With the EU Regulation 2025/1466 Key requirements for the Pharmacovigilance (PV) Noticeably, the focus is shifting away from pure formalism towards Traceability, process quality and transparent documentation. For pharmaceutical companies, this means specifically: PV processes must not only function, but proven, versioned and auditable be, and that is along the entire process chain from detection to action. 

This increases expectations for the organization, IT systems, and governance alike. In particular, the following are required: 

• Complete documentation of PV-relevant content and decisions 

• Risk-based assessment of deviations and process risks 

• Rapid response to potentially critical messages 

• international data standards and consistent chains of evidence 

• Audit and inspection capability for internal and regulatory audits 

evalii® It provides the technological and procedural foundation for this. The platform supports companies not only in meeting regulatory requirements, but also in... to actively control. 

 evalii® is a structured system for monitoring, evaluation and Documentation of potentially pharmacovigilance-relevant content, especially from digital channels. This is precisely where a practical problem often lies: While companies can often monitor social media, contact forms, or platform comments, the regulatory-required documentation is often manual, fragmented, and not consistently audit-proof. 

evalii® provides a solution here by handling all process steps standardized and understandable be depicted. 

The platform helps answer key audit questions such as: 

• Which message was detected and when? 

• How was it evaluated, classified, and prioritized? 

• To whom was it forwarded and when? 

• Who was involved and what measures were taken? 

This creates a transparent, audit-proof workflow, which can be adapted to existing role models and SOPs. 

 The new EU regulation reinforces the requirement that PV processes not only be "lived" but also formally verifiable must be. In practice, this means that companies need documented proof that..., 

• that PV-relevant content identified become, 

• like her rated become, 

• how decisions are made, 

• and which Measures were hit. 

With evalii®, this documentation no longer becomes a manual effort.  

This particularly supports: 

Compliance with new PSMF (Pharmacovigilance System Master File) requirements 

The demands placed on the PV system and its documentation are increasing. evalii® enables the consistent mapping of process logic, responsibilities, and decision-making paths – an essential foundation for auditable PV documentation. 

Risk-based assessment of process deviations 

Instead of blanket formalism, risk-based analysis takes center stage: Which deviations are critical? Which are tolerable? What measures are required? evalii® provides structured data foundations for this. 

Audits require a complete and transparent justification of decisions and responsibilities. evalii® provides a comprehensive history for this purpose: Who assessed what, when, and why? This reduces audit effort and provides security when dealing with regulatory inquiries. 

Digital channels are now a key risk factor and, at the same time, a crucial information space. Continuous monitoring is therefore not only an organizational obligation but increasingly a governance requirement: companies must ensure that relevant content is identified and assessed before it gives rise to regulatory or liability risks. 

evalii® offers not only safety, but a genuine Early warning function: 

• Potentially critical content is identified. 

• prioritized and classified 

• assigned to the relevant authorities 

• and documented along the process chain 

This creates responsiveness – and at the same time the required verifiability. 

 Conclusion:  

The new EU regulation requires transparency, reaction speed and documented quality. Companies are therefore faced with the task of not only making PV processes more efficient, but above all Auditable and revision-proof to build. 

evalii® offers a solution that meets regulatory requirements structured representation, Effort reduced and supports companies in implementing modern PV standards. 

With evalii®, the switch to... modern pharmacovigilance. 

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

In digital communication, the principle of "proximity creates responsibility" is truer than ever. Healthcare companies also benefit enormously from channels like Instagram, WhatsApp, and Facebook, but they must also face regulatory realities. As soon as users post publicly, the company becomes (partly) responsible, at least in certain areas.

Whether it's a personal account, a recommendation, or even a medication name – what seems authentic and harmless can become legally problematic. This is especially true in the context of the German Act on Advertising of Therapeutic Products (HWG).) and internal communication guidelines.

Many users describe their personal medical histories online – often combined with promotional and comparative statements.

However, depending on the context, such statements may violate Section 11 of the German Advertising Act (HWG) or general competition law provisions – especially if:

• Specific products will be mentioned.
• Disease progression or treatment successes are described.
• Acknowledgements or recommendations are given

Even if the content originates from a third party, companies are obligated to moderate or remove it as soon as they become aware of it. Furthermore, companies must ensure they can regularly access such content. Otherwise, the statement could be attributed to them.

