Post by Martin King

Regulatory Affairs & Quality Assurance Expert | QA/RA Business Enabler | Medical Device, In Vitro Diagnostics, Combination Product | Navigating FDA, IVDR, MDR, PRRC | ISO Lead Auditor | [email protected]

๐Ÿ“Œ๐—ง๐—ต๐—ฒ ๐—ต๐—ถ๐—ด๐—ต๐—น๐—ถ๐—ด๐—ต๐˜๐˜€ ๐—ผ๐—ณ ๐—ค๐—”/๐—ฅ๐—” ๐—จ๐—ฝ๐—ฑ๐—ฎ๐˜๐—ฒ๐˜€ ๐Ÿญ๐Ÿฐ. ๐—๐˜‚๐—น๐˜† ๐Ÿฎ๐Ÿฌ๐Ÿฎ๐Ÿฒ ๐—ค๐˜‚๐—ฎ๐—น๐—ถ๐˜๐˜† ๐—”๐˜€๐˜€๐˜‚๐—ฟ๐—ฎ๐—ป๐—ฐ๐—ฒ & ๐—ฅ๐—ฒ๐—ด๐˜‚๐—น๐—ฎ๐˜๐—ผ๐—ฟ๐˜† ๐—”๐—ณ๐—ณ๐—ฎ๐—ถ๐—ฟ๐˜€ Click on the ๐Ÿ”—to access the content. try the Microsoft Copilot ๐Ÿ”— ๐˜”๐˜บ ๐˜ข๐˜ฑ๐˜ฐ๐˜ญ๐˜ฐ๐˜จ๐˜ช๐˜ฆ๐˜ด, ๐˜ฅ๐˜ถ๐˜ฆ ๐˜ต๐˜ฐ ๐˜ช๐˜ฏ๐˜ต๐˜ฆ๐˜ณ๐˜ฏ๐˜ข๐˜ต๐˜ช๐˜ฐ๐˜ฏ๐˜ข๐˜ญ ๐˜ต๐˜ณ๐˜ข๐˜ท๐˜ฆ๐˜ญ ๐˜ ๐˜ธ๐˜ช๐˜ญ๐˜ญ ๐˜ฃ๐˜ฆ ๐˜ญ๐˜ข๐˜ต๐˜ฆ ๐˜ธ๐˜ช๐˜ต๐˜ฉ ๐˜ฑ๐˜ฐ๐˜ด๐˜ต๐˜ด ๐˜ต๐˜ฉ๐˜ณ๐˜ฐ๐˜ถ๐˜จ๐˜ฉ 23. ๐˜‘๐˜ถ๐˜ญ๐˜บ 2026. ๐Ÿ‘‡ ย ๐˜พ๐™ก๐™ž๐™˜๐™  ๐™ค๐™ฃ ๐™ฉ๐™๐™š ๐™–๐™ง๐™ฉ๐™ž๐™˜๐™ก๐™š ๐™ฉ๐™ค ๐™ก๐™š๐™–๐™ง๐™ฃ ๐™ข๐™ค๐™ง๐™š. ๐—ฆ๐˜‚๐—บ๐—บ๐—ฎ๐—ฟ๐˜† ๐—ณ๐—ผ๐—ฟ ๐Ÿญ๐Ÿฐ. ๐—๐˜‚๐—น๐˜† ๐Ÿฎ๐Ÿฌ๐Ÿฎ๐Ÿฒ ๐—ค๐˜‚๐—ฎ๐—น๐—ถ๐˜๐˜† ๐—”๐˜€๐˜€๐˜‚๐—ฟ๐—ฎ๐—ป๐—ฐ๐—ฒ & ๐—ฅ๐—ฒ๐—ด๐˜‚๐—น๐—ฎ๐˜๐—ผ๐—ฟ๐˜† ๐—”๐—ณ๐—ณ๐—ฎ๐—ถ๐—ฟ๐˜€ ๐Ÿ”ธDepartment of Health and Social Care: SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) Annual Report 2024 to 2025 ๐Ÿ”ธEuropean Medicines Agency: Guidance for Applicants for the Preparation of the Precise Scope Section of the Variation Application Form ๐Ÿ”ธEuropean Union Agency for Cybersecurity (ENISA): Where do SMEs stand in preparing for the Cyber Resilience Act? ๐Ÿ”ธFDA: FDA Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs ๐Ÿ”ธFDA: FDA Topical Dermatologic Corticosteroids: In Vivo Bioequivalence ๐Ÿ”ธFDA: FDA Psychedelic Drugs: Considerations for Clinical Investigations ๐Ÿ”ธWorld Health Organization: WHO and Global Regulators Advance Shared Roadmap for Greener Pharmaceuticals ๐Ÿ”ธBARBARA PIROLA: THE FIRST LAW OF PRIOR KNOWLEDGE If an Organization Cannot Reuse What It Already Knows. ๐Ÿ”ธBARBARA PIROLA: The Hidden Gap Between Knowledge Management and Quality Management. ๐Ÿ”ธBARBARA PIROLA: PRIOR KNOWLEDGE AI, Digitalization and Pharmaceutical Quality Knowledge Management (PQKM) ๐Ÿ”ธ@Christine Lee: The CAPA Quality Improvement Toolkit ๐Ÿ”ธConner Harman: Morning everyone, looking forward to Episode 10 of Regulatory Voices, where I am joined by Bhargavi Patel, Head of Regulatory Affairs at Galderma Immunology. ๐Ÿ”ธEunice Baker White: Bridging EU MDR and FDA QMSR: A Unified Approach to Post-Market Surveillance ๐Ÿ”ธFayeque Peerzade: The Good Practice Show: FDA's Elsa did not lie. ๐Ÿ”ธHadi Danawi, PhD, MPH ุฏ. ู‡ุงุฏูŠ ุถู†ุงูˆูŠ: Happy Monday-July 13 & 14, 2026. You can follow MENASA Group on LinkedIn for the latest daily pharma/clinical trials news updates. ๐Ÿ”ธLeonard (Leo) Eisner: IEC 60601-1, edition 3.2 today is ~500 pages. ๐Ÿ”ธLeonard (Leo) Eisner: The IEC 60601-1, 4th edition timeline was just revised, and here is the updated ETA. ๐Ÿ”ธMario Gabrielli Cossellu: Fees of Notified Bodies EU MDR, IVDR ๐Ÿ”ธPaula Andrea Pirson: LATAM: Registro de Medicamentos ๐Ÿ”ธRabiea ๐Ÿ”ท๏ธ Assoc. Professor: If you're ready to stop wondering how to break into regulatory affairs and actually start your career, now's the time! ๐Ÿ”ธYan Kugel: The flipbook highlights key implementation considerations for Process Analytical Technology ๐—ง๐—ต๐—ฎ๐—ป๐—ธ ๐˜†๐—ผ๐˜‚ ๐Ÿ™ for ๐˜†๐—ผ๐˜‚๐—ฟ time and please ๐—Ÿ๐—ถ๐—ธ๐—ฒ ๐Ÿ‘, ๐—ฆ๐—ต๐—ฎ๐—ฟ๐—ฒ, and/or ๐—–๐—ผ๐—บ๐—บ๐—ฒ๐—ป๐˜ Compiled with the help of Microsoft Copilot and ChatGPT

Post content