content disappears after 24 hours (Stories) or remains permanently on the profile (Reels), which requires continuous monitoring.

Direct messages:

Direct messages on Instagram allow private communication between users and companies. Here, users can share detailed and personal stories about their experiences with medication. It is important to have an effective system for monitoring and documenting these messages so that no relevant information is missed. Data protection and confidentiality must always be guaranteed.

Influencer marketing:

Another important aspect on Instagram is influencer marketing. Influencers who promote medicines or health products can have a large reach and exert considerable influence on their followers. Posts and stories from influencers who report on their experiences with medicines can also contain relevant information for pharmacovigilance. Monitoring this content is particularly important when working with an influencer to ensure that all legal requirements are met and potential ADRs are reported.

Special features of the Instagram platform for PV monitoring

While META provides an interface for retrieving comments, it can by no means be described as reliable. Changes to the interface, which META makes frequently and irregularly, must always be kept in mind in order to enable the retrieval of comments reliably.

Furthermore, Instagram accounts can only be monitored if there is an existing technical connection to a Facebook page via the API (interface).

Monitoring with evalii

Instagram is probably the most important social media platform for a variety of medical indications and thus the pharmaceutical industry, as it attracts a large number of regularly active users and visual content that can contain valuable information. By systematically monitoring posts, comments, stories, reels and direct messages, potential PV events can be identified and reported at an early stage, as required by legal requirements.

evalii offers you the possibility to efficiently monitor your Instagram projects & campaigns and ensure that no relevant information is overlooked. With evalii you can take advantage of modern technologies to optimize your patient communication and ensure the safety of your products.

Sources:

【1】 [Statista: Number of Instagram users in Germany](https://de.statista.com/statistik/daten/studie/221041/umfrage/anzahl-der-instagram-nutzer-in-deutschland/)

Der Beitrag Instagram & Pharmakovigilanzmonitoring erschien zuerst auf evalii - pharmacovigilance monitoring service.