Bu bölümde, Çin'in Ulusal Tıbbi Ürünler İdaresi'nin (NMPA) 1 Kasım 2026'da yürürlüğe girecek olan revize edilmiş İyi Üretim Uygulamaları (GMP) yönetmeliğini ele alıyoruz. 2014'ten bu yana yapılan bu ilk büyük güncellemenin, kalite güvencesi, risk yönetimi ve fason üretim denetimi gibi alanlarda getirdiği sıkılaştırılmış gereklilikleri inceliyoruz. Üreticilerin bu kritik son tarihe kadar uyum sağlamak için atması gereken pratik adımları ve NMPA'nın artan denetimlerinin yabancı firmalar için ne anlama

Kinas NMPA har reviderat sin Goda Tillverkningssed (GMP) för medicintekniska produkter, med ett obligatoriskt efterlevnadsdatum den 1 november 2026. Detta avsnitt täcker de viktigaste förändringarna, inklusive striktare regler för kvalitetssäkring, riskhantering och kontraktstillverkning. Vi diskuterar konsekvenserna av NMPA:s ökade tillsyn och ger praktiska steg för tillverkare för att förbereda sig inför tidsfristen.Key Questions: - Vilka är de största förändringarna i Kinas nya GMP-förordning

A Administração Nacional de Produtos Médicos (NMPA) da China está a implementar uma revisão abrangente das suas Boas Práticas de Fabricação (GMP) para dispositivos médicos, com um prazo de conformidade obrigatório até 1 de novembro de 2026. Esta atualização, a primeira desde 2014, introduz requisitos mais rigorosos para os sistemas de gestão da qualidade, com um foco acrescido na gestão de riscos, garantia de qualidade e na responsabilização dos fabricantes contratados. Este episódio detalha as

Cet épisode détaille les changements critiques apportés par la révision des Bonnes Pratiques de Fabrication (BPF ou GMP) pour les dispositifs médicaux de la NMPA en Chine, qui entrera en vigueur le 1er novembre 2026. Nous analysons les nouvelles exigences plus strictes en matière de système de management de la qualité (SMQ), de gestion des risques tout au long du cycle de vie et de fabrication sous contrat. Découvrez les mesures que les fabricants étrangers doivent prendre pour garantir leur

इस एपिसोड में, हम चीन के NMPA द्वारा चिकित्सा उपकरणों के लिए संशोधित अच्छे विनिर्माण अभ्यास (GMP) पर चर्चा करते हैं, जो 1 नवंबर, 2026 से लागू होगा। हम 2014 के बाद से इस पहले बड़े अपडेट में प्रमुख परिवर्तनों का विश्लेषण करते हैं, जिसमें गुणवत्ता आश्वासन, उत्पाद जीवनचक्र जोखिम प्रबंधन, और अनुबंध निर्माण के लिए सख्त आवश्यकताएं शामिल हैं। हम यह भी बताते हैं कि ये नियम विदेशी निर्माताओं को कैसे प्रभावित करेंगे और अनुपालन सुनिश्चित करने के लिए व्यावहारिक कदम क्या हैं।मुख्य प्रश्न: - चीन का नया NMPA GMP

Cục Quản lý Sản phẩm Y tế Quốc gia (NMPA) của Trung Quốc sẽ thực thi Quy phạm Quản lý Sản xuất (GMP) sửa đổi cho trang thiết bị y tế vào ngày 1 tháng 11 năm 2026. Tập này trình bày chi tiết các thay đổi quan trọng trong đảm bảo chất lượng, quản lý rủi ro và giám sát sản xuất theo hợp đồng. Chúng tôi thảo luận về tác động của những cập nhật này đối với các nhà sản xuất nước ngoài và cung cấp các bước hành động để chuẩn bị cho thời hạn và tránh các vấn đề tuân thủ.Key Questions: - Những thay đổi

Национальное управление по медицинским продуктам Китая (NMPA) вводит в действие пересмотренное Положение о надлежащей производственной практике (GMP) для медицинских изделий с 1 ноября 2026 года. Это первое крупное обновление с 2014 года, которое вводит более строгие требования к управлению качеством, управлению рисками, контролю над контрактным производством и поставщиками. В этом выпуске мы обсуждаем ключевые изменения, их влияние на иностранных производителей и практические шаги для обеспечения

Episode ini membahas revisi Good Manufacturing Practice (GMP) dari NMPA Tiongkok untuk perangkat medis, yang akan berlaku wajib mulai 1 November 2026. Kami menguraikan perubahan penting terkait sistem manajemen mutu, manajemen risiko, dan manufaktur kontrak ('entrusted production'). Kami juga membahas bagaimana tindakan penegakan NMPA yang semakin ketat memengaruhi produsen asing dan memberikan langkah-langkah praktis yang dapat ditindaklanjuti oleh tim untuk mempersiapkan diri menghadapi tenggat

