Remco Munnik

📌 NEW \- Insights on Cybersecurity in the Health Sector ⁣ ⁣  🛡️ A new European Commission study highlights serious #cybersecurity weaknesses in the #healthsector that innovators need to address.⁣ ⁣ 🔍 𝗔𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗦𝘁𝘂𝗱𝘆: The study focuses on how #digitaltransformations, such as #AI, #IoT, and #wearabletechnologies increase #security risks in healthcare. The study also points out that while cyber incidents are known to happen in healthcare, they usually do not directly link to immediate harm to #patients.⁣ ⁣  ⁣📉 𝗞𝗲𝘆 𝗙𝗶𝗻𝗱𝗶𝗻𝗴𝘀: The researchers found 21 major cyber incidents, mostly based on #ransomware, affecting healthcare services like surgery delays and therapy deferrals. However, they found no direct evidence that these incidents harmed patients. This shows a clear need for better methods to assess how #cybersecurityissues affect #patienthealth.⁣ ⁣⁣ 🏥 W𝗵𝗮𝘁 𝗧𝗵𝗶𝘀 𝗠𝗲𝗮𝗻𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀: Those of you developing #medicaldevicesoftware must put strong cybersecurity measures in place from the start. Good security is crucial not only to meet legal requirements, but also to protect patients from growing online threats.⁣ ⁣ 🤝

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Progress of the ePI initiative in the EU was in the spotlight of the #TopraSymposium2024 in Rotterdam - The proposed legislative revision makes the transition from paper to ePI possible: Dir Art. 63 - EU ePI Common Standard based on FHIR has been agreed on - EMA ePI pilot project has been completed, NCAs of DK, ES, NL and SE were involved. Report on the outcomes under preparation. - Work continues on implementation strategy and feature development - The opportunities offered by ePI will be explored also for veterinary products. It begins to look like the EU is really ready for electronic Product Information. Even though phasing in of ePI and phasing out of paper PL will still take several years, there are already concrete steps to be taken for the industry. At least we all can start moving from document thinking to content structure thinking. One way to keep updated on the progress is to check EMA Quarterly System Demos which are to demonstrate the developments achieved and to collect feedback from stakeholders. Livestream on YouTube can be joined without invitation and recordings are available on the EMA website/YouTube.

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We enjoyed creating and delivering the KPI workshop for the QP forum enormously. Together with the great energy we got back from all of you in the room we were able to inspire you and we hope we have made you starting to love KPIs a little bit more. Keep experimenting and learn how you too can use KPIs to drive good quality behavior in your organization. #KPI, #change, #continuousimprovement, #leadingchange,#qualityculture,#qualitybehavior

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what's an original record? and what represents a true copy Original record: The first or source capture of data or information e.g. original paper record of manual observation or electronic raw data file from a computerised system, and all subsequent data required to fully reconstruct the conduct of the GXP activity. True Copy: A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. Ref. MHRA Data integrity guidance

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European Medicines Agency’s data protection notice for EudraVigilance Human (EV) This Data protection notice explains the most essential details of the processing of personal data in the context of the operation of EudraVigilance Human (EV) established in accordance with the requirements of Article 24(1) of Regulation (EU) No 726/2004. The EudraVigilance Human (EV) system is designed to collect and analyze information on suspected adverse reactions to investigational and authorized medicinal products in the EU. • 𝗗𝗮𝘁𝗮 𝗣𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴: Personal data is processed for pharmacovigilance and clinical trials, ensuring the safety of medicines and investigational products. • 𝗝𝗼𝗶𝗻𝘁 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗿𝘀: The European Medicines Agency, the European Commission, and National Competent Authorities act as joint controllers for the data. • 𝗗𝗮𝘁𝗮 𝗦𝘂𝗯𝗷𝗲𝗰𝘁 𝗥𝗶𝗴𝗵𝘁𝘀: Individuals have rights to access, rectify, erase, and restrict the processing of their personal data under GDPR and EUDPR regulations. Read more @ https://lnkd.in/dqhymmVV

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The AI Act aims to ensure EU innovative capacities while preserving AI citizens’ fundamental rights and the rule of law. This Act establishes a risk-based approach of AI systems regulation, and introduces risk based prohibition of some AI systems, a complaint mechanism for citizens and transparency requirements. It also places obligations on developers, importers and users of AI systems.

