Jan Vindberg-Larsen

Registration processes require strong regulatory expertise and close collaboration with authorities. It’s rewarding to help clients navigate this smoothly here in the Nordics.

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I joined the Regulatory Affairs network at Medicon Village today for an inspiring talk about the pan-European electronic Product Information (ePI) initiative. The ePI initiative is an effort by the European Union to create a digital, structured, and harmonized format for medicine product information, replacing traditional paper leaflets. Still in pilot stage, but this will be the future, and we are staying tuned for more updates. #LifeScience #RegulatoryAffairs #Consulting #ElectronicLabelling

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On 16 September, I had the privilege and pleasure of hearing Thomas Noe Vestergaard Pedersen, Team Manager and Medicines Inspector at the Danish Medicines Agency speak about Inspection Management. Thomas also generously answered many and varied questions from the large audience at IFF, Copenhagen. Thereafter, we took the discussion to tech transfer and methods transfer at CDMO's as well as how to best ensure your CMO is ready for inspection. With FDA's radical transparency and the release of the CRL's it is clear that many companies are finding their NDA / BLA approvals running into trouble because of open 483's at the contractor. FDA's response is clear "it may not involve your product... but we expect YOU to work with your CMO to resolve the issues." So, next time your contractor tells you "it doesn't involve your product" or "we are handling it" pull up one of the letters and show them you need details, timelines and closure. Looking forward to next year at IFF and more calming walks on the beautiful lake.

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🧑‍⚕️Patient centricity is NOT posters of patients in the hallway ! I am proud to have attended Novo Nordisk international meeting where our CEO emphasised the importance of knowing the people we serve. 👉Develop the products patients want ! - not what we think they need. As a patient myself its 🎵 music to my ears - and I know that co-creating with patients and getting our true input, means : 🌻better patient compliance 🌻higher recruitment rates in studies 🌻strong real world data 🌻better service to customers And much more …… Thank you Maziar Mike Doustdar for having focus on this #patientvoice #patientengagement #nothingaboutuswithoutus #IM2026

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Recently, someone told me: “Quality and Compliance are expenses to company because they are not commercial drivers” It’s a common perception. Quality reviews, investigations, CAPAs, audits, documentation, training. None of these appear directly on a revenue line. But in regulated industries, revenue exists only because quality and compliance exists. Without strong quality systems: • Products cannot enter regulated markets • Manufacturing can be halted after inspections • Warning letters and import alerts can stop business overnight • Recurring deviations can disrupt operations Quality and Compliance may not generate revenue directly. But they protect revenue, enable market access, and safeguard the organization’s reputation. A well functioning quality system doesn’t slow business. It prevents costly disruptions, reduces repeat issues, and builds confidence with regulators and customers. So the real question is not whether Quality and Compliance generate revenue. The real question is: How much revenue is at risk without them? #Quality #Compliance #GxP #Pharma #QualitySystems #InspectionReadiness #Investigations

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𝗔𝗧𝗠𝗣 - 𝗴𝗿𝗲𝗮𝘁 𝘀𝗰𝗶𝗲𝗻𝗰𝗲 𝗮𝗻𝗱 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻, 𝘁𝗮𝗸𝗶𝗻𝗴 𝗿𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝘁𝗼 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 𝗮𝗻𝗱 𝗺𝗮𝗿𝗸𝗲𝘁, 𝗰𝗼𝗺𝗽𝗲𝘁𝗲𝗻𝗰𝗲 𝗮𝗻𝗱 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲 𝘀𝗵𝗮𝗿𝗶𝗻𝗴 These were some of the key themes discussed at the Medicon Valley R&D network event yesterday. A big thank you to Katrine Brems Olsen and Medicon Valley Alliance for the kind invitation and for organizing such a well-run and inspiring event! I really appreciated the mix of presentations, panel discussion, and the opportunity for some excellent networking. In my talk, representing GBA Key2Compliance, I focused on the importance of 𝗯𝘂𝗶𝗹𝗱𝗶𝗻𝗴 𝗮𝗻𝗱 𝗺𝗮𝗶𝗻𝘁𝗮𝗶𝗻𝗶𝗻𝗴 𝗰𝗼𝗺𝗽𝗲𝘁𝗲𝗻𝗰𝗲 𝘄𝗶𝘁𝗵𝗶𝗻 𝗮𝗻 𝗼𝗿𝗴𝗮𝗻𝗶𝘇𝗮𝘁𝗶𝗼𝗻 — not just to ensure regulatory compliance, but to consistently deliver 𝘀𝗮𝗳𝗲, 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁, 𝗮𝗻𝗱 𝗵𝗶𝗴𝗵-𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝗧𝗠𝗣𝘀. Competence is also critical to advancing products through development stages and ultimately getting them to market — and to patients. 𝗠𝘆 𝗸𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀? There’s a lot of exciting work happening in the Copenhagen–Lund region: collaborations and initiatives, new GMP and pre-GMP facilities, strong education programs, the work of ATMP Denmark, as well as organizations and companies that are pushing the field forward. 𝗕𝘂𝘁 𝗹𝗲𝘁’𝘀 𝗻𝗼𝘁 𝘀𝘁𝗼𝗽 𝘁𝗵𝗲𝗿𝗲. To truly accelerate ATMP development, we should broaden the conversation and collaboration to include the entire Nordic region. There’s so much potential in connecting expertise, infrastructure, and initiatives across borders and regions! https://lnkd.in/p/ds9WHNyb

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Competence isn’t a box to tick—it’s a leadership choice. Couple of months ago I sat in an investigation governance meeting with potential multi-batch, multi-site impact. We needed a strong lead investigator. The assigned investigator stepped up: “I’ve led complex cases and closed them successfully.” Then a senior leader publicly questioned her expertise. Moments like this define culture. Are we empowering our people or shrinking their confidence? Our job is to make sure the right people are in the right roles, with the right support, before the pressure hits. Here’s the standard I hold: • Back your people in the room. Coach in private. • Confirm competence upfront. Role-based training, SME depth, recent practice. • If gaps exist, act fast. Provide a mentor, time, access, and clear authority. • If the fit is wrong, reassign with dignity. Protect the person and the investigation. • Remove roadblocks. Scope creep, data access, decision latency—fix them. • Document the rationale. Accountability builds trust and speed. Quality NexGen starts with leadership: assign a clear owner, equip them, and remove friction so RCA and CAPA land once—effectively. Back your people in the room. Coach in private. That’s how you get truth, speed, and a culture that speaks up before issues scale. In Quality, this isn’t about pride. It’s about product release, patient safety, and inspection risk. Work done without the needed competence can cost you a Form 483—and your credibility. #Leadership #QualityNexGen #GMP #InvestigationExcellence #CultureOfQuality #InspectionReadiness #RightFirstTime

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