And this is exactly where evalii® comes into play: as a tool for all digital communication.

evalii® is far more than a pharmacovigilance monitoring system: Incoming content can not only be checked for potential adverse event reports, but also for:

• HWG-critical statements
• Violations of netiquette guidelines
• problematic comment types such as misinformation or sensitive content

As soon as relevant content is detected, a report is also issued here following a coordinated process:

• Either through our team: We review, evaluate and act according to your specifications.
• Or through your internal department/agency: evalii® immediately sends an email notification to the responsible person.

This way you can decide individually who moderates, but you won't miss any comments.

Why this matters to you:

• Greater security in the digital space – even with high interaction and high volume of comments

• Early warning system for potential violations of the German Medicines Advertising Act (HWG) – Risks become immediately visible
• Proactive moderation reduces legal risks and protects against escalations or shitstorms
• Audit-proof documentation of all incidents – traceable and verifiable at any time
• Seamless integration into existing SOPs, role models and internal processes – evalii® adapts to your organization

 

While other tools stop at PV notifications, evalii® ensures comprehensive communication security – from social media to messengers to web forms.

Your users are allowed to communicate. And you retain control.

Image: © 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.

What real benefits do these innovations bring, and what legal and practical aspects need to be considered?

E-prescription: Simplifying drug supply

The e-prescription revolutionizes the issuing and dispensing of medications. Whereas paper prescriptions were previously prone to loss or misunderstandings, the e-prescription relies on digital solutions. The prescription is fed directly into a central telematics infrastructure and is available to patients via an app or a digital prescription ID.

The advantages at a glance:

• Efficiency: No more paper, administrative effort and error susceptibility are reduced
• Speed: Patients can redeem their prescriptions faster and more easily at the pharmacy.
• Safety: Automatic testing for interactions and contraindications.

Challenges:

• Technical implementation: Not all doctors and pharmacies are yet integrated across the board.
• Acceptance: Some users are skeptical about the digital solution
• Data protection: in order to ensure the security of health data, the requirements of gematik (Society for Telematics) must be met

Legal basis:

The introduction of e-prescriptions is regulated by the Patient Data Protection Act (PDSG), which is a key driver of digitalization. The goal is widespread use of e-prescriptions starting in 2024.

Electronic patient record (ePA): Manage health data centrally and digitally

The ePA offers the possibility of storing health data securely and centrally. Findings, diagnoses, medication plans, maternity records, and vaccination records – everything is stored in a digital health folder that patients and authorized physicians can access.

The advantages at a glance:

• Transparency: Patients have access to their data at any time.
• Optimized care: Doctors can access important information and avoid duplicate examinations.
• Time saving: Documents such as vaccination or maternity records are available at any time.

Challenges:

• Data protection: The security of sensitive health data is a key challenge, especially in light of the requirements of the General Data Protection Regulation (GDPR)
• Technical integration: the comprehensive connection of all healthcare facilities to the telematics infrastructure has not yet been achieved.
• Usage: Currently, only a few insured persons actively use the ePA. This could change with the opt-out procedure starting in 2025.

Legal basis:

The ePA is regulated in Section 291a SGB V and was introduced by the PDSG.

From 2025, all statutory health insurance holders will automatically receive an ePA unless they object (opt-out procedure)

Data protection perspectives

The processing of health data is subject to the strict regulations of the General Data Protection Regulation (GDPR), in particular Article 9 GDPR, which regulates the processing of special categories of personal data. In the context of e-prescriptions and the ePA, the following aspects are important:

1. Legal basis: Data processing is carried out on the basis of the PDSG, which provides clear legal legitimacy.
2. Purpose limitation: The data may only be processed for the intended purposes, such as medical care and drug supply.
3. Transparency: Patients must be fully informed about how their data is processed and they retain control over its use at all times.
4. Technical and organizational measures (TOMs): Data security is ensured through encryption, access restrictions, and compliance with gematik requirements.
5. Opt-out procedure: The automatic setup of the ePA from 2025 is permissible under data protection law, as insured persons can actively object and retain full control over their data.

Conclusion:

With e-prescriptions and electronic patient records, two central elements of healthcare digitalization are gaining ground. They promise significant benefits for patients, physicians, and the healthcare system as a whole. Despite technical and legal challenges, initial experiences show that digitalization is the right path to making medical care more efficient and patient-friendly. The coming years will be crucial for further increasing the acceptance and benefits of these technologies. Transparency, data protection, and user-friendliness remain the key factors for success.

Der Beitrag Die Digitalisierung im Gesundheitswesen: Wie elektronische Patientenakten und E-Rezepte die Zukunft der Medizin gestalten 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.