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The European Union’s Artificial Intelligence Act (EU AI Act) was published on July 12th 2024, and it has implications for Pharmacovigilance (PV). https://lnkd.in/dTkHSR7w Here are some key points: 1️⃣ Risk Assessment and Categorization: The Act introduces a risk-centric approach to AI regulation. AI systems employed in PV may fall under the high-risk category due to the potential repercussions of inaccuracies or biases in drug safety surveillance. 2️⃣ Data Integrity and Transparency: The Act emphasizes data integrity and transparency, mandating stringent standards for the quality and openness of data used in AI systems. In PV services, this ensures the accuracy and reliability of data relating to adverse event detection and analysis. 3️⃣ Human Oversight and Accountability: The legislation requires human oversight and accountability for AI systems, particularly those deemed high risk. In PV, this requirement safeguards against automated decision-making, affirming that healthcare professionals are responsible for actions based on AI-generated information. 4️⃣ Testing and Certification Protocols: High-risk AI systems must undergo rigorous testing and certification procedures to ensure their safety, reliability, and adherence to regulatory standards. This entails validating algorithms for AE identification and signal prioritization for PV applications. 5️⃣ Documentation and Audit Trails: The EU AI Act mandates comprehensive documentation and audit trails for high-risk AI systems, incorporating details of their design, development, validation, and real-world performance. In PV, this documentation facilitates traceability and auditability of AI-driven processes, fostering regulatory compliance and post-market surveillance. AI has the potential to enable faster and more precise identification of ADR and emerging safety signals. By analyzing extensive data sets encompassing electronic health records, social media posts, and medical literature, AI systems can detect potential safety concerns pre-emptively. Stay tuned for more updates on how AI is revolutionizing Pharmacovigilance! #AI #Pharmacovigilance #EUAIAct #HealthcareInnovation https://lnkd.in/dTkHSR7w

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(Benefit-Risk Management / Boxed Warnings / US FDA CDER Research) Taking a break from a reg mtg or guidance today, today is a spotlight on a qualitative study on the perceptions of a "Boxed Warnings" when prescribing. Whether today or maybe sometime in the future, should your meds at home or for work oversight, this may provide some insight the reg science behind these label risk mitigation implements (N=52 participants). Enjoy. #fda #benefitrisk #boxwarning #boxedwarning #cder #drugs #cber #biologics

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EMA have published the proposed changes targeted for implementation in January 2025. Open for comment, it aims to streamline efficiency in procedure with the concepts of Type IA supergroups, annual reporting and obligation for work sharing. In addition there is proposals to update some of the categories of variations. #regulatoryaffairs #variationregulation https://lnkd.in/eaYXNd9g

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CYBERSECURITY: in the Health and Medicine Sector: European Commission 2024 A study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings

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In the realm of healthcare, patient safety is paramount. 🫂⛑️💊 COFEPRIS (MX MoH) is leading the way with innovative tools like VigiRam and VigiVac, designed to streamline the reporting of adverse drug reactions (ADR/ADEs/SRAM) and vaccination events (VAERS/ESAVI). These platforms empower patients and consumers, giving them a voice and ensuring their experiences contribute to the safety and efficacy of medical treatments.   Let's embrace these advancements that not only enhance patient care but also foster a collaborative environment for healthcare improvement. Together, we can build a safer, more transparent healthcare system. #PatientSafety #HealthcareInnovation #EducaPRiS.

