Dr. Florian Reiling, MBA’s Post

🔍 Sign up to our exclusive webinar to discover how AI is revolutionising Pharma & MedTech! Join our panel to explore IP protection, AI as an inventor, and safeguarding training data. Plus, get insights on contract compliance and transformative case studies. #AI #Pharma #MedTech #IPLaw

🔍 AI is revolutionising Pharma & MedTech! Sign up! #AI #Pharma #MedTech #IPLaw #Webinar

🚀 Uncover the future of AI in Pharma & MedTech in our exclusive webinar! Learn about IP laws, AI inventorship, and data protection. Don't miss our expert insights and case studies. #AI #Pharma #MedTech #IPLaw

🔍 Sign up to our exclusive webinar to discover how AI is revolutionising Pharma & MedTech! Join our panel to explore IP protection, AI as an inventor, and safeguarding training data. Plus, get insights on contract compliance and transformative case studies. #AI #Pharma #MedTech #IPLaw

Freyr Digital is setting a new standard in the life sciences industry with GxP-compliant AI solutions. Our latest white paper takes you beyond the buzzwords into the core of Trustworthy AI — showcasing how innovation meets compliance. Discover: ✅ Our AI-native approach to regulatory software ✅ Transparent, ethical, and secure AI integration ✅ Insights tailored for Pharma, Medical Devices, and more Dive into best practices and our SDLC approach, ensuring cutting-edge yet compliant solutions. 💡 Ready to transform your regulatory processes? Download the white paper now and take the first step toward the future of Trustworthy AI in Life Sciences! 🔗 https://hubs.la/Q02ZRS8v0 #TrustworthyAI #AIInRegulatory #RegulatoryCompliance #LifeSciences #Innovation #FreyrDigital #FreyrSolutions

What are your most challenging questions on regulatory affairs in MedTech? What are some of the more common questions you hear repeatedly? 🧐 I am looking for the stupid, simple, and more complex questions to better MDexpert.AI. Share your questions in the comments or via this form. 👇https://lnkd.in/dtK6nCNC I would love to hear them. #futureofmedtech #ai #medtech #medicaldevices #ivd #mdexpertai

Are you prepared for the upcoming #AI regulations? 🇪🇺 After the publication of the EU AI Act in December 2023, phased implementation and final enforcement aims to balance AI innovation with regulation. ✔️ If you’re in the pharma or medical devices field, you must: Audit your AI systems to determine risk categories (unacceptable, high, limited, minimal) and ensure compliance. ✔️ Take immediate corrective actions for non-compliance and report serious incidents to national authorities are required. ✔️ Establish monitoring mechanisms, especially for high-risk AI systems, and perform regular compliance checks. Member states will enforce the EU AI Act in collaboration with national supervisory authorities and the proposed European Artificial Intelligence Board (EAIB). National authorities will oversee day-to-day application, ensuring compliance, conducting checks, and imposing penalties, while the EAIB offers guidance on the Act. 🇺🇸 Currently, no specific regulatory guidance is in place. The FDA is seeking public comments on published discussion papers and engaging with stakeholders to enhance understanding of AI's impact on drug and medical device development. The agency intends to finalize its regulatory framework soon. Want to stay on top of changes and learn how to prepare? Check out our latest blog >> https://bit.ly/3wXuMTp #AIRegulations #Compliance #QualityManagement

There’s been plenty of conversation recently about validating AI health tools 👀 A recent Nature article suggests that not all AI health tools with regulatory authorisation are clinically validated and proposes a new validation standard to evaluate FDA authorisation as an indication of clinical effectiveness in medical AI tools. While this makes for alarmist headlines, here at Hardian, we think it’s important to clear up a few things: 1️⃣ The FDA wouldn’t authorise a device without proper review of clinical evidence 2️⃣ The publicly available summaries aren’t written by the FDA, but by manufacturers – and they’re not required to include clinical validation details 3️⃣ This isn’t an AI-specific issue. Lack of transparency in clinical trial data has been a broader concern for years across medical devices and drugs So, if someone claims that FDA-approved AI tools aren’t validated, gently remind them it’s not a question of validation - it’s a question of transparency. Read the full article ➡️ https://lnkd.in/gZ4uGGCd If you’d like to stay up to date with all things AI and regulation, sign up to the Hardian newsletter ➡️ https://lnkd.in/eaF6MMWs #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

#AI #HealthLaw & #Policy Summit that was recently held in Washington, DC. This summit was a platform for #government and #industry representatives to discuss new and emerging #globalhealth care #AIPolicies. The European Union is indeed eager to be at the forefront of #data and #digitaltechnologies #regulation. The #ArtificialIntelligenceAct proposed by the #EU is expected to have broad ramifications and establish #standards for #AIGovernance #structures within #business organizations, extending beyond the #geographicalscope of the #EUMarket. The #AIAct will apply directly to #AIProviders and #AIdeployers of #AIsystems that are marketed or used in the #EU, regardless of whether these operators are located inside or outside the EU. The Act aims to implement a horizontal, #crosssector approach across almost all industries. Panelists at the summit discussed a variety of anticipated challenges with how the AI Act will impact #compliance and #marketaccess issues in the context of the overall #healthecosystem. In the context of #medicaldevices, for example, there were concerns about the need to align the AI Act with the existing Medical Device Regulation (#MDR) and In Vitro Diagnostic Regulation (#IVDR). They analyzed scenarios where the #AIAct might apply to some technologies even where the MDR/IVDR might not apply, and vice versa. The challenge, they noted, will be in finding the right balance to ensure #safe and #responsible #AI without having a negative #impact on #innovation. Let's keep in mind #SafeAI & #ResponsibleAI goals can controversly have a #positiveimpact on #AIResearch #AITechnologies #Development. #TrustworthyAI #EthicalAI #ExplainableAI #VerifiableAI #AccountableAI

💡 Deeply Grateful for an Eye-Opening Discussion on AI in Regulatory Affairs! Thrilled to have participated in the Regulatory Affairs Professionals Society (RAPS) Webcast, sponsored by RegDesk, titled "Transforming Regulatory Compliance with Artificial Intelligence." Huge thanks to RAPS for the completion certificate! The panel discussion was truly exceptional, thanks in no small part to the incredible lineup of experts: Elizabeth (Liz) Haines (Professor, Northeastern University), Ann Vu, JD, RAC (SVP Quality, Regulatory & Clinical, ZimVie, Inc.), Donald Ellis (VP, Global Regulatory Affairs, Reva Medical), and Priya Paul (Bhutani)(Founder & CEO, RegDesk.co). Their insights were invaluable, we delved into the booming world of AI in regulatory compliance, exploring: -Current challenges and emerging trends in regulatory affairs. -Market analysis of AI in the regulatory landscape. -Strategies for biotech companies to budget for AI tools. -The potential of AI for the regulatory affairs market. -Practical tips on navigating the use of AI in compliance. This session was a treasure trove of knowledge for anyone involved in regulatory affairs! #regulatoryaffairs #AI #compliance #RAPS #RegDesk #webcast #artificialintelligence #biotech #marketanalysis #futureofcompliance