Ist es normal, mich selbst intensiv zu riechen? Wie riechen mich andere? In dieser Folge sprechen wir über das olfaktorische Referenzsyndrom und darüber, warum diese Diagnose eine ganz besondere ist. Nach einer kurzen Einführung inklusive musikalischer Bezugnahme diskutieren wir, warum es diese Diagnose neu im ICD-11 gibt, wie diese eher unscheinbare Erkrankung Leiden verursachen kann und ordnen zugehörige Literatur ein. Außerdem sprechen wir über unsere Sichtweise aus der Praxis, kulturelle

We were delighted to be joined by Johanna Kaufmann, Chief Scientific Officer at Deck Bio.Johanna has spent her career at the intersection of oncology, immunology and drug development, working across both biotech and big pharma. She started her career in cancer virology before moving through roles at Genocea, TESARO and GSK, and later joined Codagenix, where she led its oncology and immunology efforts.Today, as CSO at Deck Bio, she’s helping to advance a new approach to targeting solid tumours

What happens when a veterinary publisher, a vet and a vet nurse/podcaster sit down with a beer? Mike Brampton and Julian Hoad welcome Chris Ritchie – editor, publisher and accidental founder of "the old manosphere" – to Veterinary Ramblings.In Part 1 we cover:- Chris taking over Vet Surgeon and Vet Nurse and the future of veterinary publishing- Print vs digital – are vets still reading journals cover to cover?- The Veterinary Edge and Pet & Vet magazines- Why Tesco's straight croissants

Fascinacion por las Plantas - 268 - Lechugas fileteadas

In this episode of Stuff to Blow Your Mind, Robert chats with author, artist and educator Geo Rutherford about her new book “Spooky Rivers: 25 Strange and Mysterious Rivers that Snake Across Our Planet.”See omnystudio.com/listener for privacy information.

Planetterrian Daily🌍 Planetterrian Daily - Science, Longevity & Health Discoveries A collar-mounted sensor now records the exact particle levels wildlife breathe during wildfire smoke events. Top 15 Science & Health Discoveries Collar sensor tracks wildfire smoke exposure in animals — Phys.org Colorado State University researchers developed an open-source smoke logger that attaches to animal collars and records hazardous particle concentrations. ... Sources: phys.org · sciencedaily.com ·

«Залишаюсь заради дітей» звучить як подвиг. А чи перевіряв хтось, що діти насправді отримують від такого дому?Двоє ведучих сперечаються без компромісів. Одна сторона тримається за дані: у великому лонгітюдному дослідженні діти з низькоконфліктних шлюбів тяжче переживали розлучення. Друга показує діру в цих даних: «низький конфлікт» складають і щасливі пари, і ті, де давно нічого не відчувають. Про тихо мертві домівки наука майже мовчить.Після цього «лишаюсь заради них» перестає бути аргументом і

A lot of us think of quitting as a path to failure. Michael speaks with Lindsay Crouse, the former New York Times writer, editor and producer, lifelong distance runner and author of The Case for Quitting, about when perseverance backfires, how to tell meaningful suffering from the pointless kind, and the signs it's time to walk away. They discuss:(00:00) Cold open(00:54) Good sisu and bad sisu(06:30) The Olympic Trials goal she missed(13:12) When perseverance backfires(20:54) Where quitting pays

In this episode of Denatured, you’ll hear from Jennifer McMahon, partner at Seroba and Joey Mason, venture partner at Claret Capital. We dig into how venture debt buys time when equity can’t — and how Europe’s funding gaps, tranching habits and slower urgency shape who uses it well.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsJennifer McMahon, Partner, SerobaJoey Mason, Venture Partner, Claret CapitalDisclaimer: The views expressed in this discussion by guests are their own and

Sollten Kinder und Jugendliche weniger Zeit mit Smartphones und Social Media verbringen oder braucht es dafür sogar klare Regeln, Altersgrenzen oder Verbote? In der ersten Live-Ausgabe der Digital Health Talks sprechen Rasmus Cloes, Prof. Dr. Louisa Kulke und Tobias Windbrake darüber, wie digitale Medien auf Kinder und Jugendliche wirken.Es geht um Handyverbote an Schulen, Altersgrenzen für Social Media, Beispiele aus anderen Ländern und um die Frage, wer eigentlich Verantwortung trägt: Eltern,

👉 Quer receber os áudios todos os dias no seu WhatsApp? https://vedanta.com.br/podcast 🎓 Cursos Gratuitos e Turmas Regulares: https://vedanta.com.br/

Pfizer's Tukysa (tucatinib) wins a breast cancer maintenance approval after delaying progression, while MimiVax's SurVaxM misses its overall glioblastoma survival goal despite a younger-patient signal. Halozyme reports an injunction against subcutaneous Keytruda (pembrolizumab) in eight European markets; Caribou said yesterday it plans to halt its two donor CAR-T programs amid financing pressure. Cerevance's investigational solengepras cuts Parkinson's off time by 37 minutes a day beyond placebo