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Is your QMS ready with the #AI Act which was published in EU Official Journal? Make sure implementation dates are tracked to prevent any critical or major findings. #GMP #GLP #GCP #GDP #Valudation #Artificial Intelligence #AI #Pharmaceutical #Healthcare

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Recently, a few form 483s and #Warningletters have again raised concerns of health authorities over the #DataIintegrity lapses in #Qualitysystem. Data integrity ensures the #reliability, #accuracy and #consistency of the data. Data governance program encompasses controls primarily at three levels, which are: 1. Data integrity controls at #Organizational level 2. Data integrity controls for #Paperrecord 3. Data integrity controls for #Electronicrecord Data integrity requirements at Organizational level: 1. #QualityCulture : Fostering a culture of Quality is expected to be endorsed at the highest level of the organization by: A. Spreading #awareness of data integrity requirements B. Lead by example by the #management C. Ensure #accountability for the actions and #decisions D. Active involvement of the employees at all levels E. Creating a culture of trust 2. Code of ethics and policies: Creating policies that clearly define the Organization's approach for data integrity requirements communicating at each level along with the actions taken if found in fraudulent activities like intentional data manipulation, destruction, or unauthorized modifications. 3. Training: Adequate #training on data integrity requirements is the key to meeting the DI principles. Personnel should be trained on proper and improper conduct of data management and also the repercussions of conducting fraudulent conduct. 4. Pharmaceutical Quality System: Developing a strong Pharmaceutical quality system is the foundation of ensuring the Quality, safety and integrity of the product. This helps to identify, correct and prevent the weaknesses within the Quality System. The various PQS controls may include (but not limited to) : - Electronic data and #audittrail review - Risk Management - Investigations and CAPA program - Training Management - Computer system Validation - Self - inspection including data integrity - Vendor Management - Quality Management Review with Quality matrices - Change Management 5. #Qualitymatrices for Data integrity The organization should establish procedures and systems designed to collect, record, analyze, and maintain data integrity and providing mechanisms to prevent data integrity lapses, detecting non-compliances, measuring the impact of the lapses identified and developing strategies to prevent the integrity failures. #Staytuned for the next parts of the post where DI controls for paper and electronic records will be shared. Till time, keep learning 📚 , keep growing 🎯

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#Computerized #systems management in regulated environment can be challenging... and is not always easy… 😅 When introducing a new computerized system, one of the first steps to consider is the #GAMP categorization. According to GAMP 5 2nd edition, the entire management #strategy lays on the system category, which is based on the #risk level: Cat. 3️⃣: non-configured software. A standard solution available in the market. 👉 This is the lowest risk level. Focus should be placed on the functionality, that must fit user’s requirements specifications. Cat. 4️⃣: Configured software. A commercial solution configured to meet the specified functional needs 🔦 Focus should be place on the system’s configuration, that must be under control during the entire #lifecycle. Cat. 5️⃣: Custom software. A tailored solution, developed according to the specific company’s processes and requirements. 😱 This is the highest risk level, so it needs the strictest control and management strategy.  Specifications, testing, operation, administration… everything needs to be defined considering a risk-based approach, according to the GAMP category. But… what about SaaS? And, even more… what about AI? The less closed the system is, the higher the risk level, and the grater the effort to mitigate this risk. How do you deal with all this in your companies? Any advice to share? Looking forward to discussions in comments! 😊 #regulations #biopharma #technology #compliance #GXP #quality

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EU MDR / IVDR News! (Q&A interruption or discontinuation of supply) The European Commission has published a revision to the "Q&A Obligation to inform in case of interruption or discontinuation of supply" This Q&A provides practical guidance on Article 10a of Regulation (EU) 2024/1860 This Q&A clarifies: • Manufacturers’ responsibilities; • Notification timing; • Supply chain operator duties; • To whom does the obligation to inform applies to; • Communication Protocols; • Which devices the obligation applies to #intelligence #notifiedbody #notifiedbodies #audit #medicaldevices #medtech #euivdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #eumdr

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https://lnkd.in/ecQ4aguS good video on new regulation : NIS2. NIS 2 Directive: Navigating the challenges of implementation, impact and scope

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A strong company culture thrives on accountability. Leadership teams must fully understand and align on the principles of accountability to build a sustainable enterprise. I take pride in the fact that we at PQE Group ensure that everyone takes ownership of their actions and responsibilities, fostering trust, collaboration, and a shared sense of purpose. Mistakes are inevitable, but our response to them can always be managed and reframed to find the silver lining and improve. By setting clear expectations and embracing open communication, we ensure that every voice is heard and every idea is valued, empowering each other to excel and innovate. Accountability not only drives individual growth but also strengthens our commitment to achieving our collective mission.

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